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.

myCGS Portal

Customer Service

Appeals/Redeterminations

Electronic Data Interchange (EDI)

FAQs

Fee Schedules/Reimbursement

Forms

Innovations

LCDs / Medical Policies

Medical Review

News & Publications

Overpayments & Refunds

Prior Authorization

Provider Enrollment

Principles of Study Design

Medicare Administrative Contractors (MACs) develop Local Coverage Determinations (LCDs) based on clinical evidence as described in CMS’s Internet-Only Manual 100-08, Chapter 13 – Local Coverage Determinations and §13.5.3 Evidentiary Content.¹

In evaluating clinical evidence, the MACs must assess the certainty and quality of evidence. The analysis also must determine if the evidence supports a benefit to the Medicare population in terms of improving health outcomes.

There are many systems of evidence analysis that are considered by the MACs. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach has national acceptance as a system to provide guidance for rating quality of evidence and developing strength of recommendations and will be utilized in this educational article.² GRADE describes evidence analysis as a pyramid with the highest quality (but lowest volume) at the top, and lower quality (but more abundant) work at the bottom. In this model the layers from top to bottom include:

Randomized control trials (highest)

Cohort studies

Case-controlled studies

Case series and reports (lowest)

Systematic reviews and meta-analysis are used to scrutinize evidence.³

Assessing Individual Studies

Several criteria determine weaknesses and strengths of clinical research. High confidence studies share study designs that offer scientific validity that the outcome of interest is related to the intervention that there is a causal relationship between the two.

Consideration is given to each of the GRADE domains for assessing the certainty in the evidence such as risk of bias, imprecision, inconsistency, indirectness, publication bias, large effects, dose response gradients, and residual plausible opposing bias. Different terminology may be used to describe these domains especially as there are multiple tools (besides GRADE) for the assessment that provide slight variation in these terms.⁴

Many factors can introduce bias into a study and measures to reduce bias are essential to high-quality research. Characteristics of high-quality studies include:

Randomization- similar subjects are randomly assigned to intervention vs. control. Adequate control group and proper randomization are necessary to determine if the outcome of interest is due to the intervention or chance.
Well-designed prospective studies allow control of variables that cannot be accounted for when relying on historical populations and improve confidence in the study.
Adequate sample size to determine statistical significance. The data analytics within the study should explain how the sample size was calculated and the sample must be large enough to eliminate chance as an explanation for the study findings.
Proper masking (blinding) to ensure study participants and investigators do not know to which group the subjects were assigned to (intervention or control).
Reducing potential bias is important in study design: types of bias that may impact an investigation include selection, performance, detection, attrition, reporting bias and others.⁵
Assessing the impact of confounding variables that can distort measurements of the outcome of interest of the study, introduce bias and mislead results. It is particularly important to assess the impact of confounding in observational studies. Factors such as age, sex, co-morbidities, co-interventions, dosing, and other factors may impact the potential of the intervention to be the causal effect within the study.
Generalizability is how well the study can be applied to a broader population and is necessary to consider how well the study can be applied to the population of interest. The applicability of the results to the Medicare population is considered.
Clinically significant proper outcome measures. Risk and benefit assessments aid in determining if the health care outcomes experienced by patients from the intervention are high priority such as reducing disability, morbidity, mortality and improving quality of life, while balancing the risk of harm associated with the intervention.⁶
Appropriate length- the length of the study follow-up is important to ensure the duration is sufficient to understand the true outcome of the intervention as well as late presenting complications.
Accurate results- another important factor is how the outcome is measured and if the modality used to collect this data is sufficient for accurate results.

All of the above characteristics of high-quality studies and measures to reduce bias contribute to understanding if a study informs on the potential benefit of the intervention within the Medicare population.

Real world evidence (RWE) and real-world data (RWD) describe data that is collected outside of clinical trials from various sources such as medical records, claims data, product or disease registries and other data gathering sources like digital health technologies. These are often retrospective or observational studies. While comparative effectiveness research can be conducted from RWD sets there are many challenges to overcome. Without a control group, it is difficult to attribute outcomes to the product under investigation definitively. Controlling variables, accounting for missing data, reducing bias, and ensuring adequate group sizes are complex tasks. A benefit to RWE and RWD is that it can offer valuable insights into patients excluded in clinical trials. Therefore RWD/RWE may support the use of these products, fill in gaps in evidence and address real-life settings. RWE must be peer reviewed and published to be considered in the Summary of Evidence of an LCD and appropriately referenced in the Bibliography of the LCD.

Further details on analysis of evidence review can be found in this proposed CMS document at: https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?mcdid=34&docTypeId=-1&status=all&sortBy=title&bc=16 [cms.gov].⁷

For definitions see the GRADE HANDBOOK: Glossary of terms and concepts.5

21st Century Cures Act. https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf. Accessed 6/3/24.
GRADE. https://www.gradeworkinggroup.org/. Accessed 6/3/24.
Kirmayr M, Quilodrán C, Valente B, Loezar C, Garegnani L, Franco JVA. The GRADE approach, Part 1: how to assess the certainty of the evidence. Medwave. 2021;21(2):e8109.
Schünemann HJ BSea. The development methods of official GRADE articles and requirements for claiming the use of GRADE – A statement by the GRADE guidance group. J Clin Epi 2023.
Introduction to GRADE Handbook. https://gdt.gradepro.org/app/handbook/handbook.html#h.xivvyiu1pr3v. Published 2013. Updated 10/2013. Accessed 6/3/24.
CMS. APPENDIX A: General Methodological Principles of Study Design. CAG-00461N Web site. https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id166b.pdf. Accessed 6/2/24.
CMS. (PROPOSED) CMS National Coverage Analysis Evidence Review. https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?mcdid=34&docTypeId=-1&status=all&sortBy=title&bc=16. Published 2023. Updated 6/22/23. Accessed 6/3/24.

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")

Principles of Study Design

spacer