[This Transcript is Unedited]
J. W. Marriott National Place
1331 Pennsylvania Avenue, N.W.
Washington, D.C. 20004
DR. COHN: Good morning. I want to call this meeting to order. This is the first of two days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee is the main public advisory committee to the U.S. Department of Health and Human Services on national health information policy.
I am Simon Cohn, chairman of the subcommittee and we welcome other subcommittee members, HHS staff and others here in person. I also want to send a special welcome to our newest subcommittee member, Brady Augustine. We will give you a chance to give your introduction in just a minute.
I also want to welcome those who are here, listening in on the Internet. As I understand it, we actually are on the Internet today. So, I want to remind everyone to speak clearly and into the microphone. If you will notice, I am a little bit hoarse. I came up with a cold last night. So, all of us have to put up with it.
Today is the first of several hearings planned for 2002 on code set issues. Today's focus is the current HIPAA medical data code sets, as well as the nonmedical code sets used in the HIPAA transactions. We also want to understand the progress being made dealing with the local code set issues.
Future code set hearings will address hospital expansions of the list of codes and/or the need for new versions of HIPAA code sets. I want to thank Betsy Humphreys, Vivian Auld, Pat Brooks and Donna Pickett for their work putting this session together.
Tomorrow, for your information, we will have a session starting at 8:30 a.m., adjourning at about 1:00 or 1:30 in the afternoon. The focus will be on new responsibilities for the full committee and subcommittee resulting from the passage of the Administrative Certification Compliance Act; in this case, providing input to HHS on the development of the model compliance form.
We will also be discussing the preparation of the annual NCVHS report on the implementation of administrative simplification. Today, we are also going to try to find some time to talk about the patient medical record information letter that will hopefully be going to the full committee later on this month.
It is not on the agenda, but we will find time at some point today.
Let's now have introductions around the table and then around the room. For those on the National Committee, I would ask you if as part of your introduction if there are issues coming before us today upon which you need to recuse yourself. If so, would you please note.
Commenting on that, I actually have a couple of things that I need to announce and recuse myself in relationship to. I am a member of the CPT Editorial Panel, as well as a member of the National Uniform Claims Committee. As such, I will not be voting on issues related to the CPT or the NUCC-sponsored taxonomy code. As a result, I will be recusing myself from those.
However, with the indulgence of the subcommittee, I will participate in the discussion assuming that is okay with everyone. I have also asked Kepa Zubeldia to take over chairing this session of the subcommittee just so there is no evidence or any indications of any impropriety.
So, with that, let's do the introductions.
Kepa.
DR. ZUBELDIA: Thank you, Simon.
Kepa Zubeldia with Claredi Corporation, a member of the committee and the subcommittee and as possibility for conflicts, I also chair the Association for Electronic Health Care Transactions and I am a member of X12, NCPDP and ASDM.
MR. AUGUSTINE: Brady Augustine with Gambro Healthcare, member of the committee and member of the subcommittee. I would just like to say thanks and it is a privilege and honor to be here. It is going to take awhile for me to get up to speed, but I am looking forward to making any contribution that I can.
DR. COHN: Welcome.
MS. GREENBERG: Welcome.
I am Marjorie Greenberg from the National Center for Health Statistics, CDC, and I am the executive secretary to the committee.
MS. HUMPHREYS: I am Betsy Humphreys from the National Library of Medicine and I am staff to the subcommittee.
DR. YASNOFF: Bill Yasnoff from the Public Health Practice Program Office of CDC and I am staff to the subcommittee.
MS. BROOKS: I am Pat Brooks with the Center for Medicare and Medicaid Services, formerly HCFA, and I work ICD-9 issues.
DR. MC DONALD: I am Clem McDonald from Indiana University and the Regenstrief Institute and a member of the committee and subcommittee. I am also a member of HL7, ASPM and I chair a committee. I don't think that latter is going to be discussed today.
MR. BLAIR: I am Jeff Blair. I am vice chair of the subcommittee and I am vice president of the Medical Records Institute. I am a member of HIMSES(?), HL7, ANSI Health Care Informatics Standards Board, AMIA(?) and I think that covers it.
MS. ADLER: I am Jackie Adler with the National Center for Health Statistics.
DR. BEEBE: I am Michael Beebe with the American Medical Association.
MS. HAWK: Susan Hawk of the Division of Data Policy in ASPE, HHS.
MR. ALDER: Tom Alder(?), American Association of Health Plans.
MR. TAYE: Michael Taye(?), American Dental Association.
MR. POKORNY: Frank Pokorny of the American Dental Association.
MR. RORITY: Jim Rority(?) with the American Health Information Management Association.
MS. PROPHET: Sue Prophet with the American Health Information Management Association.
MR. GRANT: Jay Grant, counsel for the National Association of Dental Plans.
MS. IRELAND: Evelyn Ireland, executive director of the National Association of Dental Plans.
MS. GILFOY: Helene Gilfoy with Gilfoy Consulting.
MR. SHUGART: Alan Shugart with Maryland Medicaid.
MS. GILBERTSON: Lynne Gilbertson, National Council for Prescription Drug Programs.
MS. PICKETT: Donna Pickett, National Center for Health Statistics.
MS. AULD: Vivian Auld, National Library of Medicine.
MS. LEON-CHISEN: Nelly Leon-Chisen, American Hospital Association
MS. BONNELL: Claudia Bonnell(?), Blue Cross and Blue Shield Association.
MS. RILEY: Kay Riley, Centers for Medicare and Medicaid Services. I work for HCPCS.
MS. NARCISI: Jean Narcisi, American Medical Association and National Uniform Claim Committee.
MR. ARGES: George Arges, American Hospital Association and chair of the National Uniform Billing Committee.
MR. BETA: Brad Beta(?) with the National Coalition for Cancer Research.
MR. GOODE: Thomas Goode(?) with the Health Insurance Association of America.
MR. MEYERS: Tom Meyers, vice president of Mutual of Omaha and current chair of the Dental Relations Committee, HIAA.
MS. OSHENSKY: Janis Oshensky, Delta Dental Plans Association.
MR. O'BRIEN: Phil O'Brien, Delta Dental.
MR. SMITH: Roger Smith, Delta Dental.
DR. COHN: I will turn the chair over to you if you would lead.
DR. ZUBELDIA: Thank you, Simon.
We have the first group of testifiers and we would like to take them in the order that we have in the agenda, so people on the Internet can also follow whose testifying when.
We have Michael Beebe with the American Medical Association, Frank Pokorny with the American Dental Association and Pat Brooks with CMS.
So, Michael, if you want to start.
DR. BEEBE: Good morning. I am Michael Beebe, the director of CPT Editorial and Information Services at the AMA. It is my pleasure to be hear today to make a presentation to you on behalf of the AMA and the CPT Editorial Panel.
The AMA and CPT appreciates the selection of CPT as one of the HIPAA transaction standards and accepts the considerable responsibility such a designation entails. I thank you for the opportunity to share how we are fulfilling that responsibility.
In my presentation today I will summarize the views of the AMA on current medical data code sets. I will review our progress and future challenges of the AMA's CPT as the AMA and the editorial panel strive to enhance the core functions of CPT, correct problems and expand its use into different areas.
As part of this, I will discuss CPT efforts to accommodate HIPAA requirements, such as the elimination of local codes and the incorporation of services not currently described in CPT. The AMA has made significant improvements in the code set, the CPT editorial process and in the distribution of the CPT code set and associated licensing information over the Internet.
We believe that these changes validate the selection of CPT as a national standard and demonstrate the willingness of the AMA and the editorial panel to make investments and changes to support CPT in this role.
First of all, the first question that the committee is interested in, the process and schedules for updating the HIPAA Medical Data Code Sets. The AMA believes that the process and schedule for updating CPT as part of one of the medical data code sets is working well. As many of you know, January 1st of each year is the statutory date for updates to the Medicare Physician Fee Schedule.
Since CPT is associated with the RBRBS, the AMA has made every effort to accommodate the release schedule. In order to give users sufficient time to update their systems, we typically try to get the CPT code set out in early November. This year we were successful in getting the new CPT codes out in mid-October, giving users even more time to get them up and running.
A new category of codes, which I will discuss in more detail later are CPT Category III codes. These are new for this year. The CPT Category III codes are for new and emerging technology. These codes will be updated semi-annually. Once approved by the Editorial Panel, newly added Category III, will be made available twice a year via electronic distribution on the AMA CPT Internet site.
The panel chose more frequent updates for the Category III codes in order to allow users to apply and begin tracking services. Since the codes are intended to allow researchers to collect data on services performed, getting them out there into the users hands earlier is certainly beneficial.
The early release of these codes is made possible since they do not go through the AMA specialty society relative value update process, which makes recommendations to CMS on relative values for the fee schedule. So, these codes will be carrier priced or payer priced and we can get them out into users' hands more quickly.
The AMA and the CPT Editorial Panel have also taken steps to enhance the overall CPT maintenance process. CPT code change proposals, instructions for submitting the proposals and the panel's schedule are all available on the AMA CPT Internet site.
The information can be downloaded and code change proposals can be e-mailed to AMA staff to get the ball rolling on coding changes. Anyone can submit a code change proposal and we certainly encourage anyone, all users of CPT to work with the editorial panel to correct deficiencies in the code set.
In addition, the AMA is in the process of updating their web site so that the public can view panel agenda schedules and electronically comment on panel agenda issues. Furthermore, the new site will allow code change proposals to be automatically downloaded to an AMA database and tracked electronically.
Also, we are going to develop a mechanism for CPT advisers can electronically comment on agenda items and so those agenda items don't have to be sent out via the mail. We should that it should greatly expedite the whole panel process.
As many of you know, panel meetings are now open to all participating specialty societies and to health care professionals advisory committees. The panel is currently in the process of reviewing options to further open panel deliberations and the advisory input process. We are concerned that any openness -- despite any openness or along with any considerations of openness, we need to maintain a confidential and rigorous peer review editorial process.
We believe that confidentiality of panel decisions is important to preserve the integrity of the editorial process, where reconsiderations and refinements are all part of the development of the final quality product. Also confidentiality is important to maintain the integrity of the industry-wide update schedules so the codes don't leak out throughout the year.
In addition to the national medical specialty societies and the health care professionals advisory committee, the Centers for Medicare and Medicaid Services, Blue Cross Blue Shield Association, HIAA, American Hospital Association and AHIMA, all participate on the CPT Editorial process. These groups have all contributed to panel decisions and have helped shape the final work product.
The panel believes that the quality of the CPT code set is improved due to the collective input of physicians, non-physicians, payers and coders. The AMA believes that the work of the HCPCS Alpha-Numeric Editorial Panel also benefit from the input of physician groups and recommends that the CPT Panel be provided the same opportunity to serve on the HCPCS panel.
Currently, final decisions on the content of Level 2 HCPCS codes are made by representatives of the Blue Cross Blue Shield Association, HIAA and CMS. The inclusion of a member of the CPT Editorial Panel in the HCPCS maintenance process would help to maintain national coding consistency and eliminate duplicate codes.
The next question, medical data code set distribution, mechanisms, formats and prices. The AMA has made a concerted effort to provide easy, low cost access to CPT. CPT users can purchase and download CPT data files from the AMA Internet site.
Single users can purchase full data sets, the short, medium and long descripters for $67.95 and two to ten users can purchase the full data sets for $187.95. Discounts are, of course, given to AMA members. Single users can purchase individual data files, which means either the short, medium or the long, for $54.95 and two to ten users for $174.95.
These are, again, all available for download over the Internet with a credit card.
The CPT code book is available on line at the AMA Internet site, amapress.com, which is the AMA press book store, but also other Internet sites, such as amazon.com. CPT 2002 Standard Edition is $49.95 or $39.95 for members. This is the same price that was referenced in the preamble of the August 17, 2000 Final Rule of Transactions and Code Sets.
CPT users have the option of purchasing CPT Professional Edition, which contains further enhancements, such as illustrations, color coding and cross references to educational material on CPT. The AMA also has a catalog that is mailed twice a year to physicians and CPT users that contain CPT and other coding products.
In addition, there are several resellers of CPT who sell the books over the Internet and through their own catalogs. CPT licensing information, including royalty rates, are also available on the AMA web site. As I mentioned, the AMA is committed to making this CPT widely available at a low cost. The price for internal use of CPT by ten or fewer users is explained above, that I referenced earlier, at $187.95 or $174.95, depending on the number of files purchased.
Internal use of CPT beyond ten users is $50 per legal entity, plus $10 per user. Again, this is the same rate that was referenced in the August 17, 2000 Final Rule, which shows that we are trying to keep our prices low and have not raised them in the last two years.
The distribution license royalty is $10 per user per product license. Print publication is 7.5 percent of sales price and not less than $10 per distributed copy. Also, in terms of licensing, the AMA has worked very hard with CMS to allow the use of CPT on their web site, to communicate Medicare policies with carriers and providers.
CPT is contained in local medical review policies, which are posted on the CMS Internet site. The AMA is also continuing to work with CMS to allow the individual carriers have more flexibility in using CPT codes on the carrier web sites as part of their educational efforts to assist physicians in billing Medicare.
Another example of our increased use to disseminate CPT widely on the Internet is a new tool on the CPT Internet site that I am very excited about. This new tool, which came early this week is a public access site where users can look up CPT codes and Medicare fee schedule information for free. Users can search by CPT code or key words in the long descripter and the search will return the long descripter of the CPT service and Medicare fee information by geographic area.
The AMA developed this site as a free service to the public, to allow them to look up CPT codes and Medicare pricing on specific services. We intend the site to be used for personal health care purposes and not to replace products developed by vendors. As such, searches are limited to ten per day.
This is a new area for the AMA and it is something we are really excited about to allow the public to have greater access to CPT.
Another question that the subcommittee is interested in is the progress towards the elimination of local codes. The AMA supports the decision to eliminate all local health care codes and to migrate them to national code sets. We feel this is an important step towards the standardization of national health care information and will support patient care by facilitating data collection and communication among health care professionals.
It will also assist physicians and other health care professionals by simplifying the number of codes needed for payment purposes. The CPT Editorial Panel is currently working with CMS to transition HCPCS Level II G Codes into CPT or otherwise rectifying duplicate codes in the HCPCS set by revising CPT or deleting G Codes.
The AMA is very interested in formalizing our participation in the HCPCS panel so that we can further monitor this issue. In addition, as I mentioned previously, the AMA invested in a document management system, which will allow the internal AMA CPT staff to become better organized and more efficient in processing all the paperwork associated with the panel. It will allow the direct submission of on-line coding changes.
We developed and invested in this system largely because we thought that there might be a large influx of new code proposals with the elimination of local codes. To date the panel has not seen an increase in code proposals. We are concerned whether payers and providers have reviewed their coding needs with respect to the elimination of local codes.
Later, I will discuss the panel's efforts to assist payers in complying with the elimination of local codes. Some further comments that the AMA is interested in has to do with the specification guidelines as a HIPAA standards. The Final Rule on Transactions and Code Sets discusses the standard data content for adopted standards, which will facilitate the consistent and identical implementation.
Although the data content includes data dictionaries, patient specifications and modifiers for code sets, it specifically excludes guidelines and instructions for code sets. The final rule argues that while guidelines are highly desirable, objective, operational definitions for most codes are not available. The level of detail varies widely from code to code. The process for developing guidelines and instructions are typically not open and include limited participation compared to the development of the code process themselves.
The final rule goes on to adopt the official ICD-9-CM guidelines for coding and reporting, as maintained by HHS, but does not name guidelines for any other code sets. The AMA believes that the standard implementation guidelines for code sets are essential for uniform national application of the code sets.
If health plans and providers are permitted to implement and interpret medical data code sets as they see fit, the purpose of administrative simplification will not be achieved. The specification of one collection of code set guidelines implies that there is a process or criteria for code set guidelines similar to the code sets themselves. At the least it suggests that other code set guidelines could be named.
The AMA believes that CPT guidelines and instructions should also be specified as a national standard implementing CPT Code Set. The instructions and guidelines contained in the CPT book are subject to the same rigorous editorial process used to develop the CPT codes themselves.
The CPT Editorial Panel and the CPT advisers consider CPT section guidelines, specific code level instructions and definitions in the application of modifiers at the same time the language for CPT code descripters are developed. Proper use of CPT codes is based on all the associated material contained in the CPT book.
For example, simple, intermediate and complex repair are defined in the CPT book prior to the actual repair codes so that users understand the circumstances for reporting each. Also, coding conventions, such as add on codes are explained in the CPT guidelines.
The use of codes and descripters apart from this information limits the functionality of CPT in its uniform application and contributes to improper coding interpretation, which is counter to the purpose of having national standard code sets. The AMA strongly encourages the subcommittee and the NCVHS to recommend CPT guidelines and instructions for applying the codes be included as a national standard.
Now I would like to discuss some of the changes CPT has made over the past several years to make it more amenable as a national standard to incorporate other codes that weren't previously in CPT and to help with the elimination of local codes.
As a result of the recommendations of the CPT-5 Project, CPT has gradually incorporated many improvements in the structure and function of CPT codes. In August, the AMA addressed the committee regarding our efforts to develop a CPT data model to enhance its interoperability in anticipation of electronic medical records and other advanced computerized functions. We are still working on that effort.
Today I would like to talk about changes in CPT that are intended to add specificity and enhance clarity, integrate new services not previously described and supply tools for researchers and the managed care industry. CPT 2002 contains changes that are a direct result of our efforts to make the code set easier to use and more straight forward.
This year, the general instructions for use of CPT were changed to emphasize the use of unlisted procedure code when no other code exists to describe the service performed. While this seems fairly basic and kind of a no-brainer, it is important because we feel that this change will help prevent the miscoding of new services and facilitate their tracking and eventual inclusion in CPT.
It will also encourage the use of the new Category III codes for new and emerging technologies. There are many new changes in CPT that are intended to eliminate ambiguity and enhance clarity for code descriptions. As part of the CPT-5 Project, the AMA began an effort to standardize CPT terminology to choose a single term amongst synonymous terms.
The National Library of Medicine's Metathesaurus was used to analyze CPT descripters and develop lists of synonymous terms. The CPT Advisory Committee and the CPT Editorial Panel then determined the most clinically appropriate term for a given circumstance. In addition, all similarly situated codes were also changed. The panel was forced to make exceptions for different contexts and nuances.
All these changes are spread throughout the book. They include subtle things, such as "bowel" being replaced with "intestine" or "echography" being replaced with "ultrasound." The CPT Editorial Panel and the CPT Advisory Committee have attempted to take a very pragmatic approach to implementing changes.
The panel wants to avoid unreasonable or unnecessary changes that could cause problems for users in attempting to gradually phase in changes. We don't want the users to be overwhelmed and we don't want to disrupt the claims processing function.
For CPT 2002, the panel focused on the clinically appropriate elimination of ambiguous terms, such as any method, any approach and any technique. This was a relatively difficult change. In many cases, the terms "any method," "any approach" and "any technique" are place holders for a great many different types of methods or techniques.
The panel and advisers developed parenthetical lists, methods or techniques that are clinically appropriate to the service and included them in the code descriptions so people can understand what the appropriate methods or techniques for each code were. In some cases, the panel determined that the use of the term "any method" or "any technique" did not really affect the meaning or intent of the code or cause any problems for the users.
Thus, in some cases, the ambiguous term was maintained. That goes back to the whole idea of not causing undue harm to the code set. The panel has not yet completed this effort and more changes will be made for CPT 2002. The panel and advisers are currently working on elimination of additional problematic terms "with or without," "and/or" and "separate procedure" are all slated to be changed in coming editions of CPT.
"With or without" and "and/or" are causing a lot of problems for the panel because of the implication for changes to physician work relative values. But the panel and advisers have worked on a schedule for the elimination of these terms and we are moving forward with that schedule.
Another initiative from the CPT-5 Project was an attempt to prepare the CPT Code Set for the elimination of local codes. The AMA conducted a survey of private payers to determine why they develop local codes and to capture a set of local codes for possible inclusion in CPT. The survey results indicated that payers used local codes for many reasons, including but not limited to data collection initiatives, new technologies, screening and counseling services and non-physician provider services.
Based on this survey, the CPT Editorial Panel working with payers and the home health community develop new codes for home health services and home IV infusion services. These codes are in CPT 2002 and will continue to be refined by the panel with the assistance of the appropriate groups involved.
We are particularly working with the Home Infusion EDI Coalition to refine the home infusion codes for their use. The panel will continue to work with all these groups through the editorial process to help with the elimination of local coding issues. The survey results also supported a major new initiative on the part of CPT to develop two new code sets. CPT has developed Category II codes and Category III codes. Category II codes are codes for performance measurement and Category III codes are codes for new and emerging technology.
These code sets will allow CPT to meet new coding demands caused by the elimination of local codes and the increased integration of CPT with clinical and administrative computer systems. The survey of local codes show that many payers have developed their own codes for new technology services. The AMA believes CPT must expand its scope to accommodate the increased need for information contained on the administrative record to provide data in capitated settings where no bill is generated but there is need for information enrollment, encounter outcomes and quality data.
The AMA takes its responsibility to maintain CPT very seriously. Likewise, the CPT Editorial Panel as the stewards of CPT constantly strive to produce the most up-to-date accurate and intelligible code set possible. The investment and changes in CPT over the last several years demonstrates the commitment of the AMA and the editorial panel. This level of commitment will continue to shape CPT as medical data code sets are increasingly used for various purposes.
We look forward to working with the committee and this subcommittee to address your concerns and answer your questions. I would be happy to respond to any questions you have. Thank you.
DR. ZUBELDIA: Thank you, Michael.
I want to remind the testifiers to try to stay within the ten minutes.
Frank.
MR. POKORNY: Thank you, Dr. Zubeldia. Dr. Cohn, members of the subcommittee and my colleagues in the health care community, good morning. My name is Frank Pokorny and I hold the position of manager, code and third party issues, Council on Dental Benefit Programs of the American Dental Association. On behalf of the association, I would like to express our appreciation of the NCVHS interest in activities that concern the medical code sets designated as national standards in the Final Rule on Transactions and Code Sets published on August 17th, 2000.
That regulation, named the ADA's Code on Dental Procedures and Nomenclature, known as the Code or sometimes abbreviated CDT in recognition of the ADA publication in which it is printed as the medical code set for reporting dental procedures.
On that same date, the Secretary of Health and Human Services named the ADA's Central Content Committee as one of the six Designated Standards Maintenances Organizations charged with reviewing and making recommendations on changes to the HIPAA standard transactions. Prior to that, the underlying HIPAA legislation that was signed into law on August 21st, 1996, the American Dental Association was designated as a consultant to the Secretary of Health and Human Services on national standards for health care.
There is much history to the ADA's concern and active involvement in creation and adoption of standards applicable and available to the dental community. The American Dental Association has served members of the profession and others within the dental community through the development and promotion of standards for recording and conveying information on services provided to a patient.
Such efforts began in the mid-1960s and, as the decade ended, the first results included the national standard for tooth numbering, for paper claim form submission and for dental procedure coding, the latter named the Code on Dental Procedures and Nomenclature, also known the Code.
Both the paper claim form standard and the dental procedure codes have evolved with revisions on approximately a five-year cycle. The most recent versions of the ADA Dental Claim Form and of the Code were published in the latter half of 1999, the January 1st, 2000 effective date. Both items are published by the American Dental Association in a manual titled cdt-3/version 2000.
As noted a moment ago, these long term achievements in the standards arena have been recognized under the HIPAA legislation, as well as in the Final Rule on Standard Transactions and Codes and the Federal Register notice that named the Designated Standards Maintenance Organizations.
To fulfill its role as a consultant to the HHS Secretary under the HIPAA and as a DSMO, the association established the Central Content Committee, also known as the DeCC. The DeCC was established by the American Dental Association Board of Trustees and is a voting body with balanced membership from the payer, general interest, meaning other content committees and organizations, such as the Workgroup on Electronic Data Interchange, and the provider sectors of the dental community.
As a DSMO, the Dental Content is concerned with the data elements that comprise all standard transactions, bringing the dental perspective to consideration of all requested changes. The DeCC is not, however, involved in changes to the Code on Dental Procedures and Nomenclature that has been identified as an external code set that is conveyed by a data element in a standard electronic transaction.
Code maintenance has been historically the responsibility of the Association's Council Dental Benefit Programs. Evolution of the Code has followed a path that incorporates changes arising from members of the profession and the third-party payer community. In this light I would like to now address the four questions posed by the subcommittee in its invitation to participate in today's proceedings.
Are the current processes and schedules for updating the HIPAA medical data code sets working well?
The American Dental Association believes that the current process and schedule for updating the Code is working well and that the door to consider improvements is open. A brief history of the process is appropriate so that the subcommittee may appreciate how the process has evolved to where it stands today.
During the last decade, review and publication of revisions to the Code occurred approximately every five years. The decade started with what has been called CDT-1, effective January 1, 1990. This was followed by CDT-2 with a January 1, 1995 effective date. The decade ended with dissemination of the current version of the Code on Dental Procedures and Nomenclature in the ADA publication titled cdt-3/version 2000.
This schedule has been changed and the ADA anticipates that Code revisions will be periodically reviewed and published biannually. The change is due in no small part to implied expectations in the Regulatory Preamble to the Final Rule on Transactions and Code Sets that medical sets must be reviewed at least annually. In addition, the preamble clearly states that the organization responsible for code set maintenance is responsible for determining the effective dates for a particular version.
A biannual revision cycle supports a more timely accommodation of the needs for new or revised dental procedure codes to reflect improvement and change to the practice of dentistry. The cycle also enables deletion of codes for procedures that are no longer considered current, appropriate or in widespread use.
Members of the subcommittee may be wondering when this changed process comes into effect. The answer is that it has already taken place. On January 28 and 29, 2002, the ADA's Code Revision Committee met and completed its deliberations on additions, deletions and changes to the Code. These actions will be incorporated into the next version of the Code, which is to be effective January 1, 2003.
The call for Code change requests was made when the current version became effective and a page on the ADA web site, noted in the final rule's regulatory preamble, was established to allow direct electronic submission, as well as containing instructions for submission on paper. The web page was intentionally not located in an ADA members only section of the site and requests received through March 2001, a submission period lasting fourteen months total and seven months after the site was named in the notice of final rulemaking published in the August 17, 2000 Federal Register.
The recently concluded review of the requested changes was undertaken by the Code Revision Committee. This deliberative and decision-making body was organized to have a balanced and equal voting representation from the American Dental Association representing dentistry as a whole and from the third-party payer community. The named payer organizations, in alphabetical order, are: Centers for Medicaid and Medicare Services, Blue Cross and Blue Shield Association, Delta Dental Plans Association and the Health Insurance Association of America.
Planning for the next review and revision cycle is underway and the ADA welcomes thoughts and recommendations from the NCVHS, as well as other members of the dental healthcare community. Our intent is to further improve the process that yields following versions of the Code on Dental Procedures and Nomenclature.
I would like to move to the second question. Are the medical code set distribution mechanisms, formats and prices acceptable?
The American Dental Association believes that the distribution mechanisms, formats and prices are acceptable. To satisfy varied needs, the ADA has developed several avenues by which members of the profession and other interested parties may obtain copies of the Code. As a benchmark, over 84,000 publications containing the Code have been purchased since the latest version was made available.
For those interested in a print version, the ADA's Department of Salable Materials offers the manual titled cdt-3/version 2000, at a cost of $39.95 to ADA members and $59.95 to non-members. There is also a quick reference guide containing a subset of frequently used codes, which also does not include descripters and other pertinent information at a reduced cost of $7.95 for members and $11.95 for non-members.
A CD-ROM that contains the Code, as well as other functionality, such as dental claim form preparation, that supports a dentist's practice is also offered. The cost is $89.95 for members and $149.95 for non-members.
For those entities, such as third-party payers or practice management system vendors, that desire to license their use of the Code, an ASCII Text delimited file is provided. Licensing fees for practice management system vendors is based on the number of installed sites at a rate of $10 per site annually. For third-party payers, the licensing fee is to be $1,000 per annum, without limitation on the number of users within an organization.
The ADA's pricing policy arises from the business decision to apply an administrative fee that would recoup some of the costs related to developing and maintaining the Code. When determining a charge, the intent is that all users within a category, such as the member dentist in practice, should be treated as uniformly as possible. The subcommittee may not know that ADA members have been paying for their copies of the Code since 1990.
The third question, is progress being made toward elimination of reliance on local codes?
The American Dental Association suggests that the "local codes" may be better termed "proprietary codes," as there is a history of some third party payers creating and using dental procedure codes that are not found in or perhaps designated by a different code in the Code on Dental Procedures and Nomenclature. However, we believe that such exceptions are becoming less frequent.
One major action that reduced the number of dental procedure code sets was noted in the Regulatory Preamble to the Final Rule on Transactions and Code Sets, which I would like to quote:
"The ADA will change the leading '0' to a 'D' as proposed. Many organizations are already using the 'D'Codes, which contain the leading 'D,' without difficulty and we expect others to make this transition without difficulty. Although we did not receive comments that specifically addressed the removal of the dental codes from the HCPCS, generally comments about the desirability of more consolidated access to all HIPAA codes have led us to revise our position on the inclusion of 'the Code' in HCPCS. Thus, the dental codes will be available from two sources: the ADA and through a licensing agreement between HCFA and the ADA."
In late 2000 and mid 2001, the ADA made inquiries to the Blue Cross and Blue Shield Association and to the Health Insurance Association of America concerning their members' adoption of the current version of the Code. In addition, several Blue Cross and Blue Shield plans and commercial carrier dental plans were also surveyed on this question. The findings strongly suggest the widespread and continuing adoption of the Code by third-party payers.
For example, in late 2000, the survey information suggested that at least that at least 68 percent of the Blue Cross and Blue Shield plans were accepting claims submitted with the current version on the Code. Information from HIAA, reported on an aggregate basis, indicated that its member carriers, who had already adopted the current version of the Code provided dental benefit coverage to 45 million individuals. I might add that none of the 20 respondents to the ADA's 2001 survey, 13 Blue Cross and Blue Shield plans and seven commercial carriers expected problems with electronically accepting claims with the current version of the Code by October 16, 2002.
To the fourth question, other comments related to HIPAA medical code sets.
In his letter dated June 29, 2001 to Secretary Thompson, Dr. Lumpkin acknowledged, "It is clear that the current HIPAA code sets do not cover all procedures and diagnoses. This will always be a problem due to the evolving nature of health care."
Dr. Lumpkin's letter and the American Dental Association's testimony both recognize that we are in an evolutionary environment where stasis serves no member of the health care community. As noted earlier, the ADA has already adjusted its Code revision process to reflect the timely needs of the dental profession and the third-party payer community and the federal regulation promulgated under the auspices of HIPAA.
Further refinement of the Code revision process should be expected to ensure that both current and future needs of all sectors are incorporated into the Code on Dental Procedures and Nomenclature. However, it serves none of us if such evolutionary changes lead us down a deadend to extinction.
Let me close by expressing my appreciation of the interest expressed by the subcommittee in learning of the American Dental Association's views and experiences with the Code on Dental Procedures and Nomenclature in general and in the context of HIPAA . Today is but another step along a path that we believe will serve us well as we move through this new millennium.
Thank you very much for your time and attention and I look forward to addressing any questions that are forthcoming.
DR. ZUBELDIA: Thank you.
MS. BROOKS: My name is Pat Brooks and I am going to be talking about the ICD-9-CM process today. That is maintained through the ICD-9 Coordination and Maintenance Committee and since Donna Pickett from CDC and I have discussed how that works on numerous occasions, I won't go into detail on that today.
I will, however, refer you for all the gruesome details on the time frames and changes I will discuss today. You will find them all in the latest report of that committee. You can find these reports, for those of you who haven't seen them, by -- even though we are called CMS, you will need to go to WWW.HCFA.GOV., click on meeting events and workgroup and you can link right up to our ICD-9-CM reports --
DR. COHN: Pat, I don't mean to break in. Do you have any written --
MS. BROOKS: No, I don't. You will find all of that in there. Yes. I am not going to change anything but what has formally been reported from that last November committee.
Discussions on how we thought about changing ICD-9-CM were part of the proposed notice, the PPS, this past year, which many organizations in here wrote into. You can read your comments and our responses there and the response in the final notice.
We didn't make it out in time to make it into the PPS final notice. So, a separate medical technology thing went out later. All that to say we have in the Federal Register and on our home page, a description of our process. I am going to describe the three changes that we have made to ICD-9-CM in recent times.
Overall, our process was well-received. So, the public didn't want a whole lot of changes. Some of them are fairly dramatic. One, in particular, many organizations felt like it took too long to get an ICD-9-CM code. Depending on when you came to our meetings, it might be a year and a half to 11 months. They asked us to shorten it.
So, we have done something very radical. We are in the middle of it now. I can't tell you how it is going to work. I think I am making Donna very nervous. But as far as the procedure codes go, instead of our November/December meeting the last meeting of the year, we are going to attempt April meetings from now on and we are going to have any late burning procedure codes that we can easily describe and we feel like can be accomplished in the book.
We are going to try our best to get those codes out in the addendum for the following October. It is quite a challenging time frame. All this was discussed in our proposed notice when we discussed with the public what we thought we should do. Some of the drawbacks of that -- I know we are talking about coding meetings and not reimbursement today, but a drawback of that is we will be holding this meeting after the proposed notice goes out announcing the final codes.
So, everyone in this room will read our code titles in April and they will see the proposed DRG assignments and they will comment on them, but they won't know the last minute titles that make it onto the April meetings that may go out in October. So, this is a radical difference and I am not sure how it is going to work.
We will have to catch up with Donna's work on coordinating the CD-ROM and we hope that goes well. I think many manufacturers that wanted codes came to us in November -- you can read the agenda. It was quite full. So, it may be that we won't have any last minute burning ones that must make it to that meeting.
We do work with the industry closely and make sure that the codes make sense. So, if someone proposes a code and it sounds like a great idea, but some of the indexing doesn't work and we work with HIMA and HA on those or something about it, there is no way within two weeks we are going to try to finalize those codes and put it out in October and create chaos.
So, things must be simple and understandable and that is what we are in the middle of trying to figure out now.
The other thing we did different that those of you who read the summary of our meeting noticed, was that we are trying to be more responsive bringing issues to discussion sooner. It used to be we encouraged people to wait until they had something FDA approved or at least used by someone somewhere before we discussed it at the Coordination and Maintenance Committee.
As a matter of fact, if we did discuss something early, many of the audience were not appreciative if something is done by one hospital somewhere, they didn't want to take the time to put it in the book or have additional index entries for this issue.
However, you will notice when you read that November report, we discuss some things that may not get FDA approval for a year. We discuss some things that may come out during this year. There were comments for and against at the meeting that you will read. Some people thought this was a fine idea because we will get a code out earlier in October.
Some people thought that was terrible because what if it doesn't pan out. How will this work out? I haven't a clue, but we are back in the office right now working on our DRG specs for our upcoming notice and we are trying to make decisions which of these codes will go forward and which won't. So, I think we will get interesting comments from many of you when you read this notice and when we figure this out in the next week or two. That is what we are doing now.
The other dramatic difference that you noticed if you were at the meeting or you read our November program is that we are trying to add more codes and we are trying to fit things in and the book is full. We are discussing in April this whole issue of going to 10 PCS. So, I am not going to get into that. But we had to figure out a way that we can make the current book work better now.
We came up with a very radical idea. We said, well, here is a spot in front of the code book, in front of the neurology kind of section, 00, no one has used it. What if we stick everything that won't fit someplace else in there?
Well, that didn't go over too well with all of our rigid coder types, but it went over quite well with manufacturers and others, who said I have got this new procedure. You don't have room. By God, fit it in somewhere. So, you will see this fall some codes with 00 that aren't in their section of the book. They will be indexed and we hope coders can find them. How will this work? I haven't a clue.
But that is what we are working on right now. We have had input from the industry for and against and when the addendum comes out, the people who haven't bothered to read it will see this whole new section. We actually have two sections like that, but we are starting with a 00 first. So, that is the things that are different. I wish I could tell you how they are working out, but we are in our office doing those right now.
The second question I can answer for you, distribution mechanisms. We haven't made any changes in that. We have always had ICD-9-CMs in the public domain. We put up the addendum every year late spring, early summer. The national center coordinates the efforts between the two agencies to do a CD-ROM that they have sold for less than $20 every year. I imagine it is going to be about that this year. We don't have a price yet.
The CD-ROM is the entire book and it is a searchable document. A lot of people like it. We also have on our home page in our public use files and have for years, the code title with an abbreviated description. People call me every day. They decide I am going to make a million dollars. Where are your codes? And I say there they are. You know, do it.
Many of those don't know what a code is. It is an interesting thing. But we do provide all this and if we had another way of doing it, I guess we would add more to that home page.
Gaps, there probably are gaps in ICD-9-CM just because technology is changing so quickly more so on the procedure side than the diagnosis side. Donna can manage to squeeze in a new diagnosis, but everyday they are making new kind of approaches in procedures that are very difficult to update the book given its current structure.
Our approach to that I have already described. If it won't someplace, we have got this new 00 section, which will lead to a lot of interesting discussions around the country. I think most of the other questions have to do with the April meeting. So, I won't go into the why now it is not working well and what 10 PCS is all about.
I will just stop there.
DR. ZUBELDIA: Thank you. That was a very interesting approach that you have taken to the ICD-9.
We are going to have about 25 minutes for questions and we will be addressing questions to all of you. I will start with questions for Mike.
I am a little concerned about the Category III codes being released on a semi-annual basis. That is not in sync with the rest of the CPT codes. Do you have a version control system so people will know which code set is being used and the method for retiring old Category III codes and the version control of them?
DR. BEEBE: Yes. Just the new codes we released on a semi-annual basis. The full body of codes will still be released on an annual basis in the CPT book as the normal process moves along.
So, whenever codes are deleted or revised, the revisions will appear with the semi-annual updates, but deletions will be noted in the CPT book with the rest of the CPT files so we can control the code set and the migration of Category III into Category I. We are still working on the release schedule with Blue Cross Blue Shield and other payers so that it can be more easily incorporated into their quarterly tape updates and what not so that they can comply with HIPAA requirements.
DR. COHN: This is actually a question for Pat Brooks. Good morning.
I actually am not an expert in ICD Volume 3. So, you are going to have to help me with some of this. As I understood from your testimony, the procedure codes are updated once a year?
MS. BROOKS: Yes.
DR. COHN: And not more than that?
MS. BROOKS: No.
DR. COHN: The issue is is that you are trying to create a four or five month period where they all get in, get handled, get out to the public, get out to software vendors, who are putting it into their code edits and all of that. Is that correct?
MS. BROOKS: Well, there are a couple of issues and you are correct. Historically, we have done it once a year because we can only update our projected payment system once a year in October. So, that sets our time line. So, we make the changes for October. We have to finish all our codes and then get the books out and we can reprogram our grouper(?). All of that has to happen during the summer.
What we are trying to do that is different this year is many manufacturers complained that it is a long time between the November meeting and the following October. We are trying to shorten that time so that if people didn't think about calling us and waited until after November, that they would have an opportunity to get into the following April meeting and maybe make the following October.
DR. COHN: Pat, actually I understood that and I actually know who -- I can imagine the people that wanted it to be moved to April, which would be vendors of new procedures and new technologies. I think that is pretty obvious. I was actually just looking at it from the other side, which is insurance companies and, you know, software vendors and others that are trying to modify their systems and -- I was just wondering how that was all going to work, if you have been hearing from them significantly.
MS. BROOKS: In theory, because we don't have any more time than they do, we have to get our grouper out at the same point that they do. We have to get all this additional work with the existing staff done in the same time frame.
We will still have to have that addendum up by early May or June, like we always do. We will still have to make the time line to get the CD-ROM out at the exact same time. The publishers and vendors will notice no difference. They will look up there and it will be like magic. We will be the ones going nuts and hoping that we can do it in a systematic organized way with this new amount of work, same staff, get it done quickly.
Our grouper has no extra time for that either, just like the vendors don't.
DR. COHN: Okay. Thank you.
DR. MC DONALD: I have a couple of questions.
Pat, just to clarify, where exactly can you get the ICD-9 code set because that is what many people ask me. You said at CMS, but that is a big place.
MS. BROOKS: Okay. If they want it on the Internet, the best thing to do is to go to currently HCFA.GOV and if you will click on meetings, events and workgroups, you will see the ICD-9 Coordination and Maintenance Committee. That will just take you up to a page that lists a bunch of stuff, like ICD-10-PCS is there, if you want to read it. It will tell you our addendum, which tells you how things change.
If all they want is a piece of it -- most people simply want the code numbers, the abbreviated titles --
DR. MC DONALD: Yes, the whole set of ICD-9.
MS. BROOKS: Okay. And all that information on our home page lists the option of buying a CD-ROM. We have that in our summary report every time, if they want the CD-ROM version. It lists the addendum if they want to update their systems themselves. It goes over -- there is a link to Donna Pickett's web site to the diagnoses. So, it is all there on that home page.
DR. MC DONALD: But there is a source for all the ICD-9 codes and names, including the diagnosis and the procedures?
MS. BROOKS: Yes.
DR. MC DONALD: Okay. And does the CD have more than that?
MS. BROOKS: The CD is just an electronic code book. It is the whole code book with index, tabular and whatever. That is what it is. And they have search capability.
DR. MC DONALD: Then this is another question. Is ICD-9 a subset -- ICD-O, oncology, a subset of ICD-9? I have heard mixed reports on that.
MS. BROOKS: You will have to ask Donna that question.
MS. PICKETT: The ICD-O is a separate classification for -- part of ICD-O is found in ICD-9-CM.
DR. MC DONALD: I have heard that all of it is. I have heard mixed stories.
MS. PICKETT: It is -- the morphology section is an appendix to ICD-9-CM -- codes or chapter 2.
DR. MC DONALD: In ICD-10 you are saying? I missed -- I lost that.
MS. PICKETT: There are three versions of ICD-O, the current version being used by NCI is ICD-O-3. ICD-O-3 will be a component of ICD-10-CM. ICD-O-2 is part of ICD-9-CM. The typography codes are Chapter 2 of ICD-9-CM and the morphology codes of ICD-O are actually in an appendices of ICD-9-CM.
DR. MC DONALD: Okay. Thank you very much.
I had a question about the pricing of the AMA. Those ten for 150 bucks, whatever it is, doesn't sound so bad, but what does that -- if you have got a hospital with 2,000 stations, how does that translate? I mean, who has to have those licenses? Just the people down in medical records or anybody who is checking people in and out or --
DR. BEEBE: It depends how the -- if there is a hospital with 2,000 stations, we would definitely give a volume discount to it and it wouldn't be $10 per user. It might be, you know, $4, $5, $6 per user. It also depends on how they are using CPT and whether CPT is the core of what they are using or CPT is incorporated into some larger billing or payment context. It could even be less than that.
DR. MC DONALD: But is it -- I mean, users is a --
DR. BEEBE: It is a per user basis.
DR. MC DONALD: -- concurrent user or is it per station?
DR. BEEBE: It would be per user, concurrent user.
MS. HUMPHREYS: Do you know what -- are you talking the same language? I am not sure. I mean, the issue is whether if you have -- I understand, I think, that if the only people who are actually entering CPT codes are the ten people who work in medical records, then your per user is 10. Is that correct?
DR. BEEBE: That is correct.
MS. HUMPHREYS: Now, if, in fact, you have physicians or nurses or whatever at 2,000 locations on 2,000 stations putting it in, could put it in, then you would -- then would you count that as 2,000 or would you say no more than ten people may be using CPT at any given time; therefore, you only have to pay for ten? Do you see what he means by concurrent users? Some people fix it so that only that number can use it simultaneously and then they charge you for that simultaneous number, as opposed to the fact that there actually are 2,000 people who might use it at any given time in 2,000 locations.
DR. BEEBE: I see what you are saying. I was wrong before. If there are ten stations where 2,000 people could possibly use those ten stations, then it would be a per station charge.
DR. MC DONALD: It usually works in a disadvantage the other way. There are more stations than people in most hospitals now at any one time. It is horrendous actually if you add them all up. Most of those stations aren't be used for coding. The real challenge is if it is all done in medical records, it is going to be easy to manage and count and it won't be severe. but if you are talking about the clinics, where they are doing check out and physicians are checking out the CPT code and someone is entering it and you have to have verification against some table, would that count because there would be lots of those stations and it would be very hard to do the accounting as a licensing arrangement about what the concurrent users are because you are not going to really have an application program in all these things that would uniformly report back to the AMA how many people peaked out at one time using --
DR. BEEBE: Well, it would be -- the reality of the use of CPT -- I mean, CPT is just a data set and people would -- software developers, like 3M or somebody else, would incorporate CPT into their software system, which they would sell to the large clinics or the hospitals and then 3M just like the way 3M would charge for their, you know, per user or per station, however they would charge for that software, they would pay the AMA a portion of that based on their own licensing.
DR. ZUBELDIA: Jeff.
MR. BLAIR: I have two questions. Michael, my first one is for you. We have heard comments during the last several years from time to time about individuals that were concerned about the fees, the license fees for code sets. Some of it has been with respect to CPT codes. Some of it has been with respect to other code sets or prospective code sets. So, it is a general concern and issue.
One of the things that I would like to know is when you receive income as a result of the license fees for users who are using CPT codes, does a hundred percent of that income go into continued updating and maintenance of CPT code or is some of it used for other purposes within the AMA?
DR. BEEBE: The AMA licensing operation to license CPT is a very small proportion of our income. Some of that goes to offset certainly the activities of the panel or the panel process, but some of it also goes to, you know, overall AMA operations. We don't distinguish it.
MR. BLAIR: Well then, maybe you could give me some feeling for what percentage of the income from the fees goes to continued updating and maintenance of CPT codes?
DR. BEEBE: That would be a very difficult number to extract. I would have to work with our accountants to see where the money goes. The AMA accounting does not attribute it to CPT. It just goes into the AMA in general. Our licensing is about $4 million per year on CPT and the editorial process picks up -- of that licensing revenue, I would say in excess of 50 percent. That is just a very rough estimate.
MR. BLAIR: My second question is -- as you know there is a -- and this actually is a question for both Pat and for Michael. There is growing usage of complementary and alternative medicine. We are going to have separate testimony later on in this year on this. So, this question is only going to be limited to just simply the policies that you may have with respect to this.
Is it the policy in terms of ICD codes and CPT codes -- I would like each of you to answer this separately -- to attempt to include coding for complementary and alternative medicine within your code sets or is it your policy to have another code set developer develop and maintain those code sets or do you have any different type of policy?
DR. BEEBE: On CPT's part, it is certainly our policy to include any alternative medicine services and procedures within CPT. CPT currently has acupuncture codes and we are very much willing to work with any of the developers of alternative services and the providers of alternative services, to hear their proposals and to work with the panel process.
It will be certainly part of what we already do.
MR. BLAIR: Pat, are you able to help us?
MS. BROOKS: We have the same answer. We entertained requests from -- yes, same answer. We entertained requests from alternative medicines, the same as anybody else. We have acupuncture code and -- anybody that wants to come ask for a new procedure code that could be done in a hospital setting we would entertain that.
MR. BLAIR: So, in both cases it is your policy to include and expand your code sets to include complementary and alternative medicine.
MR. AUGUSTINE: I have a question for you and please educate me. There are some procedures that are included in the ICD-9 set and there are procedures in the CPT set, are they mutually exclusive or is there some overlap there or --
MS. BROOKS: People are always asking us for a crosswalk. We don't have an official crosswalk. So, I guess there would have to be an overlap. I would think there would be times when we would get a procedure code a year earlier than you would and vice-versa. I guess it depends on the need. Something done in a physician office, maybe people wouldn't have the need to come to ICD-9 and make that request.
So, I don't know that we keep up with exactly making them the same.
DR. ZUBELDIA: Before we turn to Dr. Fitzmaurice, I have a question for Frank Pokorny.
In your statement that you read from the final rule -- it is on page 7 of your written testimony -- it says, the dental codes would be available from two sources; the ADA and through a licensing agreement between HCFA and the ADA. What is the current status of that licensing agreement? Does that mean that the dental codes would be available to all of the Medicare providers for free or Medicaid providers for free?
MR. POKORNY: I don't know all the particulars of the agreement. However, the agreement, as I understand it, is in effect and it does provide licenses HCFA, now CMS, to provide the codes to Medicaid or other agencies within the HHS or HCFA, sphere of influence, for lack of a better term. I don't know of the financial arrangements that have been set up related to that, if any. I would be more than happy to go back and get the information and answer your question in full.
PARTICIPANT: Excuse me, Kepa. We have Kaye Riley here from HCPCS at CMS and I think she probably knows the answer to this question.
MS. RILEY: I am Kaye Riley. I am the HCPCS coordinator. The dental codes are part of the Alphanumeric HCPCS and would be included as the D section in the HCPCS, but it is identified as copyrighted by the American Dental Association. So, the codes in the agreement with the ADA has encouraged us to make those codes available at no charge to the entire world. So, they are included in the HCPCS and are actually posted on the web site this year for the first time with the ADA's endorsement to include it. So, the D codes that are in the HCPCS are actually the identical same codes that are included and published in the CDT-3.
DR. COHN: Kaye, maybe I need to follow up just to make sure I understand because there is copyright -- and there is availability and then there is copyright. So, what you are saying is is despite the fact that it is copyrighted by the ADA and they are charging the user for access and use of the code, you would have -- making it available under copyright restricts, but free to anybody who wants to use it.
MS. REILLY: We are making the number and the wording of the code available. We are not posting the entire guide that ADA developed, so that we don't have their instructions or any of their definitions or any of those additional bells or whistles. What we have are clearly just the code numbers and the wording for those codes. They call the descripters something different. We say the number and the descriptions and -- but we are not including the paragraphs or the additional documentation that go along with those codes and the wording in the HCPCS. They are available and endorsed by the ADA.
Previously, we were withholding them from the web and we talked with the lawyers and they said, no, go ahead and put them up now since we have the licensing agreement for all of Medicare and also the Medicaid state agency also have a licensing agreement to use those and to use the code with the words of the description in their publications and their notice.
DR. ZUBELDIA: Let me ask, Frank, a question then. Could a vendor go to the CMS web site, download those codes and redistribute those codes as part of their system to the dentists without paying the ADA a royalty, a license fee?
MS. REILLY: Excuse me. Before he answers, the dentists can go to the CMS web page, the HCFA.GOV web page and view or download the entire set of HCPCS codes. The code numbers and the wording for those codes are publicly available.
Now, when it comes to the entire documentation and guidelines, the ADA has that.
DR. ZUBELDIA: The vendor downloads the code list from the CMS web site and distribute it with their system to the dentists without paying the ADA a royalty or a license fee.
MR. POKORNY: If I may, according to the licensing agreement with HCFA, anything posted on the web site has one of these thick books of the terms -- I would have to go and check and see what those terms are in order to correctly answer your question. I suspect that that possibility was anticipated. Without knowing exactly what the language is, I would rater not comment more and get back to you on that.
DR. COHN: Could you send us a letter with that information?
MR. POKORNY: Yes, I will. Should it be addressed to you, Simon?
DR. COHN: That would be fine. To the subcommittee.
DR. ZUBELDIA: Thank you.
Michael.
DR. FITZMAURICE: About a year or so ago, there seemed to be quite a bit of confusion in the mental health community about, gee, why were DSM codes left out of HIPAA transactions and codes. At that time, I went right to the experts and got the answer. I would like to address the question to Pat Brooks, but let her feel free to call upon her team.
How are the DSM codes incorporated into ICD-9 and how will they be incorporated into ICD-10?
MS. BROOKS: That is definitely not our area. Donna Pickett from the National Center can --
DR. FITZMAURICE: I thought that might be the case.
DR. REGIER: That will be addressed this afternoon.
DR. FITZMAURICE: All right. Then I will hold the question until this afternoon.
DR. COHN: It is really part of our diagnosis hearings later on.
DR. YASNOFF: I would like to ask a question about historical integrity of the codes for all -- for the three code sets; CPT, CDT and ICD-9 and 10.
When codes are deleted, do you ever reuse the codes? In other words, can you always go back historically and figure out what codes are?
DR. BEEBE: On the part of CPT, we do not reuse codes. We have erred in the past and reused codes, but we do not reuse codes.
MR. POKORNY: In the research I have done, going back to codes in the sixties, I have encountered on occasion what might be considered a reuse of a code, but the practice that we have now is not to reuse a code.
DR. YASNOFF: I will rephrase my question.
Do you intentionally reuse codes?
MR. POKORNY: The answer is no.
MS. BROOKS: In the past there was a time or two where we reused an empty number and we got a lot of bad reactions. It created a lot of confusion. So, currently, in the last few years, our intention is not to take a deleted code and reuse it for something else. We do, however, modify the meanings and I think this happens a lot, like revise it to add or delete a concept from it and split it out and make another code.
We have conversion tables that show how that happens that we publish every year so you can kind of trail it out.
DR. ZUBELDIA: We have one minute for one last question, Dr. McDonald, and then we will have to break for a recess.
DR. MC DONALD: I have two questions, I guess, but one of them does the AMA have the same relationship to the HCPCS and the display of the codes and downloadability as CPT?
DR. BEEBE: The AMA does have an agreement with CMS that allows CPT codes to be printed as part of the Medicare fee schedule and you can download CPT codes as part of that fee schedule.
We do not allow payers, physicians, anybody else to download the codes and use them for their systems. That would be infringement of our copyright and it was a licensing event.
DR. MC DONALD: The other quick question was do you keep the codes you have deleted in a file? Because that is the best way to avoid reusing them.
DR. BEEBE: Yes.
DR. ZUBELDIA: Thank you very much. This has been very informative and we are going to have a 15 minute break and we will reconvene at 10:15.
[Brief recess.]
DR. ZUBELDIA: Welcome back to the second part of the first panel on the code set developers.
This time we have Kaye Riley from CMS and Alan Shugart from the State of Maryland Medicaid Program
Kaye.
MS. RILEY: Let me begin by talking about HCPCS. I want to clarify the meaning of that acronym. HCPCS, H-C-P-C-S, stands for Healthcare, one word, Common Procedure Coding System. The HCPCS National Panel made the decision to retain the acronym HCPCS for name recognition and to clearly identify the HCPCS data set as a national code set maintained jointly by Blue Cross Blue Shield Association, the Health Insurance Association of America and the Centers for Medicare and Medicaid Services.
In response to Mike Beebe, since the inception of the HCPCS National Process, an AMA representative has been invited to participate as a consultant to the HCPCS National Panel. The AMA CPT representative received all the information related to the HCPCS code request. Their comments are encouraged.
The current established maintenance process and schedules for updating the Alphanumeric HCPCS Code Sets are working well.
DR. ZUBELDIA: Kaye, do we have a copy of your testimony?
MS. RILEY: No. It just had bulleted items and I was just going to talk sort of like Pat did before and last night my sinuses started acting up. So, I wrote it down so I could hand it off and I thought, well, if I have it written, I will at least -- but it was to hand off to someone else if I wasn't able to make it.
Again, the current established maintenance process and schedules for updating the Alphanumeric HCPCS Code Set is working -- they are working well. The permanent national codes are updated and made available each January 1. The annual HCPCS updates are posted to the web each October and may be viewed or downloaded at no charge and it is on the HCFA.GOV web site and I can give you that specific web site if you would like. It is HCFA.GOV/STATS/PUFILES.HTM#ALPHANU. That will take you directly to the HCPCS 2002 update.
Copies of the HCPCS update are provided to the Government Printing Office and the National Technical Information Service.
MR. BLAIR: How long did it take for you to come up with a web site address like that?
MS. RILEY: I didn't designate it and I would have liked to have made it a lot shorter but because of the HCFA.GOV and so many items on the public use file, that takes you right to the site. Okay? For the entire database of the HCPCS.
The private publishers are also making copies of the HCPCS available for the public. We are aware that it sometimes becomes necessary to add HCPCS codes during the year based on the internal operating needs of the private sector, Medicare or Medicaid. We have added a page to the HCPCS web site and we have a little better web site for the HCPCS web site. It is HCFA.GOV/Medicare/HCPCS.HTM and this web site will make the interim codes with their quarterly effective dates available to the public and permit insurers and practitioners to update their database systems in a timely fashion and maintain compliance with the HIPAA requirements for all users to be able to accept the electronic transmission of the national standard code.
The HCPCS web page contains background information on HCPCS coding process, coding request information, a list of the HCPCS code corrections. Sometimes there are some typos and as well as a link to the HCPCS update database, index and table of drugs.
If you go to that web site and you click on the 2002 HCPCS update, it will take you back to that -- it will link you back to that long URL address that is a direct site there.
The HCPCS National Panel is increasingly responsible to the coding needs of the nation. We work with various professional groups and Medicaid state agencies to assist with the elimination of local codes and non-standard codes by responding to the request of the establishment of national codes.
The number of requests has increased, but not as many as expected. For the 2002 HCPCS update, there were a total of 658 alphanumeric codes added, 14 codes reactivated and 319 changes made through existing HCPCS code long descriptions. For example, a series of S Codes were established in response to the need for codes by the National Home Infusion Association. And a separate T code section has been identified for codes established in response to the Medicaid state agency needs.
You may go to the Medicaid web site and click on HCPCS Medicaid for information related to the Medicaid established process for the states to submit requests for the HCPCS code modifications. CMS also published a notice in the November 23rd, 2001 Federal Register announcing for Medicare establishment of procedures that permit public consultation under the existing process for making coding and payment determination for new clinical laboratories and for new coding and payment for new DME.
There will be three public meetings regarding coding and payment for new DME. The meetings are scheduled for March the 11th, 2002, May 13th, 2002 and June 17th, 2002. All three meetings will begin at 8:00 a.m. and will be held in the CMS auditorium, 7500 Security Boulevard, Baltimore, Maryland.
Comments regarding the procedure identified in the notice were requested to be submitted by 5:00 p.m., January 22nd, 2002. I have not yet received those comments. So, I am unable to share them with you, but I understand that there were very few.
Deadline for registration to attend and/or present comments or to submit new DME HCPCS coding requests through the established HCPCS review process in order to appear on the agenda for March the 11th, public meeting was January the 28th, 2002. The notice was published November 23rd. We had a deadline of January 28th for this upcoming meeting.
Code requests for review and consideration for the 2003 HCPCS update are required to be received and reviewed during the current review cycle. The review cycle for the 2003 HCPCS update began on Tuesday, April the 3rd of 2001 and ends on close of business on Monday, April the 1st, 2002.
This period of time permits the CMS HCPCS Workgroup to receive, review and make recommendations on the request, place the item on the next public meeting agenda for public consultation, return the item with the public comments to the CMS HCPCS Workgroup for review, following the public meeting process and prior to the review by the HCPCS National Panel for final coding decisions. So, while we are holding these additional meetings, it increases the number of times that CMS is looking and the national panel is actually looking at these code requests.
But this came out of the BIFA(?) legislation. As of January 28th, 2002, the deadline for the March 11th public meeting, only one request for coding new DME has been received and only four people have registered to attend the March 11th, 2002 public meeting on coding and payment for DME. I personally expected a much larger response.
In closing, I would like to say that the HCPCS National Panel is taking a positive, proactive approach toward the elimination and reliance on local codes and in preparing the nation for the implementation of HIPAA. Comments related to the HCPCS coding process are always welcome and they can be sent via e-mail to HCPCS@CMS.HHS.GOV or to me by telephone at 410-786-5323.
Thank you.
MR. SHUGART: Good morning and thank you for this opportunity to testify before the committee on HIPAA code sets issues.
My name is Alan Shugart. I am the director of the the Systems and Operations Administration, Office of Operations and Eligibility, Medical Care Programs, State of Maryland Department of Health and Mental Hygiene. I am here today to testify on behalf of the State of Maryland Medicaid Program and the results of a surgery of other states' Medicaid programs.
I am a member of the Systems Technical Advisors Group, S-TAG, to the Centers for Medicare and Medicaid . I serve as the state representative for the National Association of State Medicaid Directors, MASMD, to the CMS Alphanumeric HCPCS Workgroup that Kaye just talked about and participate in the National Medicaid EDI HIPAA, NMEH, Workgroup.
My statements will respond to the questions that were raised by the committee. Current HIPAA medical data code sets: Are the current processes and schedules working well? Generally, yes. However, because of the massive undertaking of converting approximately 25,000 Medicaid local codes, the process has been slower than most would like. State Medicaid programs have been working collaboratively through the NMEH over the last two years to eliminate local codes.
Specifically, concerns over the process have been addressed over CPT changes taking up to three years. Unique issues facing the Medicaid programs with federally-approved waiver programs and the request for standardized time lines for updating the multiple code sets. As we have heard earlier, the effective date of changes for ICD-9 is October, for CPT is January and CDT, currently, with the five year process, but as they stated was going to be moving more to a two-year process.
Are the code set distribution mechanisms, formats acceptable? The general consensus was yes. Comments included there should be free Internet access, that there was a concern expressed by the charging of AMA for inquiries about the meaning of code descripters and that there should be a notice of when things will actually be posted on the various sites.
Is progress being made towards elimination of reliance on local codes? Every state responded yes. However, the process as stated above is a little slow, is very labor intensive and in some cases will require the state systems to adopt extensive workarounds to do the reporting and processing that is done today.
Do you have any other comments related to the current HIPAA medical data code sets? Specific concerns were the AMA decision to use the new format for the technology codes, the four numeric followed by a T. Many systems decided that CPT was an all numeric field and were surprised by that answer.
The same service being defined in multiple code sets, conflicts as to which implementation guide should be used. There are many services that are billed through either the professional guide or the institutional guide and with the total standardization, having the ability to build both for multiple players will create coordination of benefit issues, as well as just not really meet the full needs of HIPAA.
There was also a request for a clear definition of what is a medical code under HIPAA. For example, non-emergency transportation is not, but sales tax is. I am especially concerned, as I said, about the lack of standardization regarding which implementation guide and which paper form to use. This clearly fails to meet the goals of administrative simplification and does make the coordination of benefits. I think a goal simply is done with administrative simplification that a provider should be able to bill all payers the same.
A positive sign that has come out of all of this work on HIPAA is that the state Medicaid, the mental health and substance abuse programs and their national associations have been working to create national codes for mental health and substance abuse services.
The second set of questions I was asked was dealing with the needs for the replacements or additions to the list of HIPAA medical data code sets. Are there any gaps? Generally, the answer is no. There was at least one state that did express the use for the possible universal product numbers for medical equipment and supplies and the use of the national drug codes, NDCs, instead of the HCPCS J Codes. I know there has been significant debate on that issue.
Should ICD-10-CM replace ICD-9-CM Volumes 1 and 2 of the HIPAA standard? If so, when should this occur? The general answer is no. However, I don't think that that was as much a statement as what people thought in terms of the long term coding that with all the work currently being done with the HIPAA implementation deadline, that it should not be addressed or should not come out as a standard in the near future.
In terms of when a replacement should occur, it would be suggested at between two to five years following the HIPAA extended implementation date. I have also based on my experience, it would have impact on the Medicare inpatient prospective payment system that changing -- in the creation and its use within the DRGs. I know that Medicare has a payment issue, but we also in the state use it for validation of the bills submitted by hospitals.
Should PCS replace ICD-9 Volume 3 as a standard? The general answer was no. Some commenters, though, were not even familiar with what PCS is. So, it will be hard to tell them to replace it. Others thought that ICD-9-CM Volume 3 should be allowed for outpatient claims rather than the move to HCPCS and CPT or that CPT and HCPCS should be allowed for inpatient. You will get different perspectives because each of the state systems do operate differently.
Do you have any comments about replacements or additions? The biggest concern, as was expressed earlier, was the creation of code sets for alternative medicine or at least their inclusion in the code sets that are there.
Nonmedical data code sets used in HIPAA transactions: Are the processes working well? The general answer was no. Some comments were all code set maintainers should be required to do their updates on a regularly scheduled basis for efficiency and cost effectiveness. There should be an announcement of the release dates. The process is cumbersome and hard to follow. And until the final decisions are made on taxonomy, the answer really is not known.
Are the distribution mechanisms, formats and prices acceptable? There was no consensus. One specific commenter requested free Internet access and there was a general concern about costs. There was a concern expressed that states unfortunately to participate in the various standard organizations may have limited opportunities for participation as a result of state budget issues and travel restrictions.
I myself am here representing the states in part because I am from Maryland and it is convenient to go to D.C. or to go to CMS. So that the State of Maryland does get asked not overly, but because of our closeness, we do eliminate the travel and, therefore, the states will call on the State of Maryland to do so.
Do you have any other concerns related to nonmedical data code sets? The only concerns that were expressed were the lack of specificity of adjustment reason and remark codes and the overall general uniqueness of Medicaid programs as compared with other payers because of some of the services that we extend that are traditionally not health care.
Thank you for this opportunity.
DR. ZUBELDIA: Thank you to both of you.
We are probably not going to have 25 minutes for questions. We are going to try to see if we can accelerate the panels today, so we can make room for the PMRI.
I am going to start with the question, both of you, and that is how is the effort by the NMEH to come up with national codes that would replace the existing local codes, interfacing between NMEH and the HCPCS code panel. Is that working okay? Do you like how it is working?
MR. SHUGART: As I said, basically the process is working. It has been a mammoth undertaking. There have been several national meetings that have been held. Forty states have participated at these national panels, one in Baltimore about a year ago. Each of the different areas were brought down. There were 40 different areas of coding that were identified.
A person was assigned to chair each of the subcommittees and there has been tremendous work. There continues to be. CMS worked with the NMEH to develop a process to expedite the creation of the codes and that, obviously, has worked.
At this point, 30 of the 33 that they were addressing have been essentially submitted or have been completed. So, there has been tremendous progress. There continues to be work on some of the big areas, which are DMS and DME, both of which have many local codes.
The substance abuse and mental health are in the process after looking that some of their coding was similar, yet distinct, have worked together to resubmit their submissions. The process, other than the slowness of the time and the amount of work it has taken, I think, has been very favorable has been accomplished, but I think as a result, clearly, one of the reasons that the states were concerned with the original HIPAA deadline was that the codes are not available yet. They may not be available for the next three to four months before everything is out.
With an October of 2000 deadline, it would probably not have been hospital to make the necessary system changes. The extension or the ability to apply for an extension was obviously something that was welcomed by all states.
DR. ZUBELDIA: Do you want to comment on that?
MS. RILEY: Again, the NMEH process has been a tremendous job. They have taken the codes from the 40 states and they have narrowed them down and divided them into those 40 categories and the crosswalking or reverse crosswalking, however you would like to put it to the national code sets has been tremendous, so that the majority of the codes that were identified by the Medicaid state agencies are actually -- the majority of them are already identified in the existing standard code sets.
So, the crosswalk was tremendous and there was one area where they had started out, I believe, with 3,000 codes, narrowed it down to 300. By the time they sort of just eliminated duplication, variation and wording, that type of thing, and ended up coming to the HCPCS workgroup and asking for three codes and they have been established.
So, from 3,000 to 3 was a tremendous effort on their part because they are not seeking to have individual codes for everybody's personal agenda. They were looking from a national format and that was our goal also, to work with them.
The national panel has met with the Medicaid state agencies and the request, especially on this mental health and substance abuse, to help them sort of formulate some of the guidelines to move forward and the work goes back and forth and we are expecting their submission to come to the workgroup for the final review in either -- here in February for the March agenda, you know. So, we are making progress. We certainly wish that we could go much faster for their benefit, but, again, we are responding to the requests that are being received and I am truly surprised that we are not receiving more from the -- especially for DME from the private industry.
DR. COHN: Actually, I have one comment and a couple of questions.
I think I share, Kaye, with you your concerns about the issues related to private industry and I can't help but wonder based on work we have done before that private industry and health plans may be in for some rude awakenings as HIPAA comes closer an they suddenly realize that their local codes are no longer appropriate.
But having said that, I don't know -- other than publicize the issue --
MS. RILEY: Keep reminding them.
DR. COHN: Exactly and, hopefully, that we can do all this.
Now, Alan, you made two comments that sort of resonated with me in conversations I have had with others, especially in health plans and other medical organizations. You talked about standardized time frames for release in publication of code sets. Certainly that is something that I have heard from a lot of private payers and others. In some ways they are sort of -- not quite pulling their hair out, but they are concerned that everybody seems to be on somewhat different schedules.
You also commented about redundancy and not being sure exactly what code set you are going to use to build what with. Having said that, you presented the problem. Do you have any suggestions for solutions based on, obviously, all the things that you have heard so far today?
MR. SHUGART: I think some of the solutions are the continued work on really establishing the standards. I think that the implementation guides need to take the next step. I know that there is a large matrix of who bills what on which form or which essentially HIPAA electronic record and I think that those decisions to truly allow this to be administrative simplification needs to take that next step and say that these are the formats that are medical. These are the ones that are institutional.
These are the ones that are dental. These are the ones that are NCPDP. Therefore, everybody will have their own resistance because if they are getting it today, they would like to continue, but, again, from a provider standpoint, they would not.
So, I think that that standardization of the different either paper form or preferably the electronic version that you send, should be what is the thrust. And, therefore, to truly make this standardized code, that is the work that should be done is to look at these and say all health bills on an institutional, physician bills on a medical and that that would be the next step.
Because as long as you can say you can bill on one or the other, you are not really creating the full goal of administrative simplification. So, I think that is the next step that should be addressed is the actual billing format should be identified as to who should bill what, that there should be consensus developed.
DR. YASNOFF: Alan, I had a related question, looking for solutions. You mentioned a concern about lack of standardization about which implementation guide to use. Could that problem in your view be solved by designating a single implementation guide as a standard, along with the code set itself or is there some other way that you could imagine that that problem could be solved?
MR. SHUGART: I think that the separate implementation guide would work as long as the caveat as to which provider should be billing on which type of -- using which implementation guide. I think that that needs to be in the format, whether that is an overall saying we have now said physicians and medical supplies bills medical and hospitals and home health and nursing home bills on the institutional would be the best way to do it, either it could be done at a broad level or at least on each of them saying this is what has been defined on each of the different sets.
I think that is what actually is missing is that from our standpoint, I am one of the states with a large number of local codes. We have our own unique home health and nursing home codes that we have created. But in looking at the guide for the UB-92, it says that home health in UB-92 should bill -- I mean, hospitals should -- home health and nursing homes should bill on the UB-92.
Our position is that is the default is that all of them should be billed under that particular code set, especially with the elimination of local codes. I am not sure how well you deal with it. Home health codes have been created in CPT. Well, that may now create a new view.
I think that a lack of the standardization you should use the guide as -- essentially the UB-92 says here is what providers could bill them. That would be our expectation. But it is not spelled out and it does leave it open for interpretation.
So, I think that that would really be the area that you could -- whether it is just an overall preamble that says these are the ones that are just within the guides, but I think there should be clear direction who you bill and which guide.
DR. ZUBELDIA: That is a very difficult question and I am not sure who can give that reaction. For instance, if a hospital owns an ambulance company and you are trying the type of billing on the provider, would that hospital be billing the ambulance services with an institutional claim? There is no easy answer to these questions.
MR. SHUGART: I recognize that there would be no easy -- in my view, though, the way I would enroll providers is that regardless of who is owning it, the ambulance company would be identified as a separate provider owned by a hospital, that they would need to bill.
Now, that is our rule. I don't know if that is national policy that they could not -- the hospital is not authorized to bill the ambulance service in that case.
PARTICIPANT: Let me ask the question another way. Do the multiple implementation guides serve an important function that needs to be continued?
MR. SHUGART: You have the medical implementation guide. You have the institutional. You have the NCPDP. Each of those would be separate. To combine them, I think -- yes, for each of the different electronic formats, you do need to maintain a separate implementation guide.
DR. YASNOFF: I just want to be sure understand this issue. I may be misunderstanding. There is an implantation guide for each different code set. Is that correct?
MR. SHUGART: The transaction set is the --
DR. YASNOFF: For the transaction set. Okay.
MR. SHUGART: Buried within the code set for UB-92 are the institutional -- is the reference to the UB-92
DR. ZUBELDIA: Let's take a last question from Dr. Cohn and then we will recess.
DR. COHN: Okay. And actually, Kaye, it is a question for you, which is somewhat the same question I asked Alan and realized I hadn't asked for your input. Alan dealt with yet another issue that I feel is very important, but I am concerned about this issue of standardized time frames for release of code sets. And knowing that we have heard all the way from two years for the dental codes to quarterly it sounds like for HCPCS, and I am just sort of wondering -- I mean, obviously, there are people in the private sector, who are concerned that there is so much variation and are afraid that there are not going to be HIPAA compliant because of the issues of such great variation.
Then there is the issue of redundancy, people at times not being quite certain what code to bill for what service, recognize that there appear to be some overlaps. How would you solve these problems?
MS. RILEY: I believe that the electronic access through the Internet is going to be the saving grace for all of this in order that those are published, that they are posted on the web so that people can see them and identify them. The people that are using them will certainly want them and any of the insurers or claims processors that would be receiving them would need to just make a periodic check of the web page to update their systems.
We are not talking about a large number of those interim codes during the year. Right now, in order to help Medicaid and some of the other organizations with their codes, there are a few more S Codes or T Codes or G Codes than what we would normally be having on record. We generally only have a few and it is not an excessive amount of work to, quote, enter those two, three, five, six codes into your system.
Right now we may have as many as 30 or 40 per quarter and I think that is a little much, but it is only because that we are in this crunch to get the codes and make them available for these organizations so that their systems can be ready for implementation of the HIPAA regs.
MS. HUMPHREYS: Simon, just let me comment on the issue of the -- you know, the October versus the January date. Both of those are legislatively established. We looked into this issue because, of course, when we published the original NPRM, this issue of couldn't these things be lined up arose. In fact, we had to seek legal counsel within the HHS because -- and they were looking at whether HIPAA actually trumped any of this legislation, but it did not. Therefore, if the NCVHS, listening to the community actually that those should be aligned, they would basically have to -- I believe we could ask legal counsel again, but I think they would have to propose a legislative change to make that happen.
MS. RILEY: The national code set actually is published and put out by the community in October to allow the time for the databases to be updated for the effective date of January 1 and all of the, quote, interim codes would be included in that update each year for January 1 and part of the publication.
DR. ZUBELDIA: Thank you very much for your testimony.
We are going to move on to the next panel immediately, rather than waiting until 11:15 and then maybe we can finish this panel around 11:30, 11:35.
For this panel we have Lynne Gilbertson representing the Designated Standard Maintenance Organizations, DSMO, and George Arges, representing the National Uniform Billing Committee.
So, Lynne.
MS. GILBERTSON: Do you all have a copy of the testimony? Okay. Good.
As Kepa said, my name is Lynne Gilbertson. I am here today representing the Designated Standards Maintenance Organizations, as well as George and Jean are both here from the Designated Standards Maintenance Organizations.
We would like to thank you for the opportunity to testify. Our chair, newly moved in from the vice chair, Maria Ward, was unable to be here because of X12 commitments.
Basically what we are going to report on is change requests that the Designated Standards Maintenance Organizations have seen through the past year's time frame most of the change requests you have seen in the very large report that was given to the national committee during the fast track process. So, any of the change requests, rather than read them in length, if you could refer back to that or if you need the actual verbiage of a particular request, I can provide that to you later on.
But this is just a summary of what we have seen and the recommendations that have gone forth. The first one was the addition of the HIEC codes for home infusion into change requests and the DSMO recommendation was that X12N should remove the HIEC code qualifier from the implementation guides. We recommended they work through the Level 2 HCPCS and the CPT-4. When this process was completed, if there were still incomplete code set information, then to please provide another request through the DSMO.
There were two parts to this request. One was that the HIEC requested their code set named as a HIPAA code set and the second was that even though it wasn't a named code set, they requested their qualifier to remain in the X12N implementation guides. The end result of this is that HIEC is working with CPT to have their code set needs addressed and CPT felt that they eventually could be able to accommodate them.
Secondly, the X12N has left the code qualifier for the HIEC codes in the implementation guides and as a part of the addenda process, they have added a note to the implementation guide to say that the use of the HIEC codes is not allowed under HIPAA. This approach was followed because there may be folks who are using the implementation guides outside the scope of HIPAA and would need the HIEC codes for that reason.
No. 2, the addition of the ABC code sets for complementary and alternative medicine practices, the DSMO after spending quite a bit of time reviewing this request actually requested the submitter to review and specify why HCPCS, NDC, CPT codes were not meeting their business needs and that we needed to see demonstration support for health plan supporting and paying these types of categories.
A follow-up request has been recently adjudicated by the DSMO and I published the DSMO recommendation last night, which was basically we saw information about working with HCPCS, but we did not see follow-up information working with CPT and need further information on that before we could adjudicate any further. So, that request has been completed and will be sent back to the submitter probably today.
The third request supported the local HCPCS J Codes for an additional year. The DSMO has recommended that this be a policy issue and was submitted to HHS and we obviously know where we have the additional amount of time as for the compliance. So, that is a past request and has been processed.
Four, the support of clinical nomenclature codes to classify mental disorders and the DSMO recommendation at that time was the ICD-9 codes were mandated in the final rule to proceed during that -- using that direction.
The support of temporary procedure or diagnosis codes for each code set and the DSMO recommended that the diagnosis and procedure codes are part of the medical code set as defined by HIPAA. Neither the DSMOs nor the X12 implementation guide have the authority to include any non-designated medical codes or code sets in the implementation guides. X12N recommended that the requester work with the maintainers of the medical code sets, CPT, ICD, HCPCS, CDT and NDC to request whatever codes were necessary.
It is our understanding, meaning the DSMO, that all the code set maintainers either have or are developing processes for requesting new codes and at least several are contemplating including temporary codes. We have heard more testimony this morning on that.
The last request was the support of vision code sets and the DSMO recommended that the requester work with existing code set bodies once again and we recommended involvement in the NCVHS committee hearings during 2001. If the requester did not reach consensus through that mode, to reapply to the DSMO change request system to restate needs.
There was additional dialogue that went on with the vision codes and at that point and the DSMO organizations felt that the vision industry had not come to consensus yet on their business needs and they were asking the SDOs for assistance in that point.
So, we recognized that the vision industry would need to submit a request that represents their industry, but they would need consensus to go forth. Since that point, this was filed awhile ago, this request, the vision care industry has been very active in the X12 environment from what I understand, with reaching consensus and bringing forth information for their industry.
The last thing we needed to respond on was based on December testimony. I had mentioned that the DSMOs were working on a code set procedure to assist the public in, okay, now what do I do, kind of attitude. The DSMOs are creating this process. It is in draft right now, not ready for public review yet and as soon as it is, we would like to either e-mail it to the committee or to present if that is appropriate.
It basically is a process that just says starting at the beginning, where do I go, what do I do, why should I, what do I need, and rather than use the change request system to actually make sure they understand that there steps to go through ahead of time, before they actually ask for a change request because it doesn't do any good to ask for a new code set and the DSMOs say we will go back and try CPT, ICD-9, whatever it is, HCPCS, when we should in the beginning tell them please go here first and see if your needs are being met and then come back to us with a specific request if you need something specific.
Thank you again for the opportunity to testify.
DR. ZUBELDIA: Before we move on to George Arges, I want to note that in the packet we have written testimony from Alternative Link and from the National Home Infusion Association.
George.
MR. ARGES: Good morning.
On behalf of the National Uniform Billing Committee, I would like to thank the NCVHS subcommittee for the opportunity to comment on issues related to medical and nonmedical code sets.
I am George Arges, chairman of the National Uniform Billing Committee. The NUBC is one of six Designated Standards Maintenance Organizations responsible for the maintenance of changes to the implementation guides on the HIPAA electronic transaction standards and code sets.
The final rule on transaction standards and code sets selected the code sets for sue with each of the electronic transaction standards. As you may recall, the NUBC wrote to the Department of Health and Human Services about its concerns with the requirement to use the National Drug Code when reporting all drugs and biologics. We would again like to thank the members of the NCVHS for holding the hearing last year to correct the potentially costly reporting requirement for developing non-retail pharmacy claims.
Since that time, the NUBC, along with the other Designated Standards Maintenance Organizations, reviewed a large number of change requests pertaining to the implementation guides. Although most of these requests dealt with the usage of a particular data element or segment, there were several groups that also asked us to consider expanding the use of medical code sets beyond those in the final rule.
Presented for consideration to the DSMOs for requests to expand the medical code sets by adopting HIEC codes to report home infusion services, as well as the ABC code set for the reporting of alternative care services. The NUBC indicated an interest in reviewing these change requests to the named code sets. After careful deliberation, the NUBC could not support the requestors' suggestion for adopting their code sets. There were several important reasons why our committee could not support the suggested changes.
The NUBC noted that many of the codes that comprise these code sets are not necessarily medical codes, but rather a convenient way of packaging medical services into a bundle in order to accommodate special payment or reimbursement arrangements. In addition, the members noted that the corresponding information accompanying the request was insufficient.
Lacking was the hard evidence we needed to determine why the code sets identified in the final rule would not be able to accommodate their particular medical service. Upon investigation, we noted that CPT-4 or HCPCS codes already exist for many of the same types of services. The NUBC suggested that these organizations approach the CPT and HCPCS coding groups to present their need for the services that lacked a comparable assignment within the named medical code sets.
We also hope that in the process of seeking new medical codes, every effort is made to avoid packaged or bundled services, especially those designed specifically to facilitate reimbursement.
Fundamentally, all of the DSMOs presented similar views and opinions on these code sets when they met to go over the monthly list of change requests. The NUBC continues to receive letters from these organizations and their supporters persuading us to alter our opinion about adopting these codes. Thus far, insufficient evidence has been presented to the DSMOs in order to reconsider these issues.
We are still uncertain as to whether the remaining services are medical codes or some form of external codes that were established to accommodate a particular niche of health care reimbursement. We also need to know specifically which codes describe a package of services and whether these codes are intended to identify specific types of caregivers.
The members of the NUBC also reminded me that the UB-92 data set and the electronic transaction standard for the corresponding implementation guide pertain to the institutional provider setting. Consequently, if the intended services relate to the professional component of care, then the institutional implementation guide would not apply since it represents only the facility fee portion. Again, the information provided us did not indicate whether the code list represents billing for the institutional component or the professional component of care.
If the intent is to represent the institutional component, the NUBC needs to know the following: What type of institutional provider will utilize these medical service codes and what type of health benefit plan currently covers these services?
Finally, the NUBC would like to know more about the coordination and maintenance process associated with the development of these code sets.
With respect to external code sets, the NUBC plays an important role in the development and maintenance of such codes. The NUBC is responsible for the maintenance of the UB-92 data set that includes a number of external codes, referenced in the electronic transaction standards for institutional providers.
The institutional implementation guide for claims reporting includes unique references to external codes. The guide includes references to the following external codes that are the unique responsibility of the NUBC. For instance, bill type and frequency codes, patient discharge status codes, condition codes, occurrence codes, dates, value codes and revenue codes. Because these codes are unique and an integral component of the electronic transaction standard for institutional provides, we recommend that all users of the institutional guide stay current with the maintenance of the entire set of these codes.
The NUBC also supports and follows a deliberation process that is inclusive, broad-based and sensitive to the entire user community. Moreover, the codes developed from this process are easily accessible and widely distributed. We operate on a clearly defined structure of review and communication in order to promote the integrity of the codes, as well as its usage.
As you examine the various requests for adopting medical and external code sets, we urge you to keep in mind the importance of the deliberation process. We support the approach outlined in the final rule for data maintenance bodies. The approach outlines a number of key process attributes that any data maintenance body should follow. We believe any organization seeking to become a data maintenance organization for a particular code set or a code list must be able to meet this important hurdle. The NUBC believes that all of the organizations to the DSMO process are very aware of the attributes outlined in the final rule and strive to follow these precepts whenever a change request comes before them.
With respect to future changes in medical code sets, for the short term, the NUBC is comfortable with the existing medical code sets as outlined in the final HIPAA rule. We are aware that these standard medical code sets undergo improvements resulting in a complete replacement to the previous edition. The final rule also mentioned the future adoption of ICD-10-CM for diagnosis reporting and referenced establishing a single procedure classification system, either the ICD-10-PCS or CPT. The NUBC is anticipating the possibility of adopting these upcoming changes and is looking at redesigning the UB-92 data set.
We are also looking at closing any major gaps that may exist between the paper UB and the electronic transaction standards. The NUBC has undertaken several surveys recently to identify areas that need improvement, as well as use of local nonmedical codes established to accommodate many of the state reporting requirements, including Medicaid and public health data reporting.
We are working through the survey findings and hope to have solutions that could be approved by the NUBC as early as August of this year. Some of the solutions will include establishing new NUBC codes within the existing code set elements. In addition, we will also be commenting on areas that are ripe for decreasing paperwork burden. This includes business rules on procedures for reporting sterilizations, abortions and other areas that require submission of other types of documents. We believe these rules could provide additional administrative efficiencies and increase accountability without interfering with or diluting patient rights.
We hope to complete these recommendations within the next several months and will approach the NCVHS for their viewpoint and assistance in helping to carry out these recommendations.
Thank you for the opportunity to present our views on HIPAA code set issues.
DR. ZUBELDIA: Thank you, Lynne and George.
I would like to start with the question to George Arges on these code sets that are unique responsibility of the NUBC, such as the bill type frequency code and occurrence codes. What is the version control process to maintain those code sets? How often are they updated? How is the user notified of the updates? What is their availability and what is the cost of those code sets?
MR. ARGES: Sure. With respect to the frequency of changes, the NUBC meets quarterly. We also have public calls in between the quarterly meetings. We generally have two scheduled dates for implementation, April and October of each year, for the modifications to particular codes.
In terms of the version control, we basically indicate within the implementation guide the start date associated with a particular change and, again, that normally is April and October of each year. We try to give at least six months lead time to the industry to basically be prepared with respect to those changes.
Our committee has open meetings for the most part. So, anyone can come and follow the developments. We do send out meeting minutes and agenda and we do cover the outcomes and actions of the committee, which describe the nature of the change and communicate that to a variety of state associations and state uniform billing committee organizations as part of that process.
In addition, we maintain an NUBC web site. The web site does discuss when the meetings take place, the issues that come before the committee and the deliberations. We make available to a subscriber section copies of the full UB-92 manual for those who don't want to maintain it but want us to basically maintain it but want us to basically maintain it. That price is basically, if you want a hard copy UB, it is $75. There is a $50 annual subscription fee, which means that basically you stay current on the web site.
DR. COHN: Thank you, both. This actually provides a very nice transition into the world of nonmedical code sets, which hopefully we will be able to begin to talk about before lunch.
Lynne, this is a general question with your hat on -- I know you are going to be testifying later on from NCPDP, but right now asking you to testify as previously one of the co-chairs of the DSMO. Are you still co-chair?
MS. GILBERTSON: Secretary.
DR. COHN: Secretary. Excuse me. Thank you for that clarification.
It is just a general question from the DSMO view about how the -- your view of how well this is working in terms of issues related to nonmedical code sets and code sets. Do you feel that the process is moving along pretty well in getting things updated and issues resolved or do you have any suggestions for improvement in the process?
MS. GILBERTSON: Do you mean the actual functions of the DSMO or the public's perception to their request?
DR. COHN: I think the public's perception to their request, as well as the improvements related to moving forward with the successful implementation of HIPAA. So, I guess it isn't just the public, but I am also looking -- you are one of the holders of the issue of HIPAA implementation.
You can send us a letter if you would rather.
MS. GILBERTSON: Will, I am just -- I don't have a lot of experience with the public and code sets. So, I am looking to George or to Jean to see -- because the requestors may come through their organizations for further follow-up. So, I think they may have a better perspective than I could. Functioning, I do the job of the secretary pretty quickly. So, hopefully, they are getting their responses quickly, but past that, as they go through the different organizations, I would be interested.
MS. NARCISI: This is Jean Narcisi, chair of the NUCC. I think we are really learning as we go along. This is a whole new process for us. The fast track process really put us in a spin because we had to deal with change requests to the implementation guide. We have had a few code requests come in. We are in the process of developing some guidelines and I think that will help.
I think what Lynne outlines in her statement was that some things need to be done before they go through this whole DSMO change request process. Then, of course, as she also stated, there are probably other entities using the guides that will not be, you know, HIPAA users. So, I think the process will get better within the next few months.
MR. ARGES: I guess I wanted to comment briefly, too, on -- I think initially the effort was really on making certain that changes that need to be made to the implementation guide to make them operational to be workable were our first order of business. But I think that the DSMO process is working appropriately. What we need to have are these guidelines that we are talking about that helps the requestor better understand the information that they need to provide to us as organizations, to consider a particular issue that they may want brought before and then to be able to deliberate with some degree of certainty as to the nature of the request.
MS. GILBERTSON: I think if we had the knowledge of today but a year or so ago, we would recognize that there are a lot of educational opportunities for health care in general in this whole process that could have, should have, would have been in place to help. I mean, if you are actively involved in one of the organizations, one of the SDOs, you know where to go and how to go through the process, but if you have not been involved in those practices before, what is next, you know. Those kind of guidance get me through from step one. The education of the DSMO change request system is not replacing the SDO processes.
We do not want to tread anywhere near that environment and that kind of training. The DSMOs are also learning that our responses need to be much more clear as, for example, when we ask someone to please work with an X12 organization, the X12 co-chairs are now contacting the submitter to try to talk through the request further, realizing that the submitter may not have any idea what X12 is or who it is and why. NCPDP, the same kind of thing, where we are more active in talking to the submitters than we had realized a year ago.
DR. ZUBELDIA: You said that the NUBC codes changed, NUBC intrinsic codes changed twice a year, April and October. The CPT Category III codes would change twice a year. HCPCS codes, temporary codes and so on can change quarterly. Is all of this going to be affected by the requirement under HIPAA that the Secretary not adopt a new standard more frequently than once a year? Do you see an impact or --
MR. ARGES: Part of the difficulty that we as a committee have always faced, we try to hit the April and October dates as a rule, but we always -- changes that require us to act within a month or two earlier than we anticipated. But the code sets are really designed to augment the format of the electronic transaction standard. We are not altering the transaction standard. We are staying with the transaction standard and the code sets are just another way of conveying a piece of information that is needed for whatever reason, to be implemented within a year.
I like to stay within no more than twice a year, but ideally maybe even move it to once a year if that is possible. The question remains what can we do with legislation or regulations. I am not sure we can always accommodate that.
MR. BLAIR: Lynne and George, first of all, I feel like the DSMOs are really doing a tremendous job. And I think it is a very good approach in terms of examining nonmedical code sets where you wind up having a criteria. The things that I think are my reaction to your comments on that was that I think there is a great value to be placed on extension of existing code sets because those code set organizations are already in place. They have experience meeting the needs of the industry.
I feel like those are very important reasons why extending current code sets has great value. But you had two criteria in there in terms of new code sets that I am not sure are fair. If you put as criteria for a new code set industry acceptance, then you really put a very heavy burden against them.
The other criteria that you had was their primary purpose might be for reimbursement, but that criteria I think you need to apply as well against the code sets that are already part of DSMO, the DSMO process. So, those two made me feel a little bit uncomfortable in terms of equity for an opportunity for a level playing field for a new code set entity or developer to become part of the DSMO area.
Other than that, I strongly applaud the work that you have done and the way you have really made it a lot easier for a lot of people to be able to look at adopting HIPAA standards.
MR. ARGES: Let me comment briefly. I would agree with you in terms of your assessment. At least from the NUBC, we are not trying to necessarily preclude another code set from being considered. I think we just need to understand under the circumstances when the occasion would require that reporting of that particular data element.
I mean, the NUBC has expanded indirectly some of its use in code sets by allowing some of the Medicare program changes in the post acute care setting that went to prospective payment, where an MDS RUG category, resource utilization group, had to be reported. We tried to accommodate that as part of that requirement and to allow that sort of thing, but I think it is the same sort of understanding that we needed to have when we had to face that, what the nature was and what the obligations were of the provider, the setting that it was required under and then to move forward with it once we had that understanding.
DR. MC DONALD: Sort of a comment and an applause about two things. One is the comment that it is really important to talk to the people who come to areas to understand things and I don't think we can underestimate the amount of value and intellectual effort and to sort of applaud the effort when they took the 6,000 codes or the 30,000 codes -- 24,000 codes, I guess it was -- which would have -- what you would have gotten if they were just thrown over the wall without the intellectual effort and actually look at them and think about them and what they mean and you boil it down to a little tiny number.
If we don't do that kind of thing, we are going to have a mess because we will have piles of stuff that no one knows what the difference is in the code sets. So, that is -- you know, putting that human effort in.
The second thing is there is some risk, in my mind anyway, as we go forward to kind of make everything a code in the whole world and we see this in some of the current code evolutions, where we decide if the -- you know, diabetes isn't controlled by multiplying into many codes when most clinicians would look at the hemoglobin A1C as a single number and decide that. So that we have some point where we may want to be not forcing, jamming stuff into codes, but taking the data.
Now, that is not as easily available yet throughout the world, but we hope as these standards go forward, we will be able to get real, you know, quantified data about key variables, like blood pressure and things, and not have to make a binary decision or trinary decision and jam them into a code. Because I do see the -- because of the one thing that people can count on getting, payers, managers, et cetera, is these billing codes, the whole world is trying to squeeze into that one field or those kind of fields as codes.
DR. ZUBELDIA: We are going to end this panel and pass the baton to the next panel, which is not scheduled until this afternoon. I think that will give you the opportunity to present now -- we are trying to make some room this afternoon for the PMRI discussion.
So, if we could have Susan Hawk from ASPE and Jean Narcisi and we will continue until about 12:05 or 12:10 with the panel and the questions.
MS. HAWK: My name is Susan Hawk. I work in the Division of Data Policy in the Office of the Assistant Secretary for Planning and Evaluation. I am a medical librarian by profession and volunteered to help with identifying the issues related to the nonmedical code sets.
The handout that you are getting is very much a work in progress. I started by trying to define what the universe was of these nonmedical code sets and it has been quite an adventure. Naturally, I -- oh, first of all, let me thank those of you who are here, who have spent hours of time with me, trying to orient me and bring me up to speed on these issues. Thank you very, very much.
In terms of a definition, I have come up with the idea of a nonmedical codes can refer to non-procedure or service codes that refer to claim status, adjustment, reason, payment remarks and so on. Then I discovered that there are at least two types of nonmedical code sets and I have just termed them Types A and B. I am not quite sure why.
The Type A are the external codes that are named and described in the HIPAA implementation guides and they actually appear generally as Appendix C, but they are the codes that do not describe medical events. You will see in your handout there are two tables. Table A lists the implementation guides for HIPAA and Table B gathers the external codes from the implementation guide.
Again, this is a draft. It is a first attempt to just organize this little universe. Type B code sets are actually defined within each of the implementation guides and in that case, not only are the code sets named, they are actually included within the guide.
I have started to try to identify the different types of issues. One type of issue would be that the same concept is codified differently in different cases. Those of you who heard Helene testify for the computer-based patient record in October of 1999, have already heard this example, but I think it is a very interesting one.
For example, this tiny idea of marital status separated is codified four different ways in four different established standards. You will just see it there. I won't read through, but you will have -- the same thing will be termed X as A or 4.
Another wrinkle in things could be that you have the same value but it has different meanings. For example, S may mean single or separated, depending on the context. I realize that context is everything. I hadn't quite realized how much it is everything in this instance.
Not only is context important, but the timing. One of the people who spoke with me said that these nonmedical codes are supposed to be those that were in use at the time that the transaction was initiated and that there can be quite a delay between the initiation and submission of a claim. But, of course, the claims with incorrect codes are rejected.
Another issue relating to these codes is that of version control and what I would term sort of communication flow. It seems to me that even the material that is available from one single source, namely, the Washington Publishing Company, that there is not quite true version control and that the users must read the minutes from the X12 meetings to actually discern what version is supposed to be used.
Another person told me that decisions from CMS, when they are made, are given out to the regional offices and then from the regional offices to contractors, which then reinterpret these decisions, which are in turn given to providers so that there can be different interpretations coming out at different places around the country.
You will see that some of the code sets that I have included in Table B are actually identifiers and perhaps even should be deleted or moved somehow. I kept them in for completeness because that is -- I thought I should. Also, just to keep us oriented, there are three different sets of identifiers; namely, provider, employer and plan ID, which was formerly known as payer ID.
NPRMs have been issued for the first two and those are final, but payer ID does not yet have an NPRM. I also wanted to try to clarify -- and I am not sure that I have this right, but, again, this is very much a work in progress -- I have the sense that HL7, which is the messaging standard for claim attachments, does not have the same nonmedical code sets as X12.
What I thought that HL7 includes a method of defining which code set is use, so that is another thing that at least for me, a moving target.
I will wrap up then with questions and issues and some possible next step. One of the questions I have is are the criteria for evaluating medical code sets applicable to the nonmedical code sets? Specifically, do the same issues of maintenance, updating and responsibility that are a primary concern for the medical code sets apply here as well. I know you will be talking more about that.
Would it be useful to evaluate the nonmedical code sets with each of these criteria? Are the gaps that are found in the nonmedical code set, are there gaps that need to be addressed? If so, should these be discussed with the medical gaps, such as vision and so on, if vision is found to be a gap?
Some ideas for next steps, but I am certainly very much open to different next steps. I have the sense that the definition of nonmedical code sets is not yet stable. For example, Table B that is in your handout, only refers to the code sets that are from the appendices to the implementation guide. Naturally, I think that the cure for most things is what we call bibliographic control.
I was trying to tackle the issues of different versions and so on and I found different lists of HIPAA related code sets on the Washington Publishing Company web site. I chose one, the one titled "Implementation Guides Adopted for Use Under HIPAA," but there are other guides that -- there are other parts of that web site that lists guides that are in various stages of review. I could not untangle that in time to talk with you about that.
As you will see, Table B is an attempt to gather together the nonmedical code sets with their names, numbers, sources and the number of the implementation guide in which that code set is identified. One of the people who I talked with said that it would be very helpful to have all these different lists available in one place.
Certainly, looking inside each of the implementation guides of the code sets that are contained therein would be another helpful activity. Then just as a little experiment to try to actually obtain the materials that are cited in Table B, because I had the sense that some of these are not so easily obtained as they might be.
Thank you.
DR. ZUBELDIA: Thank you.
MS. NARCISI: My name is Jean Narcisi and I am the director of the Office of Electronic Medical Systems at the American Medical Association and chair of the National Uniform Claim Committee. It is my pleasure to appear today on behalf of the NUCC before the Subcommittee on Standards and Security of the NCVHS. I would like to thank you for the opportunity to testify.
The purpose of my statement is to summarize the NUCC's role as the recently named maintainer of the Health Care Provider Taxonomy Code Set. I will also update you on the status of the newly developed web application for maintenance to the Provider Taxonomy Code Set.
The Provider Taxonomy Code Set is an external nonmedical data code set designed for use in an electronic environment. The original purpose of the code set was to code provider type and area of specialization for all medical related providers. The code set was originally developed based upon a combination of medical specialties, fields of scientific study, services, as well as age of the patient.
As you may recall, I testified last year to the NCVHS subcommittee on behalf of the NUCC regarding various issues. At that time, I identified problems with some of the nonmedical code sets. For example, I reported that the Provider Taxonomy Code Set was inconsistent in a former maintenance process was not effective.
While the primary distribution of this code set has always been the responsibility of Washington Publishing Company, the Blue Cross Blue Shield Association was the initial administrator of the Provider Taxonomy Code Set. Therefore, the code sources was classified as external the ANSI ASC X12. Ongoing maintenance was the responsibility of volunteers from Workgroup 15, which is the provider information workgroup within ASC X12N, and the members of the Provider Taxonomy Committee consisted of interested individuals from the X12N community. However, there was no formal governing protocol for maintenance of the taxonomy and participants were not able to attend the meetings on a regular basis.
I would like to share with you a little bit more background information. In the absence of an all-encompassing Provider Classification System, both X12N and the National Provider System Workgroup from the Centers for Medicare and Medicaid Services commenced working on identifying and coding an external provider table that would be able to code provider type and provider area of specialization for all medical related providers.
CMS's intent was to provide a single coding structure to support work on the National Provider System, while X12N needed a single common table for trading partner use. The two projects worked independently to some extent until April 1996, when the lists were coordinated and a single taxonomy was proposed.
A subgroup of the Workgroup 15 was charged with resolving differences in the two proposed taxonomies. Their work resulted in a single taxonomy that both CMS and members of X12N found meaningful, easy to use and functional for electronic transactions.
The subgroup initially started with the CMS draft taxonomy. This list incorporated all types of providers associated with medical care in various ways. Many of the providers listed, such as technologists or technicians, support or repair equipment and machinery. A number of the providers offer medical services in concert with others and do not or cannot bill independently for their portion.
The amount of research required to validate and classify all providers using the proposed hierarchical structure was enormous. The X12N subgroup focused on medical providers, who are licensed practitioners, those who bill for health-related services rendered and those who appeared on the Medicare CMS Provider Specialty listing.
This included providers who were licensed to practice medicine via state licensure agencies. In addition, a very broad definition of "areas of specialization" was used, which included nationally recognized specialties, provider self-designated specialties, areas of practice focus and any requests by any agency or trading partners submitted before the first taxonomy release.
This level of detail captured specialty information in categories detailed enough to support those trading credentialing information, yet broad enough to support those wishing to trade directory level specialization information. Watch what you wish for.
In 2001, X12N asked the NUCC to become the official maintainer of the Health Care Provider Taxonomy Code Set. The NUCC has a formal operating protocol in its membership includes representation from key provider and payer organizations, as well as state and federal agencies, standard development organizations and the National Uniform Billing Committee.
Criteria for membership includes a national scope and representation of a unique constituency affected by health care electronic commerce with an emphasis on maintaining a provider/payer balance. The NUCC has developed procedures for processing all outstanding and new taxonomy change requests and has worked diligently at updating the taxonomy list and definitions of the codes.
The new web site and updated list is approaching the testing phase and will be released soon. The current code list can be accessed at the wpc web site and the new one will also be located at the wpc web site.
As for the code structure, the taxonomy represents a one-to-many relationship to the individual provider. This means that many occurrences of the taxonomy may apply to a single entity or provider. For example, a provider who trains in internal medicine and specializes in cardiology may appear with specialties in both internal medicine and cardiology, which would be two occurrences of the taxonomy relating to one provider.
There are approximately 800 Provider Taxonomy Codes and they are ten digits in length. The hierarchy of provider categories incorporates four areas of provider classifications that, when used in concern with one another, create the capability to sort providers into broad and specific categories. There are four levels in the hierarchy including Level I, which represents the provider type and this is a 2 byte alphanumeric. This is a code that identifies a major group of services or occupations of health care providers; for example, dental service providers, dietary and nutritional service providers, physicians, et cetera.
Level II, classification code, also represents 2 byte alphanumeric. This is a code that identifies more specific services or occupations within the health care provider type. The coding is based on licensed provider classifications. For example, within dental service providers there are dentists, dental hygienists and dental laboratory technicians.
Level III, area of specialization, which represents 5 byte alphanumeric. This is a code that identifies the provider's specialization, a segment of the population that a health care provider chooses to service, a specific medical service, a specialization in treating a specific disease or any other descriptive characteristic about the providers practice relating to the services rendered; for example, physicians, as I mentioned previously, could specialize in internal medicine or maybe would limit their practice to a certain specialty.
Level IV is right now a place holder for future expansion. In addition, many of the provider types and classifications, the first two levels, include definitions provided by various sources.
As for the code maintenance, the process for handling all new code submissions, as well as all requests for changes to current codes will be similar to that which is presently followed with the HIPAA-DSMO change request system. The NUCC has been working with WPC on the development of a web-based system similar to the DSMO change request system. Therefore, requests will be able to be submitted electronically. The NUCC has also been working with the National Medicaid EDI HIPAA Workgroup, NMEH. Because of the large number of code proposals we have requested that the NMEH workgroup coordinate all requests related to Medicaid before they submit to the NUCC.
Representatives from NMEH regularly participate in the provider -- in the NUCC's provider taxonomy meetings. In the future, it is anticipated that all Medicaid requests received by the taxonomy web site will have been submitted to the site from NMEH.
We are also hoping to work with some of the standard development organizations, for example, HL7 has expressed an interest in working with our committee.
The NUCC developed the following guidelines for submitting change request to the Health Care Provider Taxonomy Code Set, which will be posted on the web site. Is there a proven business need for acceptance or a change? For example, will there be a cost savings or increased efficiencies with the benefits of the acceptance or the change, outweighing the costs of implementation? Because this is a national list, requests should help solve the needs on a national level versus the state level.
Is there an existing code that will suffice in place of the perceived need for a new code?
Does the new request, for example, a medical specialty code, presently exist within the American Board of Medical Specialties?
Does the organization code presently exist within the code set? Is there consistency between the list and current place of service code list being maintained by CMS?
While existing Level I Health Care Provider Type Codes and Level II codes have been defined, the same cannot be said for all Level III codes. Therefore, the NUCC is asking that every new Taxonomy Code request be accompanied by a definition. The Taxonomy Code requests lacking definitions will not be considered for inclusion in future revisions of the Taxonomy Code Set.
In addition to the guidelines for submission, the NUCC has developed criteria to evaluate requests for new provider specialty codes to be added. All new code requests must meet these criteria.
No. 1, existence of a nationally recognized specialty board or a specialty defined by a subspecialty certification or a certificate of special competence issued by such a board or a nationally recognized accrediting body.
No. 2, existence of an American College of Graduate Medical Education, accredited residency or subspecialty training program.
No. 3, in exceptional circumstances, health care fields that do not meet No. 1 or 2 will be considered if the need to identify providers in that field is determined. Such determination will be based in part on the following: Demand for services is such that a significant number of providers choose to limit their practice to that specialty. No. 2, the specialty is based on major new concepts in health science having broad professional support. No. 3, the specialty is a distinct and well-defined new field of health care that entails special concern with the problems of a specific patient group, organ system, disease entity or health care procedures.
The code requests are currently reviewed by the NUCC on a monthly basis and we will be able to have published them following their approval. We will be discussing that more at our upcoming meeting next week.
One of the statements I also wanted to make was that with the current DSMO change request process in a review of these code source requests that have come through, I think what we have been dealing with with HIPAA have been strictly billing applications the way billing is currently done or was even done a few years ago.
I think that will be changing and I think these nonmedical code sets will probably be even considered, you know, more in the medical record types of applications also.
So, on behalf of the National Uniform Claim Committee, I want to thank you again for this opportunity to comment before the NCVHS. I want to express my appreciation for the several opportunities that have been provided to date to assist the NCVHS and the Department in fulfilling the responsibilities associated with Subtitle F of HIPAA.
As one of the consulting organizations specified in HIPAA, the NUCC is highly supportive of the development and use of national standards for electronic transactions. We look forward to working closely with the NCVHS and other HIPAA committees to maintain the standards that could provide our nation with an administratively simplified health care system.
At this time, I would be pleased to answer any questions.
DR. ZUBELDIA: Thank you. That was excellent testimony.
We have about 10 or 15 minutes for questions.
I have a couple of questions for Jean on NUCC. You mentioned that one of the guidelines for the change request is whether the organizational code or the organizational code that presently exists within the code set, then is there a consistency between the list and the current place of service code? That was puzzling to me, what does the place of service have to do with the Taxonomy Code.
MS. NARCISI: Well, there are codes that list organizations or certain facilities that may or may not be in the place of service codes. We have had some conversations with CMS in the past. They currently maintain the place of service codes and I think we will have to discuss those again because it might not make sense to have them in two separate places any longer.
We may need to -- we could add them either to our code set or else other organizations should be added to their code set.
DR. ZUBELDIA: But that would be only for provider taxonomy codes that specifically represent not only the specialty but also a place of service, right?
MS. NARCISI: Well, the way that the Provider Taxonomy Code Set has been designed, the specialties are included in there and almost every other thing, including the kitchen sink was added. I think they added the organization codes because there were not codes for reporting those different facilities in a place of service code.
There, as I said, age of the patient -- Medicaid agencies had added several different codes because they have different reimbursement methodologies that maybe there was nowhere else to add a code. So, based on the specialty of the provider and maybe the age of the patient, so on and so forth, those codes were added to the provider taxonomy list. And there were several local codes that were used.
DR. ZUBELDIA: And that is a perfect segue to my second question and that is are there guidelines for when to use the Taxonomy Codes with the HIPAA and then the Taxonomy Code is not required anymore. I am concerned that it may be up to the payer to request the Taxonomy Code and the different payers are going to request Taxonomy Codes in different circumstances and it is going to be impossible for the providers to know when to send a Taxonomy Code and when not to send it. Do you have guidelines for it?
MS. NARCISI: No, there are not because it is not an actual source listed in the X12 implementation guide. It is not a required element. It has not been. However, it was added to the addenda as a situational element. I can't remember what the specific situation was.
So, it will be needed to add it to the implementation guide and that is an excellent suggestion.
DR. ZUBELDIA: The situation in the implementation guide says required if necessary for adjudication, which is a determination made by the payer, whether they need it for adjudication or not. I am afraid that the providers will never know when it is required and when it is not.
DR. COHN: Jean and Susan, thank you very much for, I think, very interesting presentations. I guess I am sort of reminded and I guess I had forgotten, we have talked about nonmedical code sets before and I think have gone on record as expressing some concern and I think I continue to have some concern based on what I am hearing.
I guess -- well, I am sure we will hear more from other testifiers about levels of concern. I am sort of reminded that there is a USHIC(?) activity going on that is supposedly supposed to begin at least to put these all together, but I really actually don't know how -- I mean, it has been more of a conceptual progression as opposed to getting done and we probably need to find out how that is going.
But, you know, Jean, I actually have a very basic question for you. You know, we have heard about all sorts of updating that has been occurring with code sets. We have heard two years for the dental codes, one year with updates for CPT. Yearly, with quarterly updates for HCPCS. Now we are hearing about monthly updates for the provider taxonomy.
What makes sense for updating do you think? I mean, it seems like two years is probably too long. Probably one month, I might go a little nuts if I had my code sets updated every month. What do you think?
MS. NARCISI: Well, the Provider Taxonomy Code Set has not been updated since 1997.
PARTICIPANT: Well, it needs updating then. Faster than that is good.
MS. NARCISI: And there were many, many outstanding requests. We have probably -- to the next version that will come out. There were probably 50 or 60 codes that will be added to that. But you are right, I think monthly, maybe that is too often. However, we are talking about really very few code requests, new code requests that we have seen come in to the provider taxonomy list.
We are not sure what the updating should be.
MS. HUMPHREYS: When George previously referred to having some code sets come forward where, you know, related to billing issues and whether they had a specific billing purpose or something and Jeff commented, I think, appropriately -- you didn't say it this way, well, these are all about billing, so why are these different, but I do know that some of the proposed code sets have actually combined the provider with the service.
So that we end up in a situation where you have n number of codes for the identical procedure or service and because part of the code is the provider, which does seem to be in some sense out of whack with everything else, so I can understand under those circumstances, this is probably not a great idea to have this in one procedure code set. Well, I know that that has been the case with some of the proposals related to alternative procedures.
So, it would seem to me that in some sense when these people come forward with these proposals, if they have done that, then it isn't enough to say go talk to CPT or HCPCS or ICD or whatever. Where they have imbedded those things, where they have combined those things, it seems to me it is also going to be incumbent upon the advice to say and if you do this, you had better go talk to the Provider Taxonomy as well and that would bring up my next thing.
Am I correct in interpreting your instruction -- I mean, your guidelines here that these would not necessarily exclude alternative providers? And I do feel that this national requirement might be problematic here because the states have very different laws about licensing of alternative practitioners and what is a valid procedure for whom to perform in a particular state. Having it have to be national in some sense might exclude many legal procedures since the states are the ones that license providers, not nationally.
So, I just wondered if those issues have come up and how they have been handled.
MS. NARCISI: Not yet and that is an excellent recommendation. We do need to consider that. Working with the NMEH group, they have really been looking at those issues and they are trying to do it on a national basis, but they are finding that I think there are going to be limits
-- there are going to be times when they are going to be limited to just, you know, state codes probably, using them within certain states.
So, hopefully, they will help us through those issues. If not, we welcome any input from anyone. We have had HL7 mention that they want to work with us. You know, we really appreciate the help.
MS. HUMPHREYS: Yes. One sort of has to feel that at some level, I mean, at some point, if it is a licensed procedure in a particular state and we are going to EDI here, I mean, HIPAA, and somebody is allowed to do it and submit a bill to a payer, if we haven't worked the code sets so that we can represent it, then we have got a big problem. That would also -- I don't know what -- when required for adjudication means either, but presumably if this is a legal set of providers doing legal procedures in certain places, then they have got to be represented also as providers, as well as the procedures they are providing in somebody's procedure code.
MS. NARCISI: Right. And we have a good listing of the medical providers, the physician providers because there is a list to go by, but we don't have a listing of the non-physician providers, I don't think adequately that are represented in that code list.
DR. ZUBELDIA: Jean, I would like to go back to the version control system for these codes, especially with monthly updates it becomes very important.
MS. NARCISI: No, they are on the seven year cycle. We never update them.
DR. ZUBELDIA: In this Table 2 or Table B that Susan has given us for Code List 139, it says it is maintained by an ad hoc group, which meets the Sunday before the X12 meeting. No structure, updating process or version control. Must attend the meeting to have interests heard. Then she has it with a question mark, it says is this true of other sets associated with Washington Publishing? I have seen some of these code lists from Washington Publishing, where you will get a code list with 200 codes and some of them will have sprinkled here and there a date that will say effective as of this date or discontinued as of this date.
The list has 200 codes. Maybe 20 of them have a date and the dates are all over the map because it happened to be the Sunday before X12 and X12 meets several times a year and sometimes the code has a different date than that Sunday before the X12 meeting.
Is that going to be the case for Provider Taxonomy or are you planning to have a more rigorous version control system?
MS. NARCISI: No, we will have a more rigorous version control system. The Provider Taxonomy Code List was maintained similar to the Claim Adjustment Reason Code. It would be the Sunday before and, you know, whoever would show up -- what bothered me is that I was attending the meetings because I was working with HCFA and trying to make sure that all the physicians, all the medical specialties were included and we had mapped it out and found out there were 35 that were not included.
I could not get those into the list. I mean, there was no really process to get them in. So, I guess I complained enough and we are doing it now.
DR. MC DONALD: I think it is finding these -- the medical codes, it is really a good thing and we have been worried about that for some time, but I do -- two cautions. One is the border between Medical and nonmedical won't always be crystal clear. I just wanted to clarify in terms of the attachment part you mentioned, that clearly the HL7 has different nonmedicals in equivalent fields, but that particular one about single, that field is not included n the attachment because the X12 thing it is contained with supersedes it.
So, just -- you shouldn't -- the attachment, I think, is pretty clear because those fields are not represented in the attachment, just the marital status.
The second thing is when you -- if there are some things in the attachments that are different, it is an X12, HL7 group that puts them together and the codes are just fed by those groups from the source code, so that if there are some complications there, you ought to pick them out and send them to Maria Ward so that they can be fixed.
I actually don't think they are at the bottom level. The single one is not in the attachment.
DR. ZUBELDIA: The X12 position on that issue has been that it thoroughly irrelevant what the actual code is because it is up to a translator to translate it whichever way it needs to go.
DR. FITZMAURICE: A question for Susan.
On the second page of what you put out and as you read it as well, there are three sets of identifiers, provider, employer, plan ID, formerly known as payer ID. NPRMs have been issued for the first two and they are final. I am not sure what is meant by "final." My understanding was the NPRMs are out but that the final rules are not out.
PARTICIPANT: Yes. I don't think they are yet.
MS. HAWK: Okay. Sorry. Thank you so much.
MS. GILBERTSON: I just had a quick -- for Susan. If you need any help with the NCPDP standards, give me a shout and also if you would like some information on the USHIC Data Registry Project, it might help you out as well.
MS. HAWK: Thank you so much.
DR. ZUBELDIA: If there are no more questions, we are going to recess for lunch. We will reconvene here at 1 o'clock.
Thank you very much.
[Whereupon, at 12:00 noon, the meeting was recessed, to reconvene at 1:15 p.m., the same day, Wednesday, February 6, 2002.]
DR. ZUBELDIA: Good afternoon.
We are going to get started with the afternoon panels. We are starting about half an hour ahead of the schedule. This is Panel No. 3 of the testimony before the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics.
We have in this panel Ed Murphy, Janis Oshensky and Nelly Leon-Chisen.
So, if you would introduce yourself before you speak and then we will proceed from there.
MR. MURPHY: My name is Edward A. Murphy. I am chairman of the board of the National Association of Dental Plans. That is an elected position. My day job is I am chief executive officer of Dental Benefits Providers, which is a United Health Group company.
We provide dental insurance programs and services for over 3 million Americans. United Health Group is a Fortune 100 company and the No. 2 most admired company in the United States.
PARTICIPANT: What was the No. 1?
MS. GREENBERG: Federal Government.
MR. MURPHY: This committee, as a matter of fact.
MR. BLAIR: Your credibility is up there.
MR. MURPHY: I get an audience wrapped in my hand very quickly.
I would like to thank the members of the subcommittee, Dr. Cohn, for the opportunity to address you all today on behalf of the National Association of Dental Plans.
NADP, as a little bit of background, represents member companies offering all lines of dental benefits, including dental health maintenance organizations, dental PPOs, indemnity plans, which is the traditional insurance ladder network, and dental referral plans, which are network access plans.
Our members include major commercial carriers, as well as regional and single state companies. NADP members provide more than 70 percent of all network-based dental benefits and a full one-third of all indemnity dental benefits in the United States. Our members provide dental benefits to 95 million of the 160 million insureds in the United States. So, we are a trade association that truly represents the payer and administrative services arm of the dental benefits industry.
We welcome this opportunity to share our insight and experience in the dental benefits industry with this subcommittee. We strongly support the move to electronic transactions and our industry is investing heavily today with significant resources to comply not only with HIPAA but to add to the productivity and efficiency in the health care system.
The use of a standardized code set is essential to facilitating these electronic transactions. Therefore, changes to the standardized code set must be developed in a fair, equitable and open process to all vested interests and constituencies.
Payers, like ourselves, have invested tens of millions of dollars to incorporate the CDT coding system into our claims systems and our benefit literature. In fact, United Health Group provides dental insurance services for about 600,000 Medicaid recipients in several states and you will find that state governments use this code set to build their benefit schedules and utilization monitoring and standard reporting systems that will take place between insurers, the state government agencies, such as a welfare department and HCFA.
Any changes to this code set, which literally are in the public domain, must be a product of consensus. The most recent change for the CDT, known as CDT3, was released to the public by the American Dental Association after the date upon which payers were expected to have incorporated that coding system into our systems and our processes. Thus, dental benefit plans did not have adequate time to modify our computer systems, plan documents, seek regulatory approvals and print and distribute the communications to the consuming public without this notice.
As a representative of the broadest cross section of the dental benefits industry, we as an association have three significant problems with the HIPAA nonmedical code set development and maintenance to bring to your attention today.
No. 1, we are deeply concerned with the lack of an open and fair process for the maintenance of the CDT as recently outlined by the ADA.
NADP, No. 2, opposes the licensing requirements being imposed selectively on dental benefit plans, which severely limit the use of the CDT.
Finally, No. 3, we and other national organizations find the CDT usage fees being demanded of dental benefit plans to be out of line with costs associated with the more widely used codes designated by the rule for other medical and health care specialties.
As the designated standards maintenance organization for the CDT, the ADA has the responsibility and the requirement within HIPAA to ensure that these principles are met and the process for code revision is fair, equitable and inclusive.
The process recently announced by the ADA does not incorporate these principles. As early as 1993, our trade association has requested to participate as a member of the CDT Code Revision Committee. On each occasion, NADP was told that the process was either funded by contracts or ongoing litigation. NADP was assured that we would be considered for membership on the Code Revision Committee as recently as 2000 when contracts expired at the end of that year.
In December of 2001, the ADA sent invitations to three organizations that have historically participated in the Code Revision Committee; the Blue Cross Blue Shield Association, the Delta Dental Plan Association and the Health Insurance Association of America. A written "Overview of the Code Revisions Process" authored by the ADA was transmitted to this group and included in our written testimony submitted to the subcommittee.
NADP received no notice of this new code revision process or have we gotten a response yet to our earlier repeated requests for participation on the committee. Of the three national trade associations invited to participate, only Delta Dental Plan Association focuses exclusively on dental benefits. The other two, the Blue Cross and Blue Shield Association and HIAA, are primarily organizations of medical care plans with a component or a committee focused on dental benefits.
In fact, NADP has been led to believe that both DDPA and HIAA are currently included on the committee as a result of ADA litigation that was settled with both these trade associations. While we believe that each of these organizations can represent their minority position, NADP and our membership represents a much more broad and much more inclusive position with the dental benefits industry.
To date, our requests to participate have yet gone unanswered by the ADA. The invitations outlined in the new Code Revision Committee and process, the committee is to consist of five dentists representing and appointed by the ADA. The letter further states that there will be five representatives from payer entities; one each from the three associations I just mentioned, along with a representative of Centers for Medicare and Medicaid Services, the CMS, and a representative of a national group purchaser of significant dental services.
It should be noted that the ADA has final approval over the last representative I mentioned, which has been referred to as an employer representative. While this may appear to be a balanced structure on the face of it, the CMS and employer representatives are not truly payers, but are purchasers with little knowledge of the detailed CDT usage issues.
This process ensures that the ADA would have a majority vote on all issues, unless all three payer representatives and the government representative and the employer representative all agree on a particular code revision or addition.
As you can see, the ADA has assured itself of at least a veto power on the committee, as well as the ability to carry out its position on any issue of dispute without the support of any other participant. Health plans have been consigned to a minority position needing at least one ADA vote in any disputed case to achieve approval of their proposal.
It should be further noted that the ADA chairs and provides all staff for the committee. This creates a concern for us as a trade association and as representatives of the payer community, as there is no assurance in the process that any suggestions that we make will ever be honored or presented to the committee.
Participants in the process have observed that the ADA staff has failed to present recommendations that were made to the committee in the format presented by members of the committee. Any preliminary screening of revisions prevents the entire committee from a full and open review process as committed.
As for the meetings of the committee, it has been difficult at best to determine the schedule and process for participation. While committee members may receive some direct notice, the public is not given adequate notice of the location and agenda for the meeting. While the meeting location can be found by a search of the ADA web site, which I am sure everybody keys into everyday, no agenda or supporting documentation can be obtained for review.
Further, observers at the first meeting were not provided with copies of the agenda or materials relating to the proposed revisions or additions to the code set. No process was apparent to allow for comments from observers unless a comment was directly related to specific issues on the agenda and observers had to be recognized by a member of the committee.
While the rule requires an open public process, during the recent meeting of the committee held on January 28th and 29th, 2001, at the Chicago headquarters of the ADA, a process was discussed for moving to executive session if there were too many observers present at the meeting.
Simply put, the ADA Code Revision Committee process does not appear to encompass the basic principles of an open public process as required by the rule. NADP would suggest that this subcommittee review the procedures used by other DSMOs and direct the ADA to set up a process that is equitable and clearly allows for the participation of all interested parties.
NADP also suggests that a neutral representative, such as a member of the Department of HHS, be designated to chair the committee and use reasonable and readily available standards for comment and input from interested parties both before and at the meetings of the committee.
As I mentioned before, the rule provides that the CDT is the code to be used primarily for dental services. It is important to understand that the CDT is the primary means for communication between a dental office where the procedures are actually being delivered and the NADP members, who are, in fact, paying for the benefits.
The use of the CDT to facilitate the payment of claims is critical to both providers and the dental benefits industry and the consumers. In the publication of the final Transaction Code Rule, HHS responded to numerous issues raised during the rule's public comment period. The issue of using existing proprietary code sets was raised by several commentators.
HHS responded by saying that HIPAA allowed HHS to select an existing proprietary code while requiring all standard code sets to be updated as needed and "that there are efficient, low cost mechanisms for distribution, including electronic distribution, for the code sets and their updates." HHS further states that the selection of a code set did not remove any copyright protections from code sets selected by the rule.
The rule made it clear that HHS intended any copyrighted material to be easily available to those mandated by HIPAA to use those designated code sets. As recently as December of last year, dental benefits plans were sent letters requiring them to sign a Dental Insurer License Agreement with the ADA to continue to use the CDT. The letter further threatened the possibility of litigation if such agreements were not signed and returned to the ADA.
The agreement grants a dental benefits plan the right to (a) install the code set on their internal computer systems to process claims, develop contracts, et cetera, with providers; (b) retrieve codes and descriptions via the commands contained in the CDT for the exclusive use of the licensee and (c) to develop utilization data using the CDT.
The next section of the agreement clearly outlines that the dental benefits plan would only have the rights I just mentioned and any and all other rights would be owned by the American Dental Association. The agreement goes on to state that a dental benefits plan is specifically prohibited from reproducing or distributing all or any part of the CDT via global computer networks, including the Internet.
Any change to the CDT as outlined by the agreement would necessitate the completion of a separate license for the revised CDT with the ADA maintaining the right to revise the agreement. The restrictive provisions of this agreement could severely limit the effective and efficient operation of dental benefit plans in severl ways and add costs to the process. And that is a key. Add costs to the process. You all know how efficient our health care system is today. We do not want to add costs to the process. We want to remove costs from the process.
That was an editorial. It is not in my testimony. While the current list of allowed codes for the CDT would appear to encompass used by most dental benefit plans to process claims, NADP is concerned that that is limited use in the agreement could unilaterally be modified by the ADA after codes are installed for use in electronic processing.
We feel that the agreement fails to contemplate many current uses of the CDT and creates serious and substantial questions for our plans. The mere existence of this agreement raises many questions since no other agreements were formerly required of any other dental benefit plan to use the CDT.
It is also interesting to note that to our knowledge, no other significant portion of the dental benefits industry is being asked to sign a licensing agreement that so severely limits our commerce. As well, agreements are apparently not being uniformly required of all dental plans. Our recent survey of our membership found that many small regional or single state carriers, as well as some Delta Dental Plans have not received the demand for licensing.
As the Internet has emerged as a resource for employers and consumers to access information, dental benefits plans could be restricted from placing a schedule of benefits using the CDT on their web site. Actually, many employers are contractually requiring dental benefit plans to make electronic copies of benefit materials available to groups and employers via the Internet. The language of this agreement on its face would prevent such state of the art dissemination of information to consumers.
Due to the volume of questions these agreements raised, our survey found few members to date that have acquiesced to signing this agreement with the ADA. The agreements raise more questions than they have answers and do not seem to comply with the basic tenets of the HIPAA requirement for code sets to be easily accessible. These licensing agreements appear to be in direct conflict with the mandates to use the CDT as the required code set for all electronic transactions for dental plans.
In the final review, providing for the standards for electronic transactions and code sets, while it generally appears that specific criteria for the establishment of low cost procedures for distribution were not included, HHS did stress the need for low cost access to the code sets.
Currently, a member of the ADA can order the code for as little as $40. A non-ADA dentist could be charged $60. However, dental benefit plans are being asked to pay currently $1,000 annually by the ADA for use of the federally mandated CDT. This practice has not occurred prior to HHS designating the CDT as the code set under HIPAA for dental services.
We believe that such an amount is well above what would normally be considered low cost distribution and represents an effort by the ADA to make a particular profit off the mandate that dental benefit plans must use this CDT in order to comply with HIPAA. We feel that there is very little in the way of additional distribution costs involved in the ADA making the CDT available to dental benefit plans versus dentists.
Our research has not shown any other designated standard maintenance organizations that has different pricing structures based on the segment of the industry to which a purchaser belongs. We would also question the use of these fees.
Does the ADA intend to use the revenue generated to offset other general administrative expenses within the ADA or will it be targeted just to offset distribution and costs associated with code sets. We would urge, therefore, that you either specify a specific dollar amount that reflects the intent of the law or call on the ADA to standardize its charges for the code to amounts more in line with what other designated standard maintenance agreements are charging for the use of the HIPAA mandated code set.
We want you to provide assurance -- we would like you to provide insurance -- I am sorry -- and provide assurance the income from these fees do not support general ADA expenses. With the ADA having been granted a monopoly position on the Transaction Standards Rule, we believe there is an equal responsibility to ensure that such a position be carried out in a fair, balanced and inclusive rather than exclusive manner.
NADP asks that you review the ADA's actions and procedures and undertake any changes necessary to ensure that appropriate trade organizations, dentists, the government and employers have an integral role Internet he code set development process.
On behalf of the entire membership of NADP, we appreciate the opportunity to address your subcommittee. NADP would welcome the chance to bring our expertise and representation of the dental benefits industry to the process of maintaining and revising the HIPAA mandated code set.
We believe that if included in the process, we would offer solutions to the many issues. We are going to add value to the process and we would be open to discussing our proposals to improve the current process.
Thank you very much.
MS. OSHENSKY: My name is Janis Oshensky.
I am pleased to be here today on behalf of Delta Dental Plans Association to respectfully offer our association's testimony on the HIPAA code set issues. DDPA plans provide coverage to 75,000 employer-sponsored group dental programs serving 39 million workers and their families.
DDPA is the nation's largest dental benefits organization with more than a 106,000 participating dentists. Our comments relate specifically to the process for updating and maintaining the current dental terminology that is maintained and distributed by the American Dental Association. DDPA and the ADA have recently settled a longstanding litigation and entered into an agreement to implement a consensus approach to code maintenance that will provide for our continued participation and the provision of industry input.
The dental code system maintained and distributed by the ADA has become a national standard in the dental industry and benefits both providers and payers in providing a consistent means to report treatment procedures and for payers to appropriate benefit disbursements. Accordingly, as the principal means of communication between dentists and dental benefit payers, the dental code is central to the core business of the DDPA and our member plans.
Participation and representation: On January 28 and 29th, DDPA and other dental payers had the first meeting with the ADA since our settlement agreement was adopted. While it is early in the process, it appears that the process in place prior to implementation of HIPAA continues to be the process for updating the CDT. No formal procedural format is followed and the agenda is determined arbitrarily by the ADA representative chairing the meeting.
Our first recommendation to the subcommittee is that the Federal Government must require standard setting organizations to follow specific rules of order commonly followed in most formal meeting settings, such as those found in Sturgis or Robert's Rules of Order. The code set is now a national standard and public participation must be facilitated in a fair and orderly manner.
The preamble to the final rule noted concerns about the ADA's process and that the ADA clarified to the Secretary that "a workable open updating process" would be in place. DDPA has played an integral role in the development and maintenance of CDT. In addition, we are represented as voting members on the CPT Editorial Panel, the body responsible for maintenance of the American Medical Association's CPT codes, on the HCPCS Alphanumeric Editorial Panel, the body responsible for maintenance of the HCPCS code system and the American Dental Association's Code Consensus Pane, the governing body for CDT.
The participation of dental benefit payers on these standards-setting bodies with voting responsibility is critically important to provide the industry input to continue these systems as the communications tools for efficient processing and reimbursement of dental expenses in particular and all health care expenses generally. Full representation and input from appropriate payer organizations is crucial to the update and maintenance process for these standards in order to balance the competing goals of fair payment and affordability and cost management.
Charges associated with access to the code standards: The code standard for dental services is maintained and distributed by the ADA for a charge. This is one standard out of five or six, depending on how you code the ICDs, recognized standards that have a charge associated with its distribution. While we recognize the ability of organizations to claim copyright for their work, we believe it is incumbent upon organizations whose work will define the standards by which our industries communicate,, to facilitate easy access to these standards.
Organizations should be able to recover the reasonable costs associated with the production and distribution of their work. However, such charges must not impede access to these public codes. The subcommittee must ensure that standard setting organizations that impose a fee do so fairly. For example, charging a fee for every update may become burdensome and impede access to these now public code sets.
Need for objective mileposts: The current process is essentially a continuation of the process employed by standard setting organizations at the time the HIPAA standards were adopted. No new process was required by law and no specific meaning or model of an open process was defined by the Secretary. Some have noted that the process used for updating the AMA's CPT codes could be used as a model for other standard setting organizations to follow.
DDPA recommends that the subcommittee consider adopting a model format for use by all standard setting organizations in this process to ensure consistency and fairness for all participants and interested parties.
The preamble to the final rule did note some elements of an open updating process, which include a panel or committee of experts that is composed of a broad cross section of relevant stakeholders, voting privileges for all panel or committee members. Any interested party may submit proposals for change and that meetings are announced in advance and should be open to the public, identification of all submitted proposals and posting of coding changes.
The Secretary suggested in the preamble to the proposed rule that standard setting organizations, such as the ADA, should hold biannual meetings with public attendance and without payment of registration fees, establish a central contact for public input and provide meaningful opportunity for participants to voice concerns and suggest changes.
Because the code set standard is now incorporated by federal law into a national standard to facilitate uniformity, we believe some objective mileposts should be established by the Secretary to provide a uniform and objective marker for judging whether or not the process for updating and maintaining these standards meets the goal of an open process.
In defining an open process for updating and maintaining the code set standards, the Secretary must look beyond merely a permitted presence and input at a meeting. Because the code set standards are core to the payer community, an open process must in practice also take into account the concerns of payers and not just providers. These additional concerns include:
Code set changes should be designed for greater efficiency and cost management. When possible, code set changes should be objectively science-based. They should not be designed to simply enhance provider payment opportunities without increased services to patients,, through code splitting or unbundling of procedures. Often times we see provider-sponsored code changes as thinly veiled attempts to manipulate coverage controversy.
An open process would balance the needs of both providers and payers. These concerns were expressed in the preamble to the final regulation and the Secretary noted the need to continue to review the process to ensure that the code sets meet the needs of the industry.
The impact of unbundling has the potential for greatly increasing the cost of health care and so once a change is established, it should not readily be changed or modified absent a scientific basis.
Impartial consideration of changes: Code set changes proposed by payers and providers must be given equal consideration and an open process would ensure that where an organization timely submits a number of proposed changes, all of those submissions are widely circulated and considered in an open and public deliberation and in a timely manner that allows equal and fair review of the proposed changes prior to the review board's gathering.
In addition, an open process should have an objective protocol set forth by which all proposed changes can be judged fairly and not arbitrarily. All stakeholders should have a voice in the development and determination of that objective criteria for judging proposed changes. This would facilitate the impartial consideration of changes and standard setting organizations might spend more time on substance than on procedure in debating proposed code setting changes.
An open process would ensure that all interested parties are given adequate written notice of the time frame when changes may be submitted. All changes that are proposed in proper format within the noticed time frame must then be considered by the standard setting organization. This notice must be conspicuous and the process for submission clear in order to be meaningful as an open process.
An open process would ensure that implementation of adopted changes occurs in a fair manner for both payers and providers. The process must balance the desire of some to begin utilizing new code set changes as soon as possible against the time frame necessary to address the administrative and physical modifications required to execute the changes.
In the case of DDPA plans, these changes must all be filed and approved by state departments of insurance. Thus, frequent changes in the code set are disruptive and time consuming to implement. Limiting updates to twice a year, for example, would make this process more manageable, although the state regulatory process is unpredictable. DDPA plans have the goal of implementing these changes simultaneously in all 50 states to ensure national consistency and uniformity.
For the above stated reasons, DDPA respectfully requests that the subcommittee consider and recommend to the Secretary that federal mileposts be established to objectively judge the openness of the code set update and maintenance process for all standard setting organizations.
These explicit mileposts would consist of recommendations of the Secretary noted in our testimony, in addition to our further recommendations that to be an open process, the standard setting organization must consider only science-based code changes, impartial consideration of these changes, adequate notice of change submissions and appropriate timely implementation of these changes.
Thank you.
MS. LEON-CHISEN: Good afternoon, Dr. Cohn, Dr. Zubeldia, subcommittee members and members of the audience.
My name is Nelly Leon-Chisen. I am the director of coding and classification at the American Hospital Association. On behalf of our 5,000 member hospitals, health systems, networks and other providers of care, I would like to thank you for the opportunity to provide comments on the current HIPAA medical code sets.
We worked with the Centers for Medicare and Medicaid Services, CMS, and the National Center for Health Statistics, NCHS, for more than 30 years to ensure the appropriate interpretation and application of ICD-9-CM codes. With the addition of the American Health Information Management Association, we are collectively known as the cooperating parties. The AHA also provides a clearinghouse function through its central office on ICD-9-CM and we publish Coding Clinic for ICD-9-CM.
In more recent years, the AHA has also worked with HHS, the American Medical Association and the CPT Editorial Panel to ensure that the same level of integrity and quality is achieved in the hospital application of CPT-4 and the Healthcare Common Procedure Coding System or HCPCS.
Our members are extremely interested in the standardization of clinical codes, especially as they apply to those identified by HIPAA. Diverse reporting requirements are burdensome, confusing and costly for hospitals. More importantly, these variations of compromise, the primary purpose of clinical codes, which is to provide an accurate record of what happened to the patient.
The AHA is very supportive of the subcommittee's effort. Before I specifically address the questions you posed, I would like to give you a summary of what our members would like to see take place.
Our members rely on the reporting integrity of clinical codes because they are a key data component used for benchmarking, quality assessment, public health research and reporting, strategic planning, as well as reimbursement. Accurate and comparable data is required to achieve these objectives. Uniformity and the standardization of the clinical data reporting process will enhance hospitals' ability to deliver high quality, well-coordinated care.
For hospitals and health systems, the important issue is whether the code development process incorporates the following principles: Sensitive to the needs of all users, capable of recognizing organized delivery systems shifts from inpatient to outpatient procedures and from physician offices to outpatient treatment facilities; structured so that instructions on code usage can be easily accessible and widely understandable; maintained through a clearly defined organizational structure that is capable of achieving a high level of coding integrity.
Complementing these principles, there should be a well-defined maintenance and implementation process. The maintenance process should include broad-based input and the coding system changes should take into account the needs of all users. The process should also be predictable and take into account the users' capabilities to adapt to these coding changes. The process should have routinely scheduled meetings, allowing providers the opportunity to review those changes and to identify the implementation date for when these changes take effect.
Ideally, coding changes should happen no more frequently than once a year. Providers should be able to utilize the same code set version over a given period with a consistent implementation date across all users, including payers. It is important for health care providers to have clear, unambiguous instructions and consistent coding and reporting guidelines. These guidelines should be readily available and widely accepted by all payers. Consistent guidelines allow for the development of comparable health information that provides a better basis for establishing an equitable payment system.
While we are pleased that the HIPAA code sets include the official ICD-9-CM guidelines for coding and reporting, there are, however, no comparable official guidelines designated or under development for the HCPCS or the CPT-4 code sets. The AHA recommends that official guidelines be developed for HCPCS and CPT-4.
I will now address the update process. The AHA supports the current ICD-9-CM update process. The Coordination and Maintenance Committee has a well-defined and broad-based maintenance and implementation process. The process strives to take into consideration the needs of all users. It is predictable. Proposed changes are well-publicized and the committee accepts public comments. There are routinely scheduled meetings to review coding changes and an annual date certain for using approved changes.
The AHA is encouraged by the recent efforts of the AMA's CPT Editorial Panel over the past few years to address the needs of our members and to consider the interests of other non-physician stakeholders.
The AHA, however, is very concerned about the lack of institutional provider input into the HCPCS Level II update process and we are encouraged to have heard today that Kaye Riley mentioned that you will now have an open meeting available.
The HCPCS Level II Editorial Panel is comprised of representatives from payer organizations, like the Blue Cross Blue Shield Association, the Health Insurance Association of America and the CMS. While proposed changes are posted on the CMS web site and public comments are accepted, this is not the same as having provider representatives involved in the development process.
With regards to update schedules, there are ongoing problems and confusion related to the frequency with which various code sets are updated and uncertain implementation dates for new or revised codes. We applaud HHS's decision to update the ICD-9-CM codes no more than once a year. More frequent updates would be burdensome to hospitals because it would require more frequent information system changes, along with new instructions on the application of the new codes and coder training. Some specific examples of more burdensome update schedules follow:
We have seen our members struggle with the quarterly changes in the HCPCS Level II codes. With the implementation of the outpatient prospective payment system, OPPS, C-Codes were developed to allow the reporting of devices, drugs and biologicals that qualify for additional payments. The code set was so fluid that some devices had two to three different C-Codes in the first 12 months of OPPS implementation. Our members have had difficulty keeping up with the excessively frequent changes to their chargemaster and billing systems.
We are concerned about implementation issues regarding several recent improvements made to the CPT-4 code set. Current practice up to this point has been for annual updates. However, we are concerned that the AMA has started early biannual electronic release of certain new codes. The new codes are to be released on the AMA web page, but no specific implementation dates have been set.
While well-intentioned, this new process could open the door for disparate implementation dates at the individual payer's discretion. This is confusing to coders since no new code books will be published mid year and more frequent and different implementation dates for the updates will result in increased costs to hospitals.
We know that different implementation dates for different code set versions are problematic for hospitals. Our members are currently dealing with the challenges of different implementation dates for the 2002 CPT-4 and HCFA changes. Traditionally, hospitals updated their HCPCS codes on January 1. This year, CMS has instructed hospitals to delay the submission of updated HCPCS codes until further notice, possibly the spring.
Other payers went ahead with the HCPCS codes updates on January 1st as originally planned. This has created operational burdens for some hospitals when their information systems were not capable of differentiating between two versions of HCPCS codes, the 2001 version for Medicare patients and the 2002 version for non-Medicare patients. In some instances, hospitals opted not to upload the 2002 version and instead manually separated the non-Medicare claims affected by the 2002 updates and processed them separately.
The final rule on electronic transactions standards specifies the use of certain clinical code sets and the requirement to follow coding guidelines. However, the regulations do not address the frequency with which these code sets may be updated to reduce the administrative costs of updating hospital information systems, the AHA recommends that ICD-9-CM and all other code sets be updated no more often than annually. The AHA also recommends that all covered entities update their code sets on the same date, preferably October 1st for ICD-9-CM and January 1st for CPT and HCPCS, all of which would follow current Medicare practice.
Providers and payers should utilize the same version of a particular clinical code set release to prevent confusion and unnecessary delays in claims processing. The AHA recommends that HHS clarify in regulations the specific version of the code sets that have been adopted for use. HHS should also develop transition rules for switching to the newer versions of the code sets. Transition rules should require that covered entities maintain and work with the older version for claims for services provided before the new version was released.
I will now address code formats. CPT-5 improvements call for CPT to address the needs of other users besides physicians, including clinical and health service researchers, who needed coded data. Category II codes were created to allow the capture of performance measurements. Category III codes were meant to provide a temporary set of tracking codes for new and emerging technology procedures and services.
Rather than the traditional five digit numeric code structure, the new categories of codes contain an alpha character as the fifth character in the string, preceded by four digits. Current CPT instructions are that if a Category III code exists, this code must be reported instead of a Category I unlisted procedure code. The AHA is greatly concerned that a number of state Medicaid programs have already indicated that their information systems are not capable of accepting the new code structure.
This places providers in a quandary. Do they follow CPT instructions and report a Category III code or have their claim denied or in other words deciding between disregarding CPT instructions and violating HIPAA standards or following Medicaid guidance by submitting a CPT unlisted procedure code. We hope that all Medicaid programs are able to update their systems by the time HIPAA transaction standards are fully implemented no later than the October 16, 2003 deadline.
In the interim, the AHA recommends that HHS declare a moratorium on structural changes to the standard code sets to allow all stakeholders to make the necessary changes to their systems to ensure HIPAA compliance.
Our members are also concerned with the lack of progress toward standardization in the application of current code sets. Because existing CPT evaluation and management or E/M codes correspond to levels of physician effort rather than the non-physician resources utilized, CMS allow each institution to develop its own system for coding clinic and emergency visits.
Consequently, widely disparate mapping systems were developed across the country with each hospital grading the visit according to its own classification system. Some hospitals use a point system. Others use time. Others narrow their physician visit level and others use a system reporting nursing interventions. However, they all use the same CPT code numbers that are also used to report physicians services.
It was expected that these mapping systems would be a temporary solution until a logical, standardized method for evaluation could be developed. The AHA has been working with CMS and hopes that a standard method for reporting facility E/M services using separate unique HCPCS codes or CPT codes be developed before HIPAA implementation in 2003.
The AHA recommends that HHS clarify that HIPAA compliance means that codes should have a single meaning to clearly identify what service is being provided and should be assigned in the standard manner with clear guidelines that instruct coders on the proper use and evaluation methods to drive E/M assignment.
With regard to the question of pricing, some of our members have from time to time raised concerns regarding reasonable pricing of CPT use. However, the AHA does not want to preclude private sector or copyrighted systems. The private sector has played a key role in the past in developing many of these systems and sometimes the availability of a copyright is an important incentive to encourage useful development.
With regard to the question of local codes, the AHA feels that some progress has been made to reduce the number of local codes but a complete resolution has not been achieved yet. We hope that the payers involved in the process continue to work diligently until they achieve the complete elimination of all local codes.
Again, thank you for the opportunity to present comments today. We look forward to coming back in April and May to talk about ICD-10-CM and ICD-10-PCS. I will be happy to answer any questions you may have.
DR. ZUBELDIA: Thank you. Thank you for your testimony and the preparation you have done.
We are going to start with 15 minutes of questions. I would like to ask a generic question to all three of you. As you understand, the development of medical terminology codes is a difficult process and it takes time and it takes a lot of expertise and money.
Obviously, we have heard about the dental codes. There is a discrepancy in that the ADA believes that they are copyrighted and they have the right to issue a license and you were saying that they are in the public domain. I am not sure which is right. I believe the ADA will probably be saying that they are right.
The question I have is how do you propose to handle licensing, copyright issues, payment for the development of these codes. Should these codes be in the public domain or are people willing to pay a reasonable fee? From what I am hearing for a health plan to pay a thousand dollars a year or a thousand dollars every five years for the CPT codes doesn't seem unreasonable.
I think that there may be more -- something else going on. Is it the license or what the problem is? I am not sure. I would like to hear the comment from all three of you.
MR. MURPHY: I would be happy to -- there are several questions in there. So, I will try and parse them. I think the most important piece of what we are looking for is an open process. If, in fact, it is one representative, one vote and not the way that this structure exists today where there is a veto power by the provider side, if you will, when most of the expense in maintaining these systems or rather the code set fall on the payers and the providers practice management systems to continue to communicate effectively so that not only can payment be transacted for efficiently, but also we can build and aggregate treatment data that, in fact, is one of the roles that we play in order to (a) take cost out of the system and (b) try and improve or participate in improving the oral health of the citizens of this country.
So, I think to your point about cost, the thousand dollars is not, in fact, a number that I think most insurers at our level would, in fact, object to. It is the arbitrary nature of a provider pays 45, we pay a thousand. We don't know what in five years, we may be asked to pay. So, if we could come back to an open process where as was being described, I believe, that the AMA is striving to carry out, where all interested constituencies are part of the process, that there is adequate notice being provided for meetings, that there is, in fact, adequate time to digest the results of those meetings and feedback so that all constituencies are satisfied.
I think that can be done in a timely manner. It is the exclusionary nature of the process that we have current objection to. So, I think it is not the fee, but it is rather we are paying fees or being -- these are being extracted from us and we are not part of this process.
So, I think my company for one would be happy to pay a thousand dollars if I knew (a) that the thousand -- what the thousand dollars was going for; (b) that we would, in fact, be a participant in a fair and open process that takes into account all constituencies because as we see it right now, we can't get our constituencies' representations even at the table.
As I qualified the size of the trade association, I will just tell you the names of a few members. United Health Group is a member. That is my company. We are a $25 billion health and dental insurance payer in the United States. Cigma is a member. Aetna is a member. Guardian Life, which is a billion dollars, has a billion dollar premium position in the dental insurance industry is a member.
None of these companies are getting to sit at the table. We are the people who are paying the bills, if you will, on behalf of employers. So, again, it isn't about the thousand dollars. It is about the process. So, all we would like is a seat at the table and an open process. I think that is really if we get to that issue and we can resolve that, I think the monitor aspect of it will resolve itself.
MS. OSHENSKY: Based on our settlement of our lawsuit with the ADA, we are in a unique position and this was part of the press release so that we have a ten year royalty-free use of a license, which is renewable. So, we just wanted to make sure that it was fair and equitable for others to use.
MS. LEON-CHISEN: We don't have a problem with copyrighted systems. We just wanted to make sure that the fees charged were reasonable. We have heard some comments from our members, but it has not been anything with specific numbers or in large numbers of members.
MR. AUGUSTINE: I can understand AMA and ADA wanting to charge for the work that they do, but that as these code sets move toward the public domain, there needs to be -- I would expect there to be some give and take on that issue, not only on the financial side, but also on the development side, as you were mentioning, kind of the taxation without representation type issue.
I would ponder whether if you query the doctors and dentists if they would be willing to assist and maybe having an extra $5 a year going -- because they benefit from these code sets being updated and as accurate as possible, as well as anyone and whether or not that type of sharing of costs would be appropriate.
DR. YASNOFF: I wanted to follow up on the process issue. The ADA Code Revisions Committee -- is that the proper name for the committee? -- do they have any role in setting prices or defining the terms of the licensing of the codes? If not, who does?
MS. OSHENSKY: I would have to defer that to the ADA. I don't know who at the ADA is responsible --
MR. POKORNY: Frank Pokorny, the American Dental Association. Hello, Jeff, how are you? It has been a few years.
The Code Revision Committee is responsible for the maintenance of the code itself, meaning determining which additions, changes and deletions would be incorporated into the next revision. The licensing of the code and maintaining the copyright is handled by other divisions within the American Dental Association.
DR. YASNOFF: So then I would ask the question rhetorically -- if you care to answer, fine -- that if all the things that you have recommended with respect to additional participation and an open process in that committee, we are all taken care of. I am not sure how that would address any issues relative to the licensing provisions or the cost. It doesn't sound like they would because that is done elsewhere.
I am trying to just clarify the issues, that there is an issue of -- one issue is -- that you have clearly raised is who is going to participate in maintaining the codes. Who is going to make the decision? Then there is this issue of the licensing provisions and the licensing costs.
I would appreciate it if you could clarify, if I am not correct, but it seems to me that those are separate issues.
MR. MURPHY: I think that was an extremely bright question that you asked. I am now -- I like everyone else now have the answer. I think, again, our focus as payers in the payer community is, in fact, more about the process. If, in fact, we have got to go back down inside the American Dental Association again to discuss fees, I think those are, in fact, the secondary issues.
MR. BLAIR: The administrative simplification provisions of HIPAA gave guidance to the NCVHS when we were going through the process of selecting standards, that preference be given to SDOs that were accredited by ANSI. The reason that that was there was that the American National Standards Institute in accrediting SDOs does require through the accreditation process that the SDOs conduct their determination of standards and updates to standards in an open consensus-based manner.
Now, I know that the ADA has been a regular member of the ANSI Health Informatics Standards Board. Frank, I thought that the ADA is an SDO that is accredited by ANSI. Is that correct?
MR. POKORNY: Jeff, that is correct. I believe you are making reference to some of the standards development work that is not related to the Code on Dental Procedures and Nomenclature. You are correct that as a matter of fact right now, I believe that Robert Owens who is the CIO at the ADA is now the HSBE(?) chair, is it?
MR. BLAIR: That is correct.
MR. POKORNY: These standards are within the ADA, are more concerned with some of the technical standards related to dentistry. I think there is a clinical records standard that has come out. There is, of course, the ISO TC-3950, the International Tooth Designation System that is administered through that area. I do not in my experience and in all my conversations with colleagues at the ADA, the code is not considered one of those standards. It has nothing to do with one of those standards.
MR. BLAIR: Thank you.
DR. MC DONALD: First was a comment. I have heard the word "public domain" bounced around a number of times and I think it is being either misused or misunderstood. Firstly, we don't want public domain. Basically, what happens, if you make it public domain, you can have 5,000 of them. There is nobody that has discipline over it if it is public domain. So, you probably want to copyright with pre-use or some very broad use, so that there is some place to control it.
The second thing was in terms of the -- it sounds like there is really -- I would like to dissect what I hear is the complaints further or partition them further. It sounds like there is one set of complaints about just bumpy process, I would call it. I mean, notice not -- that sort of thing seems like it should be easily fixable and I guess I would encourage ADA to fix that process so that it doesn't confound other issues.
The second thing is code sets as democratic processes -- it may be hard to make a code set as a fully democratic process. The way that happens, if you are doing a standards organization, you let everything come in no matter what it is. Then you don't have any irregularities. So, there is a little bit of a challenge in code sets in contrast to say technical message standards are things where you end up with a consensus. Just sort of a warning.
So, in that context, what I am trying to understand, what are the kind of things that you disagree about? I mean, what kind of codes, just to give me a model or a picture of it is that you wanted to use a 6 and they want to use a 5? Is it real minor stuff or is it -- you want to make 10,000 codes and they only wanted 6? What are the domains of dispute, the differences?
MR. MURPHY: I would be happy to answer that. From the perspective of the payers, if the trade association that represents the majority of the dental insurance payer transactions that go on in the country isn't at the table and we are not, we are not at the table, then there is a -- that is the issue that we have. Just get us a seat at the table, have a fair and open process, where it is one organization, one vote, and I think we smoothed out most of the issues.
If, in fact, there is an open dialogue between a payer and the organized representatives of the dental community, we should have the interest of the provider in mind and we do. We do not want to make it anymore difficult for a dental care provider in the United States to submit their procedures to us and be efficiently and accurately paid.
It is our objective to do that as rapidly as we can to take cost out of the system. So, what we would like to do is sit down and have a voice at the table. The key thing is enough cycle time. Once a group would agree on what the new cards are to be added or the deletions, if there is enough cycle time in people's information systems to be able to affect that and implement it.
If we are not at the table and we are not part of the process, I doubt very seriously whether or not we will have the cycle time. As I cited before, CDT-3 was announced to the public. That is us because we are not part of the process after the date of its -- after its effective date. So, that is a pretty clear example that the payers weren't at the table to negotiate a cycle time to allow us to implement.
DR. MC DONALD: I was categorizing that as bumpy process.
MR. MURPHY: It is pretty bumpy.
DR. MC DONALD: But I am still trying to get out
-- just sort of see a picture of this. I am having trouble picturing in terms of wanting to get your -- I mean, I thought I heard there was disagreement about -- some of the veto codes you wanted or -- that is what I thought I heard. I am trying to get a sense of is there really a code dispute or is this just bumpy processing?
MR. MURPHY: No, it is process.
MS. OSHENSKY: I think part of it is that the -- part of the problem is the codes that were put forth by some of the specialty organizations, like the oral surgeons and the periodontists had a lot of science-based new technology involved in, which we could support. Others collapsed codes so that work done on primary teeth versus work done on permanent teeth were all given the same code.
There really wasn't any scientific basis for doing that. So, there were some issues with the coding themselves.
DR. COHN: First of all, I think the questions and the responses, I think, have been very helpful in terms of further understanding this issue.
You know, from my view, I consider the testimony that we have received from the dental associations, from the payers' associations, to be relatively serious allegations. I don't at this moment know what to do with them. I guess I am hoping that the American Dental Association -- Frank, are you paying attention? -- will provide us in writing a response that addresses, I think, these allegations. I think until we receive something like that, I am not sure what we can do next.
But, obviously, I consider these things to be serious. I think Nelly when she -- when you were talking about principles, I was sort of taken with your first principle, which is that you would like the code development process to be sensitive to the needs of all users. I don't think we can have complete happiness there but I was sort of taken that that is a desirable part of code development, which we would like to see encouraged in this environment.
So, thank you.
DR. FITZMAURICE: I want to continue on the vein that Jeff introduced. It is my understanding that an ANSI accredited process requires representation from all parties that are materially affected by the standards. So, it is also my understanding that the ADA is an ANSI-accredited organization, but from Frank said, I understand it is not an American National Standard --
[Multiple discussions.]
MR. BLAIR: Could we give Michael a chance to finish his point because at least one terminology developer, code set developer has gone through and has become accredited by ANSI. So, it may have relevance in the thing.
DR. FITZMAURICE: So that for some purposes, particularly some international standards, as well as some American National Standards, ADA does know the ANSI process and does follow the ANSI process and is accredited, but in the case of the CDT codes, has chosen not to follow that process.
Okay so far? I am not trying to set you up or anything. I am just trying to get an understanding --
MR. POKORNY: I have taken off my jacket as you can see.
I would take exception with saying we have -- the ADA has elected not to follow the ANSI processes. The code set has never been forward as an American National Standard. And as such, would not be subject to it. If you are interested in why that has not been done, I don't have the history to tell you.
DR. FITZMAURICE: No, I just wanted to clarify the definition so that in this area, if it has not been put forth as an American National Standard process, there is no violation of accreditation or no conflict. It is just a choice of not to follow the process in this case.
MR. POKORNY: The ANSI process doesn't apply in this case since it wasn't put forward as a standard.
DR. FITZMAURICE: Okay. Thank you.
DR. ZUBELDIA: I want to thank everybody on the panel again. We are going to make another change in the schedule. We are trying to gather minutes here and there so we can discuss the PMRI at the end of the day.
So, we are going to move up the third panel of industry representatives before the break and then we will go to the break after that panel.
We have some holes in the -- Dan Rode, will you come to the table. I was going to say we have a hole here.
In this panel, we have Tom Meyers, Sue Prophet and Dan Rode and Lynne Gilbertson and it is a continuation of the previous panel. So, let's start with Thomas Meyers.
MR. MEYERS: Thank you. I will keep my comments brief, but thank you, Mr. Chairman. I appreciate the opportunity to present my comments today. I am Tom Meyers, vice president and dental product manager for Mutual of Omaha Insurance Company.
I am speaking today representing the Health Insurance Association of America, the trade association for the private insurance industry. HIAA has submitted written comments for today's meeting. I would like to summarize those comments and answer any questions you may have.
I am here today to present comments to the subcommittee in its role in reviewing the code set process for standard code sets designated by HIPAA as national dental data standards.
I represent claims, processors and data users of the code system under review today. I will direct my comments to the CDT code system for dental services developed by the American Dental Association. I would like to address the process, participation and access to CDT.
I am going to deviate from my own list of things since a lot of this was discussed in the last session. So, I will move this along rapidly for you.
In the area of process, we strongly believe that there should be early and periodic communication of code changes and suggestions. We should avoid prescreening by any one entity. We should allow open discussion of issues with the ability to suggest alternates based on submitter suggestions or in addition to original requests, it should allow an open process for interested parties and easily found information on meeting schedules and items to be discussed and allow the process to follow recognized rules of order with comment from attending interested parties.
Participation should avoid a late distribution of information to parties and process, choose payer participants for their familiarity with dental claim payment processes and knowledge of the perspective on dental issues from purchaser, payer community, allow comments from meeting attendees, other than the panel, recognizing that the attendees presence indicates an interest in the code set.
Under access, while understanding that an organization responsible for maintaining a standard code set should be able to recover reasonable costs associated with maintaining the data set, an equitable price should be charged for all interested parties.
Licensure of the ADA code set is implied in the copyright when purchased by the provider parties, while payer organizations must sign a formal licensing agreement and pay a licensure fee to obtain the access to the code. The actual licensure agreement that the payer organizations are asked to sign to obtain the code set, contain language that would seem prohibited by the responsibilities conferred upon the organization as recognized data standard organizations.
The language specifically states ADA reserves the right to modify or change the code or any part thereof at any time. This implies unilateral right to change the code without any previous announcement or schedule of code changes.
In summary, I would like the subcommittee to consider these facts in deliberating the responsibilities of the entities that have been designated data set maintenance organizations. All users must, by law, communicate using these designated national standards for the efficient electronic transmission and processing of health claim information.
We believe to do so there must be formal process with scheduled events for meeting review, communication, implementation, appropriate representation from both payer and provider communities and most importantly, there should be equitable access to the code set at a reasonable cost for all users.
MS. PROPHET: Good afternoon, Mr. Chairman and staff of the National Committee on Vital and Health Statistics Standards and Security Subcommittee and ladies and gentlemen of the audience.
I am Sue Prophet, director of coding policy and compliance for the American Health Information Management Association or AHIMA. I am joined today by AHIMA's vice president for policy and government relations, Mr. Dan Rode, who is sitting over there across the table. It is our pleasure to testify before you today on issues related to current HIPAA medical data code sets. Consistency in coding is an important issue for AHIMA and we appreciate your invitation to discuss it here.
I know many of you are already familiar with our organization. For those of you who may not be, AHIMA is a professional association representing more than 40,000 members, who manage patient medical and clinical information in the form of health records and databases and provider health plan, government research and other private organizations, facilities and practices.
We are also an educational entity in that we directly provide education in the area of coding and general health information management and accredit college educational curricula as well. To identify our perspective further, if you are interested in Appendix A of our written testimony, there is additional information on AHIMA members and our involvement in professional coding
You are also welcome to visit our web site if that information isn't enough for you at www.ahima.org. AHIMA is an advocate of our members overwhelming desire to see consistency, uniformity and best practices for coding in all standard government regulations and industry practices. We are an active participant in numerous coding standards groups, including the ICD-9-CM Coordination and Maintenance Committee. We are one of the cooperating parties. Along with NCHS, CMS and the AHA, we are responsible for approval of the content of coding clinic for ICD-9-CM and development of the ICD-9-CM official coding guidelines.
We also participate in the CPT Editorial Panel process, as well as many other national and international coding nomenclature and classification bodies, all who work together to ensure the consistency and integrity of coding standards and the health care data or information that such coding represents.
Over the course of the last 70 or so years, medical coding set use has changed just as the health care industry has changed. Our code sets and their maintainers have had to juggle multiple needs and relationships as they went about their development and maintenance duties. Never before have so many demands been made on our medical code sets and system maintainers and never before has the principle of coding uniformity and consistency been more important.
You will see in the written testimony that we have attempted to address the subcommittee's questions in detail. You will be very relieved to know that I have no intention of reading through the written testimony. I realize I don't have quite that much time, but I hope that all of you will take the opportunity to review the information as to review the other testimony, comments, answers to today's questions.
We have divided our comments into five sections, delineating current medical data code set standards and what they cover, standards processes, effective dates and distributions, costs and issues and recommendations. In subsequent hearings, we will cover ICD-9-CM and its potential replacement. We won't be talking in depth about that today. Our comments related to ICD-9-CM will mainly be related to existing problems as they might effect consistency of coding and the use of the medical code sets under HIPAA.
You will find in the written testimony extensive information about the current medical data code sets and I won't go through that today, but you are free to look at that at your own leisure. The current medical data code sets and what they cover begins on page 3 and it goes through both ICD-9-CM, CPT and HCPCS in extensive detail.
ICD-9, as I said, I won't go over it and some of the limitations or problems to face in future hearings are going to deal with that. Thinking about CPT, one issue we have identified with CPT is that these codes are still primarily designed for physician billing and to meet the requirements of the Medicare resource base relative value scale and not really for health research data tracking, quality analysis and electronic patient record systems and databases, although we have seen efforts in recent years to move towards addressing some of these issues.
This design also means that they are still somewhat less applicable for facility reporting of health care services. HCPCS is divided into three levels with Level I being the CPT codes that we knew; Level II being the codes developed by CMS, the Health Insurance Association of America and the Blue Cross and Blue Shield Association and Level III, of course, being the local codes.
Looking at the CPT and the HCPCS Level II codes, we can see that there is considerable room for duplication of codes across these code sets and a constant potential for misunderstanding what code to use, depending on the site of care, such as facility, physician's office or emergency room or the location or the source of payment.
There is also unreliable and non-comparable data resulting from some of this duplication that frustrates the implementation of any study, research or quality process that crosses the sites of service, location or plan or payer. Daily, our members face the problems of lack of coding specificity, required use of duplicative or overlapping code sets, inability to compare coded data in any meaningful way and conflicting code requirements for different individual payment policies, including government payers.
In recognition of this problem and the associations, our associations, and NCVHS's own previous recommendations in 1993, AHIMA testified in May 2001 to the ICD-9-CM Coordination and Maintenance Committee regarding the need for a significant study of the procedural coding systems currently in place and the conflicts that exist. Such a study should come from an organization like the General Accounting Office or the Office of Management and Budget to ensure a thorough investigation.
I have included a copy of our May testimony attached and a copy is also available on the AHIMA web site. Our members are taking steps on a local basis to work with health care plans and local trade and professional associations to achieve coding consistency. Part of this effort includes the use of a newly revised Payer's Guide to Health Care, Diagnostic and Procedural Data Quality. A copy of this guide has been provided to the members and staff of this committee. Anyone else who might be interested or would like additional copies, the PDF copy of this guide is available to download from AHIMA web site.
Code set processes, we have delineated information about the code set processes for the current standard medical data code sets, which you can find beginning on page 2 of our written testimony. Several problems inherent in today's code sets will not be resolved until the health care industry addresses their replacement or the modifications necessary to recognize today and tomorrow's needs.
Each of the medical code set processes in use is very different. Like the codes they maintain, each was established in a different era. Today we have to look at these processes and judge how they meet the goals and objectives of data and information consistency, both now and in the future, administrative simplification and use in a mandated HIPAA system and user integration, a provision of services across previously defined lines and the need for consistent data from these same multiple sources.
Regarding code set effective dates and distribution, we have some of these same concerns that AHA addressed in their testimony, as far as varying effective dates throughout the year, lack of knowing what the effective date is for certain code sets, such as the CPT Category III codes and variability even within a code set as to when the codes become effective.
We have heard concerns from our members that even the HCPCS Level II codes, which I understand are technically only supposed to come out and be effective quarterly, that there are private plans, health plans out there that are using effective dates outside of this quarterly schedule for implementation of some of the HCPCS on national codes. These are all issues that need to be addressed.
Regarding code set costs, certainly products utilizing medical code sets in the public domain are more readily available and affordable perhaps than those utilizing a copyright, wherein delays occur because of licensing issues. It is unclear though whether -- and I think we have all heard this with other testimony today -- it is unclear whether these costs related to code sets that have a copyright are really excessive or not. I don't think this has been adequately studied.
So, the issue of cost as it relates to medical code sets in the public domain versus those that are copyrighted really needs to be explored further. Examination of the actual differences in costs and in the processes and requirements for obtaining license agreements or fair use permission might show if such practices inhibit the development of appropriate resources for use of the code sets or related to data derived from medical codes by other than the code set developers.
We have also received some complaints from some of our members on the costs associated with obtaining official advice from the code set maintainers or other organizations designated as responsible for providing official advice. Again, we do not have a clear picture of what is really a fair cost and until the process is reformed and a coordinated and funded coding effort takes place, we must recognize somehow the cost of maintaining codes and realize that someone needs to pay for it.
Now I would like to address AHIMA's recommendations regarding issues pertinent to today's discussion. Our issues are discussed extensively starting on page 16 of the written testimony. Rather than spending time going through what these issues are, I will focus my discussion today on the recommendations.
First, we believe that all payers and providers should be required to adhere to the existing code set rules, definitions and guidelines as they have been developed by the code set maintenance organizations and published as a part of the code set. HIPAA regulations should be modified to require that users or covered entities follow a code set's rules, definitions and guidelines in line with our other recommendations.
Coding guidelines should be part of the standard code set so that all users must abide by them. HIPAA regulations should be modified to reflect this requirement. The coding system rules and guidelines should be updated on the same schedule as the code set.
Every accepted standard medical data code set organization must be required to have an organized process for the development and maintenance of the codes and rules and guidelines for the correct, consistent use of their code set. The process for developing codes, code set rules and guidelines for proper use of the medical code sets should include broad access and input and representation from a range of stakeholders, including coding and clinical experts, practitioners and users.
Input should be solicited prior to finalization of a new or significantly revised rule or guideline and meetings should be open to the public or at a minimum to the primary stakeholders. Notice of meetings should be posted at an appropriate time in at least the Federal Register and the agenda and information on submitting items for the agenda should be posted in a suitable manner.
All of these processes should be placed under the supervision or oversight of a single entity or authority. Such an entity should provide oversight and authority to the guideline development process for each medical code set, ensure consistency in processes and ensure that the various standard code sets complement one another and work in tandem without duplication or overlap.
To this degree, such an authority would act much as the American National Standards Institute or ANSI does with its various standards groups.
Given the multiple uses of coded data, with reimbursement being just one of those uses, this lead authority should not primarily focus on the needs of any one particular health care provider or plan so that it is able to objectively balance the various needs of different groups of stakeholders.
This authority must be given sufficient resources to manage this new responsibility. After much thought and discussion, AHIMA believes that the logical choice for this central authority would be an expanded and appropriately funded National Center for Health Statistics. NCHS already serves as the principal health statistics agency in the United States and is charged with providing statistical information that will guide actions and policies to improve the health and health systems of the American people and as the primary U.S. link to the World Health Organization on coding issues.
Regarding code set maintenance, we believe that four principles should guide code set maintenance in the future. Due to the rapid advances in medicine and technology and the immediate need for codes to describe these advances, the maintenance process should be more streamlined, with consideration given to the feasibility of more frequent system updates.
The length of time between the proposal of a new code and its implementation should be minimized when at all possible. There should be an established process for developing rules and guidelines for the correct application of the coding system. The process should be open and permit broad input from all stakeholders prior to finalization of a significantly revised or changed guideline. The coding system rules and guidelines and the consequent payment system changes should be updated on the same schedule as the code set and made part of the official version.
All requisite materials, code sets, guidelines, definitions and other directives, should be in formats available for government or private entities, but ensuring that all stakeholders know where to go for unfettered access to the official, most up-to-date versions and interpretive materials.
Responsibility for ensuring maintenance and coordination of these coding systems and development of the associated rules and guidelines should be the domain of a single agency so that decisions balance the needs of users, payers and providers to ensure data integrity is not compromised. Currently, authority is too dispersed and the leadership vacuum allows all the conflicting practices that have been so problematic. For each code set there can be only one official set of rules, definitions and guidelines. No health care entity should be permitted to change these rules to accommodate an adjudication process or revenue systems. The official source of coding advice should be clearly identified and readily accessible so that all users are easily able to procure official coding advice. Coding support services, newsletters and educators should be required to stay abreast of and provide direction that is consistent with all official rules, definitions and guidelines as they are released by the code set maintainer. Such requirements will help to maintain consistency in coding.
Once again, this issue highlights the need for a central or lead authority to designate the source of official medical coding information. Such an authority can also ensure the conflicts between official information are resolved by an appropriate source.
Due to the issues with overlapping and duplicate shift code sets and the use of multiple procedural code systems in this country, we recommend and have recommended in the past -- this is not a new stance for us, but a single procedural coding system should be developed and adopted for use across all sites of health care services.
We have recommended that a federally funding examination on the feasibility of moving to a single system should be initiated that examines the efficacy of alternative systems across all health care settings, for all payer types and all types of health care services. It should also address the need for uniform data to fulfill the needs of a national health care and public health infrastructure, health care research and other uses of health care data not related to direct patient care.
Studies should also examine the implementation and long term cost and benefits of a single system compared to that of operating multiple systems and a recommended strategy for implementation that takes into account the need to implement any other future system, such as ICD-10-CM, should also be addressed.
The HCPCS coding system should be revised such that this single procedural coding system as recognized as the only coding system to be used for procedures and services. HCPCS should then become a coding system with an open development and maintenance process, representing only products technology and supplies that are not procedures and services.
This is to address the issue that in addition to ICD-9-CM and CPT having overlapping and duplicate procedures codes, we have also seen the same issue within the HCPCS Level II codes.. The HCPCS coding system processes should continue to be reformed to handle the elimination of HCPCS Level III codes and the process for this new coding system and processes and the time line should be published for education and comment so that those entities using local codes, understand what they must do to secure a new code when none exists.
Code set maintenance organizations should consider changes in processes to minimize the lag time between code proposal and implementation, as I said, including consideration of delays that may be built into the code implementation process, such as requiring FDA approval, that may need to be evaluated against the value of collecting data on performance of that procedure.
There should be a single standardized process for establishment of temporary HCPCS Level II codes. Such a process must ensure that a duplicate code if not anticipated in another coding system and codes at this level should be for all parties, but should not dictate the payment policies of such parties.
This will ensure that different members of the HCPCS national panel do not create overlapping or duplicative temporary codes. Ideally, a standard time frame for implementing changes in temporary codes should be adopted. Payment or reimbursement systems should accept proper coding practices rather than requiring coding standards, descriptions or practices to be adjusted to fit payment policies.
Temporary codes should not be created for procedures, services, items or supplies that can appropriately be reported with existing national HCPCS or CPT codes.
A process should be established for transitioning temporary codes to permanent codes in the appropriate standard code set and thus, sun setting the temporary code and this should occur within a specified period of time.
An appropriate lag time between release of the new CPT Category III codes and their effective date should be required and established in a standard process for educating and notifying payers and providers about these code changes should be made. It should be made clear that these codes are part of the CPT standard code sets and implementation and use of the Category III codes is just as much required as implementation and use of the CPT Category I codes.
There may even need to be greater lag time between release of the annual CPT code changes and the January 1 effective date in order to allow systems changes to be made and ensure all payers can implement reporting of the new codes on the effective dates. We have currently seen on many delays by payers allowing transitioning periods the first part of the year because they are not ready to handle the CPT codes.
Vendors and payers should be asked for input on this issue. We are not sure exactly what the most appropriate lag time between release of the new code and the effective date should be. In the future, we would like to see the medical coding authorities, the central authority I mentioned earlier, establish a standard length of time between release of code changes and the effective date established for all medical code set developers.
Such a standard also recognizes the reimbursement implications of code changes and, therefore, what it takes to implement a code change.
In conclusion, we reiterate that the issue of medical code sets and their maintenance is very complicated, made more so by years of misuse and even manipulation. AHIMA believes that the goals of HIPAA and the need for a national health care infrastructure to support elimination of medical errors, research, data analysis and eventually an electronic medical record cannot occur until consistency and uniformity is brought to coding systems and processes.
The need for an open process for the establishment and maintenance of medical codes is crucial to the successful use of uniform, consistent code sets. The current ICD-9-CM code standard update and maintenance process and guideline development process may be far from perfect, but both are closer to a model of how a coding standard process should work under HIPAA than any other code set maintenance process in existence.
If our health care system, its infrastructure and its data quality are to meet the challenges of tomorrow, then it is time for our industry and this country to recognize the need to establish a central authority to oversee the development and maintenance of code sets and their uniform coordinated, timely and open processes.
Such an effort to succeed on a timely basis also requires a qualified, fully funded central authority. We believe that the National Center for Health Statistics is the best candidate at the current time to become such an authority. This is not a recommendation to do away with what we have. It is to take what we have and make it better right now, not much later in the future.
Mr. Chairman, members of the subcommittee, ladies and gentlemen, we thank you for the opportunity to make these comments and look forward to answering any questions you may have later today or in the future.
Thank you.
MS. GILBERTSON: Hello. I am Lynne Gilbertson from the National Council for Prescription Drug Programs.
Thank you for the opportunity to speak today. I believe our comments would probably fit under Question 4 of other comments that you are soliciting.
In your packet you will have not only my testimony but two white papers that NCPDP members have created to address their concerns on the billing of supplies and professional services. Also in the testimony if you want to pull a copy off the web site, you are more than welcome to it. I obviously will not be reading those white papers to you.
This is based on efforts that the NCPDP members representing not only providers, payers, health plans, vendors, the breadth of the pharmacy industry that are part of the NCPDP membership have put in considerable time into the creation of these two white papers.
In order to maintain the delivery of care, products and services to the patient, NCPDP makes the following recommendations. HHS must recognize NDC, UPC and HRI codes in addition to HCPCS as valid identifiers for supply, billing, transactions. These codes should be permitted via the NCPDP standards for the billing of supplies. HHS must clarify that the NCPDP standards are acceptable for the billing of supplies and they must recognize the NCPDP standards for the billing of professional pharmacy services.
The Transactions and Code Sets Final Rule names only the HCPCS as valid identifiers for supplies. Currently, pharmacies and pharmacy claim processors support the 11 digit NDC, UPC and HRI does for the billing of millions of supply claims per year, using NCPDP standards.
The NDC, UPC and HRI codes should be named in addition to HCPCS as valid identifiers for the billing of supplies. Most pharmacies and pharmacy claim processors have supplies in their databases identified via the NDC, UPC and the HRI codes. A few have both, NDC, UPC, HRI and HCPCS. Costs for programming and database purchases would be significant to switch to HCPCS only and do not provide the specificity required for the continuation of this level of current patient care.
The Transactions and Code Sets Final Rule does not name a standard for billing of supplies, but it has been inferred that a default or a suggestion would be to use the X12N 837 implementation guide. Once again, currently, pharmacies and pharmacy processors are supporting the NCPDP standards for the billing of millions of supply claims per year. A clarification is requested to allow the use of these standards for the billing of supply claims that are consumed or used during or a consequence of the administration of a drug therapy or commonly dispensed via a pharmacy. The X12 837 implementation guides should be used for the billing of medical supply claims, other than outlined above. The NCPDP standards were designed with the pharmacy industry consensus to support drugs, biologics, drug supplies and services via these codes.
Item No. 3, the final rule incorrectly states that the NCPDP standard could not support the billing of professional pharmacy services since it did not support HCPCS J-Codes. However, in another section, the final rule lists the qualities of the NCPDP standard, including the support of professional pharmacy services.
The NCPDP standards currently support the HCPCS J-Codes as a qualifier. Pharmacies and pharmacy processors support the NCPDP standards for the online, real-time billing of professional pharmacy services via HCPCS J-Codes, Professional Pharmacy Service Codes and numerous other identifiers. We are asking that the NCPDP standards be recognized for the billing of professional pharmacy services in addition to the X12 standard.
The next page, you will see a little background information, the different databases that are used by the pharmacy systems; four particular main sources, for the identification of drug and medical supplies when paying for these types of items.
HHS has already recognized the NDC code for drugs and biologics and the HCPCS for medical supplies. Many supplies are identified by an NDC.
In addition, OTC drugs and supplies do not have a valid NDC code. The manufacturers utilize a UPC or HRI, health related item, code. Additionally, the HCPCS codes that are assigned to many of these products do not permit the individual manufacturer-specific pricing.
One of the above-mentioned databases contains 13,695 active items identified via a UPC and another 5,800 items identified via an HRI. These 19,000 plus products have no associated NDC code. They include insulin syringes, diabetic test strips, incontinence supplies.
One of the concerns with -- while they may have the HCPCS codes and the associated MAC pricing, the maximum allowable cost, as defined by CMS, billing of these items and payment on most non-government sponsored payers is based on individual manufacturer costs. HCPCS alone cannot be the only identifier for these items. Any associated MAC-based pricing via HCPCS may not apply.
Basically, you can read the next bullets. They are just more supplemental information for your information on where we have come from in the past.
On the next page, there is a little chart that shows some of the OTC drugs, supplies and drug-supply combinations that are paid under the pharmacy benefit today but do not have an NDC code. They have an HRI or a UPC, all the way from birth control products, blood pressure kits, test strips, vaporizers, analgesics, all over the place, that refer to supply or an over-the-counter drug.
Now, to switch gears from supplies to professional pharmacy services, it is important for the pharmacy industry to continue using standards they have developed, implemented and intend to enhance, the NCPDP standards. The pharmacy industry currently supports the drug utilization review, DUR, and professional pharmacy services codes in support of patient care and billing of professional services.
Additionally, after professional consultation with other medical personnel, these codes are used on line in real time to automatically justify the dispensing of potentially conflicting drugs for a patient, instead of forcing the pharmacist to telephone a pharmacy processor help desk and obtain a prior authorization. These codes are part of the NCPDP standards. They are not supported in the X12 standard.
There are approximately 20 fields that are supported in the NCPDP standards for the billing of professional services. These fields are used as identifiers for reason for service, results of service, professional fee information and level of service rendered.
The industry supports the use of these fields to describe the professional service and to facilitate the information sharing for patient care. The industry is not suggesting the NCPDP standards only be named. It is asking that the NCPDP standards, as well as the X12 standards be named for professional pharmacy services.
In conclusion, I guess at this point we are asking for some guidance from the National Committee. This has been -- these two items have been topics of the pharmacy industry concern since probably before summer of last year. We don't seem to be getting anywhere. Part of the argument, as you can tell with the supplies is there are millions of claims at stake and looking for guidance as to where we can move next and what help we can -- there have been conversations with CMS. These white papers were as a result of one of them, but there is a concern that we can't change what has been published or we can't change where we are.
There is a concern that by asking the pharmacy industry, especially in the billing of supplies that we are asking them to change millions of claims a year and if there is any guidance the committee can offer for where we should be moving, we would appreciate it.
Thank you for your time.
DR. ZUBELDIA: Thank you very much for the testimony.
Lynne, I would like to start with a question to you. It seems from what we are hearing here that in the HIPAA standard transactions, the Secretary adopted standards based on the type of claim. We have the dental claim and the institutional and the professional claim and the pharmacy claim. You seem to be indicating that there should be a carve out for pharmacy where instead of being based on a type of claim, it would be based on the type of provider or the type of payer and that for pharmacy benefit managers and pharmacy payers, the claims come in from pharmacists would be in NCPDP rather than X12 formats, even though they may be for services that would be billed in other cases in the 837. Is that what you are saying?
MS. GILBERTSON: I don't believe so. I mean, I would modify that to say if they are part of their pharmacy benefit, it should be billed using the NCPDP standards. If it is part of the medical benefit, then the X12 standards are perfectly acceptable.
As you will see in the white paper, pharmacies are billing on HCFA 1500s today to help their customers who need to build those types of claims. The pharmacy industry, at least what I have been asked to present, is not against supporting both standards. They are saying for the pharmacy benefit, use the pharmacy transactions that have been developed with the pharmacy consensus.
Does that answer your question?
DR. ZUBELDIA: Simon.
DR. COHN: This is sort of probably along the lines of Kepa's question. I am sorry actually that Karen Trudel wasn't here to listen to this because it sounds like you may have had some conversations with her. I guess I was surprised that this is the first time that this has been discussed at the National Committee, to my knowledge, has been brought up. I was surprised it wasn't -- when we were talking about changes to the NPRMs last year, the NPRM processes, that it wasn't discussed. I mean, was it and I just missed it? I don't think so.
MS. GILBERTSON: I guess the short answer is not really. The billing of supplies came out and the discussion started in summer. By that point, the NPRMs were in process and it was basically an innocent question that says how do you bill supplies. The answer came back if for drug and insulin -- I am sorry -- insulin and syringe, bill the insulin as the drug using NCPDP standards and the syringe as a medical supply. At the time when it was -- the answer was listed to the NCPDP membership, they went ballistic.
At that point, the NPRM was already in progress and once it started, there were no modifications at that point.
DR. COHN: So, this was just an issue that was not identified until after that whole process.
MS. GILBERTSON: Right. I think it was one of those cases where we have been doing it for years. Why would we change? Then someone brought up an innocent question and, uh ho, there is a change.
DR. ZUBELDIA: But the pharmacies are not opposed to using both X12 and NCPDP transactions if some other benefits will be medical benefits and it would be all right with the X12 transactions.
MS. GILBERTSON: That is correct. As it states in the white paper -- in one of the discussions, conference calls we had, there was discussion about, well, what about the demerks(?). The representatives from NCPDP said we are perfectly -- if the demerks cannot support the NCPDP standards and we have to submit them in the X12, the pharmacy industry will be glad to do that. Just please let us do for the pharmacy benefits to bill under the NCPDP standards.
So, there has been some give and take and they understand that for certain benefits it makes sense to bill X12 versus the NCPDP.
DR. MC DONALD: I would like to kind of ask the question a little differently. The question really is do we -- is this a precedent that is a good precedent? I am not
-- I am just worried about the idea that each field would define their own message standards. So, the question really is if you don't have the contents you want in it because you are not meeting -- I mean, they don't know what you want or is it a question you just want your standard?
Because, you know, in the long run, you would really like to have more and more unified so that people wouldn't have to support two different ones anywhere because what this will really lead to is everyone will have to support both. I am not opposing it. I am trying to explore this issue, though, in the sense of where do we get the unity if we -- you know, before we have even got everything working in the first round, we already want to kind of carve out and do the same thing two different ways.
MS. GILBERTSON: Well, part of it I would respond that this isn't the carve out. It is current business being done today via NCPDP standards. It is just a clarification.
DR. MC DONALD: The same argument would be for the Medicare hospital bill, would be the same argument. There is an electronic standard for the Medicare bill that 90 percent of the hospitals used. So, that was the historical reality and the agreement was we are going to get to one standard.
There are issues but there are two kinds of issues generally. It is when is it -- you have got the wrong collection of people in the wrong room because they don't really know what you want. So, you don't have the carrying capacity for what you want in the one standard.
The other one is we have got our code specialized to do this particular message strategy and that is the one I think we have got to be a little more worried about because everyone is going to have that argument somewhere.
DR. COHN: I actually had a question for Clem actually. I am not sure I am following your question, but I just wanted to make sure that I could even understand it, much less the answer. Is the question you are asking, is it the transaction standard or is it the code sets that is the problem? Is that what you are asking?
DR. MC DONALD: The question I am really asking is there a problem because it doesn't have whatever, the code sets, the fields that you need, or is it just not our standard? I guess that is really the question I am asking.
If the answer is it is not our standard, we just want ours, everyone is going to say that and we are going to be divided up into lots and lots of little cubby holes, which is the natural tendency. We will be sort of, you know, Yugoslavia -- that is a bad --
DR. COHN: So, it is the code sets and related things like that. Thank you.
MS. GILBERTSON: I think in response to that, no, it is not our standard versus your standard. That has not ever entered into the discussion. It is more of -- you can see more in the white paper, but there is a very big difference with this is currently being done online, real time now and now -- where you can support the drug and the supply. Now you will be asked to split the drug and the supply and you could get two different answers and how does that affect Granny Smith, who has just come in to get her insulin and now insulin is covered but the drug --
DR. MC DONALD: I was really mixing it up in my own mind. I got mixed up between, I think, two different issues. You have got the professional billing and you have the supplies. I think they are different. You know, the supply and the drug and the pharmacy isn't that much different when I am describing people's heads. So that I could see the argument easier there than in the professional billing.
MS. HUMPHREYS: I think what you are saying is there -- it was the question of, well, what are we supposed to use and the NCPDP people who are using those standards were assuming the answer was going to be a, well, of course, you could use NCPDP for that. You have been using it all along and, lo and behold, you have got a different answer.
I mean, if they were equating the billing or the claims for drugs and supplies in the same context within your organizations, but it is interesting to me because -- and, you know, my memory for this is failing but I do not recall actually having a lot of comments. We had people who were concerned about UPNs and whether it was soon and early enough and whatever, but I don't actually recall ever getting comments from anyone from the NCPDP side of the house specifically saying, hey, folks, it is happening every day in an NCPDP standard. We are using UPNs. We are using HRIs. I don't think HRIs ever came into the conversation when we asked for input on code sets.
We did hear about UPNs from some people but that was basically, you know, a state Medicare agency or something that wanted a special exception from HCFA in order to use UPNs and we are saying we were going to foreclose them and then I guess in the end, they didn't -- I mean, they were given the exception but never ran the test or something.
It is interesting. So, I think we may just have here what we have had, unfortunately, with any process like this is there are some people who have real input, don't somehow wake up at the right moment when people are saying give us your input and give it because I really don't think we hear about this from the -- it sounds like a very real issue that we need to do something about.
DR. ZUBELDIA: Lynne, can you help us put it in perspective? I want just a guess. What is the percentage of pharmacies that are billing supplies using NCPDP codes? What percentage of pharmacies are billing professional services using NCPDP codes and transactions?
MS. GILBERTSON: I don't have that information. Sorry. The number of supplies was collected from the membership and it is in the white paper. I do have some additional information with input from the Department of Defense and some of the players giving actual numbers that I can provide to the committee. I just didn't bring it with me. Sorry.
DR. ZUBELDIA: Ball park, is it like 10 percent or 90 percent? Is it tipping towards one end of the scale or the other?
MS. GILBERTSON: Well, there are 3 billion pharmacy claims and we are talking millions of supplies. Professional services are a very small portion right now. For example, the Wisconsin Medicaid program has a very successful professional service program going under the NCPDP standards for pharmacies. They are a lot smaller in perspective.
MS. HUMPHREYS: I think the professional pharmacy services taxonomy or classification, which I am somewhat familiar with because the people who developed it had some interaction with the National Library of Medicine about principles of developing it, which we thought was very refreshing, before they developed it or as they were developing it. I think it is quite a good system, but that is relatively recently. That wouldn't have been a finished thing or on the table or in use at the time when we -- you know, if you back up to when we really did the original collection of information about standards and use for various services.
I mean, my memory of where that falls is that it would have been a few years ago that that finalized and we go back further than that in the -- but it would sound to me that there it gets back to Clem's question, whether that becomes actually a code set issue, whether for the small number of service claims that are being used with an NCPDP transaction, whether the -- as this scales up, it couldn't be X12N, but whether we have the issue of whether the pharmacy services that are represented in that classification are accurately -- you know, are available or whether that becomes a gap in what the existing code sets provide.
I think I am right. This is the PPS, right?
MS. GILBERTSON: Yes, and drug utilization review.
MS. HUMPHREYS: That one I don't know as much about. I know about the PPS.
DR. MC DONALD: I want to make sure I one of your white papers because I don't have one in front, but there is still -- it sounds like you have got a little tiny volume and you are kind of going to have to do the new ones anyway because you can't change that fast and everyone will have to it bold faced. That is what I was kind of hearing. How is it going to even save your industry if you still have to send out X12 whenever it is someone on the other side who requires it?
That is, you are going to end up with this mini-to-mini problem because that is my -- it is a philosophic question I am worried about, is you are really maybe helping your industry locally, but are you really because so many groups are going to have to support both anyway.
MS. GILBERTSON: The support of the HCFA 1500 today is basically done because the pharmacy wishes to offer a service. They don't have to do that. So, I am not
quite --
DR. MC DONALD: Well, you said you support X12 and both sides doing both things and to both places so that if anybody has -- this is sort of a HIPAA spec, it would say then, if I understand what you are wanting, that all the receivers would have to support both kinds of messages anyway. And probably all the senders would have to -- I don't know who has control, who trumps who in the rules. But all the senders may have to support both. Is that really want you want?
MS. GILBERTSON: Well, if a pharmacy does not wish to submit that kind of service -- I am sorry -- the word "service" is a little overused -- does not wish to supply Medicare billing for Granny Smith that walks in, they will have to support an X12 standard if they don't wish to do that type of business or they hand her a form or something.
If they wish to, as a boutique offering to some of their constituents, that is perfectly acceptable. I would argue that if we are looking at it from HIPAA perspective, as part of the WEDI-SNP(?) implementation guide, committee, subgroup, whatever they are calling it, we are struggling mightily trying to define -- as someone said this morning, if a hospital has an ambulance service, which form do you bill. It is not that clear in the X12 world either. It is just scratching the surface.
There are some concerns that a provider thinks he belongs to this category of implementation guide and when he goes to send his first transaction, he may find out that it is not what the payer thinks he is. So, we really have to look at the types of services and at this point what meets the business needs.
Part of the concern I have with -- that the membership has expressed is the prior authorization situation, the DUR, the drug utilization review, the fact that for one prescription, you are now having to get two different answers, one from whoever is controlling the supplies and one from whoever is controlling the drug itself and maybe at two different cycles because one is a batch transaction and one is online real time transaction.
It is all of those things that -- it is more the patient care than it is which standard it is.
DR. MC DONALD: No, I can see that is a problem, but I still thought I heard you say that you are going to have to accept both.
DR. ZUBELDIA: I think we are going to have to investigate this a lot further. I think it is a lot more than what we can digest in this one hour of testimony. Maybe we need to just give her some time just for this topic.
Michael Beebe had a question.
DR. BEEBE: Just real quick. Michael Beebe, AMA. I am going to echo a lot of the confusion that is around the table. The CPT Editorial Panel received a letter from the American Pharmaceutical Association requesting participation on our Health Care Professional's Advisory Committee, which advises the Editorial Panel on non-physician issues. The basis for that was the need to code professional services under the 837, using CPT.
The panel and the advisers haven't met to discuss this yet. We are all like everybody else around here mightily confused about which will be used where, how, when, why. So, anything you can do to help us out would be greatly appreciated.
MS. GILFOY: I just want to echo what she was saying. This is Helene Gilfoy from Gilfoy Consulting. And I just want to echo the issue because we were talking about it earlier. SNP is investigating -- it is not clear to the providers which version of the 837 they will submit and it apparently appears to be payer dependent, which is exactly what we were trying to get away from, for some services and it is not just something as clear as an ambulance service, but the one that was pointed out to me was ambulatory surgery. That appeared to me to be pretty clearcut. The hospital portion of the ambulatory surgery, the room, the surgery, et cetera, et cetera, appeared to me to be pretty clearcut, that I would submit an 837 institutional claim for that.
For the professional side, the anesthesia and the doctor's time and so on and so forth, I would submit an 837 professional. That is not clear to the payer community. That is scary because in the situation of a provider, an institutional provider or a professional provider, you could be submitting two different claim forms for the same service, but if one was being submitted to one payer, you would submit the institutional form, same service, different payer. You would be submitting the professional form and it gets even more curiouser, as the Mad Hatter said, I believe, when you get into coordination of benefits because if two payers are involved and you submit the institutional claim form, but they are then asked to send that forward for COB and the COB payer is looking for a professional claim form, then you are in deep trouble.
So, I believe the gentleman from Maryland Medicaid brought this up earlier, but he didn't elaborate on it. He mentioned it, but I don't think it was heard that this is a real, real problem and there is some guidance needed in the industry. I know SNP is doing a survey, but I don't know where we are with that, to find out -- basically going to providers and saying what do you expect to send, but more importantly going to the payers and saying what do you expect to receive. We haven't seen the results of that yet, but that could really undermine all of the efforts of administrative simplification when we get at that level.
MR. ARGES: George Arges, chair of the National Uniform Billing Committee and work at the American Hospital Association.
I just wanted to echo the same sort of issues that we are hearing from our own members, the hospital community, in terms of which guide to follow. The NUBC is also putting together a special work group to look at providing some guidance around this issue. It is very complicated. There are a number of other things to consider as well.
There are other regulations and laws that require institutional providers to comply with certain aspects of the Social Security Act. There are other types of forms, like the A55 form that CMS requires to basically indicate whether you are billing an intermediary or whether you are billing the carrier, whether you are billing the DME, that sort of thing.
So, I think as we look towards the implementation guide, what standard to use, hopefully we can provide some guidance in terms of how organizations are structured, the obligations of the organization, trying to identify certain components of service that the organization provides and then providing them with some guidance around the documents, but I think we are a little bit worried about the WEDI-SNP survey, the way it has been developed because all it is is basically gauging what the industry is doing today. That is not necessarily providing guidance and we need to define some basic terms and usages first and then set out a path that is very clear to the industry, what to do under what circumstances.
DR. ZUBELDIA: Thank you.
We are going to take a ten minute break and then we will continue discussion and PMRI.
[Brief recess.]
DR. ZUBELDIA: We are going to get started.
It seems to me that from what we have heard today, the ADA made a presentation on the process for the dental codes. Then after that, there has been testimony from various testifiers either contradicting or making some allegations on what the situation is with the dental code.
I think we need to ask the ADA to respond to that. Maybe they need to go back home and come with some response to what we have heard today, revising the testimony from other testifiers and in their response they could have changes to a process of explanations or justification or whatever.
Is that something reasonable or should we take a more direct measure asking them to respond formally?
MR. BLAIR: The only thing I have clearly processed is one of the major concerns and issues that the ADA should address. It wasn't entirely clear to me whether in addition to process, the issue of whether the license income for the ADA was going to subsidize other ADA activities. Is that also an issue that needs to be responded to or not?
DR. ZUBELDIA: They may want to address that in their allocation of elements on the part of the response. I don't --
DR. YASNOFF: I wanted to make a suggestion and ask a question.
My suggestion is that although we have clearly here requested a response, that we actually write a letter to the ADA with the testimony and ask them formally to respond, make sure that we are on record as requesting a response.
The question I have then is regardless of how we decide to proceed with this is whether we should ask for only a written response or whether we should schedule some time to allow some testimony in response or both.
DR. COHN: Maybe I can answer that. I am obviously trying to avoid this turning out to be the process that kills us. I guess my own thought is that they, I think, heard our concerns and saw the testimony. At least my understanding is that they think they will get a response back to us that will explain their position or whatever within the next month. I think based on that, then we can figure out what next to do.
That would be just my suggestion, just because it makes things easier. We can spend a couple of weeks writing a letter to them that already has the information that they have in hand.
MS. HUMPHREYS: What happens to the official minutes of the meeting? I mean, are there --
MS. GREENBERG: They do, although it is going to be awhile, obviously, but it certainly would be documented in the minutes.
MS. HUMPHREYS: That they had been officially asked to do this.
DR. YASNOFF: I understand, but I think -- I am suggesting a one sentence letter that says, "Confirming our request as documented in the minutes..." -- and you can attach them -- "... we would like to hear your response."
DR. ZUBELDIA: We couldn't attach the minutes for a couple of months or more. We could attach the testimony that we have received today.
DR. YASNOFF: Here is my concern. We have asked today if we do not get a response then what are we going to do about that?
DR. ZUBELDIA: Maybe we can ask them --
DR. YASNOFF: And what are we going to do if then subsequently they come back and say, well, yes, you know, we had our representative at the meeting, but, you know, he just left for Tahiti right after the meeting and we never heard from him again.
I just think that if you really want a response from somebody, you need to have it on the record with a direct communication to them that you notified them that you wanted a response. Other people may feel differently.
MS. GREENBERG: From the point of view of time -- if the committee wants -- the subcommittee wants to do that, if you e-mail us these two sentence or whatever letter, we can certainly get it out at the beginning of next week.
DR. ZUBELDIA: I am not opposed to a one sentence letter saying please respond to this testimony. It would have to be approved by the entire committee, right?
MS. GREENBERG: No, no. This is just subcommittee business. You are just gathering information.
DR. ZUBELDIA: I am not opposed to that approach. They know that they are going to get the letter. They can start preparing their response and we can just give them a time frame for the response.
DR. YASNOFF: Then are we going to schedule time to have them testify in response or are we just going to ask for written --
DR. ZUBELDIA: I would say let's wait until we get a response and then decide if we need to hold additional hearings.
Just suggest the language for that one sentence letter?
DR. YASNOFF: Having suggested it, I will volunteer to write the one sentence.
MS. GREENBERG: It might require two sentences.
DR. YASNOFF: It will not require two sentences because I just won't put a period in it.
[Laughter.]
MS. GREENBERG: Yes, but when we type it up, we will.
DR. YASNOFF: I will accept all friendly amendments.
MR. AUGUSTINE: Now, there were questions about process and also licensing for the ADA, but there was also
-- I believe some of you asked a question of the AMA about their licensing as well and whether that went only to the cost of preparing them or where that money went. Is that something we would like a response to as well?
MS. GREENBERG: I think you got one.
DR. ZUBELDIA: I think the response was they don't keep separate accounting and they can't tell us.
DR. MC DONALD: The truth is I don't know that that is terribly relevant. I mean, it is interesting, but it isn't really our job to minimize profit. The test really is is it a reasonable expense? My own thing is I wish I knew better what really happens to the organization or whether people are out of compliance with the medical records coding area. That is not going to -- if every place you touch is CPT code, that could be very expensive. I don't know how they enforce that.
Maybe it is all done through vendors.
MR. BLAIR: I think we have to be consistent and the issue of whether funds that are charged for license fees are diverted to other purposes within professional associations has come up as a reason that has been articulated as of concern for other medical terminologies. So, if we are going to raise that as an issue -- and I think at the time that -- you know, it has been mentioned as something that the industry has fairly widespread concern about. I think it has been raised as a valid concern.
I think we should deal with that consistently across the board.
DR. MC DONALD: I am just disagreeing with that. One organization has, you know, lobster everyday at lunch and they are not separating anything away from the committee meetings. Another organization, you know, people have to bring their own brown bag. So, they have some extra funds. I think it is the cost to the user that counts, not how they get to that cost.
So, if it is 50 bucks a year or something like that, who cares, or a hundred bucks a year, who cares? I just think it is -- this is a capitalist society for better or for worse. I don't think we have to be worried about the internals, but is it cheap and is it indefinitely cheap. That is the other question.
MR. BLAIR: -- and subsidizes it, which may be okay, too, but here is my thought, okay, because I think you raise two valid concerns. One is the ultimate cost to the user. That is a valid concern. The other, I think, is you may have a code set that is especially comprehensive or is used widely with a lot of updates and its cost may be high but it may be justified.
So, I think that the ultimate cost is one valid concern, but I think that the other piece has been the concern that has been raised by many to say, well, if we are going to pay the fee, then is it being used for updating and maintaining the code set or for making a profit for the professional association. So, I think that they are both concerns.
DR. MC DONALD: Let me go at the other -- I didn't hear that today during the testimony. So, if others heard it, I will --
MS. GREENBERG: It was one of a number of issues that were raised in that testimony, in the testimony regarding ADA. So, I think you are asking for a response to the entire testimony. That happens to be in there, but I don't think it is the same as saying we are asking -- you are asking a specific issue of one group and not of the other. I will say that, you know, this is a longstanding practice issue, whether it is WHO or government agency. You know, we sell -- and I would agree with Clem that you really I don't think can quite get into those issues.
I mean, it is important to know -- probably have some idea of what it costs to maintain a standard or classification, whatever, and then what you are charging for it, to see whether, you know, the charge is in some way relationship, but frequently, I mean, I know in the case of WHO, they sell the ICD-10, but that doesn't go back to the ICD process. We wish it would, but I mean -- and I think we have kind of agreed that it is not our role, those of us who would like more resources, say, to say that you have to do it that way because every organization has their own cost accounting process.
It is a question of really the bottom line is, is it reasonable in relationship in relationship to, you know, both what the user can pay and what it really costs to produce.
DR. MC DONALD: I mean, I thought there was some very good points like, you know, that they don't have any schedule and they are getting all screwed up by it and there seemed to be some other capriciousness in the process that is really raggedy that they need to worry about and they can't even come to meetings. That seems like a pretty bad thing. So, those complaints are solid. That is how I heard it.
DR. YASNOFF: I have to agree with Clem on this. I don't think we want to really get into, you know, costs and trying to figure out, you know, who is spending money on what. If this quote is correct in this testimony, HIPAA says HHS is supposed to, quote, establish efficient and low cost procedures for distribution, including electronic distribution of code sets and modifications made to such code sets.
I am assuming that is a correct quote. I think that is where we need to -- that is what we need to work on. So, I would not -- I would like to see what the response is and see if -- and remember, when I specifically asked the question and there were some other follow-up questions, the response as to what the issues were that were being brought to our attention.
The primary issue was the process issue. These are people who are frustrated because they feel they are not at the table in the way that they want to be and they made it clear in their answers that if that was taken care of, they felt that the other issues would go away. So, I don't want to start addressing issues that are -- you know, that we don't need to address. I agree with Clem that we don't want to try to get into this.
For example, it is not just the cost of maintenance that you might argue should be paid out of the fees, but what about the investment in creating the code set to begin with? Shouldn't the organization get some return on that investment? What should that return be? How long should -- I mean, you really get into a lot of difficult issues. I think if we could avoid those, it would be good.
MS. HUMPHREYS: Yes, I think that if we are asking them to respond to all the comments, some of them related to, you know, the cost was a -- didn't sound like it was a major issue, if others were addressed, but I think there was some concern about licensing issues not being required of everybody but of some and whether -- and, obviously, in some cases it appeared to me as if there was some effort to outline intent or principles or something by which costs or licenses would be drafted so that people would not fear that there might be some down the road gotcha.
You know, often in the absence of information people will assume the worst. You know, maybe those are other issues that could be addressed.
DR. COHN: Yes, I actually had some other issues. I think we decided we weren't going to send a letter --
MS. GREENBERG: We are going to send a letter. We are writing it here.
DR. COHN: Okay.
MS. GREENBERG: It is being written as we speak.
DR. COHN: I actually -- this is just sort of a way to sort of move us through some of these issues -- one of my concerns and one of the things I wanted to look at in this particular set of testimony had to do with issues and barriers and things that will make it very difficult for people to implement the HIPAA standards or cause increased costs or difficulties.
I think we have heard a variety of things from a variety of testifiers, some of which had to do with standardized time frames, issues of redundancy, between code sets, et cetera, that rather provide necessarily the next steps, I think the first step is that we need to maybe ask Vivian or someone else to do some analysis of the various testimony and pull out those sorts of issues, which if were fixed would help with implementation of HIPAA, which is after all, to me, one of the opportunities from this conversation, to identify those things that can be done to help make this all work better for October 2003.
So, I guess I am hoping we can do that; that is, we can look at them and decide from that what we do around next steps with all of that.
Is that a reasonable action item?
DR. ZUBELDIA: One of the biggest issues that has come up today again is the version control issue and I think that pretty much everybody has had some problems with version control, except for the traditional CPT codes, but anywhere from the Category III codes of the CPT to HCPCS to CDT to everything has had version control issues. I think that needs to be addressed.
MS. HUMPHREYS: I think the version control issue that is of greatest -- it is also the update schedule, which I consider to be a different -- quite a different issue from version control is the update schedule.
DR. ZUBELDIA: It is all linked together.
DR. YASNOFF: Simon, I wonder if -- I think that is good and we need to do that, but I wonder based on kind of our incomplete discussion of these pharmacy transactions that were brought to our attention today, if we don't need to, again, schedule some time to deal with that sooner rather than later. It sounds like that is an issue that already has not perhaps been addressed in a timely fashion, not that these other issues are not important.
DR. COHN: No. I think we are just ticking off the issues and what we are going to do about them. You are bringing up another very good issue.
DR. ZUBELDIA: And linked to that is the choice of implementation guide. It is a big, big issue.
MS. HUMPHREYS: The other issue that it seems to me -- you are talking about the choice of implementation guide for the transactions, but we certainly heard from a number of different directions the notion of including a specific implementation guide for each code set as part of the standard, guidelines -- implementation guidelines, I guess, is a better way to do it.
DR. ZUBELDIA: One thing that we have seen clearly in looking at the implementation guides with a fine tooth comb is that there are actually subsets of the implementation guide. You are going to the 837 institutional guide and you have the home health subset of requirements. This is spread throughout the guide. Then you have the outpatient requirements, which are also spread throughout the guide and inpatient and they are different. So, you have -- you can take the guide and divide it up into subguides essentially for each type of bills, the UB92. You end up with a different set of implementation guide requirements now spread out throughout the entire guide and the same thing happens on the professional guide.
You have requirements for ambulance and DME and anesthesia that only apply to those specialties, but they are spread throughout the guide. That makes the guides very difficult to implement and there is no standard industry definition of those subsets.
So, you could end up sending a claim for what you think is the proper subset and the payer wants an element that is not in the subset of elements that you are going to send and the claim gets denied. It is a very interesting situation because there is no definition of those subsets.
DR. COHN: Is there a -- that you put out?
DR. ZUBELDIA: We are working with CMS to define those subsets for Medicare because Medicare already has very well-defined instructions. The rest of the industry doesn't have that kind of instructions. So, maybe the standard development organizations, like the NUBC, NUCC, which are data content organizations can define those subsets for the entire industry still using the same guides.
DR. COHN: Other issues on what we heard today?
MS. GREENBERG: There were a lot of issues raised by AHIMA, a lot of recommendations.
DR. COHN: I think for the first cut maybe -- and once again I am throwing out my good idea -- Kepa is chairing here -- I mean, my thought is that we need to pull out initially the ones that relate to things that we talked about today. It seems to me that that testimony applies to the next three hearings and that we should pull them out as we go for further hearings.
DR. YASNOFF: The testimony relating to having an agency responsible for code sets, it may be appropriate for us to bring that to the attention of the NHII work group because this is absolutely consistent with what they have just recommended in their final report, that there be actually a new agency created, responsible for implementation of national health information infrastructure within HHS. That is the recent final report that came out. You are looking at me --
DR. COHN: I am looking at you only because I haven't --
DR. YASNOFF: You haven't seen that.
DR. COHN: I am aware of that. I just hadn't thought of them as the same thing.
DR. YASNOFF: Well, this is -- I think this is something that -- that is why I think we should bring this to the attention of the NHII group. I don't recall -- I have read that report and I don't recall whether in the list of -- long list of responsibilities for this new agency that was proposed in that report, whether supervising the maintenance of code sets was part of that. I just don't remember.
MS. GREENBERG: I don't think so and I don't think it was necessarily a new agency that was even being proposed. It was some kind of office.
DR. YASNOFF: Yes, it was an office in HHS.
MS. GREENBERG: I know it came up about privacy and that privacy was, you know, under OCR and that basically, you know, there would have to be some kind of coordination. I assume that would be the case for any aspect of this. But I didn't really view it in this way.
DR. COHN: I guess my thought on this -- I don't think we ought to come out with a letter other than our short letter that Dr. Yasnoff is going to write or has written already, but I think that this is going to be something that as we begin to look at this over the next couple of sessions, that maybe we will remember that one and consider whether it should be in broader concepts. At least that is my thought anyway.
DR. MC DONALD: They had a whole bunch of suggestions and I think I agree that we shouldn't be deciding about those because some of them need to be exposed to the world and we heard some testimony today that sounded like they are terrified of -- they were afraid of changing code sets -- well, one said not for at least five years and some others -- you know, we have had so much trouble disengaging from one to another, I think that we have to be careful going forward. You know, you end up with both of them and you have got two things forever.
DR. ZUBELDIA: I think there is another issue that was presented by the AMA and I believe by NUBC also, where the AMA strongly encourages the subcommittee to recommend that the CPT guidelines and instructions for applying the codes be included as a national standard and I believe NUBC also recommended something equivalent, that the guidelines and instructions be part of the coding system, not just the codes.
[Multiple discussions.]
That is something we need to pick up on.
MS. GREENBERG: Betsy already brought that up.
DR. YASNOFF: The issue that the guidance needs to be standardized, as well as the code sets themselves.
Another issue that I heard that maybe it shouldn't be a concern is -- and I don't remember which testifier brought this up, but that as code sets change, it is necessary for both sides to support both sets simultaneously in order to file claims for services before the change with the old set and more current claims with the new set. That seems to me to be a big burden to have to support two sets at the same time.
I wonder if there isn't a way -- if that is not an issue we should talk about. That certainly doesn't seem like simplification to me. I don't know if there is any way around that.
DR. ZUBELDIA: From what I understand, the payers never retire code sets. The payers, once they put a code set in their system, it stays there. They never take it out.
MS. HUMPHREYS: There was a lot of discussion about that issue when we were working on the NPRM and there didn't seem to be another way except to say when you create the transaction, use the set that is valid at the time of the transaction because otherwise people would grandfather themselves in forever and they would never go to the new ones.
Then the other question is, well, you know, I mean, if we -- if I bill for a procedure in early December and we switch over in January, what I am going to do, be told in February that I have to resubmit it because, you know, they just finished adjudicating it and now they are going to pay it, but they don't like my code? I mean, there just didn't seem to be a way around it except what it says in the rule, which is you use the one that is there, but the rule also is implying that the payer has to be able to process any valid transaction. That is a valid transaction. The one they created in December with a December code is a valid transaction. The fact that he didn't get around to it until later, I mean --
DR. ZUBELDIA: And the problem actually becomes very acute when that transaction becomes a coordination of benefits transaction in January. The coordination of benefits transaction created in January has to have a December code that is no longer valid. The code intentionally is no longer valid in January. But you still have to have that code because it is coordination of benefits. I don't think there is a solution for that.
DR. YASNOFF: But the one thing you have clarified, I believe, is what I heard, I guess, was incorrect or I heard it wrong, was that you need to use the code set as of the date of the service, as opposed to the date when you create the transaction.
At least if you are using whatever is valid on the date when you create the transaction, those people creating those transactions only have to support one set of activity.
DR. ZUBELDIA: It is in the final rule and it depends on the code set. There are certain codes that are valid on the date you create a transaction and other codes have to be a date of service.
MR. ARGES: For inpatient purposes, it is the date of discharge, not necessarily the date the services are performed. So, in essence, the clinical code that you would assign to be as of the date of discharge, as that part, on an outpatient claim, it would be the date of service on that date of service. Just having rules around that, I think, would go a long way in terms of guiding people to how to apply the code sets. I do think there needs to be a transition period to define in terms of how that process will work, how far back do you go in terms of maintaining. There is a burden associated with that.
But I think just a one year period backwards is probably all that would be needed, in my opinion.
MS. GILBERTSON: You addressed part of it, Kepa, in that the final rule is a bit foggy when it talks about using the medical code sets at the time of service. It doesn't say but it implies that nonmedical code sets you should use at the time that you create the transaction. As you point out, there can be a tremendous delay between the two and it also becomes an issue for coordination of benefits. But this is the issue that then gets into all of the issues surrounding the maintenance of those nonmedical code sets because they are maintained both externally, as well as internally within X12 and specifically required within the guide, that you must use specific code sets.
The only way you can find out when those code sets are valid is to actually go out to the X12 web site, the wpc web site, and look to see when it is valid. Those code sets will be listed, based on whenever they were reviewed. So, you may have to go back and look at a series of minutes to determine when a code set is no longer active. That is going to cause a real problem when you get down into actually filing a claim or doing any of the transactions.
DR. MC DONALD: I just wonder if there is not a more rational way to transition code sets. One might be -- and I am just speculating -- is that you wouldn't transit to a new code set that couldn't be backward mapped. That is, that would be part of the job of new code sets.
Then you could even imagine a transition period where you found things -- there were some codes in the early code sets that were so bad, you would never want to backward map and then maybe in the preliminary year you would knock those out. You know, you would say these are no longer valid codes.
Somehow I think we put people into a bind because we have grand ideas and we build this wonderful thing and then we launch it on them and then we find out all of its issues and why we shouldn't insist on a backward transition on any code set migration. Going forward would not possible probably because you are going to have more in the forward one, in the new code set.
Then you could solve these problems of --
DR. FITZMAURICE: One of the things I heard early on today was that, praise the Lord, we are running out of numbers. I thought God gave us an infinite number of numbers, but we have had to go to 00 on the ICD-9 and eventually we have to transit into something else, whether we have to move to ICD-10-CM-PCS, that is something that has to be on our radar screen. It is not something maybe that needs to be addressed immediately, but it is something we have to get into. As we make the transition, we need the rules for the transition, as George said. We need to know where we want to go and then what will meet the needs when we get to the end of the transition.
DR. COHN: I guess I was hoping that we could begin to close the conversation so we can talk about PMRI. Jeff, you were raising your hand and wanted to comment.
MR. BLAIR: That is okay.
DR. COHN: Final comments on this issue. I mean, this is not the last time we are going to talk about code sets, as you all know. I guess one comment I want to make before Dr. Yasnoff comments is that I think it is going to be very important that we stay at the right level for our conversations. There is a great tendency to solve every small problem that comes forward to us. We are going to have to get very smart about how we delegate and get these things resolved.
Dr. Yasnoff.
DR. YASNOFF: I just had a quick question. We did have a scheduled testimony from the American Psychiatric Association and they obviously were not here. Are we going to --
DR. COHN: We actually deferred them to -- because they are primarily talking about diagnosis gaps in the current HIPAA standards.
DR. YASNOFF: So, we will hear from them.
DR. COHN: Yes, we will definitely hear from them.
MS. GREENBERG: Just for the record, they were actually here this morning and then we explained to them that they really were more appropriate for the diagnosis hearing. They were prepared to testify, but it was --
DR. FITZMAURICE: Might we hear from Donna on whether or not the DSM codes are incorporated into ICD-9 to have a paragraph or two in our notes that would dispel confusion? I get calls from mental health people saying HIPAA didn't cover the DSM codes. It is not in there. I called Donna and Donna says, yes, they are in ICD-9. They are incorporated.
MS. PICKETT: Well, there is a difference of opinion in terms of what is actually included in Chapter 5 of ICD-9-CM, which does cover mental health and other behavioral disorders and what is actually in the DSM manual. What is in the DSM manual includes code numbers, descripters and also criteria for actually identifying the condition that the patient has. Those descripters and such are not part of ICD-9-CM Chapter 5 and in some instances the code descripters in DSM are slightly different than the code descripters in ICD-9-CM.
According to the APA, technically they are not the same. However, what they have done over time is to take the codes in DSM and make them really kind of a mirror image with what is in ICD-9-CM Chapter 5. So, basically if you are assigning a code in DSM, that code number has a parallel in ICD-9-CM that is very similar. There are some differences, yes, but, again, the descripters and the criteria by which the mental health providers assign the DSM codes are not in ICD-9-CM. The concern that I believe the APA has is that the mental health providers have been assigning codes based on the DSM codes and their criteria.
There is concern that now that ICD-9-CM has been adopted as the official HIPAA standard, that they, in fact, can no longer use the DSM codes, which is the way that the adoption process came out, but I think they now have concerns that they would like to bring to the attention of the committee that they somehow would like to have that gap covered by possibly having the National Committee look at, also adopting the DSM codes as well.
DR. FITZMAURICE: Thank you, Donna. That is very helpful.
MR. BLAIR: We are going to be having some folks testify on those alternative billing codes. I guess it is in April. Is that right? Now, do we need to also -- because apparently there is a lot of different folks involved. There are a lot of different ways to address the needs for those codes and the folks that are testifying are going to only be providing a couple of solutions, whether CPT codes might be extended to cover that, ICD-9 codes to be covered to extend those or other parts of it. Will we have, you know, like all four of them here or at least representatives of it?
DR. COHN: I would anticipate that we would have a fair range of views on all the gaps and probably some spirited discussion. That would just be my expectation.
Kepa, do you have any thoughts on that?
DR. ZUBELDIA: About the discussion, yes.
DR. COHN: Other comments? I mean, we will talk a little more about the April hearings and all this tomorrow also. Do you have any final comments?
DR. ZUBELDIA: No. I think this is the end of what we have in the agenda for today and I think the rest of the time is something we could allocate to Jeff to discuss the PMRI.
DR. COHN: And actually I want to thank Kepa for leading this session.
DR. ZUBELDIA: I want to thank everybody for participating. It was fun.
DR. COHN: With that, I think we were asking Mike Fitzmaurice to lead us through the most recent revised version of the PMRI letter. I think he is turning his power point projector on.
DR. MC DONALD: Kepa, are you responsible for us having this in this nice hotel?
DR. ZUBELDIA: No.
DR. MC DONALD: I would like to thank --
DR. ZUBELDIA: Somebody was responsible for having both rooms at the HHS building occupied.
MR. BLAIR: Michael, as you take us through, there were -- let me explain for those folks that are sort of listening in so they will kind of understand what we are about to dive into real quickly here. Okay?
This is the seventh version of this recommendation letter on PMRI message format standards. Message format standards are not the only PMRI standards we will be looking at. It is just the first phase.
The process that we have gone through is we, number one, decide what we wanted to cover during the first phase. That was back about a year ago. We wound up then speaking to many of the SDOs to wind up looking at the criteria that we would use to make sure that we were having a meaningful questionnaire to the SDOs. That process went on in the second quarter of last year. We wound up looking at the results of those, feedback from the SDOs and then we wound up asking users and software vendors to critique their experience with the different standards and we have then gone through this last quarter of this process of working on and refining this letter.
The last piece of that is that in January we asked a number of outside folks to take a look at that letter and critique it as well and get back the feedback to us by January 24th and that is -- and that became this last version of this letter that includes the only updates that we got from outside, you know, commenters.
I understand that there may be a couple of folks in the room, who still may have some additional comments and at the appropriate time as we go through that letter, we will, you know, try to make sure you get an opportunity to make your comments.
The other piece is that some of -- I actually brought copies of all of the feedback that we got. I frankly did not include in the e-mail letter those that said, gee, that is great, it is wonderful. I tried to include those that were -- that didn't involve typos or didn't involve, you know, wording clarification. The wording clarifications are in the letter itself. The other types of issues or concerns are on a separate e-mail. Michael, as you go through, some of them you could kind of directly relate to the sections as we hit them. Maybe we could hit them that way.
Then there is a couple that we may need to save to the end in terms of issues that are very generic.
DR. FITZMAURICE: I am going to go through the letter. I will read it and point out some changes that Simon and I discussed I think it was during the noon hour. Then we can cover the specific comments given from the outside private people.
Is that satisfactory, Jeff?
MR. BLAIR: Sure.
DR. FITZMAURICE: Okay. Good.
"Dear Secretary Thompson: As part of its responsibilities under the Health Insurance Portability and Accountability Act of 1996, HIPAA, the National Committee on Vital and Health Statistics, NCVHS, was called upon to study the issues related to the adoption of uniform data standards for patient medical record information, PMRI, and the electronic exchange of such information.
"The NCVHS presented this report to the HHS Data Council on August the 9th, 2000, and it is attached. This report provided a framework to accelerate the development of PMRI standards and a set of guiding principles for the selection of specific PMRI standards. The report also recommended that the NCVHS use the guiding principles for selecting PMRI standards and send the first set of PMRI standards and recommendations to the Secretary of HHS by February 2002. This letter sets forth recommendations for the first set of PMRI standards. This first set of standards, are generally referred to as PMRI message format standards."
I would suggest changing that last sentence to --
I wasn't moving the screen down exactly as I was reading it. You can see this letter sends forth recommendations. I would change that to this first set of standards refers to PMRI message formats, that last sentence. That way it gets -- it avoids the set of standards and then the standards at the end of the sentence.
DR. MC DONALD: I think it -- deals with only or something to --
MR. BLAIR: Is limited to.
DR. MC DONALD: Is limited to recommendations about is I think what I would say.
DR. FITZMAURICE: The first set of standards --
DR. MC DONALD: This recommendation is limited
to --
DR. ZUBELDIA: In the previous sentence, right?
MS. GREENBERG: Yes, this first set of recommendations is limited to PMRI message format standards.
DR. FITZMAURICE: This first set of recommendations is limited to PMRI message format standards. Good.
Any other questions, comments about the first paragraph?
DR. YASNOFF: The sentence that says, "The report also recommended that the NCVHS use the guiding principles," I don't think that is really very clear as to where those guiding -- those guiding principles are in the report. Here is what I suggest. The report also recommended guiding principles for NCVHS to use in selecting PMRI standards and that the first set of PMRI standards recommendations be sent to the Secretary of HHS by February 2002.
Does that sound good?
DR. MC DONALD: That sounds great.
DR. YASNOFF: Do you want me to read it or I can give you this?
DR. FITZMAURICE: The report also recommended --
DR. YASNOFF: Recommended guiding principles.
MS. GREENBERG: It says that in the previous paragraph -- sentence, I mean.
MS. HUMPHREYS: So you don't need the sentence at all.
DR. YASNOFF: Right. So, you can get rid of that. It is repetitive. I didn't notice that.
MR. BLAIR: Well, one of the things that is there and since I can't see it and since I wrote it two weeks ago, my memory has faded here -- one of the points I want to make sure that we don't lose is there were concerns by some that it wasn't entirely clear that this was the first set and that the first set is limited to message format standards. So, the changes that we made there was to remove that ambiguity and make it crystal clear. This is the first --
DR. YASNOFF: We did that, but actually since it says guiding principles in the previous sentence, if you want to emphasize that we use those, you could say the report also recommended that the NCVHS used those guiding principles for selecting. So that it is -- or otherwise you could get rid of it.
DR. COHN: I think get rid of the whole sentence.
DR. YASNOFF: Yes, but that is just saying we met our own deadline. So what.
DR. FITZMAURICE: It is congratulating us.
DR. YASNOFF: If you got rid of that sentence, it would read, "The report provided a framework to accelerate the development of PMRI standards and a set of guiding principles for the selection of specific PMRI standards. This letter sets forth recommendations for the first set of PMRI standards."
MR. BLAIR: Can we go that -- this set is limited to the first set.
DR. COHN: That is the next sentence.
MR. BLAIR: Oh, I am sorry.
DR. YASNOFF: The first set of recommendations is limited to PMRI message format standards.
MR. BLAIR: Okay. Good. Thank you.
MS. GREENBERG: Well, you could really make that one -- the letter sets forth recommendations for the first set of PMRI standards, which are limited to --
MR. BLAIR: There you go.
DR. FITZMAURICE: Any other suggestions on the first paragraph? Let's move to the second paragraph.
"Standards for PMRI are important because they will facilitate significant improvements in the quality of patient care, promote patient safety, control rising health care costs, enhance the productivity of clinical research and strengthen the nation's ability to identify and respond to national health care emergencies. They are critical to the creation of a national health information infrastructure."
DR. YASNOFF: Could we consider deleting "national health care emergencies"? I don't see that that is necessary, just health care emergencies in general.
MR. BLAIR: We really wanted to tie it to national.
DR. YASNOFF: Well, it does in the next sentence, ties it to that.
MR. BLAIR: Yes, but I think we want that link in both.
DR. YASNOFF: You know, it doesn't help us identify and respond to local health care emergencies? That is what you are saying.
MS. HUMPHREYS: We have already got the nation's ability to respond, to identify and respond.
DR. YASNOFF: Right. It says strengthens the nation's ability to identify and respond to health care emergencies. I think that is -- national is redundant.
MR. BLAIR: Gotcha.
DR. FITZMAURICE: Any other suggestions?
Next paragraph. "In the process to select patient medical record information message format standards, the NCVHS used the following process for the selection of PMRI message format standards to obtain industry input from standards developing organizations, health care information system vendors, health care organizations and the professional societies and other users of these standards. First, the committee adopted the PMRI guiding principles to make them more appropriate..." -- adapted -- "... first, the committee adapted the PMRI guiding principles to make them more appropriate for the selection of message format standards.
"Next, the committee incorporated the revised guiding principles into a questionnaire that was designed to help NCVHS evaluate the PMRI standards candidates..." -- probably apostrophe after "standards" --
PARTICIPANT: No, probably not.
DR. FITZMAURICE: "...in an objective manner. Finally, the committee compiled, analyzed and reviewed the SDOs responses to the PMRI questionnaire. Additional information..." -- we might as well go back to SDO, standard developing organizations here and put in SDO -- "...additional information and perspective about the candidate PMRI standards was obtained via direct testimony from health information system vendors and other users of these standards. This process continued from December 2000 through February 2002."
Any other changes to this paragraph? Okay.
"Guiding principles used as criteria for selection: NCVHS recommendations for PMRI message format standards are selected from the six SDOs that responded to the PMRI questionnaire, ASTM, DICOM, HL7, IEEE, NCPDP and Object Management Group, Health Care Domain Task Force. The committee emphasized the following four criteria..." -- "The committee emphasized the following four criteria derived from the PMRI guiding principles; the degree of market acceptance of the standard, the extent to which the standard enables interoperability between information systems, the ability of the standard to facilitate the comparability of data and the aspects of the standard that support data quality, accountability and integrity. The criterion of market acceptance is helpful because it identifies those PMRI message format standards that are implementable, cost justified and flexible enough to meet the needs of most of the relevant marketplace."
Moving on, the next paragraph is headed "Recognition of Current Standards and Incentives for Emerging Standards."
MR. BLAIR: Did you finish?
DR. FITZMAURICE: Yes, I finished --
MR. BLAIR: We have the explanation for market acceptance. Did we not have an explanation for interoperability?
DR. FITZMAURICE: No, just market acceptance.
Recognition of current standards and incentives for emerging standards: The NCVHS has recognized the important role played by the PMRI standards, currently used by the health care industry. Since it has taken years for several of today's standards to achieve broad market acceptance, they are based on older conceptual models. These models do not uniformly provide the high degree of interoperability -- those models -- those older conceptual models do not uniformly provide for the high degree of interoperability and data comparability that is necessary to support significant improvements in health care cost, quality and productivity. To promote more rapid realization of these benefits in accordance with prior recommendations in the PMRI report, NCVHS is recommending that HHS recognize current standards, as well as provide specific incentives to accelerate the development and early adoption of emerging PMRI standards.
Questions, suggestions?
DR. COHN: Rapid realization of these benefits in accordance with prior recommendations in the PMRI.
MS. HUMPHREYS: Why don't you just say to promote more rapid realization of these benefits?
MS. GREENBERG: I don't think you need that.
MS. HUMPHREYS: I don't think you need in accordance with prior recommendations.
MR. BLAIR: Here is my thinking on why that was there, because those were the benefits that we articulated in our PMRI report from July and October 2000 and that is what essentially was our foundation for our criteria for interoperability and data comparability. Maybe if they were in parentheses, if you don't want to have them as a full sentence?
MS. HUMPHREYS: I am just wondering whether this reference to the PMRI report may belong in the previous sentence. Those models do not uniformly provide the high degree of interoperability and data that is necessary to support significant -- and then you could say something, as documented in the PMRI or -- something. And then say to promote more -- I don't know.
MR. BLAIR: That is good. I agree.
MS. HUMPHREYS: It just looks very awkward in the second sentence.
MR. BLAIR: I agree. I think you made an improvement.
DR. YASNOFF: You want to say support significant improvements in health care costs -- as recommended in the PMRI report. Is that what you had in mind?
MR. BLAIR: We should maybe say PMRI report of -- reference August 2000.
DR. COHN: I don't think that this adds anything.
MS. GREENBERG: I don't know that it does.
DR. COHN: I think the sentence sort of stands
on --
DR. FITZMAURICE: We did refer to the report in the first paragraph.
DR. YASNOFF: I guess what I am hearing Jeff say is that in this next sentence that says to promote more rapid realization of these benefits. Jeff is wanting to say that is what we recommended in the PMRI report that HHS do something to report more rapid realization of these benefits. Now, to implement that, we are now recognizing or recommending that HHS do this, tying it back to our recommendation because otherwise the question might come up, well, why are we in such a hurry to realize these benefits? Well, it is because we already recommended that or is this a new finding?
Is that essentially where you are at, Jeff?
MR. BLAIR: That is true. The other aspect is that I feel our strategy in this letter is twofold, at least twofold, okay? One is we articulated that in the market acceptance piece as a criteria. The market acceptance piece is there and we wound up making -- giving recognition to current standards and we did that because we could cause tremendous disruption in the industry if we don't do that.
On the other hand, the PMRI report didn't really address that. What it addressed was how do you improve interoperability and data comparability and the way we did that with this recommendation is to go to the emerging standards and say we need the incentives, which by the way we referenced in the report from a year ago to improve the interoperability and data comparability.
So, it is a two phase strategy.
DR. COHN: As recommended in the first PMRI report.
MS. HUMPHREYS: No, that doesn't quite go now. Leave it the way it is.
DR. FITZMAURICE: Those models do not uniformly provide the -- interoperability as recommended?
DR. MC DONALD: Do we really need all that, though? Can't we just sort of get to the point -- according to our prior thinking, we are doing this or something --
MS. NARCISI: [Comment off microphone.]
MS. HUMPHREYS: Okay. Get rid of this other -- leave it the way it is.
DR. FITZMAURICE: You mean originally?
MS. HUMPHREYS: Yes.
MR. BLAIR: Jean, I think we are going to get to that again when we get down to the emerging standards and we indicate what incentives -- we are going to hit that point again. So, we won't lose it.
MS. HUMPHREYS: At the risk of saying this because you don't want anymore to be said, but can you go back down there again, to where we were? It really seems to me that you should reverse the second part of the sentence when you say to promote more rapid realization of these benefits. These are the benefits of interoperability. NCVHS is recommending that HHS provides specific incentives to accelerate the development and early adoption of emerging PMRI standards as well as recognize current standards because the previous part goes with the emerging. It doesn't go with the current.
DR. FITZMAURICE: All right. So, tell me, again, what we --
MS. HUMPHREYS: Basically, you are going to say that HHS provide specific incentives to accelerate the development and early adoption of emerging PMRI standards as well as recognize current standards.
Now you have to say PMRI standards as well as recognize current standards. And now get the "as well" off the end of the sentence and we are there.
MR. BLAIR: Let me go back to what I thought I heard you say precisely, I am not sure -- that NCVHS recommends that HHS provide specific --
DR. FITZMAURICE: Let me read that to you, Jeff. To promote more rapid realization of these benefits in accordance with the prior recommendations in the PMRI report, NCVHS is recommending that HHS provide specific incentives to accelerate the development and early adoption of emerging PMRI standards, as well as recognize current standards.
MS. GREENBERG: With the following caveat that I don't necessarily support wordsmithing a document as a committee. However, since we are doing it, one of my pet peeves and I would change it when I got it to finalize it, but "since" is not the word you want there. It is "because." "Since" is temporal. That should be because it has taken years. Thank you.
MR. AUGUSTINE: Would it sound better if you -- based on older models period and just say based on older, conceptual models, which do not --
DR. MC DONALD: We might think about doing this, going through and seeing what the factual points are and letting -- and do some further editing. Everyone thinks it is fine except --
DR. FITZMAURICE: Move on to the next paragraph?
Recommendations: Encourage HHS guidance and incentives rather than mandates is the heading. The NCVHS recommends for PMRI message format standards -- the NCVHS recommendations for PMRI message format standards advise that HHS set forth guidance for industry use and migration to new versions, rather than the creation of NPRMs and the federal regulations.
NCVHS also recommends that the Secretary direct government health institutions and other organizations to follow this guidance by becoming early adopters of emerging PMRI standards; thereby, serving as an example and as an incentive to the industry.
MS. GREENBERG: Who are the other organizations? Are they also federal?
DR. FITZMAURICE: That is a good question.
MS. GREENBERG: Because otherwise you are contradicting yourself and saying we don't want to mandate this but then direct other organizations.
DR. FITZMAURICE: HHS departments and agencies.
DR. YASNOFF: You have government health care institutions. If you said "and other agencies," I think it would be clear you mean government. So then you are saying government health care institutions and other agencies or maybe it would be better to say government agencies and -- no, I think if you switched it around, it would be bad.
DR. MC DONALD: You are really talking about the health related to health of government agencies.
MS. HUMPHREYS: But you are also talking about the federal. Some people would argue that the DOD is not a health-related institution and you might want them to implement it anyway.
DR. YASNOFF: Could you get rid of health care institution and just say the Secretary direct government agencies to follow this guidance and leave it at that?
MS. HUMPHREYS: Good idea. Love it.
DR. YASNOFF: I mean, it is a little presumptuous because the Secretary doesn't really have the power to direct all government agencies but we can recommend it anyway.
DR. FITZMAURICE: I will change the creation of to create new.
MR. BLAIR: If we are going to make it that broad, could we make it an appropriate government agency.
DR. MC DONALD: What we are really saying is hospitals and those that are dealing with health care data, FDA, government agencies --
DR. YASNOFF: I think that appropriate leaves it open to the Secretary to decide which ones are appropriate and I think everyone should follow the guidance. If it is inappropriate, there is nothing for them to do.
DR. FITZMAURICE: I have suggested another change. It read rather than the creation of NPRMs and federal regulations, I wanted to make it active, like create, because we are saying that recommendations advise rather than create. Do we need NPRMs or should we just go to federal regulations?
DR. COHN: Federal regulations.
DR. MC DONALD: We have an extra clause in the middle of the first three lines and I think that doesn't make sense and isn't necessary. I think you can leave out that HHS set forth guidance. There is an extra like loop in there. We recommend that they advise that somehow sets forth guidance.
DR. YASNOFF: Do you want to say the NCVHS recommends that HHS set forth guidance? Okay. Then you would make R lower case. So now it says the NCVHS recommends that HHS set forth guidance for industry use and migration to new versions, rather than create new federal regulations.
DR. FITZMAURICE: New versions of PMRI message format standards?
MR. BLAIR: No.
MS. GREENBERG: Yes, I think in this new paragraph you need that message format standard or new versions of what.
MR. BLAIR: Okay. Maybe so. Yes, because that is what the whole letter is about.
DR. YASNOFF: You put that after new versions. So, now it says the NCVHS recommends -- got to get rid of "advise" -- recommends that HHS set forth for industry use and migration to new versions of PMRI message format standards, rather than create new federal regulations.
DR. FITZMAURICE: That is good.
MR. BLAIR: The only thing is that you say to new -- the guidance is more than just the new. It is also the parent.
MS. HUMPHREYS: Why don't you just say industry use and migration.
DR. YASNOFF: You could put the of PMRI message format standards after "use." So, then that would take care of that problem. So, we just move that clause "of PMRI message format standards."
MS. HUMPHREYS: Don't move the clause. Just x out "and migration to new versions." Is that what you meant?
DR. YASNOFF: No. What we were suggesting is HHS set forth guidance for industry use of PMRI message format standards and migration to new versions.
MS. HUMPHREYS: Good idea.
DR. YASNOFF: Rather than create new federal regulations, which no one wants.
DR. FITZMAURICE: NCVHS recommends that HHS set forth guidance for industry use of PMRI message format standards and migration to new versions, rather than create new federal regulations.
Next paragraph, NCVHS recommendations for a specific PMRI message format standards, NCVHS recommends that HL7 be recognized as the fourth PMRI standard and that DICOM, NCPDP, Script and IEEE 1073 be recognized as standards for specific PMRI market segments. Recommendations for all of these PMRI standards are set forth in a framework identifying which version of the standard should be considered as retired, current or emerging. I deleted an extra space after 4.
MS. HUMPHREYS: I love this notion about recognizing retirement. These things have never been recognized and yet you recognize them.
DR. ZUBELDIA: You have Script. For IEEE you have a number. For DICOM, it is just DICOM.
MR. BLAIR: Yes. I kind of went through that with Todd Cooper and he said just stick with DICOM because the way they -- they don't seem to have versions --
DR. MC DONALD: One of the problems is they have got like 40 books.
DR. ZUBELDIA: Every year is a new book.
DR. MC DONALD: There are a lot of little books. They are all chapters.
MR. BLAIR: They couldn't find a concise of representing that.
DR. MC DONALD: One of the problems, though, is it might imply we are supporting some of the work -- I guess we can explain it later on, though.
DR. YASNOFF: Yes, it will be clearer when we get to the --
DR. FITZMAURICE: -- PMRI message format standards --
MR. BLAIR: On the next page, we are going to go into those and define them more precisely.
DR. FITZMAURICE: So, we are having core PMRI message format standards. We will have retired, current and emerging standards. The first paragraph is head "Retired Standards." The NCVHS recommends that HHS recognized the following PMRI message format standard as retired, HL7 Version 2.1.
DR. YASNOFF: We don't want to recognize any earlier ones as retired. They are off the map. They are gone.
DR. FITZMAURICE: Moving on with the paragraph, HHS guidance to the industry, no new products using this version of the HL7 standards should be purchased or developed. Vendors and users should plan to upgrade any system using HL7 Version 2.1 to a current version of HL7. I think we can get rid of "HHS guidance," because this is really NCVHS guidance.
DR. YASNOFF: It is HHS guidance.
DR. COHN: It has got to be recommended HHS guidance.
DR. FITZMAURICE: So, we are recommending that HHS give --
DR. COHN: I guess the question is is HHS going to respond in any way to this or is this going to be a letter we send to them and --
DR. MC DONALD: We are giving them an alert.
DR. COHN: Well, I mean, the question is is it -- I mean, we are able to apply guidance to the industry.
DR. MC DONALD: But we specifically said we are asking them to give guidance. So why not stay with that. Why waffle?
DR. COHN: So, it is recommended HHS guidance to the industry, which I think is weaker than just provide guidance to the industry.
MS. GREENBERG: Well, you do advise the Department. I mean, your recommendations often do provide broader guidance, but you advise the Department.
DR. YASNOFF: Wait a minute. Maybe we don't want to say to the industry. How about just saying guidance because we did say we wanted the Secretary to direct government agencies to follow this guidance?
MR. BLAIR: Now the thing on this is that if we just say HHS guidance, they may interpret it as internal. What we want this to be is the guidance that HHS gives to the industry.
MS. GREENBERG: I think you need to be explicit then instead of just -- we recommend that HHS provides the following guidance --
DR. YASNOFF: How about guidance to all standards users or something like -- you know, that is more encompassing.
DR. MC DONALD: Or health care information -- what is wrong with industry, health industry? Is that not understood?
DR. YASNOFF: Because that doesn't include those government agencies that you want the Secretary to direct to follow this guidance. Industry means the private sector.
MS. GREENBERG: No, not necessarily.
DR. ZUBELDIA: Provide the following guidance.
MS. GREENBERG: I think Medicare is part of the health care industry.
DR. YASNOFF: How about if we said HHS guidance to government and industry?
DR. ZUBELDIA: Why don't we just say HHS to provide the following guidance?
MS. GREENBERG: -- to whom it is.
DR. ZUBELDIA: We have already said to whom the guidance should be directed to.
MS. GREENBERG: -- users should specify that no new products --
MS. HUMPHREYS: HHS should provide guidance to the government, you know, whatever.
MS. GREENBERG: I think you need a verb.
DR. FITZMAURICE: HHS guidance to the government and industry users should specify that no new products using this version of the HL7 standard should be purchased or developed. Vendors and users should plan to upgrade any system using HL7 Version 2.1 to a current version of HL7. We will need to parallel that down below.
MR. BLAIR: Do you think we should say to a current or emerging version?
DR. FITZMAURICE: No.
DR. YASNOFF: No, because you can't -- that is why we made it emerging because you can't really do it.
DR. FITZMAURICE: That is retired standards, now current standards. The NCVHS recommends that HHS recognize the following HL7 versions and transaction sets as the current PMRI message format standard. HL7 Versions 2.2, 2.3, 2.4 and later 2.X, maybe future versions?
MR. BLAIR: We have to say 2X because it is not going to be 3.
DR. FITZMAURICE: This includes standards for the following transaction sets: order entry, scheduling, medical records/image management, patient administration, observation reporting, financial, management, patient care.
MR. BLAIR: Financial and management should be on one line?
MS. GREENBERG: It would be.
MS. HUMPHREYS: So you will fix this to parallel the other one so we can go on.
DR. FITZMAURICE: HHS recognition of HL versions 2.2, 2.3, 2.4 and later 2.X as current standards means that vendors and users of these versions will not be asked to migrate to newer versions until the more advanced version is fully implementable with the supporting implementation guides and conformance tests. I will parallel that.
Emerging standards: The NCVHS recommends that HHS recognize the following PMRI message format standard as an emerging standard based on its potential to provide superior levels of interoperability and data comparability. HL7 Version 3 --
DR. YASNOFF: To be consistent, you need to spell out HL7. You need to say Health Level 7.
MS. GREENBERG: Not now.
DR. YASNOFF: Not now, but later.
DR. FITZMAURICE: This includes standards for the following transaction set, Version 3, administrative management; Version 3, health and clinical management; Version 3, infrastructure management.
Core PMRI message format standards, emerging standards continued.
MS. GREENBERG: What is this continued doing here? It is in the middle of the page now.
DR. FITZMAURICE: That was at the top of the next page.
Recommendation to HHS: NCVHS recommends that HHS provide incentives to accelerate the development and early adoption of the HL7 Version 3 standards. These incentives include the funding of publication of Version 3 implementation guides and the development of conformance tests and the early adoption of Version 3 standards by departments and agencies within HHS.
MR. BLAIR: Bill, did you want to modify in the departments within HHS?
DR. YASNOFF: Well, I wonder if you want to limit that to HHS because up above we are saying the whole government. So, why don't you just say here the whole government.
MR. BLAIR: Could we use the same wording that you crafted above?
DR. YASNOFF: Government agencies is what we said.
Version 3 standards by government agencies, the last part of that paragraph.
DR. FITZMAURICE: After the implementation guides and conformance -- the early adoption of HL7 Version 3 proves to be successful. Additional HHS guidance to the industry will be forthcoming from NCVHS.
DR. YASNOFF: We are going to give them more guidance.
DR. FITZMAURICE: Next bullet. Market segment PMRI message format standards, current standards. The NCVHS recommends that HHS recognize the following as current PMRI message segment --
DR. YASNOFF: Market segment.
DR. FITZMAURICE: Market segment message format standards, based on their market acceptance, ability to address specific market segment needs and of their cost effectiveness. Two bullets. The first one is digital imaging and communications and medicine (DICOM). Let's get rid of that. Supports retrieval of information from imaging devices/equipment to diagnostic and review work stations and to short term and long term storage systems.
DR. YASNOFF: To be consistent, you should say the standards support. That is what you said in the other one.
DR. FITZMAURICE: Next bullet, NCPDP Script standard. This standard communicates prescription information between prescribers and pharmacies. These transactions include new prescriptions, prescription refill requests, prescription fill status notifications and cancellation notifications. The HHS guidance to the industry --
DR. YASNOFF: We are going to change --
DR. FITZMAURICE: -- new users should adopt the latest versions of the DICOM and NCPDP Script PMRI market segment standards whenever possible.
DR. YASNOFF: That gets to the DICOM version issue.
MR. BLAIR: I didn't understand what you --
DR. YASNOFF: There was a point brought up earlier about the DICOM has 40 versions and we are saying you should always use the latest one.
DR. MC DONALD: Could you go up one level up above -- could you go back half a screen? I had suggested putting imaging information -- we don't want to restrict it to just images.
DR. YASNOFF: It says information from imaging devices and equipment. Doesn't that -- that is pretty comprehensive. It is not restricted to just images. It is information from imaging --
DR. MC DONALD: What I would like to restrict it to image as stuff not lab results that would indicate you shouldn't get a shot for radiology and it was an imaging system.
DR. YASNOFF: Doesn't imaging devices and equipment satisfy your concern? From imaging devices and equipment to diagnostic and review work stations. That seems like it is imaging stuff to me. Okay?
DR. MC DONALD: Okay.
DR. FITZMAURICE: Emerging standards. The NCVHS recommends that HHS recognize the following as an emerging PMRI market segment message format standard based on its potential for vendor acceptance and its anticipated ability to address specific market segment needs.
One bullet, IEEE 1073 (1.11). It should be 1.1.1, 1.2.1, 1.3, 2.1.1, 3.2. A set of medical device communications standards also known as ISO 11073 standards.
DR. YASNOFF: These standards communicate or you could say this standard if you want to make it one. These standards communicate patient data from medical devices typically found in acute and chronic care environments (e.g., patient monitors, ventilators, infusion pumps, et cetera).
MS. HUMPHREYS: You lost the e and the s. You only wanted to lose the s.
DR. FITZMAURICE: HHS guidance to the industry. We will change it. The user should consider becoming early adopters of the IEEE 1073 medical device communication standard.
MR. BLAIR: I am sorry. Is Jean Narcisi still here?
MS. GREENBERG: No, she just left.
MR. BLAIR: Because I forgot to capture her point when we got to the emerging standards, but -- I will have to apologize to her.
DR. COHN: I guess the question also here before we move on to the next is at least there was one comment that maybe we ought to -- this is the only one where we don't have any recommendations to HHS on what they ought to do.
DR. FITZMAURICE: For supporting, like we did --
DR. COHN: There is HHS guidance to the industry, but there is nothing we want HHS to --
MR. BLAIR: That is going to come up as one of the issues, too.
DR. COHN: I thought that is what we were dealing with. If we are not dealing with that right now, we are in big trouble.
MR. BLAIR: What Jean was saying was why don't we provide incentives to help the users defray their costs and my response to Jean was that the incentives that we are recommending that HHS put forth are those that we have already articulated in the report last year and which HHS indicated they agreed with, the PMRI report from last year. So, we felt as if we had at least a reasonable opportunity that HHS would respond favorably to the four incentives that we had listed, the four of them being funding for the publication of implementation guide, the second one being funding to support conformance tests, the third one being help with government licensure of --
DR. FITZMAURICE: Early adoption?
MR. BLAIR: -- and the fourth one being early adoption.
DR. YASNOFF: One thing you could do, Jeff, in that because it says the incentives should include, you could say include but not necessarily be limited to, if you want to, you know, kind of give HHS the idea that there might be other things they might do.
MR. BLAIR: Now on this one --
DR. YASNOFF: It sounds kind of legalistic, but --
MR. BLAIR: On IEEE with the -- you know, as an emerging standard, my thinking on this was that there seemed to be concern by many members of the committee with respect to how solid this was. So, if you notice the --
DR. YASNOFF: Not necessarily.
MR. BLAIR: -- if you notice the HHS guidance that we have there, it is saying that folks should consider becoming early adopters. Is that there?
DR. YASNOFF: Yes.
MR. BLAIR: I didn't put in anything in terms of asking for HHS incentives because it didn't seem to me as if it was the will of the subcommittee for that, but should we put that in?
DR. YASNOFF: One thing you could put in is HHS should encourage government agencies to pilot the use of this standard where appropriate.
DR. MC DONALD: We went further than that, I thought. We were saying they should use it.
DR. YASNOFF: You could say HHS should encourage government agencies to pilot the use of this standard where appropriate. That is not very strong but --
DR. COHN: We actually have a note from Todd Cooper talking about the need for I guess it is profile specification and conformance testing.
DR. MC DONALD: I think he wanted the same list that the other ones had.
MR. BLAIR: No, he was more narrow and I think that is what Simon is reading in the cover letter.
DR. MC DONALD: Also they wanted incentives because they wanted support.
DR. COHN: Some additional funding could be used to create tools for supporting profile specification and conformance testing, as well as integration.
DR. YASNOFF: I thought that our concern about this one was we didn't really understand the issues related to market acceptance of this one. So, we were a little bit reluctant to recommend incentives at this point that are very strong. But I think this is so mild -- I mean, we can make stronger recommendations later, but given that it is not really out there, do you really want to pay for conformance testing and so on and so forth for something that is not really there yet?
DR. MC DONALD: The real problem we get into is --
DR. YASNOFF: I am a little reluctant.
MS. GREENBERG: Can I just interject here that it is now 5:15 and we really need to end at 5:30.
DR. FITZMAURICE: -- should consider becoming early adopters of the IEEE 1073 medical development communications standards. HHS should encourage government agencies to pilot the use of this standard where appropriate.
MS. GREENBERG: That sounds fine.
DR. FITZMAURICE: Next paragraph -- among PMRI message format standards, the NCVHS recommends that HHS encourage the PMRI SDOs to share their data elements and data definitions with the U.S. health information knowledge base (meta-data registry). Additionally, HHS should encourage the PMRI SDOs to continue their collaboration to reduce or eliminate duplicate or inconsistent data elements, especially those for patient information.
Furthermore, HHS should encourage the PMRI SDOs to harmonize their data elements and data definitions for future versions so that they are consistent with the HL7 reference information model (RIM).
MR. BLAIR: Lynne Gilbertson had a comment on this.
DR. COHN: She said she didn't know what a PMRI SDO was. Actually, more specifically, she didn't know whether she was a PMRI SDO or not. Isn't that what you said?
MS. GILBERTSON: No, that wasn't me.
DR. COHN: You basically said you wondered USHIC(?) -- harmonize data elements and data definition for the HL7 really seems to contradict the first two sentences. Show data elements and data definitions, USHIC, to reduce or eliminate -- eliminate duplicate or inconsistent data elements.
DR. YASNOFF: What is the contradiction there?
MS. GILBERTSON: The point is if HL7, NCPDP, X12 and the other organizations are all harmonizing within USHIC, how can we harmonize HL7 when they are one of the participants?
DR. MC DONALD: USHIC, you just put them all in a big pot.
DR. YASNOFF: You are just recording whatever the staff --
MS. GILBERTSON: But there is an intent to harmonize --
MR. BLAIR: I think the reason we put both in there is that we think that both are needed. The meta-data registry, which is USHIC, is at least letting the SDOs and vendors be able to compare data definitions that they might have when they are using different standards. That is a help. But the RIM is basically winding up saying if we have use cases where we are developing semantics, as well -- semantics that can be consistent -- so, what we are trying to encourage is that all of the PMRI SDOs begin to focus on some single reference information model, which is -- at this time, HL7 is the only one that has created a reference information model. So, that is probably the one we should link to in terms of common semantics that are based on use cases.
DR. FITZMAURICE: Let me move on to the next paragraph. That sounds straightforward, Jeff. Good.
PMRI standards for future consideration -- NCVHS also recommends that HHS provide funding to support these PMRI SDO collaborative efforts toward harmonization.
Next sentence, paragraph, the NCVHS has limited these PMRI specific recommendations to message format standards. The committee plans to further investigate medical terminologies and code sets in 2002 and will be forwarding recommendations to you. The committee will also consider PMRI standards for clinical documents and the content and structure of medical records -- patient records.
DR. COHN: I would like to have the 2002 deleted from that paragraph. I think that that -- even though we are investigating code sets, that leads one to expect that we will send out something later on this year. I don't want to create that --
DR. FITZMAURICE: -- artificial pressure on it.
MR. BLAIR: Helene, are you here?
MS. GILFOY: Yes.
MR. BLAIR: You had some comments about this paragraph.
MS. GILFOY: I went back and looked at my notes from previous meetings and one of the issues here is plans to further investigate medical terminologies in code sets. Then sort of as an after thought, the committee will also consider PMRI standards for clinical documents and content and structure.
My point has always been that the content of the patient medical record needs to be defined and I would suggest that you put that as a priority, certainly before terminologies and code sets, the reason being you are defining how you are going to say something without defining what you are going to say. That is always tricky because I could speak French but not know what I was talking about.
DR. COHN: Should we put them on equal footing and say as well as --
DR. MC DONALD: -- for the following is that is content is a much tougher issue. I mean, to say what I should write and do we even have any foggy idea how to define that. We don't yet have the vocabulary to say what we are talking about. That is prescriptive. So, if you are saying we are going to say you have to say these 12 sentences and -- we are talking about the organization of the chart.
MS. GILFOY: No, I don't think you need to say you are going to say these 12 sentences. I think what you need to define is basically what you have got there, content of the patient record. You need to give direction to -- I just jotted down a couple of notes. You need to assist the developers in developing clinical information systems. You need to assist providers in determining and prioritizing what they put in an electronic format. You need to assist patients as they review and understand their records so that their privacy can be protected.
When you are trying to define -- it appears to me that to define the content of something after you define what you are saying becomes sort of putting the cart before the horse. I am going to tell you what I am going to say, but then I am going to tell you -- I am going to tell you how I am going --
DR. MC DONALD: Give us an example.
MS. GILFOY: Discharge records.
DR. MC DONALD: What do you mean by that?
MS. GILFOY: What should be in a discharge record. If I look at each of the -- I am looking at the time, Marjorie -- if I look at niche providers, everyone of the providers and I have been doing this for probably as long as you have, Clem, if you look at each one --
DR. MC DONALD: You are much younger than I am.
MS. GILFOY: Oh, thank you.
If you look at each one of the providers, everybody has a different idea of what is important in a medical record. A cardiologist thinks --
DR. COHN: Helene, I don't mean to short circuit you but this is a long conversation the two of your ought to have -- we will come back to a consensus, but I am suggesting given that we have three minutes to handle things and this is for the subcommittee to consider is whether or not we say we will further investigate medical terminologies and code sets, as well as PMRI standards for clinical documents and the content and structure of the patient records and then we will forward recommendations.
DR. FITZMAURICE: That sounds good.
DR. COHN: We will leave it at that. That puts it on equal footing.
DR. MC DONALD: The codes are hot and ripe and --
DR. COHN: We know what we have got for the next three to six months. I am not arguing with you, but I think it is just basically rather than saying also we are basically saying that we are going to do these things. Is that okay with everyone?
DR. YASNOFF: I don't think it makes any difference.
MR. BLAIR: Could I suggest one thing because we are just about through with the letter, but there are a number of issues that we didn't -- will we have maybe 30 minutes tomorrow to be able to sort of discuss the issues.
DR. COHN: I can't guarantee that. I think we have actually already handled the issues. If we have 30 minutes, we will provide it. I guess the question is if everybody has reviewed the letter and are there outstanding other issues that need to be reflected in this letter?
DR. MC DONALD: I thought we just talked about them all.
MR. BLAIR: There was one from Mary Kratz and then there was also one with respect to, you know, our basic strategy that we look for Jim Scanlon to comment on. So, those were the two other issues.
DR. MC DONALD: Let's talk about Mary Kratz. Mary basically was saying don't go so fast with HL7 just to get all the stuff going on in ORBA(?).
DR. YASNOFF: Well, if something comes out, we will change it.
DR. MC DONALD: There is nothing there now.
DR. COHN: I guess I will also remind everyone this is not the last time we will have to -- what I would like to do while Clem is here is get basic approval to this recognition that we can reflect on --
DR. MC DONALD: Well, it has got to the main committee.
DR. COHN: Well, it does and then it will come back to the subcommittee for reflection. I guess I presumed that everybody saw both Mary Kratz's --
DR. MC DONALD: If anybody else heard that differently --
DR. COHN: Tom Hinks(?) also said that we ought to be tougher. I don't think we are accepting that one.
DR. MC DONALD: I consider Jeff as the main chef on this. This really has --
DR. COHN: Does somebody want to move that we approve this as stated for sending out to the full committee?
DR. MC DONALD: So moved.
DR. COHN: Would we like to vote on it?
MR. BLAIR: Marjorie, am I allowed to vote on this?
MS. GREENBERG: Sure. Why not?
DR. COHN: All in favor of sending this off to the full committee?
[A show of hands.]
So, just to emphasize that it is 5:29, this is not the final time it will be discussed. We will have a chance to further review any comments from the full committee after Jeff presents it at the end of the month. Those of you who have further issues or questions about the comments that have come in, we can certainly talk about them and as I said and bring them up. But I really do think that we have handled most if not all of the issues.
DR. MC DONALD: And you did it be February 2002, which I was --
DR. COHN: That is right. So, with that, we will continue on. We are now adjourning the meeting. It is now 5:30. We meet again at 8:30 in the morning and we will begin to move into issues around the Administrative Simplification Compliance Act.
Again, I want to thank Jeff, Vivian, Pat, Donna for their help in terms of putting this together. It has been a fascinating day. Thank you.
[Whereupon, at 5:30 p.m., the meeting was recessed, to reconvene at 8:30 a.m., the following morning, Thursday, February 7, 2002.]