Coding Change Application Category I CPT Code(s) Category III CPT Code(s) – Emerging Technology American Medical Association, Current Procedural Terminology (CPT®) Application Submission Requirements All CPT Code Change applications are reviewed and evaluated by CPT staff, the CPT/HCPAC Advisory Committee, and the CPT Editorial Panel. Strict conformance with the following is required for review of a code change application: Submission of a complete application, including all necessary supporting documents; Adherence to all posted deadlines; Cooperation with requests from CPT staff and/or Editorial Panel members for clarification and information; and Compliance with CPT Lobbying Statement. (press “Ctrl” key and click link) Application Review Links (Press “Ctrl” key and click link) Applicant’s Name Question 1 Descriptor Typical Patient Description General Criteria for Category I and Category III Codes All Category I or Category III code change applications must satisfy each of the following criteria: The proposed descriptor is unique, well-defined, and describes a procedure or service which is clearly identified and distinguished from existing procedures and services already in CPT; The descriptor structure, guidelines and instructions are consistent with current Editorial Panel standards for maintenance of the code set; The proposed descriptor for the procedure or service is neither a fragmentation of an existing procedure or service nor currently reportable as a complete service by one or more existing codes (with the exclusion of unlisted codes). However, procedures and services frequently performed together may require new or revised codes; The structure and content of the proposed code descriptor accurately reflects the procedure or service as typically performed. If always or frequently performed with one or more other procedures or services, the 1 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 descriptor structure and content will reflect the typical combination or complete procedure or service; The descriptor for the procedure or service is not proposed as a means to report extraordinary circumstances related to the performance of a procedure or service already described in the CPT code set; and The procedure or service satisfies the category-specific criteria set forth below. 2 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 Category Specific Requirements A. Category I Criteria A proposal for a new or revised Category I code must satisfy all of the following criteria: All devices and drugs necessary for performance of the procedure or service have received FDA clearance or approval when such is required for performance of the procedure or service; The procedure or service is performed by many physicians or other qualified health care professionals across the United States; The procedure or service is performed with frequency consistent with the intended clinical use (i.e., a service for a common condition should have high volume, whereas a service commonly performed for a rare condition may have low volume); The procedure or service is consistent with current medical practice; The clinical efficacy of the procedure or service is documented in literature that meets the requirements set forth in the CPT code change application. B. Category III Criteria The following criteria are used by the CPT/HCPAC Advisory Committee and the CPT Editorial Panel for evaluating Category III code applications: The procedure or service is currently or recently performed in humans, AND At least one of the following additional criteria has been met: The application is supported by at least one CPT or HCPAC advisor representing practitioners who would use this procedure or service; OR The actual or potential clinical efficacy of the specific procedure or service is supported by peer reviewed literature which is available in English for examination by the Editorial Panel; OR There is a) at least one Institutional Review Board approved protocol of a study of the procedure or service being performed, b) a description of a current and ongoing United States trial outlining the efficacy of the procedure or service, or c) other evidence of evolving clinical utilization . 3 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 Cover Sheet for CPT® Coding Change Application It is recommended that applicants consult with national medical specialties and other qualified healthcare professional organizations that will typically provide the proposed procedure(s)/service(s) requested in this application to obtain comments on the type of work and potential for development of relative value units (RVUs) by the AMA Specialty Society RVS Update Committee (RUC). With recognition of scheduling needs of the specialty societies, when assistance from a specialty society will be sought, it is highly recommended that the applicant plan for enough time for scheduling such discussions in advance of the application deadline to avoid violation of the AMA Lobbying Policy. Interested national specialty organizations may have deadlines prior to the CPT application submission deadline to allow for application review and comment. Date: Change Requested by: Name(s): Organization: Address: City: State: Zip Code: Telephone: Email: Please include this cover sheet with your application. Top ↑ 4 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 NOTICE: Individuals or organizations that believe they may be affected by a decision of the CPT Editorial Panel on your code change application may request review of your application in advance of the CPT Editorial Panel meeting. To ensure transparency in the CPT Editorial Panel process, the AMA will provide your code change application and supporting documentation to such interested parties (provided they can demonstrate a valid interest) so they can be prepared, if desired, to comment at the CPT Editorial Panel meeting from the floor microphones or to submit written comments in advance of the meeting. If the AMA receives a request from an interested party to review this code change application, you will be notified of that request and given five business days to submit a redacted version of the application that deletes any confidential and proprietary information. Failure to respond in that time will be deemed by the AMA as your approval to release the full application. The CPT Editorial Panel and CPT/HCPAC Advisory Committee will be provided the unredacted version of the application. Yes. I approve of sharing this application in full to an interested party that requests to review the application. This form plays a vital role in maintaining and increasing the efficiency of the CPT process. It can be used to submit a coding change application for either Category I or Category III CPT codes. For Pathology and Molecular Pathology codes, please utilize the appropriate application form. As you fill out the form, please consider which category of code change you are requesting. For more information and code criteria for the code categories, please see the Code Change Application Instructions. For other forms, see the AMA CPT website. (Press “Ctrl” key and click link) When requesting a new code, the entire form should be completed. When submitting a request for multiple new codes, a response should be provided for each new code. The applicant may need to create additional lines and pages as needed. Refer to the Code Change Application Instructions if necessary. Once the application is completed, submit the form electronically to the AMA. (See information on submitting applications on the last page for instructions on uploading applications, literature supplements and other documents.) You may withdraw your application up until the time that the CPT Editorial Panel takes up the agenda item at a CPT Editorial Panel meeting. At that time, the discussion falls under the authority of the Editorial Panel, and the application may not be withdrawn. If the CPT Editorial Panel determines that additional information or evaluation is warranted, consideration of your application may be tabled until later during that meeting or postponed until time certain (a specific future CPT meeting) or to time uncertain. 5 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 Code Descriptor Formatting Instructions When entering code information on this application, please use the formatting shown below., When ADDING codes, this will require specifying the recommended terminology (code descriptor) for the proposed CPT code and the placement of the proposed code in the current text of CPT (list section, subsection as illustrated below). When requesting a code REVISION you should use strike-pouts for deletions and underlining for additions/revisions (example: 33420 Valvotomy, mitral valve (commissurotomy); closed heart). You may copy and paste the following symbols as appropriate: This symbol precedes a new code (example: 1234X) ▲ This symbol precedes a revised code (example: ▲12345) This symbol indicates moderate sedation is inherent in the procedure (example: 12345) This symbol indicates an add-on code to be reported with another code (example: 12345) Example: Surgery Digestive System Stomach Incision D12345 Old procedure (Code 12345 has been deleted. To report, see 1234X1-1234X2) 1234X1 New procedure first 1234X2 each additional (list separately in addition to primary procedure) (Report code 1234X2 in conjunction with code 1234X1) return 6 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 1. Does the procedure/service involve the use of a drug, vaccine product* or device that requires approval from the Food and Drug Administration (FDA)? Yes (go to 2a.) No (skip to 3.) * Applications requesting establishment of CPT codes for vaccine products will not be considered until evidence substantiating completion of Phase III Clinical Trials and review of unblinded data is submitted to AMA. However, coding applications may be considered prior to submission of the Biologic License Application (BLA) to the FDA. 2a. If approval is necessary, have all devices and drugs necessary for performance of the procedure or service received FDA clearance or approval when such is required for performance of the procedure or service? Yes FDA has approved all necessary aspects of the service. No Some necessary element of the service has not received FDA approval (Provide details) 2b. Does the procedure/service utilize a humanitarian use device (HUD) as defined by FDA? Yes (go to 2c.) No (skip to 3.) 2c. Has FDA approval for humanitarian device exemption (HDE) been received authorizing the marketing of the humanitarian use device? Yes (Submit documentation of the FDA approval with the application) No Top ↑ 7 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 3. Indicate the specific reasons why this code change is necessary (rationale). For example, “This is a new procedure, not described in CPT”. Avoid non-rationales. Reasons like “no-code currently available” or “need new code” do not describe the clinical reason for which you are requesting a coding revision. 4. Following the Code Descriptor Formatting Instructions (press “Ctrl” key and click link) on the page 5 of this application form, specify the proposed new, revised and/or deleted codes, descriptors, inclusionary and exclusionary parentheticals and guidelines (as applicable) in the box below. List all current codes related to your request, not just the individual code changes. (Refer to the code change application instructions for more detailed information.) 5. Has the clinical efficacy of the procedure/service for which you are requesting a code change been documented in literature provided with this application? Yes No Top ↑ 8 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 6. For each NEW and/or REVISED code, indicate which CPT or HCPCS Level II code(s) is currently being used for reporting and specify why each current code is inadequate to describe the new and /or revised procedure/service. 7. For each NEW and/or REVISED code, please estimate the percentage of times a current code(s) is reported that would now be reported using the proposed new and/or revised code. Example: Current code 12345 will now be reported by 123X1 30% of the time and 123X2 70% of the time. 8. For each NEW and/or REVISED code, identify the major differences with other related codes already in CPT. 9 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 9. Provide a list of CPT codes which are an integral (inherent) part of the proposed NEW and/or REVISED code(s). This list should include all CPT codes that would represent unbundling if reported in addition to the proposed new and/or revised codes. 10. Will the proposed NEW and/or REVISED code(s) typically (more than 50% of the time) be reported on the same date with other CPT codes(s)? Or will any current CPT code(s) be reported typically (more than 50% of the time) with the proposed NEW and/or REVISED code(s)? No Yes Please specify below why the procedure(s)/service(s) are reported using multiple codes instead of just one code (Check all that apply.) The code is an add-on code or a base code expected to be reported with an add-on code. Different providers work together to accomplish the procedure/service; each provider reports his/her part of the work using different codes. Multiple codes allow flexibility to describe exactly what components of the procedure/service have been performed. Multiple codes are used to maintain consistency with similar codes. Historical precedents. Other. Please explain. 10 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 11. CPT does not set a global period. However, to assist the CPT Editorial Panel in consideration of the extent of total work involved in each proposed NEW code, select a recommended global period. NOTE: Information provided on this application has no binding effect on the Centers for Medicare and Medicaid Services and other payers in assignment of global periods. 000 (0 days of post procedure work included) 010 (10 days of post procedure work included) 090 (90 days of post procedure work included) ZZZ (add-on code) XXX (global period does not apply) What is the rationale for this global period recommendation? (e.g., Is this the same global period as similar codes? Will the proposed procedure(s)/service(s) require related post-service inpatient and or outpatient follow-up visits?) 12. For each proposed NEW code that may have a global period of 000, 010 or 090, do you request the code be modifier 51 exempt (i.e., added to Appendix E)? Yes No 11 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 13. What is the typical site of service for each proposed NEW code(s)? (check all that apply) Hospital inpatient Skilled nursing facility Hospital outpatient Nursing facility Ambulatory surgical center Assisted living facility Emergency department Patient’s home Office Independent laboratory Inpatient Psychiatric Facility Other, specify below. 14. Indicate the diagnoses (ICD codes) or conditions that the service(s) or procedure(s) described by the proposed NEW code(s) are designed to diagnose/treat. 12 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 15. What is the prevalence of the disease(s) that the service(s) or procedure(s) described by the proposed NEW code(s) is/are designed to diagnose/treat? Please quantify when possible (e.g., patients per year; admissions per year). 16. For how many years has the service(s) or procedure(s) described by the proposed NEW or REVISED code(s) been provided for patients? Indicate your source. 17. Please identify the specialties or subspecialties that might perform the service(s) or procedure(s) described by the proposed NEW code(s). 13 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 18. Are the service(s) or procedure(s) described by the proposed NEW code(s) performed widely across the United States? Yes. Please provide the source(s) for all volume, frequency and distribution statements (e.g. published epidemiology, registries, sales statistics) No. Only at limited centers/locations. Please explain below. 19. Do many physicians and/or other qualified health care professionals provide the service(s) or procedure(s) described by the proposed NEW code(s)? Yes. Please provide the source(s) for all volume, frequency and distribution statements (e.g., published epidemiology, registries, sales statistics) No. Please explain below. 14 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 20. How often do individual physicians and/or other qualified health care professionals personally perform the service(s) or procedure(s) described by the proposed NEW code(s) in a 12 month period? Commonly Sometimes Rarely 21. How often was the service(s) or procedure(s) for each proposed NEW code provided nationally in the most recent one-year period? 22. Are you aware of any practice parameters/guidelines or policy statements about the service(s) or procedure(s) described by the proposed NEW code(s)? Yes. Please specify below. No Don’t Know 15 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 23. For each proposed NEW and/or REVISED code(s), provide a clinical vignette that describes the typical patient who would receive the procedure/service including diagnosis and relevant conditions. Please refer to the sample format and examples of appropriate clinical vignettes included in the code change application instructions. NOTE: This same vignette will be used during the development of work relative value units (RVUs) by the AMA/Specialty Society RVS Update Committee (RUC), if the service requires RUC review. It is important that the description of the typical patient make apparent the typical degree of complexity of the patient receiving this procedure/service. 24. For each proposed NEW and/or REVISED code(s), provide a brief description of the procedure/service performed by the physician or other qualified health care professional. Please refer to the sample format and examples of appropriate descriptions of service included in the code change application instructions. This should be a summary description and should not contain the details for pre, intra and post service breakdowns that are required as part of the AMA/Specialty Society RVS Update Committee (RUC). It is important that the description of the service make apparent the services that are integral or separately reported. If the description includes services that are reported separately, please clearly indicate this separate reporting. If more than one physician or other qualified health care professional is involved in the provision of the total service, please indicate who does what. Top ↑ 16 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 25a. Please provide electronic (PDF or Word documents) copy(s) (and internet addresses, if available) of literature to support your application, and cite the author, title, journal, year, volume and page(s) in the “Publication Details and Attributes Grid” (press “Ctrl” key and click link) (PDA grid) that follows. Each item of submitted literature shall be identified in the PDA grid according to each of the following requirements: 1. Identify the Level of Evidence by selecting a level from the LOE table below; 2. Identify whether this is a U.S. based journal or a non-U.S. based journal, and identify whether the population studied is U.S. or non-U.S. or both; 3. Identify the number of patient studies (total of all group(s) including controls) and indicate whether study is a prospective study; 4. Provide a concise “relevance statement”. 5. Provide up to 5 references, of which at least 3 report the procedure/service in a U.S. patient population. Of these, at least 2 articles must report different patient populations or have different authors (no overlapping patient populations or no overlapping authors). Articles submitted with the designation of “Confidential” will not be accepted nor included in the supporting literature reviewed by the CPT Editorial Panel. Any “in press” manuscripts that are submitted will only be appropriate for consideration by the Panel if accompanied by the letter from the editor/publisher of the applicable journal informing the author that the manuscript has been accepted for publication in its final form, subject only to final copy editing. It is the responsibility of the submitter to ensure that such submission to CPT (despite its very limited use by the Editorial Panel) does not jeopardize publication of the article being considered. Literature Criteria Definitions: New Technology: Individuals or organizations putting forth Code Change Applications will be required to specifically indicate the pathway for FDA approval or clearance. Services or procedures requiring devices or other technology necessitating the following Food and Drug Administration (FDA) pathways are defined for CPT literature requirements as those involving “new” technology: 1. Premarket Approval (PMA) or Investigational Device Exemption (IDE) 2. Panel Track Submission 3. DeNovo 510(k) 17 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 Existing or Non-Contributory Technology: Services or procedures which are approved or cleared via other FDA requirements (e.g., traditional 510(k)) or those which do not involve technology are defined for CPT literature requirements as those where technology is “existing or non-contributory.” Most CPT Code Change Applications currently fall within this category. Limited, Specialized or Humanitarian Utilization: Only very few Code Change Applications are anticipated to be designated by this special status, intended to maintain the integrity of CPT literature requirements, but also recognize that such requirements may be impossible to meet for very unique service or procedures. To qualify for this special status, individuals or organizations submitting Code Change Applications must provide documentation of at least one of the following: 1. Evidence that the device or technology involved has been deemed by the FDA to have met criteria for a “Humanitarian Device Exemption.” 2. Proof that the service or procedure is used primarily for humanitarian reasons or is reserved for unique, small and/or underserved populations is the responsibility of requester. Using this level of proof would make it impossible to conduct research to meet CPT literature requirements for more typical or traditional services or procedures. Examples might include surgical procedures to repair rare congenital heart defects or those required to address other rare conditions. Individuals or organizations seeking this status as part of a Code Change Application would be required to provide compelling evidence to the CPT Editorial Panel that the service or procedure for which they seek a code or codes merits this special designation. The burden of evidence for assignment of this status would fall entirely on the requesting individual or organization, and the decision to assign this very unique status rests entirely on the CPT Editorial Panel. Please note that submittal of articles meeting the minimum literature requirements specified in this application does not necessarily mean that clinical efficacy has been established as required by the Category I criteria. Whether clinical efficacy has been established in the literature is a judgment reserved for the CPT Editorial Panel. 18 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 The following includes a listing of the utilization and technology types that best describe the procedure that is being requested. General Guidelines for inclusion of the articles should be chosen from one of the four types of procedures as listed in the following: Limited, Specialized or Humanitarian Existing or NonContributory New Existing or NonContributory 5 5 5 3-5 Minimum # with U.S. Patient Populations: 3 3 2 1 Minimum # with Different Patient Populations: 2 2 1 1 Minimum Level of Evidence for at least One Article IIa IIIa/IIIb IIb IV Utilization Limited, Specialized or Humanitarian Typical New # of Peer-Reviewed Publications: Category I Literature Requirements Technology Typical Make an “X” in the box for the type of utilization and technology that best fits the procedure/literature being requested. 19 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 25b. For Category III codes, please reference studies or research performed by national organizations if available. The following is used as formalized criteria by the CPT Advisory Committee and the CPT Editorial Panel for evaluating Category III code applications, and includes identification of the following elements as guidelines for establishment of a Category III code: The procedure or service is currently or recently performed in humans; AND At least one of the following additional criteria has been met: The application is supported by at least one CPT or HCPAC advisor representing practitioners who would use this procedure or service; OR The actual or potential clinical efficacy of the specific procedure or service is supported by peer reviewed literature which is available in English for examination by the Editorial Panel; OR There is a) at least one Institutional Review Board approved protocol of a study of the procedure or service being performed. b) a description of a current and ongoing United States trial outlining the efficacy of the procedure or service; or c) other evidence of evolving clinical utilization. Level of Evidence Table – LOE Level Short Description (based on Oxford Centre 2009) Ia Evidence obtained from systematic review of randomized controlled trials Ib Evidence obtained from an individual randomized controlled trial IIa Evidence obtained from systematic review of cohort studies IIb Evidence obtained from an individual cohort study IIIa Evidence obtained from systematic review of case control studies IIIb Evidence obtained from a case control study IV Evidence obtained from case series V Evidence obtained from expert opinion without explicit critical appraisal 20 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 * For each article cited, please provide a description of why the specific literature reference is relevant to the Code Change Application (e.g., “this is the hallmark double blinded controlled study establishing the value of the procedure/service”, “this is a case report describing the procedure/service in detail”, or “this is an opinion statement from a respected authority in the field”). Publication Details and Attributes (PDA) Grid Code # Click here to enter text. References Study Level of Duration Evidence Based on LOE Table Article #1 U.S. or Organization Impact Foreign Sponsoring Factor Peer Journal Reviewed U.S. Foreign U.S. or Prospective Total Foreign Study? Patients Population Studied Studied U.S. Yes Foreign No Both Provide brief description regarding relevance to Code Change Application* References Article #2 Study Level of Duration Evidence Based on LOE Table U.S. or Organization Impact Foreign Sponsoring Factor Peer Journal Reviewed U.S. Foreign U.S. or Prospective Total Foreign Study? Patients Population Studied Studied U.S. Yes Foreign No Both Provide brief description regarding relevance to Code Change Application* 21 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 References Study Level of Duration Evidence Based on LOE Table Article #3 U.S. or Organization Impact Foreign Sponsoring Factor Peer Journal Reviewed U.S. Foreign U.S. or Prospective Total Foreign Study? Patients Population Studied Studied U.S. Yes Foreign No Both Provide brief description regarding relevance to Code Change Application* References Study Level of Duration Evidence Based on LOE Table Article #4 U.S. or Organization Impact Foreign Sponsoring Factor Peer Journal Reviewed U.S. Foreign U.S. or Prospective Total Foreign Study? Patients Population Studied Studied U.S. Yes Foreign No Both Provide brief description regarding relevance to Code Change Application* References Article #5 Study Level of Duration Evidence Based on LOE Table U.S. or Organization Impact Foreign Sponsoring Factor Peer Journal Reviewed U.S. Foreign U.S. or Prospective Total Foreign Study? Patients Population Studied Studied U.S. Yes Foreign No Both Provide brief description regarding relevance to Code Change Application* return 22 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 26. Have you found any publications, in addition to those cited in the Code Change Application, which offer conflicting data or different opinions, and that you feel are important for Editorial Panel consideration in evaluating this code change application? If so, please provide the literature reference, level of evidence and reason that you consider the publication(s) relevant, and why you excluded them from the articles cited in 25a. Reference (list Author, Brief description regarding relevance and why you excluded from articles in 25a. Article #1 Level of Evidence based on LOE Table Level # Article #2 Level # Describe: Article #3 Level # Describe: Article #4 Level # Describe: Title, Journal, Year, Volume, Pages) 27. Describe: Other Comments: 23 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 Conflict of Interest Policy of Presenters Every code change proposal applicant or his/her designee(s) making a presentation (“Presenter”) to the CPT® Editorial Panel on a code change application shall disclose all individual and corporate disclosable interests as defined below, but without regard to financial limit. Presenters who are applicants shall complete a written disclosure at the time of the code change application. Presenters who are a designee(s) of the code change proposal applicant shall complete a written disclosure in response to the “presenter letter” sent to applicants approximately two weeks in advance of the meeting of the CPT Editorial Panel. All Presenters are also asked by the Chair of the CPT Editorial Panel to make a verbal disclosure of individual and corporate interests at the time of presentation. Any disclosable interest that is a material individual interest or a material corporate interest must be designated as such in the disclosure. CODE CHANGE APPLICATION APPLICANT OR DESIGNEE (“PRESENTER”) DISCLOSURE OF INTEREST I affirm that I have read and understand the Conflict of Interest Policy of the CPT Editorial Panel and Workgroup Members, Advisors and Presenters, a copy of which is available on the AMA CPT website. (press “Ctrl” key and click link) I have no individual or corporate disclosable interests at this time, except as set forth below. I understand that I have a continuing obligation to comply with the Conflict of Interest Policy and will update this form prior to any code change proposal application. Disclosure does not restrict or limit the ability of the presenter to support the applicant’s code change proposal. DISCLOSABLE INTERESTS INDICATE IF MATERIAL INTEREST Print Name Signature Date 24 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 Key Elements of Conflict of Interest Policy For convenience, key elements of the Conflict of Interest Policy applicable for Applicants/Presenters are summarized below. The Conflict of Interest Policy in its entirety is controlling (please refer to the Conflict of Interest Policy in its entirety on the AMA CPT website): (press “Ctrl” key and click link) Presenters members must disclose all individual and corporate disclosable interests as defined in the Policy held by the member or immediate family without regard to financial limit. “Immediate family” means a spouse, domestic partner, parent, child, brother or sister of a Presenter. Requirements for disclosure of interests of immediate family apply to the extent such interests are known by the Presenter. “Disclosable individual interest” means cash, goods or other value (e.g., consultancies, speaking honoraria, salary or salary support, research or other grant support, stock ownership or options, expert testimony, royalties or other intellectual property rights, service on a speakers bureau, gifts, or paid travel and vacation) that, with respect to the Applicant/Presenter or the Applicant/Presenter’s immediate family members, the individual may receive such interest as a result of the approval or denial of the code change, the value of which exceeds $1.00 in the past two years. “Disclosable corporate interest” means cash, goods or other value (e.g., increased sales, decreased sales of competitors, increased value of intellectual property, increased grant support, etc.) which in the aggregate exceeds $5,000 within the past two years or is reasonably expected to exceed $5,000 in the next two years, only where the Presenter is a consultant, agent, or employee and the Presenter should reasonably be aware that their client or employer may receive such interest from the approval or denial of the code change proposal. Individual and corporate disclosable interests do not include [i] any interest that is limited to providing clinical services to patients (including the service for which a code change proposal has been submitted), or [ii] providing professional educational services or interpretative advice on proper coding. “Material individual interest” means a disclosable individual interest the value of which exceeds $10,000 in the aggregate within the past two years. “Material corporate interest” means disclosable corporate interest the value of which in the aggregate exceeds $10,000 within the past two years or is reasonably expected to exceed $10,000 in the next two years. Presenters who are applicants shall complete a written disclosure at the time of the code change application. Presenters who are a designee(s) of the code change proposal applicant shall complete a written disclosure in response to the “presenter letter” sent to applicants approximately two weeks in advance of the meeting of the CPT Editorial Panel. All Presenters are also asked by the Chair of the CPT Editorial Panel to make a verbal disclosure of individual and corporate interests at the time of presentation. 25 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 Statement on Lobbying Applicants and other interested parties must not engage in “lobbying” for or against code change applications. “Lobbying” means unsolicited communications of any kind made at any time (including during Editorial Panel meetings) for the purpose of attempting to influence either (1) the CPT Advisors’ evaluation of or comments upon a code change application or (2) voting by members of the Editorial Panel on a code change application. Lobbying is strictly prohibited. Violation of the prohibition on lobbying may result in sanctions such as being barred from further participation in the CPT process. Information that accompanies a code change application, presentations or commentary to the full Editorial Panel during an open meeting and responses to inquiries from a Panel member or a CPT staff member do not constitute “lobbying.” In order for the CPT Editorial Panel to effectively review and act on proposed changes to the CPT code set, code change applications must be reviewed by the CPT Advisors and the Editorial Panel based on the information contained in the application and available clinical literature. CPT staff is responsible for organizing and submitting information to the CPT Advisors and the Editorial Panel for consideration. Information relating to a code change application must be submitted to CPT staff no later than thirty days prior to the start of the Editorial Panel meeting at which the code change application will be considered. In some cases, the Chair of the Editorial Panel may establish rules which allow for supplemental submissions of information to workgroups or facilitation sessions established by the Chair or for postponed or appealed agenda items. (A facilitation session is an informal meeting requested by the Chair during a CPT Editorial Panel meeting to allow interested parties to confer and attempt to reach a consensus recommendation for presentation at the meeting.) During development of a code change application, an applicant may seek input or assistance from staff or advisors of medical specialty societies but may not engage in “lobbying” as defined above. Medical specialty societies may have their own policies governing interactions with applicants or other interested parties regarding code change applications. The AMA encourages medical societies to work with applicants from both industry and other medical specialty societies to assure that code change applications are complete, coherent and consistent with current medical practice. Contacts with consulting medical societies should be limited to that which is necessary to construct and submit the code change application. After the date a code change application is posted for review and comment by the CPT Advisors and the Editorial Panel, contact between an applicant and medical society representatives should be confined to communications pertaining to feedback from the CPT staff or Advisors’ comments regarding the application. If an applicant or other interested party wishes the CPT Advisors or the Editorial Panel to consider additional information, that information must be submitted to AMA's CPT staff and not directly to the CPT Advisors or the Editorial Panel. Applicants and other interested parties are invited to participate in open CPT Editorial Panel meetings and present their views on code change applications when recognized by the Chair during the course of the meeting. The views of applicants and other interested parties may be sought during work group or facilitation sessions established by the Chair and participation in a workgroup or a facilitation session is not considered lobbying. return 26 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 Attestations By signing below, I hereby attest to each of the following: 1) the information provided in this application is true, correct and complete, and, to the best of my knowledge, accurately depicts current clinical and or surgical practice; 2) I have read the CPT Statement on Lobbying, Criteria for Development and Evaluation of CPT Category I and Category III codes, CPT Code Application Instructions, CPT Editorial Panel Confidentiality Agreement, and CPT Application Process FAQs all referenced on the Applying for CPT Codes (press “Ctrl” key and click link) page and on related pages; and 3) I have authority to sign this application in both an individual and organizational capacity. Copyright Assignment In consideration of the American Medical Association’s review of this code change application, on behalf of myself and the organization names below, I hereby assign to the AMA all rights including copyright, if any, in the changes to the CPT code set contained in the application and any variation thereof approved by the CPT Editorial Panel. Signature Print Name Organization (if applicable) Date American Medical Association CPT Coding, Editorial and Regulatory Services AMA Plaza 330 N. Wabash Avenue, Suite 39300 Chicago, IL 60611-5885 Phone (312) 464-5486 Fax (312) 224-6916 If you have any questions concerning the requirements on the Coding Change Application, please consult with AMA staff prior to the submission of your application. An incomplete application may delay processing of your request and may cause it to be returned. AMA CPT Editorial Research and Development Voice (312) 464-5486, fax (312) 224-6916 . 27 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017 Instructions for Submitting your Code Change Application Coding Change Application: Email the application and any signature pages to [email protected]. Only the Coding Change Application and any signature pages should be emailed to [email protected]. Supporting documents for your Code Change Application should be uploaded to the AMA CPT Submissions page (https://connection.ama-assn.org/sites/CPT/Submit/default.aspx). You will be required to sign in to have access to this site. Any AMA website login account that you currently have (including your CPT Collaboration website username and password) should allow access to this site. If you do not have an AMA login account, press the link that says Create an Account on the login page in order to establish access to the AMA CPT Submissions site. To use the drag and drop option for submissions of documents: The AMA CPT Submissions site is compatible with the following browsers: Internet Explorer, Chrome and Firefox. We have found that using Mozilla Firefox provides optimum performance. This browser can be obtained with a free download through the Mozilla website. Open the AMA CPT Submissions site using the link shown above. (Click the AMA CPT Submissions link or copy and paste the URL onto your browser address bar.) On the login screen, enter your username and password. Open the file on your computer that contains the documents to be uploaded. To make things easier, decrease the size of the window that you just opened as well as the size of the AMA CPT Submissions window. You may do this by clicking the icon that has the "2 overlapping boxes" located in the upper right hand corner of each page. Hold the Ctrl key down and highlight the files on your computer that you want to upload to the AMA CPT Submissions site. Place your curser in this group of highlighted files, hold down the left button on your mouse and drag the documents from the source file directly to the AMA CPT Submissions site just below the heading Drop Off Library. When you see the notice Drop Here on the AMA CPT Submissions site, release the mouse button, and the files will transfer over. You will see the titles to the documents that you just submitted. If you decide to upload each document separately, press the “New Document” link. An “upload dialog box” will open allowing you to submit an individual document. These documents will not appear on the CPT Submission home page. They will be uploaded directly to the CPT staff site. For security reasons, the files that you upload or drag and drop to the AMA CPT Submissions page will not be visible by any person other than you. Within approximately one hour, these items will be transferred to a different site that will allow the CPT Staff to review them. return 28 CPT is a registered trademark of the American Medical Association Copyright 2017, American Medical Association, All rights reserved June 6, 2017
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