License for Use of "Physicians' Current Procedural Terminology", (CPT) Fourth Edition

End User/Point and Click Agreement: CPT codes, descriptions and other data only are copyright 2009 American Medical Association (AMA). All Rights Reserved (or such other date of publication of CPT). CPT is a trademark of the AMA.

You, your employees and agents are authorized to use CPT only as contained in the following authorized materials including but not limited to CGS fee schedules, general communications, Medicare Bulletin, and related materials internally within your organization within the United States for the sole use by yourself, employees, and agents. Use is limited to use in Medicare, Medicaid, or other programs administered by the Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement.

Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CPT for resale and/or license, transferring copies of CPT to any party not bound by this agreement, creating any modified or derivative work of CPT, or making any commercial use of CPT. License to use CPT for any use not authorized here in must be obtained through the AMA, CPT Intellectual Property Services, 515 N. State Street, Chicago, IL 60610. Applications are available at the AMA website.

This product includes CPT which is commercial technical data and/or computer data bases and/or commercial computer software and/or commercial computer software documentation, as applicable which were developed exclusively at private expense by the American Medical Association, 515 North State Street, Chicago, Illinois, 60610. U.S. Government rights to use, modify, reproduce, release, perform, display, or disclose these technical data and/or computer data bases and/or computer software and/or computer software documentation are subject to the limited rights restrictions of DFARS 252.227-7015(b)(2)(June 1995) and/or subject to the restrictions of DFARS 227.7202-1(a)(June 1995) and DFARS 227.7202-3(a)June 1995), as applicable for U.S. Department of Defense procurements and the limited rights restrictions of FAR 52.227-14 (June 1987) and/or subject to the restricted rights provisions of FAR 52.227-14 (June 1987) and FAR 52.227-19 (June 1987), as applicable, and any applicable agency FAR Supplements, for non-Department Federal procurements.

AMA Disclaimer of Warranties and Liabilities.

CPT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. AMA warrants that due to the nature of CPT, it does not manipulate or process dates, therefore there is no Year 2000 issue with CPT. AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. No fee schedules, basic unit, relative values or related listings are included in CPT. The AMA does not directly or indirectly practice medicine or dispense medical services. The responsibility for the content of this file/product is with CGS or the CMS and no endorsement by the AMA is intended or implied. The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice if you violate its terms. The AMA is a third party beneficiary to this Agreement.

CMS Disclaimer

The scope of this license is determined by the AMA, the copyright holder. Any questions pertaining to the license or use of the CPT must be addressed to the AMA. End Users do not act for or on behalf of the CMS. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE CPT. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL CONTAINED ON THIS PAGE. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

This license will terminate upon notice to you if you violate the terms of this license. The AMA is a third party beneficiary to this license.

POINT AND CLICK LICENSE FOR USE OF "CURRENT DENTAL TERMINOLOGY", ("CDT")

End User License Agreement

THE LICENSE GRANTED HEREIN IS EXPRESSLY CONDITIONED UPON YOUR ACCEPTANCE OF ALL TERMS AND CONDITIONS CONTAINED IN THIS AGREEMENT. BY CLICKING BELOW ON THE BUTTON LABELED "I ACCEPT", YOU HEREBY ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD AND AGREED TO ALL TERMS AND CONDITIONS SET FORTH IN THIS AGREEMENT.

IF YOU DO NOT AGREE WITH ALL TERMS AND CONDITIONS SET FORTH HEREIN, CLICK BELOW ON THE BUTTON LABELED "I DO NOT ACCEPT" AND EXIT FROM THIS COMPUTER SCREEN.

IF YOU ARE ACTING ON BEHALF OF AN ORGANIZATION, YOU REPRESENT THAT YOU ARE AUTHORIZED TO ACT ON BEHALF OF SUCH ORGANIZATION AND THAT YOUR ACCEPTANCE OF THE TERMS OF THIS AGREEMENT CREATES A LEGALLY ENFORCEABLE OBLIGATION OF THE ORGANIZATION. AS USED HEREIN, "YOU" AND "YOUR" REFER TO YOU AND ANY ORGANIZATION ON BEHALF OF WHICH YOU ARE ACTING.

Subject to the terms and conditions contained in this Agreement, you, your employees, and agents are authorized to use CDT-4 only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. Use of CDT-4 is limited to use in programs administered by Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to ensure that your employees and agents abide by the terms of this agreement. You acknowledge that the ADA holds all copyright, trademark and other rights in CDT-4. You shall not remove, alter, or obscure any ADA copyright notices or other proprietary rights notices included in the materials.
Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CDT-4 for resale and/or license, transferring copies of CDT-4 to any party not bound by this agreement, creating any modified or derivative work of CDT-4, or making any commercial use of CDT-4. License to use CDT-4 for any use not authorized herein must be obtained through the American Dental Association, 211 East Chicago Avenue, Chicago, IL 60611. Applications are available at the American Dental Association website.
Applicable Federal Acquisition Regulation Clauses (FARS)\Department of Defense Federal Acquisition Regulation Supplement (DFARS) Restrictions Apply to Government use. Please click here to see all U.S. Government Rights Provisions.
ADA DISCLAIMER OF WARRANTIES AND LIABILITIES. CDT-4 is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. No fee schedules, basic unit, relative values or related listings are included in CDT-4. The ADA does not directly or indirectly practice medicine or dispense dental services. The sole responsibility for the software, including any CDT-4 and other content contained therein, is with (insert name of applicable entity) or the CMS; and no endorsement by the ADA is intended or implied. The ADA expressly disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice to you if you violate the terms of this Agreement. The ADA is a third-party beneficiary to this Agreement.
CMS DISCLAIMER. The scope of this license is determined by the ADA, the copyright holder. Any questions pertaining to the license or use of the CDT-4 should be addressed to the ADA. End users do not act for or on behalf of the CMS. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE CDT-4. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL COVERED BY THIS LICENSE. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

The license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. If the foregoing terms and conditions are acceptable to you, please indicate your agreement by clicking below on the button labeled "I ACCEPT". If you do not agree to the terms and conditions, you may not access or use the software. Instead, you must click below on the button labeled "I DO NOT ACCEPT" and exit from this computer screen.

Print | Bookmark | Email | Font Size: + | –

September 8, 2016

Comments for L36675 MolDX- CDD: ProMark Risk

Below are the comments MolDX received during the open comment period for MolDX- CDD: ProMark Risk L36675.

Comment 1: Criteria for Coverage We understand the rationale for consistency in the coverage criteria of the prognostic assays that have received LCDs under MolDx. We would, however, ask Palmetto to evaluate whether the‘Patient Stage’ criteria should be modified to include certain men with intermediate risk prostate cancer. The most recent NCCN Prostate Cancer Guidelines1 (NCCN Prostate Cancer Guidelines Version 2.2016) now include a statement about the use of AS in certain intermediate risk men. On PROS-4 of these guidelines it is noted that, “Patients with favorable intermediate-risk prostate cancer (predominant Gleason grade 3 [i.e.. Gleason score 3+4 = 7], and percentage of positive biopsy cores <50%, and no more than one NCCN intermediate risk factor) may be considered for active surveillance.” Given that men fitting these criteria may now be making choices about active surveillance, we believe it is important to allow access to advanced prognostic assays that can inform these decisions. We recommend that the LCD reference the NCCN Version2.2016 guidelines.

Response: NCCN version 3.2016 specifies “Patients with favorable intermediate-risk prostate cancer (predominate Gleason grade 3 [i.e., Gleason score 3+4=7], and percentage of positive biopsy cores <50percent, and no more than one NCC intermediate risk factor) may be considered for active surveillance.” Published data does not include the group of patients and no nationally recognized professional organization includes this group of patients in their AS recommendation. When published data supports inclusion of intermediate risk patients and their national guidelines recommend AS, the policy can be amended.

Comment 2: Certification and Training Registry (CTR) We agree with the goals of the proposed CTR and will work with MolDx on the implementation of the training and data collection requirements under the CTR. We are hopeful that the accumulation of additional data on the impact of ProMark and other advanced prognostic assays via the MolDx CTRs for prostate cancer will enable a transition from the CDD structures in the future.

Response: Your comment is appreciated.

Comment 3: Correction Please change the format of the company name from MetaMark to Metamark in the LCD (the second ‘m’ should be lowercase).

Response: Correction made in LCD.

Comment 4: On the other draft Urologic LCD, Promark Risk Score for prostate cancer (DL 36704), I would ask that you consider adding Gleason 3+4, small volume cancer, PSA <10 as "low risk disease" and therefore a covered indication. The policy as written, divides risk as Gleason 6 or Gleason 7 (low or intermediate risk). Unfortunately, not all Gleason 7 tumors are the same: the "7" is the sum or two components and Gleason 3+4 acts as a Gleason 3+3 (6) while Gleason 4+3 acts more aggressively. Thus, the LCD is too simplified and should recognize that a different approach may be reasonable for the lower risk of these two. Thus, an elderly man with PSA<10, T1c-T2 disease, small volume Gleason 3+4 cancer on biopsy should be covered for Promark testing. In fact, this is the most efficient use of this test (moderately older man with more than 10 year life expectancy, small volume cancer, Gleason 3+4, PSA <10 who is considering Active Surveillance or more aggressive treatment). With that minor change, the LCD is fine. Extending this argument, Gleason 3+4, small volume, PSA<10 should also be covered for Prolaris testing (another assay performed on biopsy tissue to further inform the decision to actively treat or watch with Active Surveillance) considering this as low risk disease. This LCD which is already approved should be Reconsidered and Amended.

Response: The following response to comment address comment received by Noridian Administrative Services on draft policy DL36704. NCCN version 3.2016 specifies “Patients with favorable intermediate-risk prostate cancer (predominate Gleason grade 3 [i.e., Gleason score 3+4=7], and percentage of positive biopsy cores <50percent, and no more than one NCC intermediate risk factor) may be considered for active surveillance.” [Emphasis added by author.] Published data does not include this group of patients and no nationally recognized professional organization includes this group of patients in their AS recommendation. When published data supports inclusion of intermediate risk patients and their national guidelines recommend AS, the policy can be amended for ProMark, Prolaris or other comparable assays.

License for Use of "Physicians' Current Procedural Terminology", (CPT) Fourth Edition

AMA Disclaimer of Warranties and Liabilities.

CMS Disclaimer

POINT AND CLICK LICENSE FOR USE OF "CURRENT DENTAL TERMINOLOGY", ("CDT")

Comments for L36675 MolDX- CDD: ProMark Risk

spacer