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.
NEW NEWS: HUGE TRANSCRIPT PUBLISHED
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.
AI CORNER:
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:
https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00214902
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\
##
|
01 DR MANN NOVITAS 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. |
|
2 INDIANA AL HADDAD iNTERPACE 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. |
|
5 SINAI DR LEBWOHL – Castle 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. |
|
6 HACKENSACK DR LIGRESTI Interpace 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. |
|
7 FOLEY HOAG CAREY 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. |
|
8 AUA RUBENSTEIN 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. |
|
9 PACIFIC EDGE SHOSKES 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. |
|
10 ARRON DERMATOLOGY CASTLE 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. |
|
11 INVITAE KORN 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. |
|
12 ABBOTT DR GHANDI 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. |
|
13 MIR DR WEI 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. |
|
14 CASTLE DR COOK |
|
15 CASTLE DR GOLDBERG 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. |
|
16 SLOAN CHAKRAVARTY |
|
17 CLEVELAND CLINIC KOYFMAN (CASTLE) 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. |
|
18 AMP CHANDRA 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. |
|
19 BAPTIST NIETO |
|
20 CLIN GEN DR PARIS |
|
21 ACLA THIBAULT SENNET |
|
|
