CMS PAMA advisors meeting; comments of CMS policymaker Sarah Shirey-Losso regarding G0327.
July 29, 2021 - Auto transcript
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So regarding this code, we were in a bit of a quandary with this code, G0327.
It was developed based on a national coverage determination that I believe CMS issued earlier this year.
But in terms of our annual public meeting laboratories, CLFS rate setting process we have a bit of a a cart before the horse in that we a code was created, but there at this time, there isn't a test for the NCD that would be a represented by G0327.
We included that code on the annual lab meeting back in June where we became aware a few days before that that there wasn't actually a test associated with this code.
Since that time, we have received a lot of comments from stakeholders during the meeting and written comments after.
At that point, we decided that we would retain G0327 [for now].
It {stayed available for our} panel in the in the chance that a test did become available or were made aware of a test during before or during this meeting. So as such, to our knowledge, there is not a test associated with this NCD at this time.
So, there obviously, no recommendations to be made from the panel or the public on possible crosswalks or gap filled.
So I just wanted to give a few updates on that and kind of where we were the fact that the we cannot get recommendations from the panel, because we don't have information on a specific test at this time.
Looks that we are, you know, unable to make a determination on a potential test at this time. And therefore, likely you will not see this test one our preliminary determinations document that we will have a goal to publish in mid September.
I submit that I we wanted to acknowledge some of the comments we summarized the comments in in these couple of slides here for for awareness and that they're on the record.
And if if there were any stakeholders that would like to speak at this time.
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Dr Bruce Quinn commented that it's a "regulation" to propose codes 30 days in advance, this was only a couple days in advance (of June 24 meeting).
Dr Paul Radensky noted that tests under this NCD would often be ADLTs, and the ability to use the ADLT pathway shouldn't be interrupted by a CMS code like G0327.
ACLA commented that the code should be pulled from current review, and please include ACLA in future discussions.
Greg Schaeffer for Guardant Health commented that it had submitted comments, thanks for acknowledging them, and supports withdrawing the code from current review.
Palmetto GBA issues final expanded local coverage determination effective November 22, 2020
FRIENDSWOOD, Texas--(BUSINESS WIRE)--Oct. 8, 2020-- Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced that Medicare Administrative Contractor, Palmetto GBA MolDx, has issued a final expanded local coverage determination (LCD) for the company's DecisionDx®-Melanoma test. The LCD effective date is Nov. 22, 2020. Details on the LCD and the billing and coding article are posted to the Medicare Coverage Database on the Centers for Medicare and Medicaid Services (CMS) website.
DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors. The test has been studied in more than 5,700 patient samples.
“We are pleased to have received positive expanded coverage for our DecisionDx-Melanoma test for patients diagnosed with cutaneous melanoma,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “We believe that adding the personalized genomic information provided by our DecisionDx-Melanoma test to traditional clinical and pathology factors can help clinicians and their patients make improved treatment decisions. This coverage decision provides greater access to our test for people with melanoma, as it allows additional Medicare beneficiaries to incorporate DecisionDx-Melanoma into their management plans.”
Castle Biosciences plans to continue generating and publishing scientific data to demonstrate enhanced clinical utility of the DecisionDx-Melanoma test, which is currently supported by 26 peer-reviewed publications.
About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through June 30, 2020, DecisionDx-Melanoma has been ordered more than 59,900 times for use in patients with cutaneous melanoma.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a commercial-stage dermatologic cancer company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma, DecisionDx®-CMSeq; www.SkinMelanoma.com), cutaneous squamous cell carcinoma (DecisionDx®-SCC, www.mySCCskincancer.com) and uveal melanoma (DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq; www.MyUvealMelanoma.com). Castle also has products in development for other underserved cancers, the most advanced of which is focused on patients who have a difficult-to-diagnose pigmented lesion. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix, Arizona. For more information, visit www.CastleBiosciences.com.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.
Forward-Looking Statements
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning the ability of DecisionDx-Melanoma test results to predict recurrence and metastatic risk in patients with invasive cutaneous melanoma and optimize or improve diagnostic treatment decisions. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements; although, not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, changes in the competitive landscape and the introduction of competitive products, changes in local coverage determinations, the impact of the COVID-19 pandemic on our business and results of operations, as well as the other risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 10, 2020, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 10, 2020, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.
NEW YORK – Castle Biosciences announced Thursday its DecisionDx-Melanoma test has received expanded coverage from Medicare Administrative Contractor Palmetto for patients with cutaneous melanoma.
The future local coverage determination released by Palmetto covers molecular diagnostic tests to assist in risk stratification of melanoma patients when the patient has a personal history of melanoma and has either stage T1b and above or has stage T1a with documented concern about the adequacy of microstaging. They must also be undergoing workup or being evaluated for treatment, not have metastatic disease, have presumed risk greater than 5 percent for a positive sentinel lymph node biopsy, and has a disease stage, grade, and Breslow thickness within the intended use of the test. The expanded LCD establishes a 0.3mm and thicker threshold for any use of the test, lower than the original coverage, according to an analyst note from SVB Leerink's Puneet Souda.
The tests covered in the LCD must have demonstrated through a technical assessment the clinical validity of analytes tested in predicting metastatic disease in peer-reviewed scientific literature, as well as utility beyond clinical, histological, and radiographical factors to accurately stratify patients into risk groups. It must also demonstrae appropriate analytical validity and performance characteristics equal to other similar, covered tests.
The LCD covers these tests generally but cites an evaluation of the DecisionDx-Melanoma test in its evidence review, and the company confirmed the gene expression profile test is included under the expanded coverage decision. Palmetto's LCD goes into effect for services covered on or after Nov. 22. Another MAC, Wisconsin Physicians Service Insurance Corporation, aligned its coverage with Palmetto's, and its LCD goes into effect the same day.
Castle Bio's test uses a patient's tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, along with sentinel lymph node positivity. Palmetto originally released a draft LCD proposing expanded coverage for the test last year.
Palmetto GBA issues final local coverage determination effective December 3, 2018
Friendswood, TX – October 18, 2018 – Castle Biosciences, Inc., the skin cancer diagnostics company providing molecular diagnostics to improve cancer management decisions, today announced Medicare coverage for the DecisionDx®-Melanoma test that predicts risk of metastatic disease and helps to guide use of sentinel lymph node biopsy (SLNB) in patients with cutaneous melanoma.
“Improved access to the DecisionDx-Melanoma test for the 59 million Medicare recipients can drive better-informed management decisions for melanoma patients and help to safely avoid costly surgical procedures,” said Derek Maetzold, President and CEO of Castle Biosciences. “Using the DecisionDx-Melanoma test to identify low-risk tumor biology and inform the discussion of SLNB options provides an important advance in the management of early stage melanoma patients.”
Palmetto GBA, a Medicare Administrative Contractor (MAC), the administrator of the Medicare MolDX® program that assesses molecular diagnostic technologies, issued a final local coverage determination (LCD) for the DecisionDx-Melanoma test effective December 3, 2018. Medicare beneficiaries will now have improved access to the test to help guide use of SLNB in the context of patient-specific management plans. The LCD provides for coverage of the DecisionDx-Melanoma test for SLNB eligible patients with T1 and T2 cutaneous melanoma tumors (2.0 mm in thickness or less, as defined in AJCC Staging Manual v8, 2017) and clinically negative sentinel node basins who are being considered for SLNB to determine eligibility for adjuvant therapy.
Approximately 12,000 patients had the DecisionDx-Melanoma test ordered in the last 12 months to better inform patient management decisions and help guide their melanoma care. This is an important milestone for the test, which is supported by more than 15 peer-reviewed publications including analytic and clinical validation, performance studies, and clinical utility in prospective and retrospective studies.
The final LCD is posted to the Medicare Coverage Database on the Centers for Medicare and Medicaid Services (CMS) website.
The DecisionDx-Melanoma test is a 31-gene expression profile (GEP) that determines a cutaneous melanoma patient’s risk for metastatic disease. The test classifies patients as having a tumor with low (Class 1) or high (Class 2) risk for developing metastasis within 5 years of diagnosis. Patients with a Class 1 tumor profile also have a low likelihood of being SLN positive. Thus, the individualized risk profile result of this test can be used to guide use of SLNB in the context of patient-specific management plans.
The use of the DecisionDx-Melanoma test to inform SLNB decision-making was validated in two multicenter, prospective cohorts totaling 1,421 patients which showed that a Class 1A test result can identify a population with a >95% likelihood of a negative SLNB (>95% negative predictive value [NPV]). For the Medicare-eligible population (65 years old and over), patients with a T1 or T2 tumor and a DecisionDx-Melanoma Class 1A result have an NPV of 98.4%. Data from retrospective studies has shown that patients with a Class 1A result have a 99.6% melanoma-specific survival rate at 5 years. Thus, the DecisionDx-Melanoma test can inform SLNB decision-making by identifying a group of patients with low-risk tumor biology who are less than 5% likely to be SLN positive. These patients have a very low likelihood for metastatic disease, and thus can safely avoid this surgical procedure, potentially reducing the SLNB rate by up to 52% in the Medicare population.
Sentinel Lymph Node Biopsy Background
SLNB is a surgical procedure generally recommended to assess prognosis of cutaneous melanoma patients. The procedure provides prognostic information and can determine eligibility for adjuvant therapies, but can be associated with complications, adding a significant economic burden to the healthcare system. Elderly patients account for a substantial proportion of patients with melanoma, and 60% of melanoma-related deaths occur in patients 65 years of age or older. However, while older age is associated with a poor prognosis, fewer elderly patients are found to be SLN positive, which indicates that the prognostic value of SLNB is limited in this population.
Current guidelines recommend that clinicians discuss and/or offer the SLNB procedure with patients who have a greater than 5% likelihood of SLN positivity, and do not recommend the procedure if a patient has a less than 5% likelihood of a positive SLN. For patients who are SLNB eligible, the DecisionDx-Melanoma test can inform SLNB decision-making by identifying a group of patients with low-risk tumor biology who are less than 5% likely to be SLN positive, and thus can safely avoid the procedure.
About DecisionDx-Melanoma
The DecisionDx-Melanoma test uses tumor biology to predict individual risk of melanoma recurrence and sentinel lymph node positivity independent of traditional factors. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in four prospective studies including 702 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,300 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.
Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multi-center and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.
About Castle Biosciences Castle Biosciences is a molecular diagnostics company dedicated to helping patients and their physicians make the best possible decisions about their treatment and follow up care based on the individual molecular signature of their tumor. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma, DecisionDx®-CMSeq; www.SkinMelanoma.com) and uveal melanoma (DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq; www.MyUvealMelanoma.com), with development programs in other underserved cancers, the most advanced of which is focused on patients with cutaneous squamous cell carcinoma. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix, Arizona. More information can be found at www.CastleBiosciences.com.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are the trademarks of Castle Biosciences, Inc. Any other trademarks are the property of their respective owners.
989X1Remote therapeutic monitoring (eg, respiratory system status, musculoskeletal system status, therapy adherence, therapy response); initial set-up and patient education on use of equipment
989X2Remote therapeutic monitoring (eg, respiratory system status, musculoskeletal system status, therapy adherence, therapy response); device(s) supply with scheduled (eg, daily) recording(s) and/or programmed alert(s) transmission to monitor respiratory system, each 30 days
989X3Remote therapeutic monitoring (eg, respiratory system status, musculoskeletal system status, therapy adherence, therapy response); device(s) supply with scheduled (eg, daily) recording(s) and/or programmed alert(s) transmission to monitor musculoskeletal system, each 30 days
989X4Remote therapeutic monitoring treatment management services, physician or other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient or caregiver during the calendar month; first 20 minutes
989X5Remote therapeutic monitoring treatment management services, physician or other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient or caregiver during the calendar month; each additional 20 minutes (List separately in addition to code for primary procedure)
Payment for Non-Opioid Products Under Section 6082 of the SUPPORT Act
The law requires that the Secretary must review payments under the OPPS and ASC for opioids and evidence-based non-opioid alternatives for pain management to ensure there are not financial incentives to use opioids instead of non-opioid alternatives. For CY 2022, CMS is proposing to modify its current policy, adopted under section 1833(t)(22)(A) and section 1833(i)(8), as added by section 6082(a) and (b), respectively, of the SUPPORT Act, to provide for separate or modified payment for non-opioid pain management drugs and biologicals that function as supplies in the ASC setting when those products meet certain criteria, as determined by CMS.
(22 )[136]Review and revisions of payments for non-opioid alternative treatments.—
(A)In general.—With respect to payments made under this subsection for covered OPD services (or groups of services), including covered OPD services assigned to a comprehensive ambulatory payment classification, the Secretary—
(i) shall, as soon as practicable, conduct a review (part of which may include a request for information) of payments for opioids and evidence-based non-opioid alternatives for pain management (including drugs and devices, nerve blocks, surgical injections, and neuromodulation) with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives;
(ii) may, as the Secretary determines appropriate, conduct subsequent reviews of such payments; and
(iii) shall consider the extent to which revisions under this subsection to such payments (such as the creation of additional groups of covered OPD services to classify separately those procedures that utilize opioids and non-opioid alternatives for pain management) would reduce payment incentives to use opioids instead of non-opioid alternatives for pain management.
(B)Priority.—In conducting the review under clause (i) of subparagraph (A) and considering revisions under clause (iii) of such subparagraph, the Secretary shall focus on covered OPD services (or groups of services) assigned to a comprehensive ambulatory payment classification, ambulatory payment classifications that primarily include surgical services, and other services determined by the Secretary which generally involve treatment for pain management.
(C)Revisions.—If the Secretary identifies revisions to payments pursuant to subparagraph (A)(iii), the Secretary shall, as determined appropriate, begin making such revisions for services furnished on or after January 1, 2020. Revisions under the previous sentence shall be treated as adjustments for purposes of application of paragraph (9)(B).
(D)Rules of construction.—Nothing in this paragraph shall be construed to preclude the Secretary—
(i) from conducting a demonstration before making the revisions described in subparagraph (C); or
(ii) prior to implementation of this paragraph, from changing payments under this subsection for covered OPD services (or groups of services) which include opioids or non-opioid alternatives for pain management.
How the Food and Drug Administration messes up approval of new drugs including the new one, aducanumab, that supposedly helps Alzheimer’s disease patients.
Pink Sheet - Breakthrough Therapy: 'A Lower Bar Of Evidence'?
Ramsey Baghdadi | February 07, 2018
Executive Summary
MedPAC meeting elicits negative view of designation from one members and no one disagreed. Should US FDA reiterate what the special designation actually means?
It may be time for the US FDA to reiterate to the public the high standard for granting a “Breakthrough Therapy” designation to a promising therapy in development.
Recent Announcements Published to "Latest Updates"
MolDX: Genomic Health™ Oncotype DX® Prostate Cancer Assay LCD Retirement - Effective June 30, 2021 This Local Coverage Determination (LCD) has been retired under contractor numbers: 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, NMI), and 01312 (NV). Read the complete update
Billing and Coding: MolDX: Testing of Multiple Genes - R1 - Effective July 22, 2021 This coverage article has been revised and published for notice under contract numbers: 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, NMI), and 01312 (NV). Read the complete update
MolDX: Oncotype DX® Genomic Prostate Score for Men with Favorable Intermediate Risk Prostate Cancer LCD Retirement - Effective June 30, 2021 This Local Coverage Determination (LCD) has been retired under contractor numbers: 01112 (NCA), 01182 (SCA), 01212 (AS, GU, HI, NMI), and 01312 (NV). Read the complete update
