ASGE, ACG, AGA Industry Coding and Reimbursement Declaration 

The American Society for Gastrointestinal Endoscopy (ASGE), the American College of Gastroenterology (ACG) and the American Gastroenterological Association (AGA) have an active role in establishing and/or revising CPT^® codes for new/existing procedures relevant to the practice of gastroenterology. The three societies coordinate this as a cooperative effort.  Over the past decade, the societies have introduced over 170 CPT codes with matriculation through the American Medical Association's CPT Editorial Panel process. 

Once a category I CPT code is created, the specialty societies survey the physician work and practice expense of the procedure and present the findings to the Relative Value Update Committee (RUC).  The RUC's recommendations are submitted to the Centers for Medicare and Medicaid Services (CMS), who makes the ultimate assignment of reimbursement values for the procedure under the Medicare Physician Fee Schedule (MPFS). 

The societies also provide comment to CMS on items and services that are paid for under the:

• Healthcare Common Procedure Coding System (HCPCS)
• Advisory Panel on Hospital Outpatient Payment
• Ambulatory Payment Classification (APC) for services paid under the Outpatient Prospective Payment System (OPPS)
• Pass-Thru Payment and New Technology Ambulatory Payment for devices paid under the Outpatient Prospective Payment System
• New Technology Add-On Payments for services paid under the Inpatient Prospective Payment System (IPPS)  
• Clinical laboratory services paid under the Clinical Laboratory Fee Schedule (CLAB)

 In addition, the societies provide comment to CMS and the Centers for Disease Control and Prevention (CDC) for ICD-10-CM Coordination and Maintenance issues and requests for new ICD-10 codes. 

Through our direct interactions with CMS, C-codes and G-codes have been established for new technologies that require more immediate coding for Medicare beneficiaries than possible with the traditional CPT/RUC process. 

The ability to secure new codes has evolved through early communication with industry and provision of frequent guidance on issues pertinent to coding, coverage and reimbursement. Often, these aspects are not inherent in the processes involved in FDA approval. The data necessary for optimizing coverage and reimbursement for healthcare professionals should be considered when developing efficacy, safety, and outcome studies to support widespread clinical use of new technology. These components of the process are aspects for which the gastroenterology societies are able to provide expertise.

Guidelines for Industry Seeking Assistance for Procurement of CPT^® Code(s)  

To facilitate communication with industry, we have outlined the requisite information our organizations need to assist in the reimbursement process. We recognize that the phase of development of technology will vary and not accommodate the ability to provide all of this information initially. For these projects, we are able to provide guidance as the development matures. However, all should recognize that ultimately this information is needed when attempting to procure a category I or III CPT^® code and the reimbursement associated with its use. The societies are prepared to assist companies to proceed along these lines at any step of their development. To prepare our representatives with the necessary information to support new procedures, we solicit input from individuals who are not directly involved in the development process but who have expertise in the area under consideration. Although this critical review of the new technology may appear onerous, the CPT and RUC process will engage in this debate and our organizations recognize this preparation facilitates the best proposal. 

The following section reflects our requirements for assisting with this process. Please note that companies seeking sponsorship of a Coding Change Proposal (CCP) from the GI societies must submit a completed coding change request form in addition to all of the materials listed below at least eight weeks prior to the CPT submission deadline.

CCPs that are incomplete or submitted without all of the supporting materials listed below will not be reviewed.

View the AMA calendar of CPT and RUC meetings and deadlines.   

Required Information for Consideration of Procurement of CPT^® Code(s)  

• A brief (five pages or less) executive summary of literature supporting the clinical utility of the device/procedure/diagnostic. Copies and reprints of articles and abstracts should accompany the submission. For less mature technologies, a descriptive narrative explaining the technology and preliminary investigation is adequate.
• A statement regarding potential disclosable interests for authors in quoted literature.  Disclosable interest is defined as "any situation in which financial or personal obligations held by the investigator or immediate family without regard to financial limit, that may compromise or present the appearance of compromising an individual's or group's professional judgment in conducting, reviewing, or reporting research."  The AMA defines disclosable individual interest as "cash, goods or other value (e.g., consultancies, advisory board, 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) with the company or affiliated entities". The AMA defines disclosable corporate interest as "cash, goods or other value (e.g., increased sales, decreased sales of competitors, increased value of intellectual property, increased grant support, etc.)."  The presence of a disclosable relationship does not preclude utilization of the data that the investigator is responsible for.
• A review of safety data regarding the device/procedure.
• A review of outcome / efficacy data regarding the device / procedure / diagnostic.
• A fully completed coding change request form for category I and III codes. Review a list of the general criteria for Category I and Category III codes. 

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 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.
• Data regarding physician work for the procedure (pre-, intra- and post-time) and practice expense for both the facility (outpatient hospital, ambulatory surgical center) and non-facility (office, independent diagnostic testing facility) settings. 
• A clinical vignette that describes the typical patient who would receive the procedure(s)/service(s) including diagnosis and relevant conditions should be submitted for the device / procedure, see the AMA's guidance document.
• Peer-reviewed, published literature (not abstracts) should be identified according to each of the following requirements:
• Identify the Level of Evidence

• Identify whether this is a U.S. based journal or a non-U.S. based journal
• Identify whether the population studied is U.S. or non-U.S. or both
• Identify the number of patient studies (total of all group(s) including controls) and indicate whether study is a prospective study
• Provide a concise "relevance statement". 
• Additional requirements regarding the device / procedure / diagnostic, as applicable:
• At least two articles must report different patient populations or have different authors (no overlapping patient populations or no overlapping authors)
• At least one of the publications meets or exceeds the criteria for evidence level III (i.e. obtained from well-designed, non-experimental descriptive studies such as comparative studies, correlation studies, and case control studies)
• An Institutional Review Board (IRB) approved protocol of a study or the procedure or service being performed
• Description of current U.S. trials outlining the efficacy of the procedure or service
• Identify any practice parameters, guidelines, and/or policy statements regarding the device / procedure / diagnostic
• The requestor must provide the listed catalogue price, and if available a copy of an invoice paid within the past 12 months, for any devices, equipment and supplies involved in performing the procedure.
• The requestor must provide the names of three physicians the company feels can comfortably analyze the procedure/device/diagnostic and who have no disclosable Interest (as described above) with the company, and/or no advisory/ employee/ partner relationship with a venture capital / private equity / hedge fund or a private or public company that may be a competitor or acquirer of the company.

Guidance for Industry Interactions with CPT Advisors and Staff  

• Industry may forward a request to make presentations to staff representatives of ASGE, ACG, and AGA. Depending on the nature of the request, a teleconference or meeting with the representatives, at the requestor's expense, may be scheduled. Please send a single email that includes each of the society liaisons below to initiate discussions. All society liaisons should be included in each communication with the company.
• Industry must not contact society CPT Advisors directly to follow-up on the status of a request. All communications must be sent to the society liaisons.
• Industry must abide by the AMA's anti-lobbying policy regarding contacts with CPT Editorial Panel member and Specialty Society Advisors.

Contact Society Liaisons to Initiate Discussions  

Denise Garris, ASGE, 202-527-1069, dgarris@korrisgroup.com.

Brad Conway, JD, vice president, Public Policy, ACG, 301-263-9000, bconway@gi.org

Leslie Narramore, director of reimbursement, AGA, 410-349-7455, lnarramore@gastro.org

Please send a single email that includes each of the society liaisons above to initiate discussions. All society liaisons should be included in each communication with the company. 

CPT® is a registered trademark of the American Medical Association (AMA).