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.

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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.

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Molecular Pathology (MoPath) Consideration Process: Coverage and Reimbursement

To determine coverage for molecular pathology services, a Technical Assessment (TA) will be required for all new tests/assays prior to submission of claims and for any procedure/service determined by CGS to need additional scientific documentation. To request a Technical Assessment, submit a comprehensive set of supporting documents via 615.664.5920. Please address your fax cover sheet to J-15 MoPath Consideration - Attn: Earl Berman, MD.

CGS will review all submitted requests to determine if the test/assay is reasonable and necessary and demonstrates improved patient outcomes. We recognize that it may be difficult to obtain and demonstrate improved patient outcomes for new and molecular tests/assays. Therefore, in conjunction with the analytical and clinical validity evidence, a minimum of one well-designed, peer-reviewed publication will be considered for coverage. The following published documentation may be considered in evaluating clinical utility:

Retrospective studies
White-papers written by national societies and recognized experts
Virtual or theoretical models that have been vetted in the scientific literature
Abstracts

Note: The onus is on the laboratory provider to make their best case using any and all evidence to support clinical utility.

The submitted material should be organized for submission in the following order:

Diagnostic test/assay, lab/manufacturer, point of contact (POC) and email address; or diagnostic test/assay name, provider name, provider NPI number, POC and email address
Names of comparable assays/services, if available, with similarities or variances
An executive summary with description of assay, summary paragraph for each scientific article, complete list and electronic copies of publications that support coverage
Analytical validity evidence (published or in-house) including:

Steps in specimen acquisition and handling
Step-by-step procedure with designation of time and resources
Representative positive, negative and indeterminate patient test results

Clinical validity evidence (published) including:

Sensitivity, specificity, positive predicted value, negative predicted value, accuracy, precision and reproducibility
Minimum standard of two published, peer-reviewed articles

Clinical utility (published) including:

Two (preferred) well-designed, controlled, published articles in peer-reviewed journals
Sufficient numbers of subjects to establish clinical significance and includes Medicare population in study group
Demonstrates change in physician treatment behavior based on the assay results and/or improved patient outcomes

Provide list price; prices paid by other insurers
List proposed CPT codes to bill service
Identify if the test has been certified or pending certification from New York State (NYS) or any other assessment entity. Although CGS will not perform an additional TA on NYS certified tests, this information will be used to make a coverage determination. It is not our intent to burden laboratory providers. If you have received Technical Assessments through another entity, please fax this information to 615.664.5920.
Ensure all documents/files are complete, and:

Fax documents to 615.664.5920
Enter in the subject line: test/assay name, followed by “coverage request” (e.g., EJTEST Coverage Request)
If your submission is too large for sending via fax, please mail a flash-drive, loaded with the complete submission, to the following address:

CGS
Attn: Earl Berman, MD
J-15 MoPath Consideration
26 Century Blvd STE ST610
Nashville, TN 37214-3685

Note: For this program, 'published' refers only to articles cited in Pubmed. Technical Assessments and 'white' papers by recognized experts, published opinions and treatment guidelines (College of American Pathology, American Society of Clinical Oncologist, American Society of Hematology, etc.) are considered in the coverage evaluation but are not binding to the contractor. Oral presentations and testimonials will not be considered.

Based on the determination for each assay/test reviewed, CGS will publish information to inform the provider community of the following: coverage, coverage with restrictions, non-coverage and coding guidelines.

Pricing Determinations
CMS implements 'crosswalk' and 'gap-fill' processes to calculate reimbursement for new or substantially revised AMA CPT codes.

The “crosswalk” process is used if a new test is comparable to an existing test, code description, multiple existing codes or a portion of an existing test code. The new test code is assigned the local fee schedule amount and the national limitation amount (NLA) of the existing test code(s). The crosswalk to multiple existing test codes is determined by the local fee schedule amount and the NLA amount based on a blend of payment amounts.

The “gapfill” process is used when no comparable existing test is available. CMS instructs contractors to determine a carrier-specific amount for use in the first year the new code is effective. The Code of Federal Regulations (42 CFR) directs contractors to examine:

Charges for the test and routine discounts to charges
Resources required to perform the test
Payment amounts determined by other payers
Charges, payment amounts and resources required for other tests that may be comparable

After the first year, the carrier-specific amounts are used to calculate the NLA for subsequent years.

Since CMS has not published reimbursement criteria for “not otherwise classified” (NOC) codes, CGS will consider the most appropriate process with the following conditions:

CGS is not bound to a reimbursement established by another contractor prior to jurisdictional award.
CGS may decide to continue the previously established reimbursement during a jurisdictional consolidation, but may choose to reassess reimbursement following the consolidation.
CGS encourages providers submitting NOC codes to obtain an AMA CPT code.
Providers may use the standard appeals process to request review of the amount reimbursed for NOC codes.

Reference:

Appeals process: CMS Medicare Claims Processing Manual (Pub. 100-04), chapter 29, section 200

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")

Molecular Pathology (MoPath) Consideration Process: Coverage and Reimbursement

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