Friday, October 6, 2023

Novitas Transcript for Oncology LCD Open Meeting; We Summarize All 21 Speeches

Much ink has been spilled, from here to Genomeweb and elsewhere, about a literally massive (and confusing) new LCD and billing article that Novitas is attempting to roll out for oncology-related tests.

A 44-signature public comment letter by ACLA and others has been released.


Novitas MAC has posted the transcript of the August 11, 2023 public comment meeting.  It weighs in at 44 pages, 28,000 words.  The online video runs 3h15min.


Below, under "AI CORNER,"  I list AI summaries of each of the 21 presentations.  To see the full text of each speaker, see the full transcript at this link:

NOTE: Someone informed me that on 11/1/2023, the row for the Aug 11 Oncol Mtg had vanished (the whole row is gone.).  Odd.    My cloud archive copy of it, 43pp, is here.

The "Speaker and Institutions" list is below.

  • Mohammad A Al-Haddad, MD, Msc, FASGE, FACG, AGAF – Indiana University School of Medicine

  • John Vetto, MD, FACS, FAACE – Oregon Health and Science University

  • Darrell Rigel, MD, MS – Mount Sinai School of Medicine

  • Mark Lebwohl, MD, FAAD, FACP - Icahn School of Medicine at Mount Sinai

  • Rosario Ligresti, MD – Hackensack Meridian Health

  • Brian Carey – Foley Hoag, LLP

  • Jonathan Rubenstein, MD – American Urological Association

  • Daniel Shoskes, MD, MSc, FRCS(C) – Pacific Edge Diagnostics

  • Sarah Arron, MD, PhD – Arron Dermatology

  • W. Michael Korn, MD - Invitae

  • Manoj Gandhi, MD, PhD – Abbott Laboratories

  • Qi Wei, PhD, DABCC – miR Scientific

  • Robert Cook, PhD – Castle Biosciences, Inc.

  • Matthew Goldberg, MD, FAAD – Castle Biosciences, Inc.

  • Debyani Chakravarty, PhD – Memorial Sloan Kettering Cancer Center

  • Shlomo Koyfman, MD - Cleveland Clinic

  • Pranil K Chandra, DO, FCAP, FASCP – Association of Molecular Pathology

  • Jose Nieto, DO, AGAF, FACP, FACG, FASGE, FFGS – Baptist Medical Center

  • Michael Paris – Clinical Genomics

  • Sarah Thibault-Sennet – American Clinical Laboratory Association\


MolDx held an open meeting 9/18 on its transplant donor DNA LCD, but it's not posted as a transcript yet.  Watch here.


Below, I list summarizes of each of the 21 speakers, in ~200 words from CHAT GPT 3.5 (total 4,000 words).   This slims the reading down from 28,000 original to 4,000 in the AI summary.  

N.B.: In my experience CHAT summarizes pretty well; but, I have not compared each script, to each summary.


On August 11, 2023, a workshop moderated by Dr. Patrick Mann from the Novitas Medicare Administrative Contractor (MAC) provided a platform for stakeholders to voice their concerns and insights regarding a proposed oncology test policy (LCD DL39365). This proposed policy was designed to guide coverage decisions for genetic testing in oncology. Throughout the workshop, 21 participants from various backgrounds, including healthcare professionals, test developers, and industry representatives, shared their perspectives on the policy.

Several common themes emerged from the comments during the workshop:

Clinical Utility of Genetic Testing: Many speakers emphasized the clinical utility of genetic testing in oncology. They highlighted how these tests can guide treatment decisions, identify high-risk patients, and prevent unnecessary interventions. Molecular diagnostics were seen as crucial tools for personalized patient care, especially in cases with indeterminate or equivocal initial test results.

Support for Existing Knowledge Bases: Several speakers advocated for the use of established knowledge bases like NCCN, ClinGen, and OncoKB as references for determining coverage criteria. They argued that these databases provide valuable evidence for the clinical validity and utility of genetic tests, enabling fair and consistent coverage decisions.

>> BQ: But, in addition, stakeholders OPPOSED use of the knowledge databases for DENIALS due to the ABSENCE of tests in them.

Patient Access and Timely Care: Concerns were raised about the potential impact of the proposed policy on patient access to innovative and effective tests. Participants stressed the importance of streamlining the coverage process to avoid delays in patient care, especially when dealing with emerging technologies.

ICD-10 Codes and Billing: The exclusion of certain ICD-10 codes from the policy was a significant concern. Participants pointed out that this could hinder access to essential testing for Medicare beneficiaries, including those with late-stage cancer diagnoses and those in remission for hematological malignancies. They recommended adding these codes to ensure comprehensive coverage.

Unique Test Roles: Some speakers highlighted the specific roles of certain tests, such as urine-based molecular assays for prostate cancer risk assessment and blood-based molecular diagnostics for colorectal cancer recurrence detection. They argued that these tests serve unique purposes and should be considered separately in coverage decisions.

Evidence-Based Evaluation: Several participants stressed the importance of conducting evidence-based evaluations of genetic tests, including those not covered by existing knowledge bases. They called for a flexible approach that considers the clinical potential and unique contributions of innovative assays, especially those related to minimal residual disease (MRD) testing in cancer patients.

Transparency and Fairness: Transparency in the coverage process and fairness in evaluating the clinical value of tests were overarching concerns. Participants emphasized the need for a comprehensive and transparent approach that considers input from multiple stakeholders, including healthcare providers, test developers, and patients.

In summary, the workshop provided valuable insights into the proposed oncology test policy, revealing a consensus among stakeholders on the importance of genetic testing in improving patient care. While concerns were raised regarding the policy's potential impact on access to innovative tests and the need for more inclusive coverage criteria, participants agreed on the necessity of evidence-based evaluations and the utilization of established knowledge bases. Ultimately, the workshop highlighted the complex interplay of science, policy, and patient care in the rapidly evolving field of oncology testing.



Dr. Patrick Mann, Novitas and First Coast Executive CMD, opened the Novitas' August meeting, introducing his colleagues and emphasizing the recording of the meeting as per CMS guidelines. The purpose of the meeting was to gather comments on the proposed LCD DL39365, focused on genetic testing for oncology. Dr. Mann highlighted the importance of submitting written comments by September 9, 2023, with supporting evidence. He stressed the complexity of genetic testing in oncology and the need for knowledgeable providers to interpret results properly. Only oncologists directly involved in patient care should order such tests. Dr. Mann noted the evolving nature of the field and emphasized the use of evidence-based knowledge bases in LCD development. Presenters were limited to 10-minute presentations to ensure fairness.


Dr. Mohammad A. Al-Haddad, the Director of the Division of Gastroenterology and Hepatology at Indiana University, spoke about the utility of molecular diagnostics in managing pancreatic cysts. He mentioned his conflict of interest with Interpace Diagnostics. Dr. Al-Haddad discussed studies excluded from the LCD, highlighting the use of the PancraGEN assay in risk stratifying pancreatic cystic lesions. He emphasized that DNA analysis can inform decision-making in patients with worrisome features in their pancreatic cysts, guiding management towards either surgery or conservative approaches. He presented evidence showing that DNA analysis can reduce unnecessary surgeries and be cost-effective. He also mentioned a case where molecular diagnostics revealed a VHL mutation, sparing a patient from surgery. Dr. Al-Haddad's speech underscored the importance of molecular diagnostics in personalized management of pancreatic cysts, especially in cases with indeterminate first-line test results.

03 OHSU VETTO – Castle

Dr. John Vetto, a surgical oncologist at OHSU in Portland, discussed the clinical use of the 31-gene GEP (Gene Expression Profiling) test, specifically the DecisionDx test, in managing melanoma patients. He highlighted the importance of real-world clinical experience with the test. Dr. Vetto presented data demonstrating the test's ability to predict the risk of positive sentinel nodes in Medicare-aged patients, enabling more informed decisions regarding sentinel node biopsies. He also discussed the use of the test to identify "double-negative" patients with low risk of recurrence, allowing for the potential discharge of these patients from further follow-up. Additionally, he described the test's role in identifying patients who may be at higher genetic risk despite traditional staging, facilitating earlier detection and treatment of recurrences. Dr. Vetto also briefly mentioned the use of the test in guiding decisions related to adjuvant therapy for certain melanoma patients.

4 Castle Dr Rigel

Dr. Darrel Rigel, a clinician specializing in skin cancer, emphasized the importance of utilizing gene expression profiling (GEP) tests for melanoma and cutaneous squamous cell carcinoma (SCC) in clinical practice. He noted that the NCCN guidelines, while valuable, have limitations and may not adequately reflect the dynamic nature of the field of dermatology. Dr. Rigel stressed the significance of expert panel publications and systematic reviews within dermatology, which provide strong evidence supporting the use of GEP tests for these skin cancers. He highlighted the endorsement of these tests by the National Society for Cutaneous Medicine and the consensus panel's recommendations, which include appropriate criteria for usage and can contribute to better patient management and cost-effectiveness. Dr. Rigel called for a comprehensive review of all available evidence to make informed decisions about coverage, emphasizing the positive impact of GEP testing on patient care.


 Dr. Mark Lebwohl, the Dean for Clinical Therapeutics at Mount Sinai, discussed the significance of the Melanoma DX 31-GEP test from Castle Biosciences in his presentation. He highlighted his extensive experience using the test and shared key insights into its clinical applications. Dr. Lebwohl emphasized two primary benefits of the test: guiding decisions regarding sentinel lymph nodes and informing post-excision management strategies.

He presented data from the SEER cohort, illustrating the test's ability to stratify patients into distinct risk groups, which ultimately led to differences in melanoma-specific survival and overall survival. Dr. Lebwohl also discussed how the test helps in closely monitoring high-risk patients, leading to earlier detection of recurrences and improved overall survival.

Furthermore, he stressed the importance of the test, particularly in the Medicare population, as it allows for the reduction of unnecessary sentinel lymph node procedures. Dr. Lebwohl shared a compelling case of an 87-year-old patient who decided against a sentinel lymph node biopsy based on the test's results and subsequently enjoyed a healthy life, underscoring the practical impact of the test on patient care.

Overall, Dr. Lebwohl advocated for the continued recognition and coverage of the Melanoma DX 31-GEP test, emphasizing its clinical utility in guiding treatment decisions and improving patient outcomes.




 Dr. Ligresti discussed the importance of molecular pathology, specifically the integration of molecular markers, in the evaluation of pancreatic cystic lesions. He emphasized the challenges in determining the malignant potential of these cysts through conventional means such as imaging and cytology.

Pancreatic cysts are a common finding, especially in older patient populations, and their management can be challenging. Dr. Ligresti explained that molecular markers play a crucial role in assessing the risk of malignancy in pancreatic cysts. He highlighted the significance of detecting specific mutations, including KRAS and GNAS, which can indicate a progression toward malignancy.

The presentation showcased the clinical utility of molecular pathology in pancreatic cyst management. Dr. Ligresti presented a case study of a patient with an incidentally found pancreatic cyst, illustrating how molecular diagnostic testing led to the early detection of adenocarcinoma. This case demonstrated the potential life-saving impact of molecular pathology in guiding treatment decisions and improving patient outcomes.

In conclusion, Dr. Ligresti emphasized the value of molecular pathology in pancreatic cyst evaluation and the potential to change the management pathway for patients with these lesions, ultimately enhancing their chances of curative resection and survival.




 Brian Carey, a healthcare attorney and consultant to The Coalition for 21st Century Medicine, discussed concerns related to the proposed Local Coverage Determination (LCD) for certain diagnostic laboratory tests. The Coalition represents advanced diagnostic proprietary tests and emphasized the need for a robust and comprehensive coverage process.

Mr. Carey highlighted two key issues in his presentation. Firstly, he emphasized that while guideline and professional societies like NCCN are valuable, they are just one part of the coverage process. He expressed concerns about the proposed LCD's exclusive reliance on third-party compendia, as this approach bypasses the Medicare contractor's review of evidence and denies laboratories and stakeholders the opportunity to provide input during the development of policies.

Secondly, Mr. Carey raised concerns about the potential for a de facto national non-coverage policy for new tests, particularly those not covered by NCCN or other guidelines. He stressed the need for flexibility in the coverage process, especially when new tests emerge, to ensure that patients have access to clinically valuable diagnostic tools.

Additionally, he pointed out the challenges in operationalizing NCCN guidelines as coverage policies and questioned how the standard of "significant evidence" for creating suspicion of cancer would be applied.

Lastly, Mr. Carey recommended separating the evidentiary review of individual tests from the procedural framework related to guidelines and coverage. He suggested the establishment of a contractor advisory committee for detailed examination of specific tests and flexibility in allowing Medicare contractors to review evidence for new tests on a claim-by-claim basis.

In conclusion, Mr. Carey stressed the importance of a fair and transparent coverage process that considers both established and new tests' clinical value, ensuring that patients have access to necessary diagnostic tools.




 Dr. Jonathan Rubenstein, representing the American Urological Association (AUA), the Large Urology Group Practice Association, and The American Association of Clinical Urologists, expressed concerns regarding the proposed Local Coverage Determination (LCD) for certain diagnostic laboratory tests. He highlighted that this LCD encompasses urine markers used in the diagnosis and management of bladder cancer and discussed why these markers should be excluded from the scope of this LCD.

Dr. Rubenstein emphasized the importance of urine tumor markers in diagnosing and managing bladder cancer, citing their crucial role in screening, identifying tumors, predicting recurrence, and monitoring treatment responses. He mentioned that these markers are incorporated into screening guidelines and management strategies.

He expressed concerns that urine markers for bladder cancer, such as UroVysion and CxBladder, are not genetic tests within the scope of the LCD, as they function more like stains or immunohistochemistry rather than DNA or RNA-based tests. He argued that their clinical utility and long-standing use in clinical practice should exempt them from the LCD or be considered separately.

Dr. Rubenstein highlighted that the proposed LCD could lead to worse patient outcomes, increased costs, and conflicts with AUA guidelines, potentially exacerbating disparities in bladder cancer care. He also pointed out that restricting coverage for these markers might impact patient access and outcomes, particularly in regions with limited access to urologists.

In conclusion, Dr. Rubenstein urged Novitas to reconsider covering urine tumor markers, emphasizing their importance in managing bladder cancer effectively and efficiently. He recommended either excluding these markers from the LCD or using prior LCD guidance to determine appropriate coverage criteria, including expert input and stakeholder involvement.




 Dr. Daniel Shoskes, Senior Medical Director at Pacific Edge Diagnostics, discussed the Local Coverage Determination (LCD) for diagnostic laboratory tests, specifically focusing on the Cxbladder family of tests. He emphasized the importance of correctly characterizing these tests, their purpose, and their role in evaluating and managing hematuria and non-muscle invasive bladder cancer.

Dr. Shoskes explained that the Cxbladder Triage and Detect tests are designed to address the need for cystoscopy in patients with hematuria. Since a vast majority of patients undergoing cystoscopy do not have bladder cancer, these genomic tests are intended to have a high negative predictive value and rule out patients at low risk of urothelial cancer. This approach can significantly reduce unnecessary cystoscopies, resulting in fewer complications, cost savings, and less environmental impact.

He clarified that Cxbladder is not intended to identify other types of cancer, as its sole purpose is to rule out bladder cancer, which is the focus of the AUA guidelines for hematuria workup.

Dr. Shoskes responded to criticisms in the LCD, addressing issues related to false positives, company funding, the inclusion of tests in development, the male bias in study populations, and the need for long-term follow-up. He argued that Cxbladder tests serve their intended purpose effectively and that company sponsorship is a standard practice in the industry.

In conclusion, Dr. Shoskes recommended that Cxbladder Triage and Detect be removed from the scope of the LCD, that Cxbladder Monitor retains coverage due to its utility in the Medicare population, and that references to tests not commercially available be removed from the LCD. He emphasized that restricting access to these tests could lead to more unnecessary cystoscopy procedures, increased patient morbidity, higher costs, and wasted resources, without benefiting patients.




Dr. Sarah Arron, a dermatologist and clinician at Peninsula Dermatology in Burlingame, California, discussed the DecisionDx-SCC assay, which is used to predict the risk of nodal or distant metastasis in patients with high-risk cutaneous squamous cell carcinoma (SCC). She emphasized that SCC is a skin cancer with a mortality rate equal to melanoma but has been underrepresented in research.

Dr. Arron clarified that the DecisionDx-SCC is not designed to predict local recurrence or death but specifically focuses on the risk of metastasis within a three-year period. The assay uses a 40-gene expression profile to stratify high-risk SCC patients into different risk groups, providing valuable information to guide treatment decisions.

She addressed critiques in the draft LCD, including misinterpretations of the study design and outcomes. Dr. Arron argued that the test has undergone multiple validation studies and accurately risk-stratifies high-risk SCC patients. She also highlighted the clinical utility of the DecisionDx-SCC, emphasizing that its results help physicians select appropriate treatment interventions, ultimately improving patient outcomes.

Dr. Arron pointed out that real-world data and peer-reviewed literature support the clinical use of the DecisionDx-SCC, with physicians integrating the assay into their clinical pathologic risk assessments.

In conclusion, Dr. Arron argued that the DecisionDx-SCC meets the Medicare standard for medical reasonableness and necessity, as it helps guide treatment decisions for SCC patients, particularly in cases where adjuvant radiation therapy may be warranted. She urged that physicians and Medicare beneficiaries should have access to this test to improve patient outcomes.




Dr. Korn, the Chief Medical Officer for Oncology at Invitae, discussed the proposed Local Coverage Determination (LCD) and its reference to three knowledge bases. He expressed concern that the LCD's reliance on these databases might limit the evaluation of innovative assays, particularly those related to minimal residual disease (MRD) testing in cancer patients. He argued that MRD tests could diagnose cancer progression, recurrence, and relapse, providing valuable clinical insights and enabling physicians to make better-informed decisions about risk stratification and treatment options.

Dr. Korn highlighted the potential clinical impact of highly sensitive MRD assays and mentioned Invitae's Personalized Cancer Monitoring (PCM) assay, which is designed to detect recurrence by analyzing circulating tumor DNA. He shared the promising results of studies involving this assay in non-small-cell lung cancer and breast cancer patients, emphasizing its excellent sensitivity, specificity, and ability to provide early information about disease recurrence.

Dr. Korn called for the establishment of a fourth pathway in the proposed LCD to allow special consideration of innovative and highly sensitive assays with substantial clinical potential, especially when they are not adequately covered by existing knowledge bases or guidelines. This, he argued, would ensure that assays like the Invitae PCM MRD assay could be evaluated and covered for their clinical utility.




Dr. Manoj Gandhi, the Senior Medical Director for Abbott Molecular, presented his insights on the proposed Local Coverage Determination (LCD) regarding the use of UroVysion in bladder cancer. Dr. Gandhi began by providing background information on bladder cancer, highlighting its prevalence among the elderly population and its high recurrence and progression rates.

 He emphasized UroVysion's role in diagnosing bladder cancer in patients with hematuria and monitoring tumor recurrence, noting that it is not a screening test and is used when patients present with symptoms, primarily hematuria. Dr. Gandhi argued that UroVysion should not be included in the proposed LCD because it is a FISH test categorized as cytopathology rather than a genetic test.

 Addressing concerns raised in the proposed LCD, Dr. Gandhi challenged the assessment of UroVysion's analytical and clinical validity, stating that the FDA had extensively reviewed and approved the test. He also pointed out that the proposed LCD did not consider reputable guideline bodies like the American Urological Association (AUA), which strongly support UroVysion for various use cases in bladder cancer diagnosis and monitoring.

 Dr. Gandhi presented evidence from independent peer-reviewed publications supporting UroVysion's clinical validity and utility, including its ability to predict the effectiveness of BCG therapy and its use in cases of equivocal cytology. He argued that UroVysion's sensitivity was superior to urine cytology and emphasized its importance in identifying low-grade tumors.

 Furthermore, Dr. Gandhi addressed concerns about occasional chromosomal changes in healthy tissues and other cancers, emphasizing the rarity of such events and the appropriate controls in place to mitigate their impact.

 In conclusion, Dr. Gandhi asserted that UroVysion, an FDA-approved FISH test, has well-established analytical and clinical validity and clinical utility in bladder cancer diagnosis and monitoring. He advocated for the consideration of the ample body of evidence supporting its use in Medicare patients, challenging the assertion of insufficient evidence in the proposed LCD.  



Dr. Qi Wei, VP of Medical Affairs at miR Scientific, expressed concerns about Novitas' proposed coverage policy for genetic testing in oncology. He argued that miR Sentinel, a urine-based molecular assay, should not be included in the proposed LCD as it falls outside its scope. miR Sentinel aims to refine patient selection for prostate biopsies, aiding physicians in determining who needs further diagnostic procedures without diagnosing prostate cancer directly.

 Dr. Wei emphasized that miR Sentinel aligns with guidelines from the National Comprehensive Cancer Network (NCCN), which recommend using biomarkers to improve the specificity of prostate cancer screening and assist in biopsy decision-making. He also noted that a similar test is already covered by Novitas under a different LCD.

 In conclusion, Dr. Wei urged that miR Sentinel's unique role should be considered, and the proposed LCD would limit Medicare beneficiaries' access to valuable diagnostic tools for prostate cancer risk assessment.



 Bob Cook, Senior Vice President of Research and Development at Castle Biosciences, expressed concerns regarding Novitas' draft LCD L39365 for DecisionDx-Melanoma testing. Cook argued that the draft displayed misunderstandings of gene expression profiling (GEP) technologies and established unreasonable thresholds for analytical validity. He noted that GEP testing, including DecisionDx-Melanoma, assesses the entirety of the tumor microenvironment, not just tumor cells, and suggested that the requirement for tumor and non-tumor tissue comparisons is unnecessary based on existing evidence.

 Furthermore, Cook highlighted issues with the LCD's concerns about the age of tissue samples, citing technological advances that mitigate concerns about RNA degradation in older samples. He also emphasized the existing clinical evidence supporting DecisionDx-Melanoma's accuracy and clinical utility.

 In conclusion, Cook stressed the importance of a thorough review and cautioned against imposing unnecessary requirements that could negatively impact patient care for melanoma diagnosis and management.



 Dr. Matthew Goldberg, Senior Vice President of Medical at Castle Biosciences, presented concerns about Novitas' draft LCD L39365 for DecisionDx-Melanoma and DecisionDx-SCC testing. Dr. Goldberg highlighted that these tests have been clinically available since 2013 and 2020, respectively, and have met Medicare definitions of medical reasonableness and necessity since 2018 and 2022. They have strong clinical adoption and are used to inform the management of thousands of patients across the United States.

Dr. Goldberg argued that the proposed LCD's independent review pathway is not a viable mechanism for test evaluation and coverage determination. He expressed concerns that the criteria imposed on molecular tests differ from established Medicare definitions, slow down the delivery of healthcare advancements to patients, and create inequalities between disease states.

 He also emphasized that DecisionDx-Melanoma and DecisionDx-SCC fill an unmet clinical need and recommended that the LCD either confirm coverage for these tests following a comprehensive evidentiary review or remove them pending a new evidentiary review and open comment period.

 In summary, Dr. Goldberg urged Novitas to reconsider the proposed LCD to ensure that well-validated molecular tests can benefit Medicare beneficiaries and improve patient care.



 Debyani Chakravarty, the lead scientist for OncoKB, presented information about OncoKB, a precision oncology knowledge base, and its role in annotating and ranking genetic alterations in the context of clinical cancer sequencing reports. OncoKB separates the signal from noise in clinical sequencing reports, focusing on driver mutations that are clinically actionable. It curates data from various sources, including FDA drug labels, NCCN guidelines, scientific literature, and more, to provide structured information about the biological and clinical consequences of genetic alterations.

 Chakravarty emphasized that OncoKB is used institutionally at Memorial Sloan Kettering and has FDA recognition for annotating variants. It ranks alterations based on evidence of clinical actionability, including standard care, investigational, or hypothetical implications for patient treatment. OncoKB's oversight involves a multidisciplinary panel of experts and an external advisory board.

 Chakravarty addressed comments in the proposed LCD, noting that OncoKB meets most criteria for clinical validity and has FDA recognition for its evidence. She emphasized that OncoKB is agnostic regarding companion diagnostics and operates without conflicts of interest.

 In summary, OncoKB provides valuable information for clinicians, test developers, and patients to understand the clinical implications of genetic alterations in cancer. Chakravarty highlighted the importance of recognizing OncoKB's role in the proposed LCD.



 Dr. Shlomo Koyfman, a radiation oncologist at Cleveland Clinic, provided a clinician's perspective on the use of DecisionDx-SCC for high-risk cutaneous squamous cell carcinoma (cSCC) and addressed the draft LCD's concerns. He emphasized that DecisionDx-SCC focuses on assessing the risk of regional and distant metastases, not local recurrence or disease-specific death.

 Koyfman discussed how DecisionDx-SCC has met Medicare criteria for medical reasonableness and necessity. He explained that the test was developed to better identify patients who may benefit from adjuvant therapy, as existing clinical risk stratification tools are highly imperfect. The test helps refine treatment recommendations based on a patient's genomic profile, improving decision-making and patient outcomes.

He presented data from different cohorts, illustrating how the test's genomic information informs treatment decisions. Koyfman highlighted the significance of DecisionDx-SCC in guiding personalized treatment recommendations, and he argued that the LCD should consider approving the test based on its evidence base and clinical utility in 2023.




Pranil Chandra, Senior Vice President and Chief Genomics Officer at PathGroup, represented the Association of Molecular Pathology (AMP) and presented concerns regarding the draft Local Coverage Determination (LCD). He emphasized that while the draft LCD relies on specific databases such as NCCN, ClinGen, and OncoKB, AMP believes that additional evidence-based guidelines from professional societies like AMP, ASCO, CAP, WHO, AUA, should be considered as acceptable sources for coverage inclusion to provide a comprehensive approach to determining coverage criteria.

 Chandra disagreed with the classification of UroVysion FISH as not medically reasonable and necessary, pointing out that it is included in guidelines and is often used in combination with urine cytology. He highlighted the need for a clear distinction between somatic and germline testing in the LCD to avoid confusion.

 Chandra also raised concerns about provider qualifications, suggesting that the requirement for the ordering provider to be the treating clinician could delay patient care, particularly in multidisciplinary team settings. He called for the removal of these requirements from the policy.

 Furthermore, Chandra sought clarification on the coverage of liquid biopsy tests when tissue samples are unavailable. He requested confirmation from Novitas that liquid biopsy testing would be indicated in such cases.

 Finally, AMP noted that several ICD-10 codes were omitted from the final LCD, including those with the term "unspecified." They expressed concerns about potential patient access issues and would provide a list of recommended ICD-10 codes for inclusion in the final LCD.

 AMP intended to submit written comments consistent with their presentation to address these concerns.



 Dr. Baptist Nieto, a clinical gastroenterologist, shared his experience with molecular genetics involved in pancreatic cysts through clinical cases. He highlighted the importance of molecular tests, such as PanGen (formerly Pathfinder), in helping to stratify pancreatic cysts and make informed clinical decisions.

 Dr. Nieto presented a case from 2009 where a patient with a pancreatic cyst underwent repeated evaluations with traditional methods like cytology and CEA, but the results were inconclusive. Molecular testing was then performed, revealing aggressive genetics, leading to surgery. The patient's life was significantly improved as early detection likely prevented invasive adenocarcinoma.

 He emphasized the value of molecular testing in distinguishing between benign and precancerous lesions, improving sensitivity compared to traditional methods. Dr. Nieto also mentioned the importance of providing patients with more accurate risk assessments, allowing for personalized management and avoiding unnecessary procedures.

 In conclusion, Dr. Nieto stressed that molecular testing in pancreatic cysts not only aids in diagnosis but also plays a crucial role in patient management, offering the potential for early intervention and improved patient outcomes.




 Mike Paris, CEO of Clinical Genomics, expressed his disappointment with the proposed non-coverage determination for Colvera, their blood-based molecular diagnostic test designed to detect molecular residual disease in patients previously treated for colon or rectal cancer. Clinical Genomics has invested significant effort in generating and publishing clinical data supporting Colvera's efficacy.

 The primary issue cited in the proposed LCD is the reliance on carcinoembryonic antigen (CEA) for colorectal cancer (CRC) surveillance, despite its known limitations. CEA's specificity is affected by various external factors, impacting its reliability for CRC surveillance. Clinical Genomics has presented clinical evidence demonstrating that Colvera outperforms CEA in CRC recurrence detection, particularly in asymptomatic patients.

 Paris emphasized the importance of improving personalized surveillance for CRC patients and addressing the unmet need for reliable recurrence detection in stage one CRC patients, which Colvera can potentially address.

 He concluded by stressing that access to innovative technologies like Colvera is essential to advance medicine and enhance patient care by providing more accurate and sensitive tools for cancer surveillance.



 Sarah Thibault-Sennet, Senior Director of Reimbursement Policy at the American Clinical Laboratory Association (ACLA), highlighted two main concerns regarding the draft Local Coverage Determination (LCD) for genetic testing in oncology.

 First, Thibault-Sennet expressed concern that the draft LCD lacks a clear pathway for coverage if a test is not included in one of the three knowledge databases. ACLA believes that the LCD process should be the only permissible basis for establishing a policy of non-coverage for clinical diagnostic laboratory tests. They recommend modifying the LCD to remove the limitation that tests not included in the specified databases are presumptively non-covered.

 Second, Thibault-Sennet pointed out that the draft article excludes many ICD-10 codes that are included in the current articles. This omission could hinder access to standard and medically necessary testing for Medicare beneficiaries. For example, some not otherwise specified (NOS) ICD-10 codes, which are frequently used for late-stage cancer diagnoses, are excluded. Additionally, ICD-10 codes related to remission for hematological malignancies are missing, potentially preventing testing that establishes remission status. ACLA recommends adding additional ICD-10 codes to the billing and coding article before implementing the policy.

 ACLA intends to submit detailed written comments to address these and other concerns related to the draft LCD.