StartUp Tools: Medical Device Resources

bmesource_org is a shared web portal for the biomedical technology design community. It provides a guide to high-quality, basic information about clinical problems, biomedical technologies that address them and business and law resources that assist in technology transfer.

4.1 Intellectual Property Basics

The process of background searching and then preparing a patent filing can often seem monumental to the first-time innovator. Fortunately, the "upstream" parts of the biodesign innovation process provide a useful base of information that can be augmented with the materials and guidelines outlined on Chapter 4.1. The steps below have been excerpted from the chapter and are presented with active web links to assist innovators in getting started.
Compile Background Information

1. What to Cover - Begin by assembling complete background information on the concept/invention and the area in which it will be practiced. This will generally include the disease state and a review of existing treatment technologies/approaches. Consider writing draft claims that cover the basic invention. These can be in plain language, not "legalese." Brainstorm about keywords for the search. Try to identify as many of these as possible (see example in text). A thesaurus and medical dictionary can be helpful.
2. Where to Look - Refer back to information collected as part of 2.1. Disease State Fundamentals and 2.2 Treatment Options. Augment this data with additional research as needed.

1. What to Cover - Start with patent database searches as the most efficient way to see a broad range of prior art (before searching non-patent sources). Consider hiring a patent agent or attorney to assist with the prior art search. Many inventors benefit greatly from a more formal "prefiling search" or patentability assessment. An attorney can help identify the areas where patent protection is most likely and can help focus the content of the patent application covering the invention.
2. Where to Look -
   • The U.S. Patent and Trademark Office Web Patent Databases - U.S. patents issued from January 1976 through present are full-text search enabled. Patents from 1790 through 1975 are searchable only by patent numbers and current U.S. classifications. Full-page images are available for most patents from 1970 to present. A tutorial on how to use the database is available on the site. Note that issued patents and patent applications are in separate search fields.
   • U.S. Patent and Trademark Office Official Gazette - Weekly publication to announce those patents being issued and those trademarks being registered or published for opposition. Users can search or browse from 1964 to present to stay informed regarding new patents and changes in the field.
   • Google Patent Search - Provides searchable access to the full text of the U.S. patent corpus to find patents of interest.
   • Delphion Intellectual Property Network - A subscription database that allows individuals to search the bibliographical and claims portions of U.S. patents from 1974 to present. This service recently added European Patent Office and World Intellectual Property Office (WIPO) text and images. All patent references are hyperlinked for citation searching. Classification codes are also hyperlinked to assist in finding similar patents granted.
   • Derwent Innovations Index - Provides a database of international patent information. On the site, "equivalent" patents are available in multiple languages. This database is provided by the Institute for Scientific Information.
   • Free Patents Online - Allows quick searching through U.S. patents, U.S. applications, and European patents. The most useful aspect of the site is being able to download PDFs of actual patents.
   • International Patents Databases -
   • Other Databases - Be sure to search PubMed and other medical sites for articles and abstracts, as well as perform general Google searches for more obscure references to relevant information.

1. What to Cover - The first step is to determine which of the patents and other materials that have been located via the prior art search are most relevant to the patentability of the invention. The draft claims from section 1.1 above are useful here. The more elements of the claims that are taught by the prior art, the more relevant this patent is to the search. Aim for the most relevant 10 to 20 patents in the first cycle. The second step is to broaden the search out again, using either citation search or classification index from the patents of interest identified in the first cycle. This should result in some new patents, and excluding some others from the first step. Repeat this cycle of broadening and filtering. Once the list of patents of interest stabilizes at some relatively small number (probably 5 to 15), these are key patents. Remember that new art is published daily, however, so searching is an ongoing process
2. Where to Look - Use the information gathered from the prior art search to complete this analysis. When necessary, go back to the sources listed above to perform additional research.

1. What to Cover - For provisional patent applications, the application can be prepared by the inventor, but it is wise to have it reviewed by a patent attorney or patent agent. Although any material can be filed as a provisional patent application (including a drawing on a napkin or a PowerPoint presentation), it is essential to have a thorough description of the invention, including the main sections of a provisional application described in the chapter. For a utility patent application, a patent attorney or agent needs to be involved in writing the application, but the inventor can save considerable time and expense by drafting the background, providing rough drawings, and drafting key claims in plain language (see 5.1 IP Strategy for more information about selecting an IP attorney and the costs involved). If draft claims have already been written (as in step 1.1 above), modify these based on the prior art to clearly demonstrate advantages provided by the new invention. Identify possible variations. Make sure all possible ways of putting together and carrying out the invention have been covered. Consider drafting both method and device claims. Prepare all necessary figures - the USPTO requires that drawings show each and every element claimed in the patent application. Next, draft the specification. With the new claims and the drawings as a guide, write a description of the invention. Be sure to include all of the elements of the invention, and all variations that have been brainstormed. Now there can be an effective meeting with a patent attorney or agent.
2. Where to Look - Even if an inventor is planning to work with a patent attorney to file, the following resources can be helpful in understanding and preparing for the patent application process:

1. What to Cover - Both provisional and utility patent applications can be filed online using the USPTO's system, EFS-Web. Documentation of receipt will be provided by the site. To file the application by mail, download the coversheet and transmittal form from the USPTO website. Make sure to fill out a return receipt postcard (this will be the only documentation of the priority date provided if the filing is by mail). It is wise to use a stable return address (students may want to use the address of their university's office of technology licensing). It is best to mail by United State Postal Service (USPS) Express Mail rather than FedEx or some other express carrier. If the document gets lost, only USPS handling guarantees that the mailing date will be the filing date.
2. Where to Look - Refer to the USPTO website and the EFS-Web system for more information.

5.1 IP Strategy

Developing and maintaining an effective IP strategy is a challenging but essential step in preparing to take an innovation to market, as explained in Chapter 5.1. The steps below have been excerpted from the chapter and are presented with active web links to assist innovators in getting started.

1. What to Cover - A key part of assessing how one should define an IP strategy is knowing what patent references exist in the area of invention. Creating an assessment of IP landscape begins with patent searches to identify key patents and patent applications. Patent searches should be performed early in the biodesign innovation process to help a company understand the IP landscape and assess its general freedom to operate in the field. The output from these searches can be used to help shape how the innovator thinks about the claims s/he develops for the invention, as well as for developing strategies to work around prior art, challenging existing patents, obtaining licenses, or avoiding wasted investment. An explanation of how to perform these searches is included in 4.1 Intellectual Property Basics. A sample format for keeping track of prior art search results and summarizing the IP landscape can also be found in that chapter. Because new IP is published every week, and other prior art is published daily, keeping an IP landscape up-to-date is a constant challenge, but it is extremely important in understanding competitive IP.
2. Where to Look - Refer back to the resources and references listed in chapter 4.1 for more information.

1. What to Cover - The goal of an FTO analysis is to find any patent claims from another inventor that are currently in force and that explicitly cover some feature of the new invention. For any claim that appears to read on a feature of the new device, assess each word and clause of the claim carefully to make certain that it applies completely. Interpret words in the claim in the context of their definitions (and diagrams) in that patent. If a claim does appear to block the new device, make sure to consult an IP attorney to confirm that there is in fact an FTO issue. If FTO is indeed in jeopardy, conduct brainstorms to see if there are ways that the troublesome feature can be circumvented. If not, consider options for licensing the patent at issue.
2. Where to Look - Use the USPTO website, Google Patents, or another search engine. For keywords refer back to information collected through prior art searches and the assessment of the competitive landscape.

1. What to Cover - Invest early in hiring an IP attorney or patent agent. This person (or team of people) must have deep, first-hand experience with patent filings - ideally in the domain of the invention - as well as with IP strategy and protection.
2. Where to Look - The best way to identify a qualified IP attorney is through a referral from a trusted source. Network with professionals in the field and ask for assistance in meeting and choosing an IP attorney. Other source to consider include:
   • IP Professional Societies - Associations such as the American Intellectual Property Law Association can be a resource for referrals.
   • American Bar Association (ABA) Lawyer Locator - Another resource for finding IP attorneys in different areas of the U.S.
   • USPTO Patent Attorneys/Agents Search - A searchable database of contact information for attorneys and agents with licenses to practice before the USPTO.
   • University Office of Technology Licensing - If a company or entrepreneur is affiliated with a university, the on-campus office of technology licensing (OTL) should be able to provide information as well as referrals related to IP issues.

1. What to Cover - The key to developing defensive and offensive strategies is to maintain an up-to-date understanding how the technology is evolving within the team (internal monitoring) while continuing to evaluate the technology and IP of competitors (external monitoring).
2. Where to Look -
   • Internal - For internal monitoring, it is essential to calendar regular meetings between the technology group and IP counsel to assess what new technical directions are underway (and how these may be creating new IP and/or moving away from the original coverage.
   • External - External monitoring is time consuming and difficult, but critically important. Set up Google alerts for any news items or published IP relevant to the technology. Talk with physicians in the field. If possible, visit hospitals where competitive technologies are being used. Attend medical meetings, making sure to spend time in the exhibit halls, visiting competitor's booths, attending evening sessions, and being alert to gleaning information in the hallways.

1. What to Cover - Begin by specifically outlining what would constitute an ideal patent portfolio for the company. Formalize this vision into a comprehensive IP strategy that clearly lays out what the team needs to do in order to develop this portfolio. Work closely with an IP attorney in these first steps. Create a work plan that outlines the critical milestones for operationalizing the strategy, linking them to other important milestones (e.g., R&D accomplishments, funding needs). Use this strategy and work plan as a guide for continually strengthening the IP portfolio. Revisit the strategy and plan to keep it current. Make adjustments frequently based on changes in the internal and external environment.
2. Where to Look - Work together as a team in collaboration with an IP attorney who truly understands the company's business, strategy and plans for the future, as well as the timing of its operating milestones. Validate the company's plan with the board of directors and/or other trusted advisors and experts in the field.

4.3 Reimbursement Basics

Understanding reimbursement in the U.S. and around the world can be challenging, particularly for those innovators new to the medical field. However, the information in Chapter 4.3 can be used to help the innovator effectively come up to speed and prepare a reimbursement analysis for the concepts under consideration. The steps below have been excerpted from the chapter and are presented with active web links to assist innovators in getting started.

1. What to Cover - Determine the setting in which the procedure will be performed.
2. Where to Look - Based on what is known about the innovation, determine the most appropriate setting for the procedure. Use the following sources to benchmark the settings used for similar or related procedures and to justify the determination:
   • PubMed - A database of the U.S. National Library of Medicine that includes more than 16 million citations from MEDLINE and other life science journals back to the 1950s.
   • Up-To-Date - A database of evidence-based clinical information. [login required, Stanford students have access]

1. What to Cover - For the most similar and relevant existing procedures, research the coverage decisions made by Medicare and private insurance, as well as any technology assessment decisions. Determine when, how, and why they received reimbursement and any technology assessment recommendations. Identify the assigned CPT codes for each procedure, as well as any related MS-DRG, APC codes, and technology add-ons. Typically, it is easiest to identify the CPT code and then map that to MS-DRG/APC codes and technology add-ons using the information obtained in this step, or in steps 3 and 4 below. (Note: Keep in mind that there may be multiple relevant CPT codes. Conversely, some devices may not be assigned a CPT code(s) and/or may not have been awarded reimbursement coverage. If an appropriate CPT code cannot be identified in this step, proceed to the next step.)
2. Where to Look -
   • Private Insurance Medical Policy Websites - Such as Regence, Wellmark, or Aetna.
   • Medicare Site - Be sure to search for both local and national coverage decisions.
   • Technology Assessment Sites - Be sure to identify all technology assessment reports generated by the Blue Cross/Blue Shield Technology Evaluation Center, NICE in the U.K., and other related technology assessment groups.
   • Ingenix CPT Expert (Thomson Delmar Learning, 2005) - This book is the recognized standard for hospital coding. It contains all CPT codes categorized by organ systems. Since many codes could potentially be used for one procedure, it is helpful to review the filtered list of codes with someone familiar with the codes being assessed, such as a clinician or office practice manager. (link works for Stanford students and others with subscriptions)
   • Treatment Research - 2.2. Treatment Options may include technology assessment data for the different treatment options.

1. What to Cover - If no coverage decision information or CPT codes are available, look for reimbursement-related information on manufacturer websites. Often, manufacturers will provide status updates on their progress toward receiving reimbursement to educate potential customers and keep them interested in their devices. They also might include information detailing the CPT codes they are pursuing for reimbursement, the time frame within which they expect to receive reimbursement, the process for appealing coverage decisions, and/or the number of appeals that have been won if reimbursement has been granted on an exception basis. (Note: If candidate CPT codes are identified in step 3 but not in step 2, go back to step 2 and research those codes and their relevant coverage decisions.)
2. Where to Look -
   • Device Manufacturer Websites - Companies such as Medtronic offer general reimbursement assistance on their website for certain practice areas (e.g., for cardiac rhythm management). Similar information can be found by searching other sites for major manufacturers. Guidelines are often provided by product or treatment area to help physicians choose the most appropriate code(s) for maximizing their reimbursement.
   • Federal Register.
   • HCPCS Physician Fee Schedule - Download the fee schedule from Medicare's website.

1. What to Cover - Find the Medicare reimbursement rates for the relevant CPT code that has been identified. Be sure to account for physician and facility reimbursement using the resources listed below.
2. Where to Look -
   • HCPCS Physician Fee Schedule Look Up - Multiply the RVU for the appropriate CPT code by the conversion factor to get the Medicare payment to the physician. If the procedure is performed in a facility setting, use the RVU listed under the fully implemented facility total. Otherwise, use the fully implemented non-facility total or use the resource below.
   • Medicare Hospital Outpatient Prospective Payment System (OPPS) - Available online on the Medicare website. Search for the HCPCS code in the document, find its corresponding APC code, and then obtain the facility payment. [as of Apr 09 this is a Limited Data Set]
   • Cost of Procedures Covered by APC and Number of Procedures Performed - This Excel file is available online. It displays median costs, by APC group, for services payable under the OPPS in calendar year 2007. The data are based on claims for hospital outpatient services provided January 1, 2005 through December 31, 2005.
   • Ambulatory Surgical Center File - If the payment cannot be located in one of the outpatient files, then try the Ambulatory Surgical Center File and search by HCPCS code.
   • Hospital DRG File - If reimbursement rate information still cannot be located, try these Hospital DRG files. Be sure to download the final version of the list of all DRGs. Using this file, identify the DRG and its "relative weight." Next, this will need to be multiplied by a base payment rate that consists of a labor and nonlabor component. Access these files from the Medicare website under Acute Inpatient - Files for Download.

1. What to Cover - Identify the number of procedures performed per year, reimbursement per procedure, and payer mix.
2. Where to Look -
   • HCUPnet - A free, online query system based on data from the Healthcare Cost and Utilization Project (HCUP). It provides access to health statistics and information on hospital stays (inpatient encounters) at the national, regional, and state levels.
   • Medicare Part B Physician/Supplier Extract Summary File - This file summarizes the number of procedures, total submitted charges, and total payments by HCPCS code. The file can be ordered from the Center of Medicare and Medicaid Services.
   • Other Databases - Verispan (now SDI) and National Patient Profile are subscription services that provide procedural data before HCUP releases it.
     • National Patient Profile - A desktop-enabled database (i.e., on a CD) provided by Verispan. It is searchable by diagnosis or procedure codes (ICD-9 only) and includes information similar to that on HCUPnet, except that it is often more up-to-date and has an interesting feature to show the frequency of different ICD-9 diagnoses for each procedure.
     • Verispan - A subscription service that provides access to data on the frequency of procedures carried out for patients who are diagnosed with specific conditions. The data is provided in such a way that in-depth customization and analysis can be performed.

5.6 Reimbursement Strategy

Creating a reimbursement strategy is challenging and complex. As discussed in Chapter 5.6, most companies will benefit from the services of an expert reimbursement consultant. However, before approaching a consultant, the innovator should perform a preliminary assessment of the reimbursement landscape. The steps below have been excerpted from the chapter and are presented with active web links to assist innovators in getting started.

1. What to Cover - Repeat the basic reimbursement analysis performed as described in 4.3 Reimbursement Basics, using information gathered on the final solution concept under development and/or proxy devices. Be sure to understand the mechanics related codes (existing versus new); coverage decisions (Medicare, large commercial payers, payers outside the U.S.); reimbursement levels; and the status of technology assessment in the given field. Identify critical gaps in codes, coverage, and reimbursement payments that should be addressed via a reimbursement strategy. Rank payers and technology assessment groups based on expected perception of the company's technology.
2. Where to Look - Refer to 4.3 Reimbursement Basics.

1. What to Cover - Identify 10 to 15 target payers based on the number of lives they cover, the number of procedures they would cover, and the analysis in step 1. Research policies of any new payers identified. Identify key contacts within each payer organization (either through independent searches, by engaging a reimbursement consultant, or through referrals by KOL since medical directors in health plans can have links to KOLs). Interview medical directors and health policy analysts. Use the questions in Table 5.6.6 in the book as the basis for each discussion.
2. Where to Look - See Appendix B in the book for a preliminary list of major U.S. payers. Work with KOLs and reimbursement consultants to facilitate introductions to target payers and medical directors willing to be interviewed. In addition, refer to the following resources:
   • Technology Assessment/Evidence Based Reports -
   • Payer Policies -
     America's Health Insurance Plans (AHIP) - AHIP's website Provides a comprehensive list of private payers in the U.S. Their websites can be used to research the policies of any new payers that have been identified. See Exhibit 5 in the book for an overview of select U.S. private payers.
   • Government Policies -

1. What to Cover - Determine whether existing code, coverage, and reimbursement levels are adequate or whether new codes and/or modifications in coverage and reimbursement are needed. Questions to consider include: Are existing codes, coverage, and reimbursement levels directly applicable? Is the current reimbursement level appropriate for the pricing strategy? Do the payers perceive a significant need that the product addresses and that justifies any required changes in coverage and reimbursement? Think about these questions from the perspective of both private and public payers. The same conclusion may not be reached for all payers. Determine whether new codes are needed and whether coverage determinations need to be modified for all or some payers.
2. Where to Look - Utilize the results from the primary and secondary research performed in steps 1 and 2. Compare existing payment levels to pricing considerations from 5.7 Marketing & Stakeholder Strategy. Convene a payer advisory board, if appropriate.

1. What to Cover - Identify studies and publications used to support reimbursement for proxy devices. Determine studies, including specific clinical and economic endpoints, needed to support the reimbursement strategy. Consider primary and secondary data collection, clinical trial studies, database studies, registries, etc. Prioritize studies based on their costs and likelihood of influencing reimbursement decision makers. Develop a preliminary economic model and use it to identify gaps in available data. Share the model with consultants and KOLs to verify its strengths and weaknesses. Include studies in the clinical trial design plan.
2. Where to Look -
   • Results from Steps 1 and 2
   • Exhibit 1 from Book (for different types of economic models)
   • Payer Advisory Board
   • Technology Assessment Reports and Coverage Policies for Proxy Devices
   • PubMed - For studies performed for proxy devices and used successfully to support reimbursement.
   • CPT Background and Categories of CPT Codes - The American Medical Association's website summarizes requirements for new CPT codes.
   • Requirements for Pass Through Payments - If the procedure will be performed as part of an inpatient hospital stay, then an application for a DRG add-on can be submitted-this is a supplemental sum to augment the standard DRG code when the new device is used. See CMS's "Application for New Medical Services and Technologies Seeking to Qualify for Add-On Payments Under the Hospital Inpatient Prospective Payment System for Federal Fiscal Year 2009."
   • National Coverage Determination Requirements - Medicare's website has documents on "Medicare Program; Revised Process for Making Medicare National Coverage Determinations" and on "Factors CMS Considers in Opening a National Coverage Determination."

1. What to Cover - Prepare a reimbursement dossier and education material for payers and advocacy groups. Involve KOLs. Educate and communicate with specialty societies, the AMA, CMS, local Medicare carriers, private payers, and payers outside the U.S. Initiate coding, coverage, and reimbursement initiatives. Identify contacts in each key constituency and map them to specific reimbursement plans. Determine priority order for targeting payers and the appropriate sequence and timing of all activities. Determine requirements in terms of consultants and in-house expertise necessary to execute the plan. Develop a preliminary plan for supporting reimbursement post launch.
2. Where to Look - Take stock of decisions made in step 3 and 4. Network with KOLs, clinical advisors, and reimbursement consultants. Review timeline for similar tactics for proxy device.

India Curriculum - a set of slides to be used over a 13-week course that teaches the Biodesign process in an Indian context. The content is available through our Instructor Resources.

Global Sourcebook Chapters - We're now offering free chapters of our new Global Sourcebook - first up Singapore. The four chapters discuss healthcare systems, regulation, reimbursement and IP in Singapore.

Regulatory Video Briefs that cover regulatory basics, fundamental strategies, and short case studies on medtech companies and their interactions with the FDA.

The biodesign innovation process has been developed to help medical technology innovators increase their likelihood of success in identifying important clinical needs, inventing new medical devices and instruments, and implementing these advances in patient care. This approach is described in detail in the book Biodesign: The Process of Innovating Medical Technologies.

This website is a companion to the text, designed to provide innovators with active web links to support the Getting Started sections at the end of each chapter, relevant content updates, short videos of experts in the field, and links to other useful resources as they apply the biodesign process to projects in industry or academia. Use the menu on the left to access these materials by chapter.

4.2 Regulatory Basics

As noted throughout Chapter 4.2, regulatory issues require expert assistance fairly early in the biodesign innovation process. However, it is extremely useful for the innovator to develop a first-hand sense of which regulatory pathway is likely to be required for a particular device concept. The steps below have been excerpted from the chapter and are presented with active web links to assist innovators in getting started.

1. What to Cover - Determine which branch of the FDA is most likely to regulate the device under development (for most medical devices this will be CDRH).
2. Where to Look -
   • Is the Product a Medical Device? - Information on the FDA website that defines requirements for medical device categorization.
   • Federal Food, Drug, and Cosmetic Act - Chapter II of the Food, Drug, & Cosmetic act specifies the precise definition of what the FDA considers a drug or device.

1. What to Cover - Search the FDA's device classification database and the device classification panels to ensure that the best possible classification decision can be made. Be aware that comparable products may have several different classifications. Finding as many comparable products as possible will help narrow the range of classification options and submission types for the product under development. Collect the following information for each one: device class name, seven-digit regulation number, class number, submission type, physician review panel. Even if a device is quite novel, it may be possible to classify components of the product or utilize similar products as a guide. If the above methods do not result in a classification, use the CDRH Super Search. When performing a search, use the manufacturer, brand name, or common name for one or more similar products.
2. Where to Look -
   • FDA Classification Database - A FDA search page that enables a user to classify a device based on the device name, review panel, regulation number, product code, submission type, third-party eligibility, and device class.
   • Device Classification Panels - This FDA website lists the medical specialties used to review medical devices. Selecting the most likely specialist that would use the product under development enables the user to see the seven-digit device classifications categorized within the specialty.
   • CDRH Super Search - Allows individuals to search through multiple FDA databases, including the device listing database, 510(k) and PMA databases, Products Classification database, the Code of Federal Regulation (CFR) Title 21 database, and the Clinical Laboratory Improvement Amendments (CLIA) database. For device classification purposes, the first four databases listed above will prove most useful.

1. What to Cover - Depending on the device classification, determine if it is necessary and appropriate to pursue a 510(k) or a PMA path (or if the device may be exempt). The key question is: can a reasonable argument be made that the new product combines features of products that were on the market prior to 1976, products that themselves have been cleared through the 510(k) pathway, or exempt products? If so, the 510(k) pathway is probably appropriate. In practice, it can be difficult to be certain which pathway to take and help from a regulatory expert will ultimately be necessary.
2. Where to Look -
   • Device Advice - CDRH's self-service site for obtaining information concerning medical devices and the application/submission processes.
   • CDRH Guidance Documents - Documents prepared for CDRH staff, regulated industry, and the public that relate to the processing, content, and evaluation of regulatory submissions, design, production, manufacturing, and testing of regulated products, as well as CDRH inspection and enforcement procedures.
   • CDER and CBER Guidance Documents - Guidance documents (as defined above) for investigational new drugs.

1. What to Cover - Look for regulatory advice from an expert early-at least by the time the team enters into the development strategy and planning stage of the biodesign innovation process.
2. Where to Look -
   • Regulatory Affairs Professionals Society - Ask for a contact in the local chapter nearest to the location of the company.
   • Personal Networks - Network with professionals in the field and ask for assistance in meeting and choosing a regulatory consultant. Board members and venture capitalists may have contacts in this area.

When your application has been received, AMA/CPT staff review the application to determine whether it addresses a new issue, or presents significant new information about an item that the Panel reviewed previously. Staff also looks at responses to each question in the application to verify that each question has been completed. If this is not the case, the application is returned to the applicant for completion within a defined timeframe (e.g., 5 business days). Applications for multiple codes require a separate response following each question for each code. This is especially important when completing the portion of the application that asks for the vignette and description of the service, since each code requires a "typical patient" vignette and is intended to represent a distinct service.

Upon receipt of the completed application, the application is published to the secure CPT website for review by the CPT Advisory Committee and the Health Care Professionals Advisory Committee (together the CPT HCPAC/Advisory Committee or "CPT Advisors"). The CPT Advisors are composed of representatives of national medical specialty societies seated in the AMA House of Delegates and the Health Care Professionals Advisory Committee (HCPAC). The HCPAC is composed of representatives of organizations representing qualified non-physician health care professionals.

Prior to submitting an application, applicants are encouraged to work with the relevant specialties whose members would most logically provide the requested procedure/service. Applicants who wish to contact the specialty societies prior to submitting an application should contact the departments of coding and reimbursement for the national specialty societies listed in the front matter of the CPT code book. Similarly, those who wish to contact the organizations representing qualified non-physician health care professionals that belong to the HCPAC should contact the departments of coding and reimbursement for these organizations that are listed in the front matter of the CPT code book.

Only the CPT Editorial Panel has the final authority to decide on code category assignment. You are allowed in the application to request the final assignment of the CPT Code category to the codes you seek. The assignment of the code category is based upon Panel evaluation relative to the code criteria outlined in the online CPT process booklet.

For Category I/Category III codes, the following criteria are used to assist the CPT Advisors and Panel in determination of the code category assignment.

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 Policy.

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.

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 serviceis documented in literature that meets the requirements set forth in the CPT code change application.

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

• 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 a 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.

The CPT Advisors submit their opinions to the CPT Editorial Panel based on the information contained in the application and clinical literature you have submitted with your application. The questions in the application require you to supply the details related to the relevant procedure(s) to assist the CPT Advisors and the Editorial Panel in:

• determination of whether existing codes are currently reported for this service,
• identification of the physicians and other qualified health care professionals who commonly provide the requested service,
• determination if other services are provided at the same time as your described service,
• determination of how the procedural components of your service are depicted in the description,
• determination of whether the literature submitted to support your service addresses the efficacy of the described service (as opposed to description of a related service),
• whether all of the components of the service have FDA approval.

Panel deliberation takes place three times yearly at the CPT Editorial Panel meetings, as described in the CPT/RUC calendar that can be found on the CPT website. Panel review of the code change applications begins one month prior to each Panel meeting.

The Editorial Panel can accept as written, accept with modification (e.g., altered descriptor wording, different code category), reject or postpone the request for a new or revised code. You will receive an email notice from AMA staff three weeks after the conclusion of the meeting to notify you of the outcome of the Panel's consideration.

If accepted, the wording of the code descriptor and any relevant coding instructions is included in the notice of acceptance. However, you may not release this information to any other parties since future Panel actions may impact your code(s).

If your code application is rejected or approved in a code category different than you suggested, you are offered the option to submit a request for reconsideration within ten days of receipt of the notice.

If your application is postponed, you will receive an email notice from AMA staff three weeks after the conclusion of the meeting, with specific instructions for the required information for re-presentation of your application.

If an applicant believes an action of the Editorial Panel was in error, the applicant may seek reconsideration. Requests for reconsideration must be in writing and received within fourteen (14) days of receipt of notice of this Panel action. The request must address the reasons and/or instructions given in the notice for the Panel's action. Requests for reconsideration are referred to the CPT Executive Committee for an initial determination followed by referral (with or without recommendation) to the Editorial Panel for reconsideration. If a request is rejected upon reconsideration, a second request for reconsideration will not be entertained until one year after the first reconsideration by the Executive Committee, unless new information directly relevant to the Panel's original consideration of the request becomes available in the interim. This second request must respond to the Panel's original rationale.

Once the application has been submitted to the Editorial Panel, all actions related to the code application are under the authority of the Editorial Panel. Although the applicant is asked to provide specific language for the new code descriptor(s), you should not expect that Editorial Panel acceptance of your application will result in addition of the exact description you provide in the application. A part of the Editorial Panel's consideration of the code change application is deciding on a specific option from a number of descriptor options resulting from the review by the AMA staff, the CPT Advisors, and consideration by the CPT Editorial Panel. An important objective of the Panel is to ensure that the final descriptor adheres to CPT conventions, is clear and unambiguous, does not include proprietary references and is not seen as an endorsement of a particular device or service.

You may withdraw your application until the time that you begin your oral presentation to the Editorial Panel. At that time the discussion falls under the authority of the Editorial Panel and the request may not be withdrawn. If the Panel deems that additional information or evaluation is warranted, it may be postponed until time certain (a specific future CPT meeting) or time uncertain.

In assisting you for preparation of your presentation to the Editorial Panel, AMA staff will provide you with the agenda item for your application ten days prior to the meeting. This agenda item contains information not included in your application, including all alternate ballots and options provided for the Panel's consideration as a part of the CPT Advisors review, and a summary of all comments from the CPT Advisors related to your request.

Your presentation to the Editorial Panel begins with a brief introduction of yourself to the Panel and disclosure of any potential conflict of interest. Following initiation of discussion by Panel members specifically assigned to discuss your Code Change Application, they or the Chairman may ask for a brief overview of the procedure or service for which you are requesting a CPT code. You should be prepared to respond to questions posed by the Editorial Panel related to your application. Please prepare to answer questions regarding the purpose of the requested code(s), why existing codes are not sufficient, and the specific nature of the service(s) or procedure(s) based on the clinical vignette(s) submitted with your application. You should familiarize yourself with the content of the CPT code set and its conventions (e.g., use of symbols and modifiers, structure and format of code descriptors), and the guidelines in the introduction of the code book.

You may have more than one presenter for Panel discussion of your application. For the most effective presentation to the Panel, the presenter(s) should be a physician or other qualified healthcare professional who performs the service or procedure. All presenter(s) should be prepared to respond to the Panel's questions related to the details of providing the procedure/service.

Provision of additional handout materials to the Panel during the meeting is not allowed. The Panel cannot perform a reasonable review of these materials on short notice while giving full consideration to your application. Audio-visual aids (slides, videotapes, etc.) cannot be used. Formal presentation of your written material is not necessary or allowed since the Panel received the agenda materials well in advance of the meeting. Your application for a code change is expected to stand by itself with the supporting peer-reviewed literature to provide the Panel with the information needed to make a determination on your application. Prior to Panel discussion, all presenters are required to provide signed statements of confidentiality and disclosure of potential conflict of interest. These forms are provided by AMA staff prior to the meeting.

The Lobbying Statement is intended to protect specialty societies and their CPT Advisors, and the members of the CPT Editorial Panel, from inappropriate lobbying regarding code change applications. "Lobbying" is defined as unsolicited communications of any kind made at any time (including side bar discussions during Editorial Panel meetings) for the purpose of attempting to improperly influence either (1) CPT/HCPAC Advisors' or their societies' evaluation of or comments upon a code change request or (2) voting by members of the Editorial Panel on a code change request. Any communication that can reasonably be interpreted as coercion, intimidation or harassment is strictly prohibited. Please see the AMA statement on lobbying on the AMA Web site.

This prohibition is balanced against the legitimate need for code change applicants to receive valuable feedback from specialty society experts, which helps assure that code change applications are complete, coherent and consistent with current medical practice and can be dealt with efficiently by the CPT Editorial Panel. Thus, sending information to a specialty society to inform the society of the code change application and seeking evaluation of (or assistance with) the application does not violate the Lobbying Statement, even if it includes a request to support the code change application.

The Panel also invites public statements at the Editorial Panel meetings and in certain workgroups. These are not considered "unsolicited comments" but must be made in manner that would not otherwise violate the prohibition or are disparaging to individuals or their organizations.

The prohibition of lobbying is intended to preclude threatening, coercive or harassing communications or activities-or repeated conduct of this sort, especially if the recipient has made clear further contacts are unwelcome. For example, if a society or its CPT Advisor indicates that there is no interest in receiving further information from the applicant, then communications from the applicant and its representatives should cease.

Your application for a code change and peer-reviewed literature is expected to provide the Panel with all of the information needed to make a determination on your application. If an applicant or other interested party wishes the CPT/HCPAC Advisors or the Editorial Panel to consider additional information after a code change application has been submitted to the AMA, that information must be submitted to AMA's CPT staff. Such information will be handled through the CPT process.

Those who wish to contact the specialty societies for assistance in construction of a code change application related to that specialty should contact the departments of coding and reimbursement for the national specialty societies listed in the front matter of the CPT code book. Similarly, those who wish to contact the organizations representing qualified non-physician health care professionals that belong to the HCPAC should contact the departments of coding and reimbursement for these organizations that are listed in the front matter of the CPT code book.

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 for distribution to the entire roster of CPT Advisors and to the Editorial Panel. This information must be provided to CPT staff no later than two months prior to the Editorial Panel meeting. You are not permitted to provide information directly to Editorial Panel members or CPT Advisors. Such contacts or providing information is considered improper "Lobbying" and is prohibited.

Revision of your application after the deadline date is strongly discouraged as this may cause confusion during CPT Advisors' review. Occasionally, during AMA staff review of your application and prior to CPT Advisors' review, deficiencies in your application may be identified. You will be instructed to provide additional information within the timeframe defined by AMA staff. This is the only instance that revised applications are appropriate.

Following finalization of the Panel minutes you will receive an email notice from AMA staff, approximately three weeks after the conclusion of the meeting, to inform you of the Panel actions related to your application.

Discussions of an agenda item often take place at multiple times throughout the meeting. For this reason, a specific time or day cannot be provided with certainty for any item. Presenters should plan to be present for the entire meeting schedule.

The CPT Editorial Panel agenda is available on the AMA CPT public website. While the monitoring of discussion of issues at the meeting is open to all, the actual meeting agenda materials are considered to be confidential and are not available for review. Public attendance at a meeting requires that you sign a confidentiality agreement.

Attendees can request recognition at the floor microphones at the Panel meeting to provide comments on agenda items under discussion. Speakers who wish to comment must submit a signed conflict of interest statement prior to speaking. When you are recognized, the Chairman will ask that you introduce yourself, identify any organization that you represent and declare any potential conflict of interest. AMA staff will provide the necessary documents for signature by prospective participants upon request.

The sharing of information about the CPT Editorial Panel meetings is restricted by the terms of the confidentiality agreement you have signed. Panel decisions are posted following each meeting in the CPT Editorial Panel Summary of Actions, published on the AMA web site CPT home page. Disclosure of Panel actions and deliberations is limited to the information contained in the Summary of Actions.

Specialty society members, staff and any others who are involved in surveys for the AMA/Specialty Society RVS Update Committee for approved Category I codes are also notified of Panel outcomes through the "Level of Interest" process. Immediately following CPT Editorial Panel meetings, applicable codes go through the RVS Update Process (RUC) for survey and review, for inclusion in the list of RUC relative value recommendations to CMS each year. For a complete account of the RUC, see The RVS Update Process.

New and revised code descriptions may be further refined prior to publication each year. For this reason code numbers are not assigned, nor exact wording finalized, until just prior to publication of the annual CPT code set.

Premature release of coding information other than the Panel Summary of Actions is prohibited under the CPT Confidentiality Agreement.

Current Procedural Terminology (CPT®), Fourth Edition, is a listing of descriptive terms and identifying codes for reporting medical services and procedures. The purpose of CPT is to provide a uniform language that accurately describes medical, surgical, and diagnostic services, and thereby serves as an effective means for reliable nationwide communication among physicians and other healthcare providers, patients, and third parties.

CPT descriptive terms and identifying codes currently serve a wide variety of important functions. This system of terminology is the most widely accepted medical nomenclature used to report medical procedures and services under public and private health insurance programs. CPT is also used for administrative management purposes such as claims processing and developing guidelines for medical care review.

The uniform language is also applicable to medical education and research by providing a useful basis for local, regional, and national utilization comparisons.

The American Medical Association (AMA) first developed and published CPT in 1966. The first edition helped encourage the use of standard terms and descriptors to document procedures in the medical record; helped communicate accurate information on procedures and services to agencies concerned with insurance claims; provided the basis for a computer oriented system to evaluate operative procedures; and contributed basic information for actuarial and statistical purposes.

The first edition of CPT contained primarily surgical procedures, with limited sections on medicine, radiology, and laboratory procedures. The second edition was published in 1970 and presented an expanded system of terms and codes to designate diagnostic and therapeutic procedures in surgery, medicine, and the specialties. At that time, a five-digit coding system was introduced, replacing the former four-digit classification. Another significant change was a listing of procedures relating to internal medicine.

In the mid to late 1970s, the third and fourth editions of CPT were introduced. The fourth edition, published in 1977, represented significant updates in medical technology, and a system of periodic updating was introduced to keep pace with the rapidly changing medical environment. In 1983 CPT was adopted as part of the Centers for Medicare and Medicaid Services (CMS), formerly Health Care Financing Administration's (HCFA), Healthcare Common Procedure Coding System (HCPCS). With this adoption, CMS mandated the use of HCPCS to report services for Part B of the Medicare Program. In October 1986, CMS also required state Medicaid agencies to use HCPCS in the Medicaid Management Information System. In July 1987, as part of the Omnibus Budget Reconciliation Act, CMS mandated the use of CPT for reporting outpatient hospital surgical procedures.

Today, in addition to use in federal programs (Medicare and Medicaid), CPT is used extensively throughout the United States as the preferred system of coding and describing health care services.

The Administrative Simplification Section of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 requires the Department of Health and Human Services to name national standards for electronic transaction of health care information. This includes transactions and code sets, national provider identifier, national employer identifier, security and privacy. The Final Rule for transactions and code sets was issued on August 17, 2000. The rule names CPT (including codes and modifiers) and HCPCS as the procedure code set for:

• Physician services.
• Physical and occupational therapy services.
• Radiological procedures.
• Clinical laboratory tests.
• Other medical diagnostic procedures.
• Hearing and vision services.
• Transportation services including ambulance.

The Final Rule also named ICD-9-CM volumes 1 and 2 as the code set for diagnosis codes, ICD-9-CM volume 3 for inpatient hospital services, CDT for dental services, and NDC codes for drugs.

All health care plans and providers who transmit information electronically were required to use established national standards by the end of the implementation period, October 16, 2003. In addition, all local codes were eliminated and national standard code sets were required for use after October 16, 2003.

The CPT Editorial Panel is responsible for maintaining the CPT code set. This panel is authorized by the AMA Board of Trustees to revise, update, or modify CPT codes, descriptors, rules and guidelines. The Panel is comprised of 17 members. Of these, 11 are physicians nominated by the National Medical Specialty Societies and approved by the AMA Board of Trustees. One of the 11 is reserved for expertise in performance measurement. One physician is nominated from each of the following: the Blue Cross and Blue Shield Association, America's Health Insurance Plans, the American Hospital Association, and the Centers for Medicare and Medicaid Services (CMS). The remaining two seats on the CPT Editorial Panel are reserved for members of the CPT Health Care Professionals Advisory Committee.

Five members of the Editorial Panel serve as the panel's Executive Committee. The Executive Committee includes the Editorial Panel chairman, co-chairman and three panel members-at-large, as elected by the entire panel. One of the three members-at-large of the executive committee must be a third-party payer representative.

Supporting the CPT Editorial Panel in its work is a larger body of CPT advisors, the CPT Advisory Committee. The members of this committee are primarily physicians nominated by the national medical specialty societies represented in the AMA House of Delegates. Currently, the Advisory Committee is limited to national medical specialty societies seated in the AMA House of Delegates and to the AMA Health Care Professionals Advisory Committee (HCPAC), organizations representing limited-license practitioners and other allied health professionals. Additionally, a group of individuals, the Performance Measures Advisory Group (PMAG), who represent various organizations concerned with performance measures, also provides expertise.

The Advisory Committees' primary objectives are to:

• serve as a resource to the CPT Editorial Panel by giving advice on procedure coding and appropriate nomenclature as relevant to the member's specialty;
• provide documentation to staff and the CPT Editorial Panel regarding the medical appropriateness of various medical and surgical procedures under consideration for inclusion in CPT;
• suggest revisions to CPT. The Advisory Committee meets annually at the CPT Fall meeting to discuss items of mutual concern and to keep abreast of current issues in coding and nomenclature;
• assist in the review and further development of relevant coding issues and in the preparation of technical education material and articles pertaining to CPT; and
• promote and educate its membership on the use and benefits of CPT.

Specific procedures exist for addressing requests to revise CPT, such as adding or deleting a code, or modifying existing nomenclature.

Medical specialty societies, individual physicians, hospitals, third-party payers and other interested parties may submit applications for changes to CPT for consideration by the Editorial Panel. The AMA's CPT staff reviews all requests to revise CPT including applications for new and revised codes. If AMA staff determines that the Panel has already addressed the question, staff informs the requestor of the Panel's coding recommendation. However, if staff determines that the request presents a new issue or significant new information on an item that the Panel reviewed previously, the application is referred to members of the CPT Advisory Committee for evaluation and commentary. Applications that have not received any CPT Advisor support will be presented to the CPT Editorial Panel for discussion and possible decision unless withdrawn by the applicant. Applicants will be notified if their applications have received no CPT Advisor support approximately 14 days prior to each meeting of the CPT Editorial Panel meeting. Applicants have the ability to withdraw their applications up until the agenda item is called at the meeting-thereafter the CPT Editorial Panel has jurisdiction over the agenda item.

The CPT Editorial Panel meets three times each year. AMA staff prepares agenda materials for each CPT Editorial Panel meeting. Panel members receive agenda material at least 30 days in advance of each meeting, allowing them time to review the material, review CPT Advisor comments and confer with experts on each subject, as appropriate. The Panel addresses nearly 350 major topics a year, which typically involve more than 3,000 votes on individual items.

A multi-step process naturally means that deadlines are very important. The deadlines for submitting code change applications and for compilation of CPT Advisors' comments are based on a schedule which allows at least three months of preparation and processing time before the issue is ready for review by the CPT Editorial Panel. The initial step, which includes AMA staff and CPT Advisor review, is completed when all appropriate CPT Advisors have been contacted and have responded, and all information requested of an applicant has been provided to AMA staff.

Following review and compilation of CPT Advisors' comments, AMA staff prepares an agenda item that includes the application, compiled CPT Advisor comments and a ballot for decision by the CPT Editorial Panel. Once the Panel has taken an action and preliminarily approved the minutes of the meeting, AMA staff informs the applicant of the outcome.

The Panel actions on an agenda item can result in one of four outcomes:

• addition of a new code or revision of existing nomenclature, in which case the change would appear in a forthcoming volume of CPT;
• referral to a workgroup for further study;
• postponement to a future meeting (to allow submittal of additional information in a new application); or
• rejection of the item.

Applicants or other interested parties who wish to seek reconsideration of the Panel's decision should refer to the process described on the AMA/CPT website.

All complete CPT code change applications are reviewed and evaluated by the 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 appliction, including all necessary supporting documents;
• Adherence to all posted deadlines;
• Cooperation with requests from the CPT staff and/or Editorial Panel members for clarification and information; and
• Compliance with CPT Lobbying Policy

General Criteria for Category I and Category III Codes:

• 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 ae 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 ohter procedures or services, the descriptor structure and content wil 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 circumstnces 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.

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 of 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);
• 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.

CPT Category II codes are supplemental tracking codes that can be used for performance measurement. The use of the tracking codes for performance measurement will decrease the need for record abstraction and chart review, and thereby minimize administrative burdens on physicians and other health care professionals. These codes are intended to facilitate data collection about quality of care by coding certain services and/or test results that support performance measures and that have been agreed upon as contributing to good patient care. Some codes in this category may relate to compliance by the health care professional with state or federal law.

The use of these codes is optional. The codes are not required for correct coding and may not be used as a substitute for Category I codes.

Services/procedures or test results described in this category make use of alpha characters as the 5th character in the string (i.e., 4 digits followed by an alpha character). These digits are not intended to reflect the placement of the code in the regular (Category I) part of the CPT code set. Also, these codes describe components that are typically included in an evaluation and management service or test results that are part of the laboratory test/procedure. Consequently, they do not have a relative value associated with them.

Tracking codes for performance measurement are released three times yearly following approval of the Panel minutes after each Editorial Panel meeting (March 15th, July 15th, and November 15th) on the AMA CPT Category II website ( http://www.ama-assn.org/go/cpt-cat2), and published annually in the CPT book as part of the general CPT code set.

Tracking codes are reviewed by the Performance Measures Advisory Group (PMAG), an advisory body to the CPT Editorial Panel and the CPT Health Care Professionals Advisory Committee (CPT/HCPAC). The PMAG is comprised of performance measurement experts representing the Agency of Healthcare Research and Quality (AHRQ), the American Medical Association (AMA), the Centers for Medicare and Medicaid Services (CMS), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the National Committee for Quality Assurance (NCQA), and the Physician Consortium for Performance Improvement. The PMAG may seek additional expertise and/or input from other national health care organizations as necessary for the development of tracking codes. These may include national medical specialty societies, other national health care professional associations, accrediting bodies, and federal regulatory agencies. PMAG recommendations are then forwarded to the CPT/HCPAC Advisory Committee just as requests for Category I CPT codes are reviewed. The PMAG is interested in:

• measurements that have been developed and tested by a national organization;
• evidence-based measurements with established ties to health outcomes;
• measurements that address clinical conditions of high prevalence, high risk or high cost; and
• well-established measurements that are currently used by large segments of the health care industry

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 CPT 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.

CPT's effectiveness depends on constant updating to reflect changes in medical practice. Suggestions from physicians, medical specialty societies, state medical associations, and those who deal regularly with health care information are the only way to ensure that CPT reflects current practice. Accordingly, the AMA welcomes correspondence, inquiries, and suggestions concerning old and new procedures. Coding change request forms are available through the AMA and are required to initiate a review of a proposed coding change by the CPT Advisory Committee. These forms play a vital role in maintaining and increasing the efficiency of the CPT process.

The next items are questions that should be answered before submitting suggestions for changes to CPT:

Generally, all the components of a procedure are included in the code for a procedure. For example, CPT code 58150 Total abdominal hysterectomy (corpus and cervix), with or without removal of tube(s), with or without removal of ovary(s), includes all of the components listed if they are performed at that operative session. Requesting a new code for total abdominal hysterectomy (corpus and cervix), with removal of tubes would be an example of fragmentation. However, if the physician intended to perform an abdominal hysterectomy with bilateral salpingo-oophorectomy but only removed both tubes (bilateral salpingectomy), CPT code 58700 Salpingectomy, complete or partial, unilateral or bilateral (separate procedure) would be used to report this component of what is normally considered an integral part of a total service.

To summarize, if there are several components of a procedure that are usually performed as part of that procedure, a separate code is not generally assigned for each component, unless the component is performed alone. The separate procedure is indicated after that procedure.

In the example above, creating a code for total abdominal hysterectomy (corpus and cervix) with removal of tubes would fragment an existing procedure that already includes these components when they are performed as well as additional components (bilateral removal of ovaries).

Certain procedures describe only a portion of a surgery performed, such as resection of a lesion or tumor. The procedure that is performed after the resection will vary, depending on the individual patient and the extent of the disease or other complicating factors. This may require reporting two or more procedure codes to completely indicate the services/procedures performed to treat one problem.

For example, CPT code 42120 Resection of palate or extensive resection of lesion, identifies the surgical resection performed, but the repair of the defect will depend on the exact location of the lesion and the extent of the resection. An adjacent tissue transfer or a free skin graft may be performed, or a flap or surgical obturator may be used to repair the defect. The CPT Editorial Panel does not try to create codes which cover all possible combinations for the removal/resection of the lesion and the subsequent repair. It is expected that two or more codes will be used to report these procedures.

CPT lists descriptive terms and identifying codes used to report medical services and procedures. Review the proposed coding change/addition. What does the actual service involve? If the only service provided is the review information stored in computers and does not require performance of a test, CPT code 99090 Analysis of clinical data stored in computers (eg, ECG, blood pressures, hematologic data) can be used to report this analysis. While many sophisticated devices and equipment to perform procedures or provide services exist, CPT's intent is to list those services/procedures in which actual work performance or direct supervision is required from a physician or practitioner. The device/equipment they use is not listed in the code.

A modifier indicates that a service or procedure performed has been altered by some specific circumstance but not changed in its definition or code.

For example, if a physician performed a cholecystectomy on a patient who was morbidly obese, a cholecystectomy would still be reported. The fact that the physician spent two additional hours performing the surgery (because of the complexity of the procedure due to the obesity) does not change the actual procedure being reported. The physician may add modifier 22 to the reported cholecystectomy code. The physician should attach a copy of the operative report or a narrative note to the claim form when submitting it to the third-party payer, indicating the additional work involved to perform this particular procedure.

• a complete description of the procedure/service (eg, describe in detail the skill and time involved. If this is a surgical procedure, include an operative report that describes the procedure in detail);
• a clinical vignette which describes the typical patient and work provided by the physician/practitioner;
• the diagnosis of patients for whom this procedure/service would be performed;
• a copy(s) of peer reviewed articles published in US journals indicating the safety and effectiveness of the procedure, as well as the frequency with which the procedure is performed and/or estimation of its projected performance;
• a copy(s) of additional published literature which you feel further explains your request (eg, practice parameters/guidelines or policy statements on a particular procedure/service); and
• evidence of FDA approval of the drug or device used in the procedure/service if required.

If the answers to the preceding questions suggest a new descriptor/code is needed, you may submit your proposal by completing a coding change request form, which will require the following information:

• Why aren't the existing codes adequate? (Be very specific.)
  What specific descriptors are you proposing? (Suggest wording for what you are proposing as well as placement of the proposed code(s) within the existing code range.)
• Can any existing codes be changed to include these new procedures without significantly affecting the extent of the services? (If not, give reasons why the existing codes are deficient.)
• Give specific rationale for each code you are proposing, including a full explanation on how each proposed code differs from existing CPT codes.
• If a code is recommended for deletion, how should the service then be coded?
• How long (ie, number of years) has this procedure/service been provided for patients?
• What is the frequency in which a physician or other practitioner might perform the procedure/service?
• What is the typical site where this procedure is performed (eg, office, hospital, nursing facility, ambulatory or other outpatient care setting, patient's home)?
• Does the procedure/service involve the use of a drug or device that requires FDA approval?

Refer to the current section of the CPT to which you believe the proposed code/coding change relates. In your letter, provide the rationale to answer the following questions:

Coding change request forms to introduce new procedures or to delete or revise procedure codes already in CPT are available on the CPT Website ( http://www.ama-assn.org/go/cpt-application).

Simply completing the information requested does not ensure that the CPT Editorial Panel will adopt your suggestion. Since the initial AMA staff and CPT Advisory Committee review process takes several weeks, you may contact AMA staff for any questions related to the deadline dates and schedule which apply to a particular CPT year cycle. CPT schedule information is also available on the CPT Editorial Panel Process Calendar ( http://www.ama-assn.org/go/cpt-calendar). Following preliminary finalization of the Panel minutes, AMA staff will notify you of the action that the CPT Editorial Panel has taken on your application.

As the designated standard for the electronic reporting of physician and other health care professional services under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), CPT codes are updated annually and effective for use on January 1 of each year. The AMA prepares each annual update so that the new CPT books are available in the fall of each year preceding their effective date to allow for implementation.

Category I vaccine product codes, Molecular Pathology and Category III codes are typically "early released" for reporting either January 1st or July 1st of a given CPT cycle. In order to comply with HIPAA requirements, the effective dates for these codes have been altered to become effective six months subsequent to the date of release following code set updates. As a result, codes released on January 1st are effective July 1st, allowing 6 months for implementation, and codes released on July 1st are effective January 1st.

Category II codes are typically "early released" for reporting three times yearly (March 15th, July 15th, and November 15th) following approval of the Panel minutes after each Editorial Panel meeting. The effective dates for these codes have also been altered to become effective three months subsequent to the date of release following code set updates. For example, codes released on July 15th are effective October 15th, allowing 3 months for implementation.

The American Medical Association has many CPT related products. The AMA Store has a full listing of the CPT related products. You may also call (800) 621-8335 to ask for a copy of the catalog to be sent to you.

Co-founder and President of Fractyl Laboratories Inc.

Helped build the world leader in aesthetic devices as COO of Candela Corporation, through its acquisition by Syneron.

As VP R&D of InfraReDx, developed a novel catheter-based cardiovascular imaging system.

Led engineering of HeartMate II from pre-clinical stage to first human use, as VP Operations, Thermo Cardiosystems through its acquisition by Thoratec.

MBA with distinction from The Wharton School.

BSEE from MIT.