Comments

OPTN Pediatric Transplantation Committee | 03/19/2025

The OPTN Pediatric Transplantation Committee (Pediatric Committee) thanks the OPTN Liver and Intestinal Organ Transplantation Committee for its work on this proposed guidance. There was support for the addition of contrast-enhanced ultrasound (CEUS) as an optional imaging option to provide a pathway to automatic standard HCC exception approval. No specific concerns were raised regarding the incorporation of LIRADS-5 criteria, or otherwise.

Society of Pediatric Liver Transplantation (SPLIT) | 03/19/2025

The Society of Pediatric Liver Transplantation (SPLIT) appreciates the opportunity to comment on the Updates to the NLRB. In regard to contrast enhanced ultrasound (CEUS) we are in support of utilization of this new diagnostic modality. We feel it is beneficial for cost, lack of need for sedation, and lack of radiation. It will be important to ensure CEUS is an optional study but not required as a new modality as not all centers have access to the technology.

To specifically address the question: “Do pediatric practitioners incorporate LIRADS-5 criteria into case management? If not, what system or categories should be used to classify pediatric HCC?” It is the collective opinion of SPLIT that HCC in most pediatric patients are different tumor biology from adults- and thus LIRADS is not as useful for pediatric patients. We often rely more on histopathology. Previous literature has shown that pediatric patients have favorable outcomes when transplanted beyond Milan criteria (PMID: 35267604). Wash-out on imaging is also not the same in certain disease states, such as patients with Fontan physiology.

Lastly, we want to ensure that members of the NRLB are specifically made aware of updates specific to pediatric patients to ensure exception requests are appropriately reviewed.

Alan Gunderson | 03/19/2025

In guidance and policy, portal hypertension consequences like ascites, encephalopathy, and gastrointestinal bleeding do not qualify for MELD exception pionts. Each should contribute to morbidty and clearly some, like encephalopathy, are indepent and significant mortality risk factors. I have been concerned about the continued inclusion of hepatic hydrothorax, another portal hypertension consequence, for exception points to the exclusion of the others. In reviewing this over the course of years on the NLRB, it appears that it's inclusion may prevent some otherwise very reasonable candidates from pursuing TIPS, which in at least some cases may obviate the need for transplant as it does in some patients with ascites and resulting progressive circulatory dysfuction leading to kidney impairments and nutritional deficiencies/sarcopenia.

Please consider removing hepatic hydrothorax as a matter of consistency and fairness, or considering all portal hypertensive consequences for equal exception points under standard criteria.

Region 10 | 03/19/2025

Sentiment: 0 strongly support, 9 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. An attendee highlighted that these changes represent an improvement and are supported as they align with current practices. Another attendee noted that the most significant aspect is the specific exception score recommendations for transplant oncology indications. While there is some inconsistency in the HEHE guidelines—particularly regarding limited extrahepatic disease not being a contraindication—it is understood that the final draft of the HEHE guidance may not have been included in this public comment item. 

Region 6 | 03/19/2025

Sentiment: 2 strongly support, 11 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

Vanderbilt Transplant Center | 03/19/2025

On behalf of Vanderbilt Transplant Center, we appreciate the opportunity to provide feedback on this proposal. In general, we agree with the proposed changes to update the adult MELD exception review and adult transplant oncology guidance documents and develop score recommendations for certain diagnoses. However, we would like to see additional diagnoses included, specifically ongoing biliary issues including recurrent biliary drain exchanges or recurrent biliary infections. We also agree with adding contrast-enhanced ultrasound (CEUS) as an additional imaging option for automatic standard HCC exception approval.

Hospital of the University of Pennsylvania | 03/18/2025

We appreciate the OPTN’s ongoing efforts in updating guidelines and policies for the benefit of patients in need of liver transplantation. We agree in broad terms with the proposed modifications, particularly facilitating access to transplantation for PSC patients with refractory severe infectious complications, and for alignment with LIRADS in introducing CEUS as an adjunct modality in assessing HCC. In it's current state, our key recommendations of content to address include:

1. The guidance document needs to have a list of diagnoses that or at least examples of metabolic diseases that can be considered for exception scores. In addition to traditional mitochondrial ones that we can all agree on, there are a host of other inborn genetic errors that might not be considered traditional metabolic disorders. For example - hypercoagulation disorders, or different types of amyloid.

2. The language around HEH describing the proposal and evidence cited are contradictory. The proposal excludes extrahepatic disease, but yet the committee cites evidence that extrahepatic disease results in good survival. Traditionally extrahepatic disease (pulmonary mets) has not been a contradiction to transplant. The committee needs to review this and clarify the language.

3. The addition of contrast ultrasound for LI-RADS is confusing and needs clarification. Is this a substitute for MRI or CT? Are MRI and CT still required? If so, do they have to be repeated, or is contrast ultrasound able to replace repeat CT and MRI's


We propose the following adjustments / clarifications:

- Refractory hydrothorax patients who are ineligible to TIPS are extremely difficult to manage. In addition to the morbidity of frequent thoracenteses, they have a documented increased mortality not accounted for by MELD. We propose considering, in addition to allocating MMaT-3 at baseline, upgrading to MMaT if criteria for exception points continue to be met for 3 months at the second exception review.

- Criteria for CEUS benefit from clarity to explain that CEUS is used to provide a diagnostic assessment of individual lesions but should not replace a contrast enhanced CT or contrast enhanced MR, since, unlike cross sectional imaging, it is not a modality that is used for staging HCC.

- We agree with initiatives that encourage the use of alternative curative therapies for HCC when feasible. We believe this goal has a loophole that should be closed: currently a treated T1 recurrence after T1 ablation or resection would result in no exception points. Since in effect this results in having to wait on a diagnosed HCC (by LIRADS criteria) to grow to 2 cm when multifocal disease is documented, it unnecessarily delays care, and may even discourage definitive treatment for the original T1 lesion until it increases in size to 2 cm. We believe T1 recurrence after attempted cure of a T1 lesion should be allocated MMaT-3 as multifocal disease is not curable by alternative modalities, regardless of lesion size. This would be similar to T2 recurrence after T1 ablation/resection or T1 recurrence after T2 ablation/resection.

- We applaud the inclusion of guidelines that allow access to transplant for select patients with metastatic colorectal cancer (CRC), as supported by the literature. We are concerned however by the allocation of MMaT-20 for two reasons:

1. The way the exception point allocation is designed always results in MELD 15, which makes it only nominally related to MMaT. In fact, this is the only exception point allocation recommended by OPTN that is unrelated to MMaT. This defeats the purpose of equal access to transplantation in different regions intended by the use of MMaT as the standard for exception point allocation.

2. By allocating a relatively low number of exception points to CRC pts, we risk the utilization of lower quality organs in this patient population, thereby attenuating the benefits to transplantation described in the literature.
While we agree with the need for more data to better allocate exception points in this patient population, allocating MMaT-6 for example would be truly related to MMaT on one hand, and would reduce the risk of using lower quality organs for CRC patients on the other hand.

Region 9 | 03/18/2025

Sentiment:  0 strongly support, 6 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose 

Region 11 | 03/18/2025

Sentiment: 5 strongly support, 12 support, 7 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: Region 11 supports this proposal. One member explained that contrast enhanced ultrasound is not performed nationally and radiologists differ on whether it provides enough granularity for diagnosis.

Alpha-1 Foundation | 03/18/2025

Public Comment Submission on OPTN Winter 2025 Proposals

The Alpha-1 Foundation appreciates the opportunity to provide feedback on the Organ Procurement and Transplantation Network (OPTN) Winter 2025 public comment proposals. As an organization dedicated to advocating for patients with Alpha-1 Antitrypsin Deficiency (Alpha-1), we represent individuals who frequently require lung and liver transplants due to progressive chronic obstructive pulmonary disease (COPD), emphysema, and liver cirrhosis.

The Alpha-1 Foundation strongly supports efforts to improve the transparency, efficiency, and fairness of the organ allocation system. We appreciate the opportunity to provide input on these critical issues and look forward to continued collaboration with OPTN to ensure the best possible outcomes for Alpha-1 patients.

Updates to National Liver Review Board Guidance and Further Alignment with LI-RADS (Liver & Intestinal Organ Transplantation Committee) The Alpha-1 community is deeply impacted by liver transplantation policies due to Alpha-1-related liver disease. We support efforts to align liver allocation guidelines with the Liver Imaging Reporting and Data System (LI-RADS) and recommend:

•Clearer guidance on LI-RADS scoring for Alpha-1 patients, as liver disease in this population presents differently than viral hepatitis-related cirrhosis.

•Priority consideration for Alpha-1 patients with rapidly progressing liver disease to ensure they are not disadvantaged in the allocation process.

The Alpha-1 Foundation appreciates the opportunity to engage in this process and will continue to advocate for policies that improve transplant outcomes for our community.

Region 8 | 03/18/2025

Sentiment: 1 strongly support, 11 support, 0 neutral/abstain, 2 oppose, 0 strongly oppose 

University of Arkansas | 03/18/2025

Our center supports this proposal, and the efforts made to provide high-quality uniform care for transplant patients. We believe that this proposal improves communication among the transplant community and allows for a standardized review process.

NATCO | 03/17/2025

NATCO appreciates the opportunity that the OPTN Liver and Intestinal Organ Transplantation Committee has provided to review their Updates to National Liver Review Board (NLRB) Guidance and Further Alignment with LI-RADS proposal. We would like to provide the following feedback:
The addition of contrast-enhanced ultrasound (CEUS) is a welcomed additional diagnostic tool in for HCC diagnosis. CEUS has demonstrated value in its real-time and radiation-free nature, both of which are beneficial to enhanced patient care and, therefore outcomes.
NATCO also supports the efforts put forth to provide exception score recommendations. These guidelines will allow for uniformity within the NLRB as well as transplant centers across the country. The objectivity of these efforts is also appreciated for its intended efficiency and equity.

American Society of Transplant Surgeons | 03/17/2025

Attachment.

View attachment from American Society of Transplant Surgeons

Region 1 | 03/17/2025

Sentiment:  3 strongly support, 3 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

This was not discussed during the meeting, but attendees were able to submit comments. A member expressed strong support for updating this policy to include contrast-enhanced ultrasound (CEUS) as an imaging modality for HCC diagnosis.  A member shared support for the proposed updates, along with several recommendations for improvements. The references provided by the committee support acceptable post-transplant survival for patients with vascular invasion and extrahepatic tumor, but the member disagrees with these limitations to exception point access. They do not find it useful to include a negative staging laparotomy at the time of transplant as a criterion for exception points. The member supports broadening access to exception points for patients with sclerosing cholangitis and requests clarification from the committee regarding what qualifies as a history of resistant organisms, specifically whether infection history is required, as opposed to mere colonization. 

Melanie Caserta | 03/16/2025

I am in strong support of the proposed OPTN modifications with updates to NLRB and alignment with LIRADS. I am in agreement with the ACR LIRADS steering committee that modifications should be made to the role of CEUS. As a radiologist with 9 years of experience performing contrast enhanced US exams, CEUS should be considered an independent diagnostic tool for the diagnosis of HCC and not an adjunct tool (see points 1,2,3 of the ACR LIRADS letter on the comments page).

Sincerely,

Melanie Caserta, MD

Region 2 | 03/14/2025

Sentiment: 2 strongly support, 11 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose 

Comments: This was not discussed during the meeting, but attendees were able to submit comments with their sentiment.  One attendee noted their support for alignment with liver imaging reporting data systems. 

American Society of Transplantation | 03/13/2025

The American Society of Transplantation (AST) generally supports the proposal, “Updates to National Liver Review Board Guidance (NLRB) & Further Alignment with Liver Imaging Reporting and Data System (LI-RADS®).”

Regarding the proposed policy revisions for diffuse ischemic cholangiopathy and late vascular complications, it is important that all patients who develop late ischemic cholangiopathy are eligible for an exception, even if a discernable risk factor cannot be specifically identified. Aside from late vascular complications or DCD liver allograft, an unrecognized injury to an accessory right hepatic artery during procurement may result in biliary ischemia. Additionally, in some cases, a single identifiable risk factor for ischemic cholangiopathy may not be defined.

The AST has concerns with the recommendation to reduce pleural fluid documentation from two instances to one for both negative culture and benign cytology as it pertains to hepatic hydrothorax. The sensitivity of pleural cytology is approximately 60% and thus it is good practice to assess it on two separate thoracentesis. Further, patients who will benefit from this policy have refractory hepatic hydrothorax and would have undergone no less than 4-6 thoracentesis, as the document well establishes. Thus, it is unclear how this change will benefit patients, and it increases the risk of undiagnosed malignancy. The AST does support eliminating TIPS as a requirement, and adherence to MMAT-3.

To better facilitate the NLRB’s review of hereditary hemorrhagic telangiectasia (HHT) exception requests, the AST suggests that the guidance document also specify how high output cardiac failure and “severe” ongoing complications of heart failure will be defined. Ambiguity around these factors will make it difficult for NLRB members to assess these HHT MELD exception requests. The AST is supportive of the recommended MMAT-3 for HHT, and MMAT for more severe cases with associated higher mortality.

Finally, although the OPTN has requested feedback about how this proposal would facilitate discussion of exception priority between medical providers and patients or patients’ families, there is no explicit guidance in the policy text nor in the implementation considerations about provider-patient communication. We suggest that the OPTN consider adding recommendations or resources to support truthful, transparent, and trustworthy communication about exception priority as a part of future implementation guidance for this policy. For example, the OPTN could provide suggested language for providers or educational materials suitable for both providers and patients to facilitate these discussions.

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/13/2025

This proposal is not pertinent to ASHI or its members.

American College of Radiology LI-RADS Steering Committee | 03/12/2025

Dear National Liver Review Board,

The LI-RADS Steering Committee is pleased to express our strong support for the proposed OPTN policy modifications outlined in “Updates to National Liver Review Board Guidance (NLRB) & Further Alignment with Liver Imaging Reporting and Data System (LI-RADS®).”

We commend this forward-thinking initiative that further aligns OPTN policy with LI-RADS and formally recognizes LI-RADS categorization contrast-enhanced ultrasound (CEUS) as an imaging modality for hepatocellular carcinoma (HCC) evaluation, and incorporates it in a pathway for automatic standard HCC exception approval under Policy 9.5.I.

Our committee recognizes the robust capabilities of CEUS as an independent diagnostic tool, with clinical evidence demonstrating its diagnostic accuracy is comparable to that of CT and MRI. CEUS offers real-time, radiation-free imaging that is invaluable for the precise characterization of liver lesions—especially in cases where CT or MRI results remain indeterminate. This independent capability not only enhances patient safety but also streamlines diagnostic workflows, ensuring optimal clinical management.

In support of these advancements, we respectfully submit the following changes for your consideration:

1. Table 9-9 Clarify that CEUS is an acceptable independent diagnostic tool for standard HCC exception, rather than an adjunct to CT or MRI, as per current LI-RADS guidelines.

2. Highlight that LI-RADS 5 categorization can be determined by “CT, MRI or CEUS” rather than “CT or MRI with or without CEUS.”

3. Consider removing the requirement that CEUS be performed within 90 days of CT/MRI. This change would alleviate complications in patient management when CEUS is performed before CT/MRI—for example, to categorize a focal liver lesion detected on screening ultrasound examinations.

4. Consider removing the requirement for lesion size measurements on late arterial or portal phase images and instead refer to LI-RADS Technical Recommendations for appropriate lesion measurement guidelines.

5. Policy 9.5.I.i. 2. Consider replacing the current language “An evaluation that the lesions meet Class 5 criteria according to Table 9-9 using a dynamic multiphase contrast-enhanced computed tomography (CT) or (MRI)” with the following: “An evaluation that the lesions meet Class 5 criteria according to Table 9-9 using a dynamic multiphase contrast-enhanced computed tomography (CT) or (MRI) or contrast-enhanced ultrasound (CEUS).”

We believe that these modifications will modernize liver imaging practices, enhance diagnostic precision, and ultimately improve patient outcomes by ensuring that each imaging modality is utilized to its full independent potential. Recognizing CEUS as a stand-alone diagnostic option reinforces its proven value in clinical practice and supports a more streamlined, evidence-based approach to HCC evaluation.

Thank you for considering our recommendations. The LI-RADS Steering Committee remains committed to supporting innovations that enhance the precision and reliability of liver imaging, and we stand ready to collaborate further on these important advancements.

Sincerely,

Chairs, LI-RADS Steering Committee:

Dr. Kathryn J Fowler MD, FSAR FACR
Dr. Victoria Chernyak MD MS, FSAR FESGAR FSABI FACR

View attachment from American College of Radiology LI-RADS Steering Committee

Anonymous | 03/12/2025

I agree with this change

Amir H | 03/11/2025

I have family I agree with this change

Region 4 | 03/11/2025

Sentiment: 3 strongly support, 6 support, 7 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: None

Society of Radiologists in Ultrasound | 03/10/2025

Letter from the Society of Radiologists in Ultrasound (SRU)

OPTN Liver and Intestinal Organ Transplantation Committee
United Network for Organ Sharing (UNOS)
3100 N. Venetucci Blvd.
Kansas City, MO 64117

Subject: Endorsement of Policy Enhancements to Incorporate CEUS in HCC Evaluation

Dear Committee Members,

The Members of the Board of the Society of Radiologists in Ultrasound (SRU) hereby convey our firm support for the proposed modifications outlined in the OPTN Public Comment Proposal “Updates to National Liver Review Board Guidance (NLRB) & Further Alignment with Liver Imaging Reporting and Data System (LI-RADS®).” We advocate for the integration of contrast-enhanced ultrasound (CEUS) as an adjunct diagnostic modality for hepatocellular carcinoma (HCC) and for establishing a pathway to automatic standard HCC exception approval under Policy 9.5.I.

CEUS represents a pivotal advancement in liver imaging, offering a multitude of technical and clinical advantages, such as real-time imaging, excellent contrast safety profile and operational efficiency. Importantly, it is critical to stress that CEUS is not merely an adjunct to CT or MRI—it is an independent imaging modality for liver lesion categorization. Clinical research supports that CEUS can deliver diagnostic accuracy for lesion characterization comparable to that of CT and MRI.

When conventional CT or MR imaging yields indeterminate results, CEUS offers additional, high-quality diagnostic information that clarifies lesion categorization in up to 40% of patients, thereby guiding appropriate patient management and treatment decisions. Incorporating CEUS into the established imaging framework will not only standardize diagnostic criteria but will also improve patient outcomes by facilitating earlier and more precise detection of HCC.

The SRU is confident that these changes along with incorporation of LI-RADS into OPTN guidelines will foster greater consistency and efficiency in clinical practice and ultimately benefit patients across diverse care settings.

We appreciate your thoughtful consideration of this proposal and stand ready to provide further technical insights if needed.

Sincerely,

Society of Radiologists in Ultrasound
Mark Lockhart, MD, MPH
Nirvikar Dahiya, MD
Helena Gabriel, MD
Anne Kennedy, MB,BCh
Jason Wagner, MD

Society for Pediatric Radiology | 03/06/2025

attachment

View attachment from Society for Pediatric Radiology

Region 7 | 03/04/2025

Sentiment:  1 strongly support, 5 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose 

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. The region was generally supportive of this proposal. One attendee commented: “Outstanding work! The policy is catching up with disease realities. Obviously, the need for this update is that folks with these diseases do not deteriorate in line with other diseases. This proposal will ensure that patients with these diseases, some of which can cause sudden cancers and other issues, are hopefully able to reach transplant before it is too late.”  

Yuko Kono | 03/03/2025

I strongly support updating this policy to include contrast-enhanced ultrasound (CEUS) as an imaging modality for HCC diagnosis. CEUS is a safe and highly accurate option, as demonstrated in a large prospective international multicenter trial (Lyshchik A et al., Hepatology 2024, 79(2): 380-381), which reported a high specificity of CEUS LI-RADS 5 (95.1%). The latest EASL HCC guidelines have also endorsed the use of LI-RADS with CEUS alongside CT and MRI for HCC diagnosis. Additionally, CEUS is safe for patients with chronic or acute kidney disease. Incorporating CEUS into diagnostic protocols can enhance equitable access to transplantation and improve clinical outcomes.

Region 3 | 03/03/2025

Sentiment: 0 strongly support, 10 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

Comments: None

Region 5 | 02/28/2025

Sentiment:  4 strongly support, 20 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose 

Comments: The region supports this proposal and commented that it will help provide uniformity across the organization; improve and streamline communication; and allow for more informed decision making. Another said they support the efforts to make these assessments as objective as possible.

Anonymous | 02/25/2025

I am incredibly excited by and supportive of these updates to OPTN guidance as it relates to harmonizing the criteria for the non-invasive imaging diagnosis of HCC to align with LI-RADS, a system that focuses on high-quality imaging and is itertively updated based on rigorous review of emerging evidence and new technologies and techniques. This includes my strong support for the inclusion of CEUS as a diagnostic pathway to diagnosing HCC for exceptions, a modality that is commonly used at our institution, and available both in inpatient and outpatient settings. This also further aligns with AASLD guidance, such that liver specialists across the care spectrum of chronic liver disease can all leverage the same terminology and techniques, allowing for more consistent and reliable imaging, reporting, diagnosis, and patient care.

Maria Stanczak | 02/22/2025

I strongly support the proposed OPTN policy change that will recognize contrast-enhanced ultrasound (CEUS) as an acceptable diagnostic imaging tool for evaluating hepatocellular carcinoma (HCC), and will align imaging classification criteria to the LI-RADS® terminology.


CEUS is a safe, reliable, real-time, readily-available, radiation-free diagnostic imaging tool. Its sensitivity and specificity are comparable to contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI) in diagnosis of HCC, and it provides decisive information in cases of indeterminate liver lesions. In addition, for patients with renal impairment or contraindications to iodinated or gadolinium-based contrast agents, CEUS may offer the only practical diagnostic imaging option.
The proposed OPTN update will modernize liver imaging practices, align with best practices outlined in multiple international guidance statements, enhance patient safety and access to advanced, reliable imaging, and ultimately improve clinical outcomes.


I appreciate your consideration of this important policy update.

Jaime BOSCH | 02/21/2025

I am excited to see OPTN considering these guidelines. I am strongly supportive of its efforts to align with the American College of Radiology’s CEUS LI-RADS. This represents a relevant step forward for the clinical adoption of liver imaging contarst ultrasound based liver imaging in the United States and recognizes the numerous benefits of CEUS for HCC patients. It is also important for the international community as in many countries we are following the OPTN recommendations and were missing a positive consideration of CEUS, which is a very very useful diagnostic tool.

Jesse Civan | 02/21/2025

As a transplant hepatologist, I enthusiastically support the addition of LI-RADS 5 findings on contrast-enhanced ultrasound as an alternative to LI-RADS 5 findings on MRI and CT to establish a definite radiographic HCC diagnosis for the purpose of HCC MELD exception. I believe this will benefit patient care.

I speak for myself as an individual physician, and do not claim to represent my transplant program or home institution.

International Contrast Ultrasound Society | 02/20/2025

The Board of Directors of the International Contrast Ultrasound Society (ICUS) respectfully submits this letter in response to the OPTN Public Comment Proposal entitled “Updates to National Liver Review Board Guidance (NLRB) & Further Alignment with Liver Imaging Reporting and Data System (LI-RADS®).”

After giving considerable attention to the Proposal, we wish to strongly support the proposed modifications to the Hepatocellular Carcinoma (HCC) policy and guidance, particularly the inclusion of contrast-enhanced ultrasound (CEUS) as an acceptable option for providing a pathway to automatic standard HCC exception approval in Policy 9.5.I, and the alignment of imaging classification criteria to the LI-RADS® terminology.

Background

The International Contrast Ultrasound Society (ICUS) is a non-profit global medical society focused on the safe and appropriate utilization of CEUS where medically indicated, in order to improve patient care and outcomes. Our members bridge the fields of radiology, oncology, hepatology, vascular imaging, cardiology, gastro-intestinal imaging, and other medical subspecialties. Since 2017, ICUS has offered a broad array of CEUS educational programs, including CME-accredited webinars offered live and on demand. Interest in these programs is steadily growing across clinical settings, and hundreds of thousands of learners from the USA, Europe and China have now participated. This growing participation is consistent with indications from our sources that CEUS utilization is likewise expanding across diverse medical settings, including small private clinics as well as advanced academic centers.


Benefits of CEUS in HCC Diagnosis

CEUS offers numerous clinical advantages that make it a valuable imaging modality in the diagnosis and management of HCC:

• Real-Time Dynamic Imaging: CEUS enables dynamic assessment of hepatic lesions in real time. Its ability to capture arterial phase hyperenhancement and subsequent washout patterns is critical for accurate lesion characterization, aligning seamlessly with LI-RADS® criteria.

• Safety Profile: Compared to contrast agents used in computed tomography (CT) and magnetic resonance imaging (MRI), ultrasound contrast agents have a more favorable safety profile, particularly for patients with renal insufficiency or contraindications to iodinated or gadolinium-based contrast agents.

• Cost-Effectiveness and Accessibility: CEUS is widely available, cost-effective, and can often be performed at the bedside. These features facilitate rapid diagnosis, reducing diagnostic delays and expediting the pathway to treatment.

• Enhanced Diagnostic Accuracy: Fully integrated with LI-RADS® terminology, diagnostic and management recommendations, CEUS has demonstrated high sensitivity and specificity for HCC diagnosis.

Support for Policy 9.5.I Modification

ICUS commends the proposal’s provision to include CEUS as an alternative imaging option to provide a pathway to automatic standard HCC exception approval in Policy 9.5.I. We believe that this policy modification is a critical step toward modernizing the diagnostic framework for HCC. By incorporating CEUS, the policy will:

• Improve Patient Access to Timely Diagnosis: The rapid and non-invasive nature of CEUS facilitates early and accurate diagnosis, ensuring that patients receive prompt evaluation and appropriate management.

• Promote Uniformity in Imaging Assessment: Aligning CEUS findings with LI-RADS® categorization will foster uniformity in imaging interpretation across centers, enhancing interobserver reliability and supporting evidence-based decision-making.

• Enhance Clinical Workflow: With its ease of use and immediate availability, CEUS can serve as an effective adjunct, streamlining clinical workflows and reducing the time to treatment initiation for patients eligible for standard HCC exception approval.

Conclusion

The International Contrast Ultrasound Society firmly supports the inclusion of contrast-enhanced ultrasound (CEUS) as an acceptable adjunct diagnostic tool in the updated UNOS/OPTN policy framework for HCC diagnosis. We are confident that the proposed modifications, particularly the pathway to automatic standard HCC exception approval via Policy 9.5.I, will lead to improved diagnostic accuracy, better patient outcomes, and a more efficient evaluation process. We appreciate the Committee’s commitment to integrating innovative imaging modalities and evidence-based practices into the liver transplant policy landscape.

Thank you for considering our perspective. We stand ready to provide additional information or participate in further discussions to support these important policy changes.

Sincerely yours,

The International Contrast Ultrasound Society Board of Directors

Steven B. Feinstein, MD, FACC, FESC;
Stephanie Wilson, MD, FRCPC;
Petros Nihoyannopoulos, MD, FRCP, FESC, FACC, FAHA;
Michael Main, MD; J.
J. Brian Fowlkes, PhD, FAIUM, FAIMBE, FAAPM, FASA, FIEEE;
Richard G. Barr, MD, PhD, FACR, FSRU, FAIUM;
Jordan Strom, MD, MSc, FACC, FASE;
Andrew Appis, MD;
Maria Cristina Chammas, MD, PhD;
Dirk-André Clevert, MD;
Kassa Darge, MD, PhD, DTM&P, FAIUM, FSAR;
Pintong Huang, MD, PhD;
Orpheus Kolokythas, MD, FSAR;
Yuko Kono, MD, PhD, FAIUM, FAASLD;
Andrej Lyshchik MD,PhD, DSc, FAIM, FSRU;
Wilson Mathias, Jr., MD, FACC;
Christina Merrill, BSc, CRGS, CRVS, RDMS, RVT;
Sharon L. Mulvagh, MD FRCP(C), FACC, FASE, FAHA;
Fabio Piscaglia, MD, PhD;
Arnaldo Rabischoffsky, MD;
Roxy Senior, MD, DM, FRCP, FESC, FACC;
Maria Stanczak, MS, RDMS, RVT, R.T(R)(M);
Joan Olson, B.S., ACS, RDCS, RVT, FASE;
Jessica Stout, RDCS, FASE;
Viktor Zhelov, MD (Honorary);
Barry Goldberg, MD (Emeritus);
Beverly Gorman, RDCS (Emeritus);
Edward G. Grant MD, FACR (Emeritus);
Paul A. Grayburn, MD, FACC (Emeritus);
Tom Porter, MD (Emeritus)

View attachment from International Contrast Ultrasound Society

John Eisenbrey | 02/18/2025

I am very excited to see OPTN considering these guidelines and supportive of its efforts to align with the American College of Radiology’s CEUS LI-RADS. This is an important step for clinical adoption and recognizes the numerous benefits to HCC patients that has been well documented for decades. I would also encourage the committee to look into incorporation of the ACR’s CEUS LI-RADS Treatment Response Algorithm in the future.

Flemming Forsberg | 02/18/2025

See attachment

View attachment from Flemming Forsberg

Scott Matherly | 01/21/2025

Overall, I am pleased with the changes suggested. While recently serving on the NLRB, it was mentioned that there would be a potential path to meld exception for intrahepatic cholangiocarcinoma but I do not see that included. Will this be looked at in the future?