[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Subcommittee on Standards and Security

Hearings on HIPAA Code Set Issues

April 10, 2002

Hubert Humphrey Building
Room 705A
200 Independence Avenue, S.W.
Washington, D.C. 20020

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
(703) 352-0091

TABLE OF CONTENTS


P R O C E E D I N G S (8:10 a.m.)

Agenda Item: Call to Order and Introductions

DR. COHN: Good morning. I want to call this meeting to order. This is the second day 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 issues.

I am Simon Cohn, Chairman of the subcommittee. I am the National Director for Health Information Policy for Kaiser Permanente, and a practicing physician.

I want to welcome fellow subcommittee members, HHS staff and others here in person. I also want to welcome those listening in on the Internet. I want to remind everyone both at the table and participating in attending these sessions to speak clearly so that people on the Internet can hear. Also, we would ask if there are any comments from those attending the session, please identify yourself before you speak, and come to a microphone to address questions to the participants.

The focus of the hearings today is on HIPAA medical data code sets, and whether there is a need for possible expansions to a list of codes or needs for replacements to those codes. I want to thank especially Vivian Ault as well as Betsy Humphreys, Pat Brooks, Donna Pickett and Karen Trudel for their help and work in putting this session together.

With that, let's have introductions around the table and then around the room. I would ask as part of your introductions, for those of you on the committee, if there are any issues coming before the subcommittee today that you need to recuse yourself about, would you please so indicate in your introduction.

With that, Karen, would you like to lead off the introductions?

MS. TRUDEL: Karen Trudel, Center for Medicaid and Medicare Services, staff to the subcommittee.

DR. ZUBELDIA: Kepa Zubeldia with Clareden Corporation and member of the committee and subcommittee. I am also a member of X-12 and chair of AFFECT.

DR. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC and executive secretary to the committee.

MS. BEEBE: Susie Beebe, NCHS, CDC, staff to the subcommittee.

DR. YASNOFF: Bill Yasnoff, CDC, staff to the subcommittee.

DR. KAPLAN: Laurie Kaplan, the National Home Infusion Association.

DR. MIRIN: Stephen Mirin, American Psychiatric Association.

DR. HUMPHREYS: Betsy Humphreys, National Library of Medicine and staff to the subcommittee.

DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and Quality, liaison to the National Committee and staff to the subcommittee.

DR. SQUIRE: Mary Ann Squire, NCHS and staff to the subcommittee.

DR. AUGUSTINE: Augustine, Director for Special Projects, senior statistician, Gambro Health Care, member of the committee, member of the subcommittee.

DR. PAKORNY: Frank Pakorny, American Dental Association.

DR. BEEBE: Michael Beebe, American Medical Association.

MS. WARD: Maria Ward, PriceWaterhouseCoopers and chair of the DSMO Steering Committee.

DR. KASSEL: Gene Kassel, American Psychiatric Association.

DR. TRENTE: Nancy Trente, American Psychiatric Association.

DR. CUTLER: Jay Cutler, American Psychiatric Association.

DR. WHEELER: Gladys Wheeler, Center for Medicaid and Medicare Services.

DR. LEACH: Jim Leach, ACI Group.

DR. MURRAY: Tom Murray with the National Community Pharmacists Association.

DR. PICKETT: Donna Pickett, National Center for Health Statistics, CDC.

DR. AULT: Vivian Ault, National Library of Medicine.

DR. KUHN: Catherine Kuhn, National Community Pharmacists Association.

DR. WINNEROF: Jeff Winnerof, Christian Science Committee on Publication.

MR. MILLER: Bob Miller, Legislative Director for the Christian Science.

DR. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC.

DR. WHITE: I'm Jane White, the Executive Director of the American Psychiatric Nurses Association.

DR. MC CABE: Susan McCabe, representing three national and international psychiatric nursing associations.

MR. MUSCO: Tom Musco with the Health Insurance Association of America.

MS. LEON-CHISEN: Nellie Leon-Chisen, American Hospital Association.

MR. CHARO: Robert Charo, Crowell and Mooring.

MS. MULLINO: Cynthia Mullino, Alternative Link.

DR. REILLY: David Reilly, internist, University of New Mexico Medical School and health services researcher.

MS. FREIBERG: Elizabeth Freiberg, independent contractor.

MS. GIANINI: Melinna Gianini, President, Alternative Link.

DR. COHN: I want to announce before we start the session that, I think most of you know I am a member of the CPT editorial panel, which you also know is a HIPAA-named medical code set. Because of this, I will be recusing myself from any votes taken on the topics related to procedure code sets. I have also asked Kepa Zubeldia to lead the sessions. With the agreement of the subcommittee, however, I will participate in the discussion and question periods.

So, Kepa, with that, would you like to take over the session?

Agenda Item: Panel 2 - Previously Identified Gaps in Code Sets

DR. ZUBELDIA: Thank you. In the interest of time, we are going to try to see if we can finish on time today. I would like to start with the testimony, starting from our left to the right, and then we will have questions for the entire panel.

DR. MIRIN: Mr. Chairman and members of the committee, I am Dr. Stephen Mirin, Medical Director of the American Psychiatric Association. It is a medical specialty society that represents more than 40,000 psychiatric physicians nationwide.

I would like to thank you for the opportunity to address the subcommittee and to take this opportunity also to present our concerns about the current code set designations currently laid out in the Health Insurance Portability and Accountability Act of 1996, and to further request that the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, the fourth edition, be designated as the code set for the diagnosis and reporting of mental disorders. In my testimony, I will spell out the rationale for this request.

As you know, HIPAA has three fundamental goals: to improve the portability of health insurance, to reduce fraud and abuse in federal health care programs, and to promote administrative simplification.

Under the current plans for the implementation of HIPAA, ICD-9CM is the only approved code and descriptor set for the transcription of medical diagnoses, including diagnoses of mental disorders. However, in the case of mental disorders, the proposed adoption of ICD-9CM and the codes and the accompanying definitions, will impede rather than facilitate efforts to reduce fraud and abuse, and will inhibit rather than promote administrative simplification.

Let me explain why we believe this to be the case. Since the ICD-9CM diagnostic codes are already required for Medicare claim submissions by the Center for Medicaid and Medicare Services and by private insurance carriers as well, it might appear that having ICD-9CM as the only approved diagnostic code set under HIPAA would not create any difficulties for the health care community. However, for over 20 years, mental health practitioners have been using an alternative set of descriptors for ICD-9CM provided by the American Psychiatric Association. This alternative classification system is found in the Diagnostic and Statistical Manual of Mental Disorders, now in its fourth edition.

The DSM-4 is used nationally by virtually all providers of mental health care, including psychiatrists, psychologists, social workers, nurses, as well as mental health administrators and policy planners for communication, for clinical management and for recordkeeping. Epidemiologic surveys and studies of mental health practice patterns use DSM-4 definitions for ascertainment of caseness. In our country, all practice guidelines designed to improve and standardize care for the mentally ill, including people with substance use disorders, are key to the DSM definitions. Virtually all research studies on mental disorders define study populations in terms of DSM categories. Finally, all students of medicine, law, psychiatry, psychology, social work and nursing and all other mental health professions in the U.S. rely on textbooks that describe mental disorders based on DSM definitions.

DSM is also the de facto official code set for various funding agencies and for virtually all states. There are over 650 federal and state statutes and regulations that rely on or directly incorporate DSM diagnostic criteria.

For example, the Department of Veterans Affairs disability program uses the diagnostic criteria in DSM-4 to asses whether an applicant qualifies for a disability on the basis of a mental disorder. CHAMPAS requires that a mental disorder be a condition listed in the DSM, and Medicaid beneficiaries who apply for admission to nursing facilities as a result of a mental disorder must meet the diagnostic criteria set out in DSM.

At the state level, the same situation pertains. For example, in California, Medicaid reimbursement to hospitals is keyed to DSM-4. In Tennessee, mental health qualifications to serve as a police officer incorporate by statute reference to the DSM, as to driver's license provisions in Pennsylvania.

Finally, state and federal courts rely heavily on the DSM as the common diagnostic language in discussing the possible role of mental disorders in serious crime.

In recognition of the importance of keeping the diagnostic nomenclature in mental health linked with the nomenclature used by the medical community in general, and to meet the regulatory requirements of both the federal government and private insurance carriers, the DSM diagnostic codes correspond to the more or less equivalent categories in ICD-9CM.

Many but not all of the diagnostic terms are identical in the two systems. This reflects the adoption of a number of modifications requested by the APA over the years to facilitate efforts by clinical coding specialists to use DSM terms to locate ICD-9CM codes in the alphabetical index.

DSM-4 is also fully compatible with ICD-10 through our collaboration with the World Health Organization. The key difference between the two systems is in the definitions of the disorders themselves. Unlike DSM-4, which provides operationalized diagnostic criteria using straightforward terminology that can be easily assessed for each mental disorder, ICD-9CM includes a brief glossary of definitions, using somewhat vague and subjective and most unfortunately, archaic terminology. Indeed, the ICD-9CM glossary definitions were written in the mid-1970s and have not been updated since that time. As a result, the definitions are peppered with anachronistic terms that the vast majority of practicing mental health professionals are unfamiliar with.

One practical example. A highly prevalent disorder, major depression, is classified under both systems under the code 296.2. This is where the similarity between the two systems ends. In ICD-9, the discussion of this highly prevalent illness consists of three sentences, using terms like wretchedness, mood of gloom and other somewhat archaic descriptors. In contrast, the DSM-4 description of major depression occupies at least a dozen pages in this volume, and is much more specific. That has been the product of an evolutionary process overseen by the APA, but involving countless organizations over the last 25 years.

In contrast to the ICD-9CM, the DSM diagnostic criteria are updated every seven to ten years. There have been two major revisions since 1980, remembering that ICD-9CM descriptors were developed in 1977. The updates are based on a comprehensive and methodologically sound review of scientific data, along with extensive input from and collaboration with federal government agencies, including the National Institute of Mental Health and NCHS, the World Health Organization and clinicians, researchers and policy makers. A process has begun in collaboration with these national and international partners to update the DSM by the end of this decade, to incorporate the latest advances in scientific research and the classification of mental disorders.

For these and other reasons, as a practical matter, implementation of HIPAA regulations as currently stated would require mental health practitioners, agencies and institutions to abandon their use of the DSM-4 diagnostic criteria in favor of the ICD-9CM definitions, which reflect medical science as it was in 1977. This would impede rather than advance two of the fundamental goals of HIPAA as they apply to the classification of mental illness, namely, efforts of public and private payors to enforce fraud and abuse laws and efforts to promote administrative simplification.

Today, Medicare auditors seeking to determine whether a psychiatric hospitalization was medically necessary review a patient's chart for the signs and symptoms consistent with the DSM-4 diagnostic criteria, and for assessing the severity of the disorder. A mandated use of ICD-9CM will not permit this, and thus may undermine efforts to fight fraud and abuse. Similarly, mandated use of ICD-9CM will undermine the more than 650 state and federal laws that specifically incorporate DSM classification system, thus complicating rather than simplifying the use of medical information and the practice of medicine.

For these reasons, we humbly request that the DSM-4 be adopted as the designated code set, and that the American Psychiatric Association also be accepted as a designated standard maintenance organization like the AMA and ADA, and to qualify we are aware that the APA to demonstrate that adopting the DSM-4 as a designated code set must result in significant improvement to the current standard in terms of the ten specified principles. We believe that it does.

It is widely used by providers in state governments as well as by the federal government. It is used for medical diagnosis, reimbursement and forensic purposes and thus DSM if adopted as the mental health diagnostic code set, will improve uniformity, meet health care provide standards, have low implementation costs, no development costs and it will have the ongoing support of the APA in maintaining and refining the code set.

DSM is precise, unambiguous and as simple as possible, and its adoption will minimize data collection and paperwork requirements, since it is already the mental health standard used by providers, private payors, states and even funding agencies. It is also adaptable and regularly updated, and it is technologically independent of computer platforms and transmission protocols.

We would not expect any significant problems to arise from this edition. DSM-4 is only partially a different code set. As I mentioned, it is only the definitions, diagnostic terms and coding conventions that differ. The actual numerical codes remain identical to the ICD-9CM.

Furthermore, there is ample precedent for proprietary code sets to be adopted under HIPAA, and the American Psychiatric Association has already established an open and inclusive process for periodic revision of the DSM. Finally, we believe it will not impose any burden on users, since use of the DSM is already the diagnostic standard for the field.

Thank you for allowing me this opportunity, and I would be happy to respond to any questions you may have.

DR. KAPLAN: Good morning. My name is Lorrie Kline Kaplan. I am the Executive Director of the National Home Infusion Association. Over the last two years, our organization has had an intensive immersion in the DSMO process, as well as in the HCPCS CPT process for requesting new codes. Thank you for the opportunity to share these experiences and recommendations with you this morning.

I do want to point out that copies of my testimony were provided, and I hope that everyone has that at this time.

We are a 501c6 nonprofit organization. We are relatively small, as our health care sector is relatively small. NHIA's activities on coding and electronic claiming are coordinated by our Home Infusion EDI Coalition or HIEC.

Home infusion is the management or specialty, often IV, of medications and nutritional solutions for patients who are at home or ambulatory, by a specialized non-traditional licensed pharmacy. This market represents approximately four to five billion n health care expenditures annually, but its role far exceeds that dollar value because of the significant savings compared to inpatient care. If not cared for by us, our patients would be in inpatient facilities to receive those IV medications and have their care managed.

While private payors have covered home infusion for nearly 20 years to reduce inpatient costs, there is no explicit Medicare coverage. This has led to very non-standard coding, which makes us a good HIPAA test case.

Almost every payor has its own codes for home infusion, although most of these share common features. Most payors use a per diem approach to cover home infusion, like the method adopted for Medicare home health and outpatient services. A bundled daily rate is prospectively determined, based on the therapy provided. These are determined through negotiation between payors and providers. Payors know in advance what the cost of care will be, and providers know what the reimbursement will be. The billing unit is each day the patient is on home infusion services.

What is the status of our coding system currently under HIPAA? NHIA coding system follows the per diem methodology and was designed for use under the ASC, X-12 and professional claims standard, and was part of that standard until recently. It was not approved under the HIPAA rule, but HHS recommended specifically that additional standards be adopted to fill existing coding gaps needed to meet the business needs of our sector.

These gaps mentioned by HHS were not minor. At that time, there were no codes available in the HCPCS or CPT system for home infusion that were even similar to the HIEC codes or other private payor codes, or being used in the marketplace. So that was significant for us.

In a December 2000 policy change request, NHIA applied to the DSMOS for an approval of the HIEC system as an approved medical code set under HIPAA. We continue to believe that the HIEC coding system fits the criteria that we believe would be appropriate for evaluating this request.

Those criteria in our view should be: is this an established health care sector, i.e., is there a business need for these codes; are there significant coding gaps in the approved system, i.e., a lack of duplication with current systems, and is this a sizeable body of codes, i.e., more than 50 or 100 or, in our case, over 200; does the methodology used in the system reflect current coverage models in the marketplace; does it meet the needs of providers and payors of this sector; is specialized expertise required to properly design and maintain the system, and does the code set maintain or have the necessary systems in place to professionally maintain these codes to HIPAA requirements.

NHIA's NIEC system meets all of these criteria. However, we found that these were not the criteria used by the DSMOS.

By mid-summer 2001, NHIA's request earned its final rejection by the DSMOS. We still believe that the above criteria should have been used. It is not clear what the criteria were or are, as these have never been spelled out to us anyway.

Nonetheless, we were directed to work with the HCPCS and CPT maintainers to address the quote-unquote gaps. For the basic survival of our members and lacking all other reasonable options, we have pursued that directive with great zeal.

I offer comments in three areas on HCPCS, CPT and the DSMO process. I wish that time would allow me to describe the benefits of the HIEC coding system, but I'm not going to do that for your benefit at this time.

HCPCS. We are pleased to report that many of the home infusion coding gaps have been in fact addressed through the 2002 HCPCS. Much of the HIEC coding system was freely adapted for inclusion in the 2002 HCPCS, about 80 new per diem codes which taken together comprise a fairly comprehensive system. While there are still important areas we are attempting to address, we are much further along than we were a year ago.

While we still believe approval of the HIEC codes would have been beset, we have embraced the HCPCS and commend the panel for the major steps it has taken to address these issues. We are working hard to facilitate adoption of the HCPCS, and have found that most providers and payors are pleased with them. We hope that they are indeed permanent codes, but we have no assurance that they are.

We urge NCVHS to consider whether additional changes to the HCPCS infrastructure may be needed to accommodate all the new demands placed on this system. Specifically, we recommend first that HCPCS S codes should not be called temporary codes. HCPCS must now house private payor coding. These non-Medicare S codes are now called temporary codes. We are told they are permanent, but we have no formal assurances.

Payors and providers are hesitant to convert their systems and contracts to codes that are temporary. We recommend the S codes be called non-Medicare codes or another appropriate name that reflects a permanent status. Until this happens, everyone is uncertain about the future.

Second, HCPCS S codes should be usable by Medicare Plus Choice plans. These plans cover home infusion to reduce their inpatient expenditures, and they should be able to continue to do so. We are told that they cannot.

Third, the HCPCS application should be updated. HCPCS increasingly address services and not just products, but the application is designed for products. It is also very much designed for manufacturers and not for providers or payor groups who have identified coding gaps under HIPAA.

Lastly but not least, health care providers should have input on HCPCS. Providers currently have no formal opportunity for review and comment on coding requests and issues. The law only requires this openness for clinical laboratory services and durable medical equipment. We are not aware of new procedures for openness in other coding areas.

We strongly support representation for home care on the HCPCS panel itself. Also because of our expertise in our niche area of home infusion coding, we request that NHIA have a formal advisory role in the considerations of the HCPCS panel related to home infusion coding. We already maintain systematic published processes for reviewing and recommending coding requests, providing a clearinghouse and review function before sending requests to the panel, and we would like to see these functions formally incorporated into the review process. Other health care sectors should also be provided this advisory status formally.

Let's turn to CPT. We appreciate AMA's inclusion of NHIA in recent months in some key meetings, and we hope to continue working closely with them. However, we would like to share some observations.

First, the AMA developed home infusion coding without public input and published these in 2002 over industry opposition. These codes do not fit the home infusion clinical or business model, and are at odds now with the current HCPCS. We continue to ask that the CPT codes be withdrawn, as we see them as the number-one obstacle to coding standardization in home infusion. With all due respect, I believe these codes are a perfect example of what happens when one sector of health care develops a framework of coding for another sector in which it does not have appropriate experience.

The number-two obstacle is the lack of adequate coding for home infusion nursing visits. We are currently participating in an AMA work group to recommend CPT coding approaches, and we are pleased to be part of that panel. We have learned however that changes will not appear until at least 2004. This is an extremely long lead time in our current environment.

Three, when codes are on the books that don't fit the needs of the marketplace, coding misuse can and will occur. Payors are already talking of changing the descriptors. Stakeholders must focus on complying with the descriptors, not just the numeric code values. It should also be noted that significant education is needed to gain standardization in coding use, and is vitally important for the success of HIPAA.

We have developed a comprehensive educational resource entitled the National Coding Standard for Home Infusion Claims Under HIPAA. This is available for free download at our website, www.nhianet.org/hiec_issues.htm. That is in the written testimony. We encourage you to download that document and see our attempt to provide education in this matter.

The DSMO process. Finally, as one of the early requesters in the DSMO process, I would like to offer some observations regarding our experience. An advance read of Maria Ward's testimony later this a.m. shows that many issues are already being addressed since last year, and that is fantastic.

As a requester, we were distressed at how much dogged persistence it took to participate and provide input into this process. For example, we submitted considerable supportive documentation for a February 2000 NUBC and NUCC joint meeting in which our request was to be considered.

We were pleased to have the opportunity to attend that meeting. However, it appeared that committee members had not received her materials and were not prepared to discuss this request. We were naturally surprised to find that her request was turned down after that. Later meetings with these groups were more successful. After we appealed the original rejection and had been denied again, none of the other DSMOS asked to discuss our request.

Our attempts to get transcripts or minutes explaining the DSMO decisions were also unsuccessful. I therefore read the February subcommittee testimony on this subject with great interest, as none of the reasons for the denial had been provided to us previously. With all due respect, many of these reasons now cited appear to be based on misunderstandings that we would have been very pleased to have had the opportunity to clear up, before the request was denied. Some of them we did address prior to the denial, in our view.

A recent DSMO change request by NCPDP related to the billing of professional pharmacist services will provide NHIA with another opportunity to experience the DSMO process. In a letter we are sending to the DSMOS following this meeting, we note that we opposed this NCPDP request, and we request the opportunity to testify at any upcoming DSMO hearings in which this issue will be discussed.

All of the DSMOS and the code set maintainers should be expected by HHS to meet standards of fairness, openness, equal representation and public accountability, the standards required for example of ANSE accredited organizations. We believe that we were fortunate that many of our needs have been addressed for now, but we believe luck was on our side, and if we had not been such a squeaky wheel, the outcome would have been very much different, and it still could be different shortly down the road, which is a very frightening prospect for us.

Our industry has and will continue to have a significant volume of coding needs. They must account for our entire practice. The organization representing the sector, us, has no formal role in this process, and the codes that have been granted to date are listed as temporary codes. We believe that very significant decisions are being made that will absolutely control our lifeblood by entities that do not have significant expertise in home infusion.

Thank you very much for allowing me to offer these comments, and I would be happy to answer any questions that you have.

MS. GIANINI: Good morning. I would like to thank Chairman Cohen and members of the National Committee on Vital and Health Statistics Subcommittee on Standards and Security for inviting me here today to speak about a critical gap in codes for alternative medicine, nursing and other non-physician services. These codes are needed by more than 2.7 million licensed health care providers inadequately served by existing HIPAA code sets.

My name is Melinna Gianini. I am the founder and president of Alternative Link, and one of the original developers of ABC codes. ABC codes are five characters in length and are followed by a two-character modifier. Because these codes are the same length as HCPCS's level one and two codes, ABC codes fit into existing software applications and health information systems, as well as onto UB-92 and HCFA CMS-1500 forms.

ABC codes support non-physician practitioners licensed as health care providers in one or more states who have completed accredited training programs and have met national and state certification requirements.

The code set is designed to allow over 11 million coding combinations. It has been market ready for databases ready for downloading and coding manuals in print since 2001. In fact, the ABC coding manuals were featured by Delmar Thompson Learning at this week's American Association of Professional Coders convention here in Washington. The codes met the approval of every coding professional software application developer and coding expert who learned of them, and they were viewed as long overdue.

ABC codes directly reflect the effectiveness of DHHS' implementation of the Congressional intent under HIPAA. The code set was designed specifically for HIPAA compliance to address an existing and rapidly expanding gap in coding for alternative medicine, nursing and other non-physician interventions. This gap had already been identified by the National Library of Medicine and was recently reiterated by the White House Commission on Complementary and Alternative Medicine Policy.

ABC codes deliver the infrastructure needed to determine which alternative medicine, nursing and other non-physician interventions could help manage access, improve health care quality and alleviate skyrocketing health care costs. In developing the codes, Alternative Link explicitly followed the guidelines created under HIPAA for code set development and approval, especially those pertaining to administrative simplification and avoidance of billing fraud and abuse.

The code set meets each of the ten guiding principles outlined in the Federal Register from the May 7 proposed rules of 1998. We documented adherence to the guiding principles within the 60-day comment period following that proposed regulation.

Market-ready information, products and consulting services are available to support HIPAA-covered entities and business associates in implementation of this code set. Among the information products are three publications, some now in their second year of print. These are the CAMEN Nursing Coding Manual, the State Legal Guide to CAMEN Nursing and Relative Values for CAMEN Nursing.

Alternative Link has already submitted extensive testimony pertaining to the development and acceptance of ABC codes. We have received and followed specific instructions from the DHHS, designated standards maintenance organizations, ASC, X-12N, HL-7 and EDI experts. We have submitted letters of recognition and support from thought and practice leading organizations in the health care industry. These letters demonstrate that ABC codes address public health and business needs not currently met by code sets adopted under HIPAA.

The code set supports benefit plan design, utilization management, claims management and appropriate reimbursement. It also facilitates the development of evidence based practice guidelines through clinical trials, health services research and actuarial analysis.

ABC codes offer functionality that cannot be achieved by any of the other code sets. This functionality fulfills a unique and essential need of alternative medicine, nursing and other non-physician practitioners. The code set design gives users the ability to link services and supplies to state scope of practice laws for multiple practitioner types.

Despite our developing ABC codes within Congressional intent following HIPAA and DHHS requirements, the DSMOS established by DHHS to oversee changes in HIPAA standards have not yet recommended ABC codes be a main standard code set. Most recently, the DSMOS redirected Alternative Link to approach both the American Medical Association and HCPCS authorities to determine whether ABC codes could somehow be managed as part of HCPCS's level one and level two codes. Alternative Link complied with this request, even though the AMA had been consistently uncooperative and heavy-handed in past interactions.

Recently, we have been encouraged by the tone of the AMA's response to our request to collaborate. At the same time, we remain concerned that collaboration could continue to be difficult and more important, time consuming. For example, within the last month, AMA encouraged us to apply for CPT codes through the existing code application process without informing us that this would transfer our intellectual property to them without compensation. By the way, this is six and a half years of development time and millions of dollars.

Also, when we noted this and asked for more specific guidelines about how to deal with the particular challenges of addressing ABC codes, AMA were not able to respond until the day the CPT application was due. Had we not anticipated these responses, we could have lost our ability to represent non-physician practitioners and our efforts could have been stalled by three more months. As it was, we were able to submit an adapted CPT application within hours of receipt of their guidance letter on April 4 of 2002, and still retain rights to develop the codes and of the rights to non-physician providers to an unbiased review process.

Our adaptive CPT application points out the unique and essential functionality of ABC codes as well as the extent of code set development. In other words, there are about 4,000 service and procedure codes in the ABC code system. It asks the AMA to either acknowledge the differences in code set functionality and recommend ABC codes be a named and separate standard, or two, propose a way to accommodate the codes and serve the needs of non-physician practitioners. Given the AMA's encouraging tone, we remain hopeful.

In relation to adding ABC codes to HCPCS's level two, we received the support of Kay Reilly, the director of the HCPCS panel. Unlike allopathic physicians, alternative medicine, nursing and other non-physician providers are governed by different laws in each state. While the AMA CPT editorial panel is expert in coding conventional medicine, it does not have the expertise in coding alternative medicine, nursing or other non-physician interventions. If it did, it would already have developed thousands of codes comparable to ABC codes. Instead, only a handful of non-specific codes have been developed. For this reason, claims for non-physician interventions often need to be manually processed or supplemented by extra paperwork to document treatment rationale. In relation to non-physician interventions, CPT codes do not meet Congressional intent vis-a-vis HIPAA.

Legal experts realize that no two states have the same laws regarding alternative medicine, nursing and other non-physician providers. To our knowledge, Alternative Link is the only organization that has built this type of information into coding functionality on a code by code, state by state and provider by provider basis. Thus, the entire domestic health care industry needs ABC codes in their present form.

Here I would like to also add that this is a national code set. The codes don't change from one region to the next, only the ability to use them.

We have analyzed overlaps with CPT and found less than a ten percent crosswalk. Our code set maintenance process is impartial. Applications may be submitted by anyone. Code development approval and obsolescence are overseen by independent coding administrators based on written procedures and formal standards with systematic reviews by training, licensing and other authorities. These procedures and standards are described in coding publications and on the Alternative Link website.

The code set is updated continually. New releases of codes are issues annually. Adoption by payors is forthcoming upon naming as a code set standard. Coding manuals include general guidelines for coding as well as expanded definitions for each procedure to avoid confusion over the appropriate use of those codes. Expanded definitions are available in both electronic and hard copy formats.

Current users adhere to guidelines and have not needed to develop their own definitions. Updates are disseminated by Alternative Link and its distribution partners, Thompson Learning and Relative Value Studies, Incorporated. Alternative Link codes are available for $49.95 as an ASCII flat file and for $59.95 as a PDF coding manual. State code reports for each provider in each state are available for $19.95 per report.

The codes are available in both hard copy and electronic formats. The licensing fee structure is comparable to the fee structures established for existing code sets.

In conclusion, ABC codes fill a critical gap in coding, support Congressional intent and include intelligence that current HIPAA code sets and the proposed ICD-10 codes were not designed to provide. Should the NCVHS decide on a single national code set in the future, Alternative Link will map ABC codes and modifiers to the new national standard.

In the meantime, Alternative Link pleads with NCVHS to make a decision pertaining to ABC codes today. ABC codes will provide critical information urgently needed for benefit plan design, utilization management, claims management, appropriate reimbursement as well as health services research, actuarial analysis and outcomes research. The industry needs the codes now.

Thank you very much.

DR. ZUBELDIA: Thank you for the testimony. As you probably know, it is a set of controversial issues that have been lingering for awhile. We need to have the best information possible.

We have at least 15 minutes for questions. I would like to start asking Melinna, how are these alternative services being billed today? You said in your testimony that the adoption by payors is forthcoming.

MS. GIANINI: We already have an HMO that is using the code set now. We have a PTO network that represents 23 million covered lives that is anxious to adopt this as soon as it becomes a HIPAA standard, to enroll practitioners in this network. We have had large payors such as Blue Cross Blue Shield organizations say, very interesting, but we want to see it be a HIPAA standard first.

DR. ZUBELDIA: How are these services being billed today?

MS. GIANINI: Excuse me?

DR. ZUBELDIA: How are the services being billed today?

MS. GIANINI: How are they being billed today? Usually insurance companies carve benefits out for chiropractic and acupuncture if they have any benefits at all for acupuncture. It is a carveout, where the insurance company agrees to pay caps on dollars or numbers of visits, and very little data is being used or captured.

DR. ZUBELDIA: What kind of codes do they use?

MS. GIANINI: In many instances, the insurance companies are pulling the claims in from the providers and just counting dollars or numbers of visits. There are two codes for acupuncture services, acupuncture and electrical acupuncture. There are four ms for chiropractic services, and then those practitioners are also using some physical modality codes in CPT. No data has emerged to prove efficacy based on the way things are being coded right now.

DR. HUMPHREYS: Are there any local codes involved?

MS. GIANINI: In our set?

DR. HUMPHREYS: No, I mean in current billing practices.

MS. GIANINI: I believe that Blue Cross Blue Shield has S codes specific to some of these services.

DR. ZUBELDIA: S codes? Those are?

DR. HUMPHREYS: The temporary codes.

MS. GIANINI: Temporary codes.

DR. ZUBELDIA: But I understand they are permanent temporary codes.

DR. KAPLAN: Yes, that is where I think the confusion is coming out. But in conversations we are having with payors, they are actively saying we don't want to adopt these codes because our understanding is that they are temporary, so we think that that nomenclature can be resolved easily for the benefit of all.

DR. FITZMAURICE: Is the issue generally that the potential users don't find the coding system useful? Or they just don't want to pay for the services?

MS. GIANINI: I believe that it is a chicken and egg problem. They would like to have actuarial analysis before they decide to jump off and pay for services, because they don't know what their exposure is. But without codes, you can't do the actuarial analysis. So it is a kind of mobius loop.

DR. FITZMAURICE: But they can hire a researcher to go out and categorize what is being done, and look at evidence that it works and then decide what to pay for. I gather some of those steps haven't been taken yet. So I am just wondering about coding something where people don't want to pay for it. I don't want to pay for a lot of things, either, but I have to pay for them. Versus looking at the evidence and then making a decision whether it is a medical necessity or not. I don't know how to sort this out, but --

MS. GIANINI: I'm going to have Cynthia take this question.

MS. MOLINA: I am Cynthia Molina, the CEO the Alternative Link. We have encountered many self-insured payors and third-party administrators who have experimented with benefits in this area. The challenge they have had is, they have no mechanism today to control utilization management. So when they open up benefits, there is a flood of demand for the services without evidence of differential outcomes.

As a result of that, many of them have withdrawn those benefits, because they don't have a way to manage access, quality and cost of those interventions. Does that answer your question?

DR. FITZMAURICE: I think so. As I listened to the description of the coding systems, I can see why somebody might not want to pay for -- here is a person spending a day of time doing something, but if you need to define that something to the patient very clearly, then it would seem that a coding system is useful, if only for looking at what is being done and measuring the benefits.

MS. MOLINA: Yes, there are tremendous benefit just in the actuarial potential.

MS. GIANINI: I also think that there is tremendous benefit in a provider being able to just manage his own business, even if there is no insurance reimbursement available, because the providers are probably coding things as hours and not putting any specific detail into their own billing systems.

So it is just like running any business; you know more how to manage your business if you have more detailed information about what you are doing.

DR. FITZMAURICE: So what is it you are asking NCVHS to do?

MS. GIANINI: We are asking NCVHS to make a decision and to keep us from having to go through any more processes. We hope that that decision will be in the affirmative to adopt this code set.

DR. FITZMAURICE: So you are asking us to make a recommendation.

MS. GIANINI: Okay, I will formally state this as a recommendation to please adopt the ABC codes as a national HIPAA standard.

MS. MOLINA: We are looking for your recommendation to the Secretary of Health and Human Services to adopt the code set.

We do have one other individual who could comment on your questions effectively. That is a medical doctor who has an experience in health services research and alternative medicine. If you don't mind, I would like to introduce him.

DR. FITZMAURICE: Go ahead.

DR. RILEY: My name is David Riley. I am an internist in Santa Fe, New Mexico. I at the request of the insurance industry in New Mexico ran and administered an alternative medicine IPA of providers, doing peer review of quality assurance for three years.

The state insurance commission of New Mexico has required that all insurance plans sold in New Mexico provide alternative medicine benefits. Yet, the insurance industry doesn't really have an effective mechanism for doing that or knowing what they are doing, so they threw their hands up. I just gave a presentation to them one day, and they said, would you please help us coordinate this.

So for three years, for Presbyterian, which was working with an NCO in Santa Fe, I helped guide the delivery of benefits for acupuncturists, chiropractors, traditional osteopaths, massage therapists, therapeutic yoga and homeopathy. The lack of codes was a particularly onerous issue. There were all sorts of things across the map in peer review and quality assurance, with some acupuncturists saying, I found this insurance company will pay me if I bill it as a surgical intervention, because I am using needles, and another one over here would say, I don't want to do that, I want to do this, because I find this better with this insurance company.

I realized the data that I was trying to get out of it, I wanted to develop actuarial data to look at what interventions might be most effective for certain conditions. It was impossible, because there was no coding information on which to base a rational decision. I could get a little bit from costs, but I couldn't get anything else out of it.

DR. FITZMAURICE: Thank you.

MS. BEEBE: I have a question to Steve. I believe in your testimony, if I understand, you referred to comparisons of ICD-9CM. Were there any comparisons to ICD-10CM?

DR. MIRIN: Yes. The APA is working closely with the WHO so that the current DSM-4 codes will be identical to the codes used in ICD-10. The advantage however of ICD-10 is that the descriptors will be much closer to what we understand about mental illness in the year 2002 than what we understood about mental illness in the year 1977.

MS. BEEBE: So do you see this as a possible solution to the problem?

DR. MIRIN: We would be very pleased if the rest of the world adopted ICD-10. In that context, we would do essentially what we have done in the past, which is that the mental health portion of ICD-10 would essentially be DSM-4 or its successors.

DR. COHN: Steve, I actually want to follow up, since we have gotten into your area. First of all, let me say I am a physician, but I am an emergency physician, so I look at psychiatric notes and usually see these access things.

DR. MIRIN: Yes.

DR. COHN: I don't know what they are, but I have always presumed them to be somehow related to DSM-4.

DR. MIRIN: I'll leave you a copy of this book.

DR. COHN: Okay. And certainly after your testimony, I am going to have to go back and talk to some of my psychiatric colleagues.

DR. MIRIN: Sure.

DR. COHN: However, as I was listening to you, I was struck -- and just to make sure I have the correct understanding here, at least the way DSM is set up at this point, you are effectively using the ICD codes, but you are expanding them and giving them greater depth and understanding about what they mean.

DR. MIRIN: Exactly.

DR. COHN: It is almost like a knowledge base around what the codes really are and requirements and all of this.

DR. MIRIN: Right. When we have used the codes for the DSM, in order to avoid widespread confusion, we want to use the same codes for the particular diagnosis, although sometimes in the crosswalk between DSM-4 and ICD-9CM, it may be difficult for a practitioner to be quite certain that apart from the name of the illness, that we are actually talking about the same illness, because the descriptions vary significantly from what we understand today.

DR. COHN: So let me just follow this along. If somebody is sending a bill to a managed care environment or to a health plan or whatever and you have a code that looks for the world like an ICD code, --

DR. MIRIN: That's correct.

DR. COHN: -- does it make a difference whether you have used DSM or ICD in terms of doing it? Or are there substantive differences, or is it more of an updating and greater knowledge around the guidelines for this?

DR. MIRIN: When the practitioners use the codes, they uniformly refer to DSM-4, and they put down the DSM-4 code. In fact, that is what they are asked to do.

DR. COHN: Except for Medicare.

DR. MIRIN: In some instances, in Medicare it is also the DSM-4 code that is used. The numbers are identical.

DR. COHN: That is what I mean. The numbers are identical and it is really more the knowledge base behind it.

DR. MIRIN: That's right.

DR. COHN: The question I have is, in all of this, we tend to think of there being codes, and then there are guidelines for the use of the codes. As I am listening to you, I am wondering if DSM-4 is really a large set of guidelines around the application of those ICD codes. I am just wondering whether really what we need to do is to have DSM-4, if we are considering it, identified as guidelines for the use of the mental health codes, and that is really what we mean, as opposed to asking for a different set of codes, which doesn't sound like DSM. Am I off on this one? Help me. If I am saying something wrong or I am barking up the wrong tree, please help me with this.

DR. MIRIN: Let me respond to this by asking Bob Charo, who has worked very closely with us on this issue, to respond.

DR. CHARO: While you are correct that the ICD-9CM is the official code set for Medicare purposes, for reimbursement purposes, it is in fact not the official code set for audit purposes, for inspection purposes, and for purposes of the Office of the Inspector General. The DSM-4 is used for all of those purposes.

So when an inspector or a surveyor appears at a hospital within a given state, the inspection criteria for that hospital -- and if you check the inspection forms that are in the CFR, they list the DSM-4 criteria, and the inspector is asked to check medical records against those criteria.

The Office of Inspector General, in determining medical necessity, for instance, uses the DSM-4 criteria. The DSM-4 in essence spells out the definitions of what each code is.

DR. COHN: I may be wrong, but I think you are agreeing with me.

DR. CHARO: Well, I am and I am not. It is very difficult to have two words that are spelled the same and yet have different definitions.

DR. COHN: Let me ask one more question and then I'll stop. Does DSM have additional codes that are beyond what is in ICD? Or is it more this great expansion and greater understanding of all the ICD codes?

DR. MIRIN: Following the original set of codes was matched to ICD-9. Then subsequently as the DSM evolved from DSM-3 to DSM-3R and now to DSM-4, there have been as a consequence of medical advances more precise definition of mental disorders and additional codes. Those have been included, and the description of those disorders are now included in a separate appendix to ICD-9CM.

MS. TRUDEL: And are those additional codes included in ICD-10?

DR. MIRIN: I believe that they are, but we would have to check that and respond back to the committee.

DR. ZUBELDIA: Let me ask again about this same issue. We have two code sets, the DSM-4 and the ICD-9. It seems to me like they are about the same thing, the same codes, and with the same sort of definitions. Are there any definitions in conflict with each other? Is the same code used for conflicting definitions?

DR. MIRIN: That is my major point. The coding numbers are the same, because we endeavor to make them the same, in order to be part of organized medicine, and enable physicians across all disciplines, not just psychiatrists, but internists, family practitioners and others, to use the ICD system in coding the diagnoses. But it is precisely in the area of definition that they are vastly different.

DR. ZUBELDIA: I understand they are different. Are they in conflict with each other? Is the same code used for depression and for something else in the other code set?

DR. MIRIN: No. The code number would be the same, but when you put the definition of major depression, for example, that you would find in the glossary that accompanies ICD-9CM next to the definition of major depression that you would find in DSM-4, you will find that the language is very different, that the ICD-9CM language reflects what we understood about that disorder in 1977, and the language in DSM-4TR reflects what we know about that disorder in the year 2002. So they are vastly different in terms of the actual diagnostic criteria.

DR. ZUBELDIA: But it is the same disorder?

DR. MIRIN: It is the same illness, but it is sort of like saying that malaria is a disease characterized by high fever, rash and death versus, this is a mosquito-borne, et cetera.

DR. PICKETT: Donna Pickett, National Center for Health Statistics. I wanted to help clarify a couple of issues. The question was previously asked about harmonization between ICD-10CM and the DSM. In fact, yes, NCHS has worked very closely with the American Psychiatric Association in the expansion and further development of Chapter 5 and ICD-10CM, so that there is a complete harmonization. We have worked very well and very collaboratively with the APA to accomplish that harmonization. So it would be almost seamless in 10CM. However, we could not accomplish that in ICD-9CM.

Further, to help the discussion about the definitions, for the most part, we do not include diagnostic criteria within the ICD. Chapter 5 of the ICD contains a glossary and some definitions as placed there by WHO. But in the clinical modification, we have not made modifications to those things because we have deferred to the various medical specialty groups that do maintain diagnostic criteria, which is independent of the classification and the code number assignments.

So for instance, for diagnostic criteria for any other medical condition, not just psychiatric conditions, those criteria reside outside of the classification.

DR. HUMPHREYS: Donna, could I ask a question? Getting back to Simon's point, if you were to say that there were basically clinical guidelines for the various parts of the code set, and were we to identify these, the APA is for this set, others for other sets, does that cause a problem to anybody? Or probably it just wouldn't be done?

DR. PICKETT: Well, clinical guidelines currently exist for a number of medical conditions, and most medical providers know about those diagnostic criteria and refer to them independently in diagnosing their patients. Hopefully, that information is finding its way into the medical record documentation, such that when codes are being assigned, that information is translated into the appropriate assignment of an ICD code.

But again, the criteria has been independent, because it has been independently developed. One could go to the NIH websites or other medical websites and see many criteria for diagnosing various conditions. Again, those reside outside of the classification, but are routinely used by the professionals in diagnosing their patients.

DR. FITZMAURICE: I have a question about home infusion. I am looking over your testimony, Lorrie, and I see that you asked -- I infer that you are asking NCVHS to recommend approval of the ATIC system as an approved code set under HIPAA. You would like NCVHS to consider whether there should be changes to the HCPCS infrastructure needed. Then at the end of your testimony, you may just be referring to the DSMO process, but we believe we were fortunate that many of our needs have been addressed for now. So everything is fine so far. Am I mischaracterizing this, or did I hit it on the button, what you are asking us to do?

DR. KAPLAN: Our first choice would be approval of the code set. However, that did go through the DSMO process and it was rejected. If there were a way for us to continue to appeal that decision and mechanism, we would certainly love to do that. However, we haven't seen that as a live option at this point. We are trying to do whatever we can basically to get a solution.

So the solution that we have right now at this moment, we are optimistic. However, language such as temporary coding and the fact that we feel we have really contributed a lot to this process and making sure that these HCPCS codes are appropriate in providing input on the CPT process. But we have no formal role in any of that.

We believe we have an organization that can provide the expertise and input to these processes, and make everyone's life a lot easier to help guide these things going forward, but we don't have a role there.

So as I look forward for our members, I can say right now we feel we have a solution. But I feel it is very tenuous. So it is a temporary victory.

DR. FITZMAURICE: So you are looking for greater appropriate use of these codes for home infusion?

DR. KAPLAN: Yes.

DR. FITZMAURICE: You would like greater representation on coding bodies that consider codes for medical services.

DR. KAPLAN: Correct.

DR. FITZMAURICE: One thing I noted is that you didn't get into the reasons why there was denial by the DSMO process. You referred to them, but --

DR. KAPLAN: We could refer back to the February subcommittee testimony for the reasons that we provided at that time. But I did want to emphasize that reading that testimony, that was the very first time we had ever seen those described. So it was quite interesting to us.

DR. FITZMAURICE: I note at the very beginning, you note that there is no explicit Medicare coverage of home infusion. Yet I read that for over 20 years, private payors have paid for home infusion. Did they use your codes?

DR. KAPLAN: That is where it gets a little tricky. They used per diem codes, and they used payor specific proprietary codes. Almost every one of them has their own.

What we tried to do several years ago, even before HIPAA, was create a standardized code set that reflected what was actually happening in the industry, but could be put forward as a national code set. We provided the carrot as, you will gain administrative efficiencies by going to this standardization. But those efficiencies would have accrued to providers, not to payors. We had no luck whatsoever in trying to gain standardization, and it was quite frustrating, frankly.

So we saw HIPAA as a major opportunity to finally address this. The cost of the inefficiency of having so many coding systems for so many payors is unbelievable. I think we could reduce our costs significantly if we did not have 180 days sales outstanding on our claims, and 100 different code sets for every provider. It is ridiculous.

So now, instead of the carrot that we had before, we now have the HIPAA stick that says, you have to come into compliance, you have to come into standardization. So we see this as a really important opportunity.

So now, the HIEC codes had not gotten very far in the marketplace, I would not claim that they had. However, that code set is very, very similar to what is actually taking place in the marketplace. That is where I think the DSMO process was very unlike what we had expected. We could tell as soon as we got into it that the information that we were presenting that we felt would be the criteria by which the requests would be judged were really not the way it was going to be looked at. When you read the testimony from February, I think compared to our criteria, you really see that clash of perspectives.

DR. FITZMAURICE: Have you done a correspondence or a mapping between your code set and the proprietary code sets used by many different payors?

DR. KAPLAN: Yes, and we have presented that. We also did a crosswalk of our codes versus HCPCS and CPTs. I can provide that to you subsequently, but we have mapped it against the code sets used by many payors, very large payors, not all payors.

DR. FITZMAURICE: So the efficiency concerns that you raise are real, as reflected in the mapping, the fact that you could consolidate a lot of those different codes into one set of codes?

DR. KAPLAN: Right.

DR. ZUBELDIA: We have time just for two questions. We are running really late, so let's try to keep it short.

DR. YASNOFF: I actually have two questions. This is Bill Yasnoff from CDC.

DR. ZUBELDIA: Not two from you. One from you.

DR. YASNOFF: I've been waiting a long time, Kepa. I have two questions, and I want to ask them, and you can cut me off if you want.

First question is about DSM-4. Would it be correct to say that when physicians use the CPT codes, DSM-4 codes, the CPT codes that are included in DSM-4, and whenever anyone uses them, in essence the assumption would always be that they are using the DSM-4 definitions?

DR. MIRIN: Just one point of clarification. You talked about CPT codes. We are talking about the ICD, DSM-4 --

DR. YASNOFF: Excuse me, the ICD-9 codes and the DSM-4 codes, which are essentially the same codes. When those are used by physicians, and when they are read by whoever reads them, payors, peer reviewers, anyone, is it always essentially the assumption that they are using the DSM-4 definitions for those codes?

DR. MIRIN: Yes, it is.

DR. YASNOFF: Second question. What does DSM-4 cost?

DR. MIRIN: Cost in terms of?

DR. YASNOFF: What do you charge for various things related to DSM-4? Do you charge me to use it? Do you charge for the book? What is the cost structure to me as a provider?

DR. MIRIN: If you had difficulty sleeping and you wanted to read this book, the cost would be about $50. I don't know the exact cost of this particular volume, but that is the only cost to the provider. If you wished only a book that had the codes with very brief definitions and no accompanying text, the cost would be significantly less.

DR. YASNOFF: And are these code definitions available online at no charge?

DR. MIRIN: I have to refresh my own memory on that, but I believe that they are.

DR. YASNOFF: Thank you.

DR. MIRIN: Mr. Chair, if I could just follow up with one comment to clarify a statement that had been previously made, it is true that many medical specialty societies developed clinical criteria for particular diagnoses. The APA developed criteria for DSM-4 are unique, in that they are the only code set and accompanying criteria that are used uniformly in the promulgation of both state and federal law and regulations. So there are 650 separate state regulations in which DSM-4 is the code set that is referenced. The OIG at the fedreal level uses DSM-4 as well.

DR. COHN: You may have answered one of my questions already. I know Kepa would like to move on.

First of all, Steve, I really appreciate your testimony around DSM. One of the things that we will need to think about is how it all fits in. I don't know that we need to wait for ICD-10 to figure out how it fits in. Once again, my own view is that it is a guideline. From my view, one of the deficiencies of ICD diagnostic codes is that there isn't a lot in relations to definition of terms and otherwise.

So you have created obviously a solution to that problem, that we do need to go back and see in the final rules how we have described guidelines and how we have characterized them. But it seems to me that that may be the spot for that, but we will need to talk about that more.

Having said that, Lorrie, I want to thank you for providing a case study for us. Am I right, as I listen to all of the issues that you bring up, I just want to make sure in terms of prioritization, what I am hearing is that it has been rocky, that things are sort of, kind of working okay. I want to check that out with you.

It sounds to me like the biggest concern that we need to be aware of and deal with somehow has to do with the ongoing role of groups with particular expertise in the ongoing control, but input into those codes. Is that the biggest issue that you are bringing forward?

DR. KAPLAN: Yes. For us, I think the most important issue is our temporary status. I think that is very damaging to adoption of the codes, and it really does not make us feel like we actually have a victory. We might find out three months from now that we don't have those codes at all, so we think that is a significant issue.

But I have tried to focus my recommendations on ways to improve this process overall, and not just speak specifically about what we need, but what we think needs to happen to make this process go better. So I do hope that those recommendations can be considered, because we did put a lot of thought into those.

So it would be hard for me to weight them all, frankly. I realize there are several, but they are offered in the spirit of, how can we improve this process. For a small group like ours that nobody understands, no one knows what home infusion is, it is very, very difficult to get those needs met within this process.

We are happy to have achieved what we have had with the help of the HCPCS panel, but we would like to see that made formalized. We do think that there is a real need for providers to have some kind of representation in that process, because there is no formal process for representation in the HCPCS panel whatsoever. I think that is a major issue for us and for all the provider community.

DR. COHN: One final comment. I know Kepa wants to wrap this one up. That has to do with a comment in your testimony about a letter you were going to send to the DSMOs related to the professional pharmacy services.

DR. KAPLAN: Oh, yes.

DR. COHN: Would you cc us on that letter, since that seems to be on our issue list also?

DR. KAPLAN: Thank you. Yes, I will. Thank you.

DR. COHN: Thank you.

DR. ZUBELDIA: I want to thank the testifiers for their testimony and answering the questions. I would ask you to not go away yet. We are going to have another panel, and then after the break we are going to have 45 minutes of committee discussion during which you may be asked additional questions or contribute some additional information, so if you could please stay.

We are ready for the next panel, which is a pretty busy one. We have five people on the panel. So let's think about a two or three minute break.

(Brief recess.)

DR. ZUBELDIA: Let's continue with the second panel this morning, talking about the industry perspective on the gaps in the code sets. We have five members in the panel. I am going to ask, please limit your testimony to the time allocated; we are already running late, and we need to have enough time for questions and discussion. So let's see if we can control the time a little bit. It is ten minutes each for the oral testimony, and then we have some time for questions. If the ten minutes turn into 15, then we won't have any time for questions.

Let's start from our left to the right. Introduce yourselves before you testify. Alan?

MR. SHUGART: Good morning. Thank you for this opportunity to testify before this committee on gaps in the current HIPAA medical code sets issues. The gaps under discussion are alternative medicine presented by Alternative Link, home infusion procedures presented by National Home Infusion Association, and mental health presented by the American Psychiatric Association.

My name is Alan Shugart. I am the Director of Systems and Operations, Office of Operations and Eligibility, Medicare Care Programs, State of Maryland Department of Mental Health and Hygiene. I am here today to testify on behalf of the State of Maryland Medicaid program and the National Medicaid EDI -- NAMI -- work group. My background is Medicaid claims and data processing with the State of Maryland. I serve as the state representative for the National Association of State Medicaid Directors, to the Center for Medicaid and Medicare Services and to the alpha numeric HCPCS work group, and as a state representative to the Medicaid systems technical advisory group to the CMMS.

My statements will respond to the questions posed by this committee, and will address each of the three different gaps under discussion.

Are states seeing billing for these types of services? If so, how? Unfortunately, I did not receive any response that would indicate whether or not other states are seeing billing for alternative medicine. Several comments have been received regarding the need for the establishment of codes for alternative medicine. In Maryland, if the services are being billed today, they are being billed with local codes.

In Maryland, we process home infusion services electronically through our pharmacy point of sales system. The claims are currently submitted in the current NCPDP 3.1 format using NDCs. It is planned for these claims to be processed through the HIPAA compliant NCPDP 5.1 transaction set.

I have received comment that other states are using coding structures for home infusion programs similar to the HIEC set within their local code sets. The response I have was that the HIEC methodology is considered good and the structure is easy to understand.

For mental health, in Maryland mental health claims are submitted using ICD-9 diagnoses with professional services billed using CPT-4, HCPCS or local codes, and institutional services are billed using the EB-92. At least one state is currently using DSM diagnoses. Therefore, they will be facing some gaps when they implement the ICD-9 diagnoses as required through HIPAA, since the DSM codes cannot be added to the standard transactions.

Two. What would benefit the states the most, the addition of these codes to the HIPAA medical data code sets, the addition of the code sets to the existing HIPAA medical data code sets, or the codes not needed at this time? I will address each of the three.

It would be easier for the states and the providers to have these alternative medicine codes included in the existing named code sets of CPT-4, CDT or HCPCS, as long as they are expeditiously added. To add another code set would add complexity. I received comments that the codes for acupuncture, massage therapy or naturopathic medicine would be a good addition, but that there are a lot of codes in that code set related to small increments of nursing time that appear complex and may not be useful.

It would be easier for states and providers to have the codes for home infusion named code sets added to CPT or HCPCS, as long as they again are expeditiously added. The other option is to allow home infusion services to be billed through NCPDP in the pharmacy system.

I received comments that it would be better if DSM could be included in the ICD-10 structure, and that it should not be however implemented until ICD-10 is adopted. Please note in my previous testimony before this committee, it was my recommendation that ICD-10 diagnoses should not replace ICD-9 until two to five years following the October 16 HIPAA implementation date. That of course would affect -- if included in ICD-10, would affect DSM.

I would also like to comment, although not directly addressing this, as part of the collaboration between the state Medicaid, the mental health and state substance abuse programs, CMS, HIAA and the Blue Cross Blue Shield Association concerning the creation of national procedure codes for mental health and substance abuse services.

Third. Are there problems with HIPAA procedures for addressing gaps in the code sets that need to be brought to the attention? I believe that it is too late now, but in anticipation of the number of requested changes that HIPAA would require, all code maintenance committees should have developed an expedited process to address gaps in code sets that was caused by the elimination of all local codes.

The process to address the elimination codes has been very labor intensive, slower than anticipated, and may result in extensive work-arounds.

Are there other gaps that need to be brought to the attention of the subcommittees? Some thoughts are that there are some ideas expressed about using universal product numbers, UPINs, for medical equipment and medical supplies. The Medicaid programs have identified the biggest gap as being lack of national codes for medical supplies and medical equipment. Supplies and equipment represent the largest number of local codes that all Medicaid programs were addressing.

There has been a tremendous amount of work to address the development of national codes and significant collaboration between NEMI, CMS and the medical supply and equipment industry, but no one is confident that the establishment of these national codes will be accomplished by the deadline. A significant amount of manual processing may be required to properly pay these claims where today they were local codes and in the future, they have to go to a generic code.

The last area is Medicaid home and community-based services waiver programs that include both health and non-health services. To insure uniformity of processing and reporting, the non-health services such as home and vehicle modifications and homemaker services will need to be incorporated into the standard code sets. The current code sets should be adequate to meet the needs of these programs.

The one thing I perhaps would also like to add if it is appropriate would be to address the issue of the possible replacement of the ICD-9 Volume 3 procedures with ICD-10 PCS that the subcommittee addressed yesterday.

Many of the states currently use ICD-9 procedures on outpatient claims. On behalf of the states, I would like to request that the subcommittee consider allowing this code set to be used on standard outpatient transactions. Further, it is my recommendation that if the decision is made to replace the ICD-9 procedures with ICD-10 PCS, that the implementation should occur at the same time as the implementation of ICD-10 diagnosis. As stated above, that would be from two to five years following the October 16 deadline.

Thank you for this opportunity.

PARTICIPANT: October 16 -- ?

MR. SHUGART: 2003.

MS. LEON-CHISEN: Good morning. I am Nellie Leon-Chisen, Director of Coding and Classification at the American Hospital Association. On behalf of our nearly 5,000 member hospitals, health systems, networks and other providers of care, I would like to thank the subcommittee for the opportunity to provide comments to you today on the gaps in the current HIPAA medical code sets.

The AHA has worked with HHS, CMMS and NCHS to insure appropriate interpretation and application of ICD-9CM codes. We have also worked with HHS and the American Medical Association to insure that the same level of integrity and quality is achieved in the hospital application of CPT and HCPCS.

Standardization of clinical codes is extremely important to our members, particularly as they relate to the transaction standards identified in HIPAA. Hospitals and health systems are opposed to diverse reporting requirements for each of the clinical codes being considered by the subcommittee today, because it is costly and burdensome to deal with more than one code set. In addition, wide variations in the use of the clinical code sets compromise the primary purpose of clinical code reporting, which is to provide an accurate record of the patient encounter.

I will briefly now address the current code sets. At the present time, we see no gaps in the current HIPAA code sets that could not be addressed by first approaching those responsible for maintaining the designated clinical code set standards, namely ICD, CPT, HCPCS and CDT. We strongly support the current coordination of maintenance process for ICD-9CM diagnostic and procedural codes. ICD-9CM has a well-defined and effective maintenance and implementation process. This process is open, broad based and it strives to take into consideration the needs of all users. Committee meetings are routinely scheduled and open to the public. Proposed changes are well publicized on an annual date certain for adopting the approved coding changes.

The AHA is encouraged by the recent efforts of the AMA's CPT editorial panel 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 two update process.

Recently, public meetings have been held for the discussion of proposed durable medical equipment -- DME -- HCPCS codes. However, there is no comparable process for the remainder of the HCPCS codes.

The code development process for all codes should be sensitive to the needs of all users, capable of recognizing shifts in organized delivery systems, structured and with easily accessible instructions on proper code usage. These instructions should be understandable by a variety of different provider settings and maintained through a clearly defined organizational structure that is capable of achieving a high level of coding integrity. Providers should be able to rely on routinely scheduled meetings in order to review coding changes and to identify the implementation date for when approved coding changes take effect.

Our members tell us that ideally, coding changes should occur no more frequently than once a year. Providers should be able to utilize the same code set version over this given period. The use of this version must follow a consistent implementation date across all users, including payors.

Those responsible for maintaining codes should make the code request procedures available to the public, so that users not currently familiar with the process may easily maneuver their way through the code proposal process.

Code maintainers should be acutely aware of the need to also have a broad based process that is receptive to the needs of all users, not just their traditional users. For example, CPT, long considered by many to be originally designed for physician use only, is now a reporting system that must take into account the needs of non-physician providers, especially when making decisions regarding new code proposals. The CPT editorial panel decisions regarding codes should not be based only on how much physician work is involved in a particular service, but rather on whether there are sound business needs or other data collection and reporting requirement needs when it comes to approving a proposal.

The subcommittee has specifically requested input regarding coding for mental health, alternative medicine and home infusion procedures. I will now address each of these areas individually.

With regards to mental health coding, our members currently use ICD-9CM to report mental health diagnoses and conditions. The DSM is used primarily by psychiatrists as a diagnostic tool for assessments. In recent years, several proposals approved by the ICD-9CM coordination and maintenance committee now make ICD-9CM more compatible with DSM. In addition, there is a crosswalk available between ICD-9CM and DSM-4, as well as published guidelines for using the crosswalk.

We believe that ICD-9CM currently meets the needs of hospitals and health systems for reporting mental health diagnoses and conditions. As we heard earlier from Dr. Mirin, the actual code numbers used are identical between ICD-9CM and DSM-4.

ICD-9CM is sufficient for hospital coders. As we know, hospital coders are not allowed to diagnose patients on their own. They base their coding on the documentation provided by the physician.

So in many ways, we see DSM-4 being slightly related to the documentation guidelines that are available for the ENM codes that CPT has. There are clinical criteria for assigning the codes, but we believe that ICD-9CM codes are sufficient at the moment.

With regards to alternative medicine coding, Congress established the National Center for Complementary and Alternative Medicine, NCCAM, as part of the National Institutes of Health in 1998. According to information provided on NCCAM's website, complementary and alternative medicine is generally defined as those treatments and health care practices not taught widely in medical schools, not generally used in hospitals, and not usually reimbursed by medical insurance companies.

Approximately 15 percent of community hospitals in the United States provide complementary and alternative medicine services. When they do provide such services, however, the consumer generally pays for them. As such, the HIPAA electronic transaction standards would not apply to these type of services, since an electronic claim is not submitted to a health plan.

However, we are sympathetic to the needs of providers who may need a method to codify and classify alternative medicine services for other non-reimbursement related needs such as research, benchmarking, public health tracking, et cetera. In addition, if therapies currently considered complementary medicine are more widely adopted or covered by traditional insurance, there could be a need to report those services by hospitals and other providers.

Therefore, we strongly urge providers of complementary and alternative medicine services to develop and present code proposals to the maintainers of the existing HIPAA medical code set standards. We oppose alternative coding systems that are proprietary or copyrighted, which would add to the already significant expenses incurred by providers to submit claims.

In many instances, these coding systems also do not follow traditional or mainstream coding conventions, since many of these codes represent bundled or packaged sets of services. These codes may not only represent the service provider, but may have information regarding the provider type, the type of insurance coverage or licensure or state specific information.

With regards to home infusion procedures coding, some of the hospital and health systems provide home infusion procedures through their home care services. They have not reported to us a gap in the current HIPAA code sets. We have been encouraged that a substantial number of new home infusion codes have been implemented in CPT-4 and in HCPCS for 2002. If additional gaps in home infusion procedures are identified in the future, we support the addition of these services into existing HIPAA medical code sets.

Again, thank you for the opportunity to present comments to you today. I will be happy to answer any questions you may have.

MR. BEEBE: Good morning. My name is Michael Beebe. I am the director of CPT at the American Medical Association.

I do not have any written comments, as I will essentially be summarizing and moderately expanding my rather lengthy and verbose comments from February that you all suffered through.

The AMA believes that the current process for the selection of standards and transactions and code set standards under HIPAA has been successful. Data standard maintenance organizations and the National Committee on Vital and Health Statistics have done a tremendous job of reviewing the myriad suggested revisions to the existing standards and petitions for new standards. The final recommendations for changes to the existing HIPAA standards have been prudent and well conceived.

The AMA agrees that the addition of new medical code sets will be disruptive and confusing to users. It is important that existing gaps in the existing data code sets first be remedied by the existing standards.

The AMA and CPT editorial panel recognize a responsibility as a national medical data code set to work with these other groups. The AMA and the CPT editorial panel have taken steps to enhance the overall CPT maintenance process to expedite review and to deliberately include new groups.

CPT code change proposals, instructions for submitting proposals and the panel's schedule with submission deadlines are all available on the AMA CPT Internet site. Information can be downloaded and code requests can be submitted via e-mail to CPT staff. In addition, the AMA is in the process of developing and updating our website, so that the public can view the panel meeting agenda and electronically comment on issues. This site will also allow CPT advisors to review and comment on code change proposals electronically, and for panel members to download agenda books offline. We believe that these changes will all help to expedite the CPT process.

As always, anybody can submit a CPT code change proposal, and we encourage all users of CPT and prospective users of CPT to work with the panel to correct any deficiencies or shortcomings in CPT.

In response to the CPT-5 project, panel meetings are now open to all participating national medical specialty societies as well as the health care professionals advisory committee, which includes American Nurses Association, the Occupational Therapy Association, the Physical Therapy Association, Podiatric Medical Association, Chiropractic Association, the Speech, Language and Hearing Association, physician assistants and dieticians.

The panel is also in the process of reviewing options with the assistance of a consultant to further open panel deliberations and advisory input, while maintaining a confidential and rigorous peer review process. We believe the confidentiality of the panel decisions is important to preserve the integrity of the editorial process when reconsideration and refinements are part of the development process for a quality code set. We also believe confidentiality is important to maintain the industry-wide annual update schedule.

One issue from the CPT-5 project was an attempt to prepare the CPT code set for the elimination of local codes. Part of this effort was a survey that went out to private payors to determine why local codes are being developed, and to capture a set of local codes for possible inclusion in CPT.

Based on this survey, the CPT editorial panel, working with payors and the home health community, developed an initial group of home health codes. Further refinement of this group of home health codes occurred with the assistance of Blue Cross Blue Shield Association.

We became aware of HIEC. We worked with HIEC in August of 2001 to further refine the codes. The panel approved those recommendations in November of 2001, in time to get them out for CPT 2003. HIEC upon looking at their revisions made some additional changes, changed their mind about how they thought things should be done, and recommended those changes to the panel in February, just in time to get them in for CPT 2003 also.

At that time, the panel said these are significant new changes. Maybe the most prudent thing to do would be to re-establish the home health and home infusion work group. That home infusion work group has been re-established to examine all coding issues in this area and further refine the CPT codes.

In addition, we are also working with Alternative Link, indeed, have just begun to do so. I think in the case of both HIEC and Alternative Link, it has been a very good learning process for the panel. The HIEC codes initially were very different from CPT codes or HCPCS codes. I think after sitting down and talking with them, working with them, we have realized that we can meet their needs with a combination of HCPCS codes and CPT codes, to cover the services, to cover the supplies and the equipment. We will continue to do so.

With respect to Alternative Link, the CPT editorial panel is currently uncertain of how these codes are currently being billed, but we definitely are looking forward to work with Alternative Link in the future and learning more about the needs of alternative medicine providers.

That is all I have to say. I'd be happy to answer any questions you have.

DR. ZUBELDIA: Thank you.

DR. MC CABE: Good morning, Mr. Chairman, members of the committee. My name is Dr. Susan McCabe, and I am here this morning representing the American Psychiatric Nurses Association, the International Nurses Society on Addictions and the International Society of Psychiatric Mental Health Nurses. I believe you all have a copy of the written testimony, in addition to a brief two-page fact sheet.

These three professional nursing organizations represent psychiatric nursing nationally and internationally and work collaboratively to influence health care policy to promote equitable, efficacious mental health care for individuals, families and communities.

It is our belief that care provided by advanced practice psychiatric nurses is distinct and different from care provided by physicians. Advanced practice psychiatric nurses practice based on a distinct body of scientific knowledge different from medicine that has been built on theory and tested through research. Psychiatric nursing is necessarily holistic and considers the health needs and strengths of individuals, families, groups and communities, rather than being oriented exclusively to illness.

The advanced practice psychiatric nurse is a licensed registered nurse, educated at at least the master's degree level and oftentimes holding a doctoral degree. Advanced practice psychiatric nurses function in independent autonomous care roles reflective of the distinct body of nursing knowledge and are often the primary providers of mental health services to their patients, providing such care as diagnostic evaluation, psychotherapy, prescriptive authority, and ordering and managing patient medication regimes. Many have inpatient admission privileges, and advanced practice psychiatric nurses are reimbursed for these services through many third party reimbursement systems.

The advanced practice psychiatric nurses provide a wide spectrum of services, caring for children, adults, older, family, communities, underserved, uninsured, chronically ill and disabled. Advanced practice psychiatric nurses can be found in hospitals, clinics, soup kitchens, high school classrooms, battered women's shelters, detox and drug and alcohol treatment facilities.

But while some of our psychiatric nursing care practices include shared actions also performed by physicians, most care activities performed by advanced practice psychiatric nurses are distinct and unique activities.

As a representative of the three largest national and international psychiatric nursing organizations, we wish to express our belief that there is a substantial gap in the current code set recognized by HIPAA. We believe that those gaps make it impossible for psychiatric nurses to document their care accurately, making it impossible to trace the health outcomes of that care, and that the gaps culminate in care that is disconnected from outcome measurement, and that makes it difficult for us to control costs of care for our patients.

Our belief is based on the following. The current code sets recognized by HIPAA are assumed to include standard vocabularies, terminologies and classification systems that name many of the diseases, procedures, medical problems, supplies and services encountered in the health care industry. While required to use these currently, psychiatric nurses have had very little input into the development of these code systems, and have currently no role in offering, maintaining or authorizing these sets. Yet, we are required by HIPAA to use these very sets to code the clinical practice in which we engage.

These code sets are medically oriented to physician based care and to concepts of illness rather than health. While physician based models of care have traditionally been viewed as the prototypic delivery system, attention to managed care concepts, other cost containment strategies, legislative and regulatory changes and responsiveness to consumer demands have propelled the development of nursing based models of care.

Nursing's orientation and nurse-based care focuses on health as well as illness, and nursing actions are different from physician actions. Models of care based on advanced practice psychiatric nursing have been demonstrated to be efficacious, cost effective and well received by consumers, yet are poorly reflected in the HIPAA code sets.

We believe that currently adopted sets to not accurately reflect the work done by psychiatric nurses. Examples of this include the CPT and ICD codes do not adequately capture psychiatric nursing interventions such as health promotion and health maintenance interventions. Things such as general health assessment, assertiveness training, stress management, anger management, parenting classes, general health teaching, preventive activities that mediate the potential complications related to the symptoms of mental illness and adverse treatment effects.

This means for example that we are unable to code for a common psychiatric nursing care activity such as preventive family education that is not therapy without using a collateral therapy code. We are unable to code for promotion, self care interventions such as weight management programs, promoting recreational activities, and facilitating development of the practical skills of community life such as shopping, managing a checkbook and using public transportation.

This means for example that we are unable to code for common psychiatric nursing care activities such as the development and implementation of a weight management program for a schizophrenic patient who is at high risk for developing diabetes as a consequence of his medication treatment.

It means we are unable to code for psychobiological interventions such as relaxation techniques, sleep/rest scheduling, other semantic complementary therapies, including diet and nutrition regulation, hypnosis, therapeutic touch, meditation, guided imagery and the use of light therapies. This means that we are unable to code for common psychiatric care such as nutritional education and counselling for a patient with anorexia nervosa or bulimia. We are unable to code for psychiatric rehabilitation interventions provided by the psychiatric nurse, such as actions targeted towards functional improvement in the person, the development of life skills, increasing use of environmental supports, and the design and implementation of mental illness prevention interventions such as screening and at-risk evaluations. This means for example that we are unable to code for common psychiatric nursing care activities such as relapse prevention and the recovering and alcoholic adolescent.

We believe the CPT and ICD-9 code sets are focused on interventions done by physicians for illness. While psychiatric nurses focus on illness, we also focus on health, and have no code set that directly identifies these actions.

Other concerns with the current code set. The ICD-9 code does not capture functional disabilities that are often drivers of high health care costs. Examples include patients who lack the ability to care for their daily needs, such as feeding themselves, obtaining and maintaining adequate housing, or administering medications to themselves. These patients often require more nursing time in order to have adequate outcomes.

Since there is currently no way to code these functional problems using the ICD or the CPT codes, costs associated with this care have shifted to receive adequate reimbursement. The lack of coding leads to the loss of detail about patient need, the loss of opportunity to manage fully the needed health care services, the inability to fully track health outcomes, and relate them in meaningful ways to the care really rendered.

The ICD codes are antiquated and are less useful for psychiatric nurses than the DSM-4 in describing mental disorders. The DSM-4 is better than the ICD-9 code set from our perspective. The DSM-4 is modern, empirically tested, and current. It gives detailed criteria for making a diagnosis not available with the ICD-9 codes. Yet adoption of the DSM-4 codes does not resolve the issue of physician oriented code sets, and would still leave psychiatric nurses with no way to code many of our health maintenance, health promotion care activities.

The bottom line, psychiatric nurses are currently applying code sets that do not reflect our practice and the care we provide. The lack of appropriate code sets forces us to attempt to squeeze our care practices into existing code sets that do not fully reflect our practice. In so doing, we are forced to make sometimes arbitrary and imprecise decisions to match care actually provided with non-representative codes.

Because the code sets poorly reflect the state of nursing science and provide no mechanism to accurately code the totality of the care delivered by psychiatric nurses, we are not able to reflect our care. This reality restrains our practice to those things that are coded, which usually are shared care practices rather than our unique care practices. This limits our reimbursement for well documented, efficacious care practices for which no code exists. It limits our ability to measure the outcomes of our care, as collected data poorly reflects the care we provide. Without specificity, important details for analyzing the delivery of mental health services are lost, and important details for costing health care cannot be maintained.

If forced to continue to use only CPT and ICD codes as they currently exist, the mental health field will have a difficult time deriving outcomes from our care. We all need to have a coding system where outcomes are clearly identifiable and allow for altering care practices based on outcomes in order to improve quality while controlling costs.

What is needed? Using the current HIPAA recognized code sets is very time consuming for advanced practice psychiatric nurses. It is burdensome, does not improve our efficiency, and constrains our practice. Psychiatric nurses need a code set that embraces the care practices that are distinct and unique to nursing and that have been demonstrated to be efficacious, cost effective, and that produce positive health outcomes.

We believe a significant gap exists in the currently recognized code sets, that changes in those code sets are required and psychiatric nurses need to be included in the planning as new codes are refined or put into place.

We do not advocate for a code set exclusively to us. We are asking for inclusion into what we believe are currently exclusionary code sets.

I thank you for your time this morning and would be happy to answer any questions.

DR. ZUBELDIA: Thank you. Maria?

MS. WARD: Good morning, Mr. Chairman and members of the subcommittee. My name is Maria Ward, and I am the chair of the designated standards maintenance organization steering committee.

As you know, the DSMO steering committee includes members of ASCX-12N, HL-7, the National Council for Prescription Drug Programs, the National Uniform Billing Committee, the National Uniform Claim Committee --

DR. COHN: I'm sorry, do you have copies of your testimony?

MS. WARD: I brought them this morning. I think they were handed out, Simon.

DR. COHN: I'm sorry to break in.

MS. WARD: That's okay. Does everybody have one that would like one? Is it okay to proceed?

DR. ZUBELDIA: Go ahead.

MS. WARD: Again, naming the members of the DSMO steering committee, including X12-N, Health Level 7, the National Council for Prescription Drug Programs, and National Uniform Billing Committee, the National Uniform Claim Committee and the dental content committee of the American Dental Association.

On behalf of the DSMO steering committee, I would like to thank you for the opportunity to provide the subcommittee with an update on our process for adjusting requests for new code sets to be added as standards under HIPAA.

I am compelled here just for a minute to make a clarification with reference to something that was mentioned this morning. The AMA and AHA and ADA are not members of the DSMO steering committee, although they are involved through the National Uniform Billing Committee and the dental content committee, but that is an important distinction to make. Just for the benefit of the subcommittee, I want that to be understood as we go forward.

As you know, for the past 16 months, the DSMO has been addressing requests for changes to the transaction standards adopted by HHS for HIPAA. During that time, we have seen requests made by individuals, organizations and associations. While the majority of requests pertain to actual data elements that are used in the X-12 and NCPDP implementation specifications, we have also had several requests to add new code sets as standards under HIPAA.

These requests are included in Attachment A, and that is actually the information that Lynn Gilbertson gave to you in February. It is essentially just a list of the different requests that have come through the process so far relative to code set additions.

After reviewing and discussing the first several requests relative to additional code sets, the DSMO recognized the need for creating a document that will provide guidance to all involved in this process. The intent of the document is to outline the steps the submitter should follow, provide information of what organizations are available to them, and present a series of questions the requester should answer before entering a request into the change request system.

While the document is still in development, I have identified its major components below. Upon completion, the document will be available on the DSMO website. It has also come to our attention recently that WIDI SNP has a team that is developing a white paper on code set maintenance. While the process addresses additional code sets versus maintenance, we will be providing this team with a copy of our deliverables so they can be incorporated as appropriate into the WIDI SNP paper.

What follows, the next two and a half pages, are essentially the major components of this process that we are developing to assist the public with code set requests.

Number one. On the DSMO website we are providing introduction to the issue, including an executive summary of what is being addressed. This is intended to provide background for the requester, as well as familiarize them with how code set requests are handled differently from requests for changes to the implementation specifications.

Number two. We will produce a document outlining the framework for how the DSMO steering committee is going to work with the national code set maintainers. We believe that it will be beneficial for this framework to include things such as having the chair of the DSMO send a letter to all code set maintainers named in HIPAA. This letter will explain our role and charge for maintaining the standards under the MOU. It will also explain how the DSMO is advising requesters that have code set issues to proceed.

Establishing a liaison between the DSMO steering committee and each of the named HIPAA code set maintainers. There are several logical possibilities in this regard, such as someone from the dental content community as liaison to the CDT and someone from the National Uniform Claim Committee as liaison to CPT. This will allow us to bridge any potential gap that may occur between what a requester of a new code expresses to the DSMO and what they need to present to the code set maintainer.

When appropriate, these liaisons will work directly with the code set maintainers in matters regarding any DSMO code set request. They will also report back to the DSMO steering committee on a regular basis.

We will post the process for requesting that a code set be recognized as a HIPAA standard to the DSMO website. This process will explain among other things the intention of the DSMO with regard to facilitating the expansion of code sets named as national standards under HIPAA. We will emphasize that all requests for new code sets must first be addressed with all appropriate existing code set maintainers before we can consider the request to add a new code set.

Agreeing to consider such a request does not imply that the DSMO will recommend the addition of that code set. As with all DSMO recommendations, the NCVHS will also have an opportunity to review the DSMO decision. If after the requester works with the existing code set maintainers it can be demonstrated that the business need has not been met, the requester will be advised to submit the request through the DSMO process.

It will be a requirement of any request to recognize a code set as a HIPAA standard, to include a report on the work they have done with the existing code set maintainers. This should include documentation regarding the code set maintainers that were approached, the outcomes and the reasons why the solution was unacceptable or the request was denied. The process will then identify the next steps for entering a request for new code sets to be added under HIPAA.

The next steps noted above include the requester entering the change request into the change request system. They will select change request system option on the website, and at that point select from a dropdown box, add a national code set. The steering committee at this point is also considering other options in additional to just adding a national code set.

As is currently the case when a selector selects claims attachments or NCPDP selection, the selection of a code set option will trigger a questionnaire for the requester to complete. The requester will have to complete the form in order to make the request and be assigned a change request ID number. If the questionnaire is properly completed, the request will be added and considered by the DSMO in the next monthly batch. If all required questions are not answered, an error message will appear, indicating that they need to answer all the required questions before a change request ID number can be assigned.

The DSMOs are currently developing a questionnaire that will be added to the change request system. Questions under consideration or issues to be addressed include, have you addressed the business need for adding this proposed code set with the appropriate code set maintainers named in HIPAA? At which point, we will also list those maintainers and contact information. They will have an option of choosing yes or no. If no is selected, the requester will be advised to read the material in the DSMO website regarding code sets and instructed to contact the appropriate code set maintainer. They can also contact an individual DSMO directly if they need additional guidance. Also, if no is selected, the requester will not be able to continue entering a change request.

If yes is selected, the requester will be able to continue entering the request, completing the questionnaire. If yes is selected, the following questions will need to be answered.

The first one deals with demographic information, details of which we are still working through, but things like the requesting organization, contact information, et cetera. The second question, they will be asked to state a business case for adding a new code set. Within that, we will have additional sub-questions that will deal with things such as what entities are affected by this code set request, what percentage of the overall business is affected by the code set request. They will be asked to provide documentation regarding the code set maintainers that were approached, the outcomes and reasons why the solution was unacceptable or the request was denied.

There is a note here that says that we do also have on that website a U.S. postal mailing address if people want to send in hard copy information about any of their past experiences with code set maintainers.

We will ask if an appeal has been filed with the code set maintainer and if so, what the outcome was, and if not, why that path was not pursued.

There are additional questions that are being considered, and we are currently in the process of trying to flesh that out and come up with a comprehensive set of questions.

In summary, the DSMO steering committee recognizes the benefit of having a more structured process relative to considering additional code sets as HIPAA standards. We believe we are being responsive to this need while at the same time continuing to adjudicate the monthly batches of requests, even those regarding new code sets, in a timely manner. It is our intention to have this process defined and available to the public soon. The DSMOs intend to see this completed and available to the public in May of this year, providing our website maintainer can make the changes as soon as we are ready.

Thank you again for the opportunity to share our progress in this important issue. I certainly welcome your input, and I look forward to answering any questions.

DR. ZUBELDIA: Thank you, Maria. Thanks to everybody on the panel. This is a very interesting part, complementing what we heard in the previous panel with the industry experience.

I would like to start with a question. I can't find it now. I will turn it over to Simon until I can find my question.

DR. COHN: First of all, I have a question for Maria. First of all, I want to thank you for putting so much thought into the process about how to deal with code sets and code set requests. I think this will obviously be helpful to everyone, especially its publication and dissemination.

Now, one question I had as I listened to all of this -- and this is probably my own reflection of the issues that I have been hearing from people coming forward asking for code sets -- typical people come with a business need. Sometimes they have developed a code set and the question is now, how to meet those new needs.

I am just reflecting on one example I was thinking of, where it turned out that there needed to be a fair amount of analysis or probably should have been a fair amount of analysis at the very first step, to identify what part of the business need needed to be part of a medical code set versus what parts might for example be handled by the taxonomy codes or other types of solutions. How is that going to be handled in this process?

MS. WARD: I think initially, our inclination is to understand why there are not folks coming forward with new code set requests, have had conversations and addressed this need with existing code set maintainers.

You have heard today testimony both for and against adding individual new code sets or trying to incorporate the current needs into the existing medical code sets. I think our inclination is to say, we have to at least know that that has been considered, and know what the dialogue was around whether or not it is appropriate to try and add and accommodate those code set needs in the existing medical code sets.

DR. COHN: Right, but what I am asking is, sometimes the needs are not spanned. There is a standard transaction, a code set may address one field, and it may require a couple of other fields to be handled to meet that.

MS. WARD: Right.

DR. COHN: I am just trying to think of how you handle that, or how we need to handle it.

MS. WARD: I think what you are suggesting is that the DSMO committee would have to upon receipt of any request for an additional code set thoroughly review that code set and the documentation, versus taking a first step up, saying have you talked and worked with CPT, have you talked and worked with HCPCS.

DR. ZUBELDIA: Maria, I think the question is more similar to a situation we have with vision, where they need a code set, and the process for billing vision services where they have different components of the lenses and the frames and all that and the service, and how are they going to structure the billing around a code set? There are two different components.

DR. COHN: That is a good question.

MS. WARD: Vision is a whole different conversation, Kepa, and you and I have been involved in it for quite some time now. I am not sure that a code set is the answer for the vision problem. I think there is a lot of work that needs to be done before we make that decision.

DR. ZUBELDIA: You have a structured mechanism to resolve that sort of issue, where the code set is not enough, there has to be another component. How is that addressed?

MS. WARD: That would be, if a request came through the process, as the process is right now, that would be something that the committee would have to discuss as a committee. Or actually more technically correct, the DSMO members that choose to participate in that particular discussion because they feel it is something that affects their domain and their constituents.

That is another point of clarification. I think if I can take a step back just for a minute, in a general response to a lot of the comments that were made this morning, there is a big education issue here around how the process works, what the process is intended to do.

There were comments from the HIEC testimony that only the NUBC and the NUCC were actively engaged and the others weren't. I don't know the request specifics offhand, but that is more than likely because those were the two that opted in on that particular request. So that was appropriate for them to be the only ones engaged.

So if a request comes in and a number, two, three, four, five or all of the organizations feel that they have something to contribute to that, and the conclusion of that affects their constituents and deals with their domain, then all of those organizations would, as our process provides right now, have that conversation.

I don't have specific answers for you, other than to say that if as an organization we feel it affects us, we would be part of the discussion through the DSMO process.

MR. BLAIR: I think this question is addressed to Maria and to Michael Beebe. That is, help me understand a little bit more, if a new code set comes to the AMA or if a new code set comes with their appeal to the DSMO process, in both cases, one of the criteria is that there is a business need, how do each of your organizations assess or determine whether there is a valid business need for a new code set?

MS. WARD: I can briefly answer that, Jeff. That is something that we are trying to work through right now as we come up with our guidance and our criteria. So I don't have all of the answers to that for you at this time.

DR. BEEBE: A business need in CPT-speak I would translate as a service that is being performed by a large number of health care professionals across the country. That is how we would define what a business need is, something that is being done by health care professionals throughout the United States.

MR. BLAIR: Help me, Michael, because I don't understand these things well enough. Wouldn't that almost by definition preclude a code set that addresses complementary and alternative medicine?

DR. BEEBE: I don't believe so. We currently have chiropractic codes in CPT for chiropractors. We have osteopathic codes, osteopathic manipulation. We have codes for acupuncture in CPT. If anybody can demonstrate that it is a service that is being performed by a health care professional throughout the country, then it will be seriously considered for a CPT code.

MR. BLAIR: When you say a health care professional, and I'm not familiar with a number of the practitioners that Melinna mentioned, but do you consider the practitioners of Oriental medicine and -- and again, I don't even remember the names of all of them -- are those considered to be health care professionals?

DR. BEEBE: I think for the CPT process and for the editorial panel, they would be considered to be health care professionals. The AMA is a different story.

DR. HUMPHREYS: Just to follow up on this a bit, Jeff's question, the HIPAA code sets, come 2003, are all there is. So if there are five states in the country where there are providers in those states that are being built and transactions are going back and forth in those five states for procedures which have not yet been accepted and therefore, we couldn't say that they have national adoption, but if these people are going to have electronic transactions, those procedures have to be covered in some code set, or they will be out of luck, because they will have to send a form when everything else is electronic.

So I do feel that there has to be a view of what is a business need, and it would seem to me that if there are players in this whole system, insurers, providers, whatever, who are sending around electronic transactions for procedures which are legal where they are being performed in the United States, that we can't have a coast to coast requirement, or it will bring the system to a halt.

DR. BEEBE: It is not a strict coast to coast, 50 state and territories kind of requirement. It is a state that is being done by more than just one practitioner in New Mexico or one practitioner in Florida. Certainly if it is legal according to a state law to do this for that entire estate, then that would certainly meet CPT's requirements.

MR. BLAIR: Help me with one other piece on this. This will be my last question on the subject here. If we have a situation where there is a code set that is applying for alternative medicine, I think it makes sense the way, Maria, you have pretty much pulled together the process, to try to discourage a proliferation of new code sets, and for the first step to be to see if it could be accommodated within the existing code set. I think that makes perfect sense.

On the other hand, if the new code set developer is then directed to a code set organization where they don't have practitioners represented for the new health care domain, then it would appear to me -- and correct me if I'm wrong -- a way to delay, discourage the adoption of that new code set, and meeting that new business need, if they have to first go through the acceptance through an organization that does not -- in many ways by definition they will not meet the criteria for acceptance within that organization.

So I am wondering whether there could be some adjustment, some recognition, that if the practitioners are not represented within that organization, that there be some way for a new code set that meets a business need, to not be hung up and delayed and put into what appears to me to be Catch-22 situations.

For example, and again, correct me if I'm wrong on this, but I believe that the same person that represents the NUCC is also the same person that represents the AMA on many occasions. So it seems to me as if it is not a level playing field.

MS. WARD: From a DSMO perspective, Jeff, I would like to respond to that. I have had this conversation with other folks as well, people who have shared a similar perspective.

I can tell you that the NUCC's participation in the DSMO does not represent an AMA perspective. I sit and have a vote on the NUCC, as does Simon, as does the Blue Cross Blue Shield Association. So while one or two individuals may actually be employed by the AMA, who sit and have some position on the NUCC, the results and the decisions that are made by that committee as a committee are representative of the committee, not of the AMA.

I say that with confidence from the DSMO perspective. I don't think at all that it is an unlevel -- or not a level playing field with regard to what is happening in the DSMO. Furthermore, if I did think that, you would have heard about it a long time ago.

MR. BLAIR: For those people on the Internet that cannot see my head shaking in agreement, if Maria tells me that is so, I completely accept that.

DR. HUMPHREYS: I wanted to follow up a bit on something that Kepa said originally. I think that the process of helping to educate people and trying to have legitimate business needs met through existing code sets makes sense. But I do see a problem when people have a business need and may not have sufficient sophistication to know whether they should be asking for an adjustment or an additional data element or some other feature within a transaction set, or whether they should be applying to one of the code set maintainers.

So having discussed a variety of related issues over a long period of time with people who were interested in vocabularies vis-a-vis the OMLS project and other things that I am involved in, it is often true that people have a real point here somewhere, but they are not quite sure which piece of this overarching system addresses it.

So I do feel that you probably need something to help people work that through, rather than having them fill out lengthy forms, only to be told by the AMA that this is a transaction issue. I'm sure you are trying to address that in your educational materials.

MS. WARD: Yes. I think in putting all of this in context, this process couldn't be any newer. I know this committee knows that. So we are trying to as we start out make good decisions as we go forward, so that this works for the entire industry.

As did Kepa, you bring up a very good point. I think we have the expertise on the DSMO steering committee with the group of us to be able to have those conversations and consider that, and see if perhaps there isn't some sort of a parallel track.

One of the things that -- first of all, we don't want this to be a lengthy, time consuming questionnaire that is just so prohibitive, people don't even want to do it, because they have to go through a process. One of the things that might do is guide a requester through thinking through some things that might actually get them to be more specific about their request. That is the feedback I have gotten.

I also co-chair the claims attachment committee in the Health Level 7. We have that form out there for HL-7 on the DSMO website. X-12 doesn't have a form out there, they just have a text box. So if you want to request something for an X-12 standard, you just type it in and half the time, we sit around on the steering committee scratching our heads, trying to figure out what they really mean.

We have been told by requesters already who are entering requests for attachments that our form has forced them to go back, do their homework, think about their request, be very clear about the request, and when it comes through, it is very clear. So there isn't this, is it a code, is it a transaction.

So hopefully a form that help guide that a little bit, but you bring up a good point which we haven't discussed very much in the context of medical code sets, which is, what if there is a combination of issues about the transaction as well as the code set?

MR. BLAIR: Clearly, I have expressed anxiety and concern about a level playing field for complementary medicine. May I invite you to please either reassure me or correct my impressions or somehow indicate to me that my concerns or anxieties are not well founded, in terms of how the AMA might consider accommodating complementary and alternative medicine code sets?

DR. BEEBE: I'll be more than happy to, try to, at least. I would also like to respond to Betsy's question, and maybe in doing so, maybe I can help you out, Jeff.

I think if we look back at the experience that the editorial panels had working with HIEC, it is a good example of the kind of dialogue that needs to take place surrounding these new code sets.

Basically, what happened, we looked at their code set, they looked at our set. We didn't really understand each other, but we came to understand each other. We saw that we could help HIEC in certain areas, in terms of coding services, home infusion services. We also knew that we would not be able to help HIEC in other areas. They had an amalgam of identifying the actual health care professional providing the service, identifying the supplies, drugs for the service, as well as the service itself. We realized that in that amalgam, we could only achieve one portion of it.

So the provider taxonomy is going to achieve the other portion of it, the HCPCS code supplies equipment and drugs, will achieve the other portion of it. So I suspect that we are going to run into something very similar when we sit down with the alternative medicine folks. We are going to look at their code set, and they have 20 or 30 or 40 acupuncture services right now, we have two. Clearly, if there is a need for 30 different acupuncture services, we are going to expand our current services to address that need. Whether we are going to address acupuncture provided by an advanced nurse practitioner or an acupuncturist provided by an Oriental medicine specialist, I'll tell you right now, no. We are not going to say who the provider is who is doing the service. From our point of view, that is the job of the provider taxonomy codes.

So I think that we are more than willing to look at the actual services provided and want to help them out there, but we may not be the complete solution.

MR. BLAIR: Thank you, Michael.

DR. ZUBELDIA: Simon?

DR. COHN: Jeff, thank you for finishing that up, because I was actually going to comment on that. I have a question for Alan, but it is going to be on a different topic. You want to do a followup on that before we move on to a slightly different topic?

MS. TRUDEL: Yes. I think possibly one additional tool to crank into this analysis process is the NCVHS' own characteristics of a procedural coding system. That might be of use to the DSMOs as they begin to look at any requests for code sets that don't fit necessarily into the existing code sets. This may be of interest to the maintainers as well.

One of our requirements is that codes have to be setting and provider neutral, that codes have to be limited to classifications of procedures, no diagnostic information or other data elements are included. This kind of rolls right back into what I think Michael was just saying, and perhaps the committee's characteristics might be something that we need to make more available to people who are trying to assess these things for the Secretary.

MS. WARD: I would like a copy of that, Karen, if I could get that.

DR. ZUBELDIA: Marinna?

MS. GIANINI: I have been on the X-12 committee and was helping to develop that provider taxonomy until it moved over to the AMA. I believe that it is a very extensive list of practitioner licensure types, but it has no relationship to the legislative issues according to state statutes, administrative regs and case law.

What we tried to do is take all of those names and map them back into a core licensure issue, because the regulations are based on titles that the state gives the provider. Although that list is incredibly extensive, it has no relationship whatsoever to state law.

If you are going to have 663 different regulations governing one service, you need to really have an electronic way to find out if that service is allowed, according to fraud and abuse regulations, as an allowed service for that provider in that state. Unless you are willing to supersede state law, you have this issue with 13 licensed health care practitioners that we have coded so far, and probably ten more that need to be in there right now.

DR. ZUBELDIA: Yes, but do you agree that the provider taxonomy issue is separate from the procedure coding?

MS. GIANINI: I do. The procedure can stand on its own. If you however use the modifier along with the code to help you get into the information that exists in state laws, then you can electronically adjudicate a claim that would otherwise cost people hours, time, energy and put the provider and the payor at risk of processing a fraudulent claim, and high risk, not just small risk.

DR. ZUBELDIA: I would encourage you to work with the provider taxonomy work group in making sure that the provider taxonomy covers the needs of your providers. But that is separate from procedure coding.

MS. GIANINI: Right, and I agree. I just think that this is a technology that no one has seen before. I invite you to see how it works before you make a general judgment about, it shouldn't be because we have a rule.

I think that the intent of HIPAA is being met, because it reduces paperwork, it reduces fraud, it is more specific, and it does a lot of things that maybe nobody has ever thought about doing before.

We were developing this prior to all of these things that came on afterwards as rules that were going to be followed.

DR. ZUBELDIA: Thank you. Michael?

DR. BEEBE: I think Melinna just did a great job of summarizing my views of the critical importance of Alternative Link. That is, to achieve a link between procedures, providers of those procedures and state licensing issues that alternative medicine has to deal with across the country. They can do that on the back end to help process claims on the parts of payors. I think that is a tremendous value. That is the services they provide, and that is wonderful.

DR. HUMPHREYS: I do feel that it is the issue of -- I see a distinction in my mind between the standard code set or even the provider taxonomy and a set of additional services rules, algorithms, data that are put together and highly useful to the community, that basically determine whether a particular claim can be submitted in a particular state for a particular service.

I think this is an incredibly valuable service. I just think that there are only pieces of the information that it requires to make to use that fall within the definition of what is a HIPAA code set or even a provider taxonomy.

DR. ZUBELDIA: I would have to agree with that. We are running into that same problem with vision coding. There is at least three different ways. One is with an attachment, another is coded like compound drugs, another is with an implementation guide. They also need code sets, which they don't have.

There are different ways, and I think there has to be assistance to those groups to do the right thing.

Related to the topic, Susan, the question that I have that I misplaced is, what is the alterative that you have for your problem? You said that CPT and ICD-9 doesn't work. I'm not sure if you are proposing an alternative, if you are going to be working with the CPT editorial panel to build codes for you. What is the alternative? Is there a new different coding structure, or is it more than that?

DR. MC CABE: I don't think we are arguing for a new code structure. I think to me, the concept of the level playing field summarizes it best. I think the problem is representation and access to the current code sets.

Certainly, any group has the ability to propose, to ask. But I think the representativeness of who controls those panels is an important key point. What we are arguing for is inclusion, that there be a better ability to say please, may I, that you actually have some voice in there, that you are able to make it perhaps a little bit clearer, what you do and why you need it.

Right now frankly, many of those panels are physician controlled. I think sometimes there isn't a clear set of what we do and why this may be necessary. Our access and representativeness is limited, and thus we can ask, but we may never get.

MR. SHUGART: May I respond? Having listened to the presentation, the mental health associations have submitted codes to the HCPCS panel. They have been reviewed with Blue Cross Association and the Health Insurance Association of America. Those codes of course are still in the review process, but yet may still meet some of the very needs by listening to what is being described, because these were specific mental health codes to describe the services, many of which I heard were being requested here.

So I think there is not only of course the CPT issue, but even the HCPCS issue. And looking at that submission, that may be one way that some of the needs for the nurse association would be covered by the submission for the mental health. Those are still in process. I think there is hope that they would be out within a couple of months.

DR. ZUBELDIA: Simon?

DR. HUMPHREYS: I had a question. I keep forgetting what the current name of this classification is, Marjorie. So my question is whether, Susan, your groups have examined that classification and whether you would see that as -- if it were adopted, and this may be coming up more in a future hearing, but I am just curious, because you brought it up, whether you would see that as addressing your needs vis-a-vis functional status.

DR. MC CABE: Yes, I think that is a much closer strategy. The difficulty I think is a philosophical perspective. As nurses, we are much more perhaps health oriented, preventative oriented, than some of the other health care providers. >From that perspective, a lot of the preventative work occurs before a disease is diagnosed, before a person actually carries a mental condition.

There is great argument that that kind of preventative work clearly is cost effective. If you can do a parenting class before an at-risk child -- before he has a medical diagnosis, that seems to be a strategy that would be impactful. Yet, it is difficult within the current structure to code for that before you have a person diagnosed with illness. So any strategy that goes towards looking at health and coding for health would be something that would greatly enhance our work.

DR. HUMPHREYS: I listened to what Alan said, and I think this gets back to some of the issues that CMMS will be addressing in our next hearing. Maybe all the people who are interested in mental health services didn't even know that HCPCS was working on it.

DR. MIRIN: I am Stephen Mirin from the American Psychiatric Association. I just want to follow up a previous comment.

I think that there are a number of coding and definitional issues that do need to be addressed in an inclusive process. In fact, APA has just about a year ago begun the process of the development of DSM-5. This in fact is one of the key issues that needs to be addressed in the development of DSM-5.

So we would support that, although we think it would be less confusing if there was a single code set as opposed to multiple code sets that were used to diagnose and ultimately treat people with mental illness.

DR. ZUBELDIA: Thank you. Simon?

DR. COHN: This is on a different topic. This is for you, Alan. I was just reviewing your testimony. I actually had two questions.

Your testimony almost appears as though you are talking about other people, in terms of the code set developers. Yet I know that you sit on the HCPCS board.

MR. SHUGART: Yes, I do.

DR. COHN: So I guess I was A, surprised by your comment about the lack of national codes for medical supplies and medical equipment that you note as a major problem. Knowing that you are working in the HCPCS area, can you tell us about that just a bit? Then I have one other question for you.

MR. SHUGART: Okay. To address the DSM and DME area, I think when the Medicaid program started, there were about 25,000 codes that they had established through all the 50-plus states. Five to 7,000 of those were to explain supplies and equipment. There are differences in part because of reimbursement methodologies. Many of the services that are done at the generic level are very broad based. That is fine if that is how you reimburse, but if you are doing it on the cost base or the charges, to go from ten codes to explain one service and say this is the proper reimbursement becomes a little more complex, when you say this one is ten dollars, this one is eight dollars, this one is six dollars, which many of the Medicaid programs have done. We will pay the cost of it, or cost plus reimbursement, manufacturer's cost.

The Medicare policy or some of the codes that were originally established were more done on a reasonable charge. So the difference is the cost base or reasonable charge.

The supplies and equipment are more like national drug codes. There are thousands and thousands of those codes that you are having to adopt down to a much smaller level. And of course, some of the original codes were done from a Medicare perspective, whereas a lot of the services for Medicaid is child oriented.

I know from a pediatric standpoint there are differences for some of the supplies from pediatric to adult. Those are some of the distinctions.

DR. COHN: So what I am hearing from you is that HCPCS isn't going to solve this problem.

MR. SHUGART: They are still working on it. They are working with the national associations to try to establish -- it is still a ways off. Unfortunately, I think you get nervousness that people would like to have the answer today, not four or five months from now.

DR. COHN: A final question, and then I will stop, and we probably need to move to our next phase. I was reading your last paragraph, and I was somewhat astonished. Are you actually asking the NCVHS to consider whether ICD-9, Volume 3, should be used on outpatient claims?

MR. SHUGART: Yes.

DR. COHN: And this is a serious proposal that you are bringing forward now?

MR. SHUGART: That would be a consideration. Today for paying hospital outpatients, we use ICD-9 procedure codes instead of CPT or instead of HCPCS. I have surveyed, and there are others doing it. The HIPAA transaction just said you can no longer use ICD-9 procedure codes. You must use CPT or HCPCS. That is something that we will convert our systems to do. But the question is, is there really a utility in how you are reimbursing outpatient hospital services.

From our standpoint, the answer is no. I will adopt it, because that is the rule of HIPAA that says I will, but I don't know that it will gain me anything in terms of the processing of claims.

Now, I speak clearly on behalf of Maryland, which has a Medicaid waiver. We are the only state that does have a Medicaid waiver. Therefore, my hospital reimbursement is based on a commission rate. So I do not get involved in pricing at the procedure level.

But yet, the other state that I heard from said they also use the ICD-9. This was a switch. The Medicaid rule says you will process UB-92 and you will process ICD-9 procedure codes and ICD-9 diagnoses. So most of us built our systems around for the outpatient services of procedure coding based on ICD-9 procedure codes.

We will adopt it because we have to. There is not a reason not to. I would say, yes, our recommendation would be to allow ICD-9 procedure codes on an outpatient claim.

DR. AUGUSTINE: I just wanted to ask, I guess somebody from CMMS would be the best person to answer about functional status and how we are working on that. I remember reading in a major peer reviewed journal not too long ago that there was some type of study; they showed that the trust fund would save like $30 million a year if they incorporated functional status into the reimbursement. Can anyone help me out with this?

MS. TRUDEL: There is some functional status, I believe, built into the MDS and the Oasis assessment tools that are used for home health and long term care. I am not aware of anything happening in any other area.

DR. GREENBERG: NCHS is working with CMMS on an issue of health care financing review, which is scheduled for spring of 2003, on collecting functional status for payment and quality. It may be the first of two issues, so we are definitely addressing this with CMMS, at least from the point of view of getting into the literature.

As Betsy said, the recently approved by WHO international classification of functioning, disability and health is a comprehensive classification for collecting functional status information, as has actually been pointed to by this committee, the full committee, as something that needs further study, but merits attention.

I would say it would be premature to be bringing this forward now, but you will be hearing more about it in the future, as more developmental work is done.

DR. ZUBELDIA: Would you like to make some closing comments? We need to wrap it up.

MS. MOLINA: Yes, thank you. Cynthia Molina with Alternative Link. There are a couple of themes that I have heard here today that I think are really important for the subcommittee to consider in light of these code sets and potential code set gaps.

The first is a public health issue. In relation to the Alternative Link ABC code set, there were some 629 million visits to complementary and alternative medicine practitioners in 1997, compared to 427 for primary care physicians.

It has been four years since that assessment was made, and there are currently no codes available, which suggests there may be some kind of problem with the existing code sets and implementing codes in response to public health needs.

In terms of business needs, I think there is a challenge in the structure of the existing process for naming code sets. As evidence for that, I can present my own experience. I am a recent addition to the Alternative Link organization. When I looked at the evidence of this organization having approached existing code set authorities, it was very clear to me that there were level playing field challenges.

I think that if the subcommittee members will look at the attachments to today's testimony, they will see timelines and interactions that are in some regards appalling from some of these code set authorities. They suggest that at least in the past, the code set authorities have not been responsive to public health needs and business needs. In fact, there has been some attempt to block access to this cost saving administrative simplification and quality enhancing mechanism to block that for a whole category of practitioners.

Now, our interactions with the American Medical Association in particular recently have been very promising. We have been very encouraged by the tone of the interactions. At the same time, I think if you refer to the testimony, you will see that the actions that we have encountered even in our recent interactions have created a perception in our minds that there still is not a level playing field.

For example, you heard in the testimony that although we were trying to find a way to apply to CPT, our guidance for CPT application came back the day CPT applications were due. If we had missed that deadline, we would have been stalled by another three months.

Our organization is funded in large part by a philanthropist who is interested in seeing this code set be adopted nationally and then ultimately internationally for the protection of the public. When we have that kind of encounter, it makes it very difficult for us to continue to represent the interests of complementary and alternative medicine practitioners and nursing practitioners. We have a very big, very well funded organization on the one hand that may have members who are very interested in collaboration, but by its mission and design is intended to protect the interests of allopathic physicians. If you look at the website of that organization, it says in the website, for public consumption, that that is the intent of that organization.

So Alternative Link, it appears to me, came through the process and even in anticipation of new DSMO requirements approached the appropriate authorities, presented evidence that that approach was not successful, documented that that approach was not successful, and then is being asked again to re-approach

those authorities.

Now, we enjoy working with Michael, and this is in no way meant to be disparaging to Michael. It is the organization behind Michael that we are really concerned about. We do not believe there is a level playing field.

We are delighted and hopeful in working with Michael because frankly, the DSMOs have given us no choice whatsoever. It is our only hope that we will work with Michael, because we have no other options at this point.

So I need to make that absolutely clear to the subcommittee. We think this is really appalling, and we hope that you will look at the issue of level playing field and look at the issue of the public health need and the business needs, and make a rational decision that will be in the interest of Congressional intent and the public health.

DR. ZUBELDIA: Thank you. Let's take a five-minute break and we will continue with the discussion of the subcommittee after that.

(Brief recess.)

Agenda Item: Subcommittee Discussion of Testimony on Gaps in Code Sets

DR. ZUBELDIA: Let's resume the meeting. We are going to have about 20 minutes of committee discussion. We will see if we can wrap up in 20 minutes.

We have heard about several topics. We have heard about the different code sets from both perspectives, the code sets developers and the industry perspective on the code sets. I would like to maybe start the discussion with the potentially less controversial topic of the DSM coding guidelines. Is it possible for the Secretary to adopt the DSM coding guidelines using the ICD-9 coding structure? Using the ICD-9 coding structure, but still use the DSM guidelines? Is that possible?

DR. COHN: The question I would have on this one is, are we closing questions or are we trying to come up with answers today? It seems to me that we need to identify the questions that we have remaining, that maybe we can know more about it in May and come to some sort of final conclusion.

So I think the question you are asking, which is, is indeed DSM a set of guidelines on how to code ICD, or is there something else about this that makes it incompatible. I think it is a very valuable question. I am confused about that myself. I thought they were guidelines, then I hear about a crosswalk. I think we need to ask our staff to do a little bit more work to flesh that out for us. Donna, is that something we can ask you to help us with?

DR. PICKETT: Certainly.

DR. ZUBELDIA: If that was to be the situation, the Secretary has adopted ICD-9 that includes coding guidelines. Can those coding guidelines of ICD-9 be overridden with coding guidelines of DSM for --

DR. PICKETT: The guideline issue is slightly different from what was described this morning about the diagnostic criteria. So there is a difference. The guidelines generally are to help someone apply the codes appropriately and consistently. Diagnostic criteria for coming up with a definitive mental health diagnosis is well beyond just the issue of coding guidelines. They are a separate issue.

DR. COHN: Well, I think we need to look at this a little bit, because I actually think it is a slippery slope. I think that they are different, but they are not so different. I think we are more talking about shades of gray.

DR. PICKETT: I'm not sure if it is different shades of gray. I think as you might have heard, I think it was AHA that might have mentioned it, the diagnostic criteria is what a physician uses to develop a definitive diagnosis for that given patient. Coders do not use diagnostic criteria. They are coding from what the physician has definitively diagnosed, but they are not applying diagnostic criteria in developing and identifying the code that says this person has a manic depressive disorder. That is the physician's role to come up with a definitive diagnosis.

That is what the diagnostic criteria from my understanding is used for. It is not the coding guidelines at all. They are separate.

MR. BLAIR: One of the things that I would like to understand better in order to know how I would come down on what side on this issue is, -- and Michael, if you are here, maybe you can help. Michael?

DR. BEEBE: Yes?

MR. BLAIR: With respect to DSM, for example, DSM-4 or the infusion codes or any of these that may come to AMA, --

DR. PICKETT: It is a diagnosis. It is not a procedure code.

MR. BLAIR: Yes, I know, but weren't we talking about -- I'm sorry, did I get confused here?

DR. YASNOFF: Yes. DSM-4 are diagnostic codes, and so they wouldn't go to AMA. They don't have anything to do with CPT.

MR. BLAIR: Okay, I'm sorry. Never mind.

DR. HUMPHREYS: The issue that I see here is that it seems to me that what I think is the slippery slope is the issue that in a standard for whoever determines what the diagnosis was or whatever the procedure was to form, here is the code you use to transmit that piece of information in an administrative claim.

It seems to me that having it in a federal regulation that anybody who is a licensed practitioner has to follow some particular book to determine a clinical diagnosis, this strikes me as a very weird approach. Here is the regulation. DSM comes out with DSM-5. We are off. We go through a whole review procedure or something? I don't think you want clinical criteria to be part of a federal regulation, it seems to me, but maybe I have missed something.

DR. YASNOFF: The problem I think, Betsy, is that it is already. The guidelines for ICD-9 are -- no? Go ahead.

DR. HUMPHREYS: The guidelines for ICD-9 are given that the doctor has reported to you X, code it this way. That is not saying, this is how the doctor determined it was X, which is really what DSM as I understand it addresses. So those are two different things.

This is just saying, given documentation that says this is what the diagnosis was and this is what the procedure was, here is how you code. It is a separate thing from saying, here is how you are going to determine the diagnosis, which seems really off the page of an administrative regulation.

DR. YASNOFF: Why don't we let the APA folks address this?

DR. ZUBELDIA: I think that the APA folks have addressed it. I think they have recommended to the psychiatrists that they use DSM-4. That is a professional association, that is what they are doing, and that is fine.

DR. HUMPHREYS: Then there are other laws that deal with quality of care and assessment and so forth that say, we want you to use these particular criteria that have been set forth by the APA in order to determine whether people are eligible for certain types of whatever, which is absolutely fine, too. But I think that is independent of a coder or anyone else looking at the clinical documentation or even a physician, having one set of rules that he is applying to determine a diagnosis, and then knowing that the same code can be sent as a bill.

DR. ZUBELDIA: Probably one thing we can do is support the use of DSM for diagnostic criteria in determining what the diagnosis is, and support the coding of the diagnosis itself using an ICD-9 code, which happens to be the same code as the DSM for the same diagnosis, anyway. I think that is probably a good position, where we can support the use of the diagnostic criteria to support the ICD-9.

DR. HUMPHREYS: I guess this is just Betsy Humphreys talking, but it sounds like that might be a very appropriate position for the NCVHS to take. But I'm not sure we want a federal regulation that specifies a particular method.

As I say, when the revision comes out, if the reg is out of synch with the revision, then this could be another set of problems. We all know that these regs don't get revised and published as rapidly as we would like.

MR. BLAIR: Does that mean that the American Psychiatric Association would then become one of the DSMOs?

DR. COHN: No, code set developers aren't.

DR. ZUBELDIA: Jeff, I'm not saying support the DSM codes. I am saying support the DSM diagnostic criteria for them to come up with the ICD-9 code that represents a diagnosis based on that diagnostic criteria.

MS. TRUDEL: My concern is where this leads. Donna has mentioned that this is something that goes well beyond a traditional coding mind set. We have heard this morning that the APA is not the only medical organization that develops and proposes its own clinical diagnostic guidelines.

My concern is, who will we hear from next? What if we hear from organizations that have conflicting guidelines? I'm not sure that the Secretary wants to be in this business, but I'm not speaking for him.

DR. GREENBERG: We also heard at least from the point of view of the conflicting language in ICD-9CM and DSM that hopefully, that is a short term problem that will be resolved when ICD-10CM is adopted. This antiquated 1970s language -- it sounded a lot like what we were hearing yesterday about how ICD-9CM is broken. Certainly in this area, this language is a reflection of what an old classification it is, and has been addressed in 10CM.

So that may have a solution down the road, though admittedly not in the short term. Why are you frowning?

DR. COHN: I'm thinking.

MS. TRUDEL: My proposal would be that because this very much links into the discussion of the ICD-10CM update, that we table the discussion for the time being and discuss it in a better context at the next hearing.

DR. ZUBELDIA: That sounds good.

DR. COHN: But I would like a little more work done on having to do with the crosswalk identification and identifying what that is. But I think we need to talk to some of our colleagues and other expert resources to see how this all might fit.

I think my view on this one is that the coding guidelines have in some cases gotten a little closer to this area than one would necessarily think. So I think we need to reflect on that with some of the other expert coder resources that we all know. But I am happy to defer this conversation until May so we can do that.

DR. ZUBELDIA: Okay. So we will defer it to the next meeting, waiting for your homework.

The next topic is the national home infusion codes. I will start by saying my impression from this is that they have a solution that is working. It is not what they were expecting at first, but the combination of certain CPT codes and HCPCS codes is working for them.

I think that they have identified problems. It is very good to identify problems in new processes so they can be fixed.

DR. COHN: I think we are having somebody from CMMS coming in May. We maybe want to add the question with them about the issue of S codes being defined as temporary codes and get some clarification about that.

MS. TRUDEL: I am taking that back with me today.

DR. COHN: Okay. So I think Karen Trudel already has that as an issue to get resolved with CMMS. I heard that was a very vexing issue. I would be very uncertain about that also.

DR. HUMPHREYS: The other question is whether we are underway with a resolution to the problem of there possibly being conflicting and overlapping codes at the moment in CPT and in HCPCS because of this kind of little disconnect on changes being made to both systems simultaneously.

DR. ZUBELDIA: Michael Beebe explained a little bit about what the expectation of the CPT editorial panel was in assigning those codes. Maybe it is a matter of education and it is a matter of documenting how it is supposed to work. The connection between the provider taxonomy, the service with the CPT and the supplies with the HCPCS, and how to use those three in combination to produce the result that they want.

Maybe that is something that the Home Infusion EDI Coalition can put together some informational paper on how this is supposed to work to educate the industry, especially the payors.

DR. KAPLAN: We have done so, with our national standard coding document that we -- we have almost 600 organizations that have downloaded that for free, including about 100 payors. We are getting a lot of good interaction on that.

But it seems that there will be a significant amount of time where those very conflicting and duplicative codes will be on the books, in the HCPCS and the CPT codes, because the AMA was unable to rescind those for 2002. So it is going to be at least the beginning of 2003 and potentially later before that is resolved.

We do think that AMA is -- we are working towards an effective solution for the nursing visit component for home infusion within the CPT codes, but everything else surrounding the home infusion, the pharmacy professional services, care coordination, services and supplies, that payors do bundle together is in HCPCS, and that we are very pleased with. So we think that the two -- we are optimistic that eventually those two will fit together very nicely. But right now, it is a major problem. It is a major problem.

DR. ZUBELDIA: It is a major problem that probably has no solution immediately, because you cannot go to the CPT books and put stickies on top of that section. So maybe all you can do for now is educate your members, educate the payors on what is the way to do it, and what would be a solution for next year.

DR. HUMPHREYS: We were planning on following up with the AMA for the next hearing on some process issues and other things, too. So maybe we can get a clarification on this. We are hearing that maybe this overall problem cannot be resolved before 2004. Did I hear you say that?

DR. KAPLAN: That was my understanding, but Michael corrected me to say we could do that earlier. So perhaps my understanding is outdated.

DR. BEEBE: One issue the panel is considering is the possibility of an earlier release for these home infusion codes. We recognize that there is confusion, we recognize that there is overlap.

So in light of the need to implement these codes for HIPAA, the panel has discussed and considered the possibility of an early release to the industry through the Internet, notifying all the appropriate payors that this is something that we are doing to help people comply with HIPAA and help people code these services.

DR. KAPLAN: Can I ask for one clarification, just so I have not inadvertently misrepresented something? Would that mean, Michael, that the quote-unquote per diem home infusion codes that are in the CPT book at present, that are so conflicting with the HCPCS, will not be in the book in the future?

DR. BEEBE: The future book is what we are working on now, making the changes. We need to sit down with your group as part of the home health work group that we just re-established, to figure out what it is exactly that you want.

DR. KAPLAN: Okay. Thank you.

DR. BEEBE: You're welcome.

DR. ZUBELDIA: So I think there is probably no action from the subcommittee on this issue, other than the S codes that Medicare or CMMS needs to take care of, and maybe congratulating them for the good work, because it is really impressive.

DR. KAPLAN: Thank you. Could there be any consideration in the future of an advisory role? I think in both processes, the HCPCS and the CPT process, there is a lack of representative of our members, of pharmacy, of various other health care sectors. The temporary code designation will be one aspect of making this a more permanent situation, but there is no representation in that process within the health care providers advisory committee of CPT editorial panel, no representation for pharmacy or home infusion in particular, and no representation on the HCPCS committee.

DR. HUMPHREYS: The issue of representation and similar concerns were raised at the last set of hearings. I think our plan is to have CMMS and AMA address those at the next hearing.

DR. KAPLAN: Oh, fantastic. Thank you so much.

DR. YASNOFF: Would it be reasonable to ask for an update as to the progress for our next meeting?

DR. ZUBELDIA: Yes, it would be.

DR. COHN: That might be a little quick. You mean by May?

DR. ZUBELDIA: End of May.

DR. YASNOFF: If there is no progress, then we can be informed that nothing has happened. But I think if attempts are being made between now and May and there are problems, we might as well know about them earlier.

DR. COHN: I was just going to make a general observation. I think this applies to generally the code set developers and how this all progresses.

A business need doesn't go away overnight. It isn't like you stick X number of codes into a code set, shake hands, and that is the last time you ever talk.

DR. KAPLAN: Right.

DR. COHN: Clearly, if a code set developer is incorporating domains into their code sets, there is a responsibility for an ongoing dialogue, which is I think what you are describing.

DR. KAPLAN: Yes.

DR. COHN: Now, exactly how that works, I don't know. We probably need to ask the code set developers how they propose to do that. And of course, if your case, I am a little bit confused about whether it is the HCPCS level two or the CPT or --

DR. KAPLAN: Both.

DR. COHN: -- a combination.

DR. KAPLAN: But I think it is primarily because we are going to be housed in the HCPCS. I raise that as our most pressing concern. However, I think that that has led to some of the issues on the CPT side, and we see some potential for some ongoing issues for pharmacy, for home infusion within the health care professionals advisory group.

DR. ZUBELDIA: So what you are asking is for a recognition of your domain expertise.

DR. KAPLAN: Yes. Thank you for those nice words. Yes, that is what it is.

DR. COHN: Probably that is an additional question we need for HCPCS. I think everybody needs to be on the HCPCS national panel, but there needs to be some sort of a structure for all the code sets, of incorporating that sort of interaction with the domain expertise.

DR. BEEBE: I would also support that. In addition to home infusion, there is lots of overlap between especially the S codes and CPT codes. So the editorial panel has a lot of concerns about how to eliminate that overlap in the panel's participation in the HCPCS decision making process, so that we don't have going down the road duplicate codes.

DR. ZUBELDIA: Which brings us to the Alternative Link codes. Michael, don't go away, because I think that you are going to be involved in this discussion, too.

It is encouraging to see and to hear what we have heard today, that Alternative Link is working with the AMA, and maybe assist the CPT editorial panel with their domain expertise in coming up with new codes in CPT and perhaps in HCPCS, that represents their needs. Is that going to be a solution? Is that something that -- Melinna?

MS. GIANINI: My concern is that -- Kay Riley and I talked about this at length. When we talked about including ABC codes in HCPCS, which at first blush sounds like a great idea to us and to them, we found out that the need for an X-12 indicator that ABC codes would follow is key to the electronic record, working correctly with the way that the code set was designed.

So when you are debating and deliberating this, I ask you to remember that that is also an issue. To gain the depth of information that is available from the code set, it seems that an X-12 external code set indicator is needed.

DR. ZUBELDIA: Do you know perchance what version of X-12 incorporates a code qualifier that points to ABC?

MS. GIANINI: Yes. It was added to the 4022 version of X-12, and then implementation guidelines were developed for it in the 4050.

DR. ZUBELDIA: So it won't be until the 4050 guides that that is even a possibility?

MS. GIANINI: Right.

DR. ZUBELDIA: I infer that a better possibility now would be to incorporate at least some of your codes into CPT and HCPCS so that they can be used immediately. In that case, you don't need a separate qualifier. If some of the internal medicine codes are incorporated, say in the S section of HCPCS, they will just become HCPCS codes.

MS. GIANINI: I think that we will have a design issue, but I am certainly willing to open my mind up and look in every corner, and see if there is a solution there.

DR. ZUBELDIA: I would like to encourage that you work with both the CPT editorial panel and with the HCPCS code committee. Maybe if there is some progress, bring a report to the next subcommittee at the end of May.

MS. GIANINI: That would be good.

DR. ZUBELDIA: That would be good, to hear of progress or lack of progress, and if there is no progress, why.

MS. GIANINI: Thank you.

MR. BLAIR: Kepa, did you also want to invite Michael to return and report along with Melinna on the status?

DR. HUMPHREYS: Michael is going to be here, anyway.

DR. ZUBELDIA: Yes. I would like to invite Alternative Link, Michael representing the CPT editorial panel, and the APA probably should be here, if Donna is going to bring the report. Maybe we can have some time aside for this kind of discussion.

The agenda for the next meeting is pretty full, too. So we won't have a lot of time, but maybe we can get a quick report on this.

MS. BEEBE: This is an issue that probably can be discussed at another time, but being a part of the SDAs myself as a voting member, both X-12 and HL-7, one of the issues at X-12 is something that we have been discussing.

For example, there is a public health reporting guide that has been accepted, and we are working on building that based on the 837 standard. So I am trying to make an example of an analogy of an issue that I see that could come up.

With going to CPT as you recommended, Kepa, for Alternative Link to look to, if we take the reporting guide for example and use the 837 standard, the institutional then says, if you have got it in the reporting guide we don't need it in the institutional.

So added to the process of going to the right place, when in fact ABC Alternative Link becomes the code set that could be accepted as a standard, what happens in the process to take back out of the CPT or out of the HCPCS what was put in, waiting for the code to be accepted. Does that make sense? If it is not built into the process, it is going to be a problem down the road.

DR. ZUBELDIA: It does. Let me explain how I understand it works. Let's say Alternative Link is working with the CPT editorial panel, and they build into a CPT code for the next release that is available to them, ten codes. When the ABC codes come out as a standard in the future, it probably would not have those same codes that have already been built into the CPT anymore, because there is already a CPT that refers to the same service. So they would not have a need to have a CPT and an Alternative Link code.

They may have, because it is a different coding system, a duplication. I think it would be up to them to tell their practitioners, for this service you use a CPT code, for this service you use an ABC code. I think it is a decision they would have to make as code set maintainers. I don't know.

DR. PICKETT: That may create some problems and confusions. As the AHA testified this morning, it is simply not just having a new code set, but how that explodes out into all the different vendor systems, the multiplicity of codes that a provider must use depending on which payor does or does not accept. So then you end up having multiple ways to report the same procedure or service, which adds sometimes a lot more burden to a provider when you do that.

DR. COHN: My view is, reflecting on the issue of coordination needed between the code set developers, I'm not sure how it plays out in this case. Obviously there are discussions. I don't know where these codes will find a home, but it once again speaks to things we have already heard about, for example, HCPCS and CPT talking together better, so that there is an overlap there. It just percolates through the industry, and I think we need to be aware of that as we move forward.

DR. HUMPHREYS: This is why we keep hearing about, wouldn't it be nice to have a similar procedure code set.

DR. GREENBERG: I may be missing something, but even if in the 4050 the ABC codes are recognized as an external code set, it doesn't necessarily mean that it will be adopted in the HIPAA implementation guide.

DR. ZUBELDIA: That's right. It would have to be adopted.

DR. GREENBERG: Just getting it into the standard does not mean that it --

DR. ZUBELDIA: The problem is that even if they were adopted today, they couldn't go in the transactions, because there is not a qualifier for them. So the best solution as a short term solution would be a CPT-HCPCS combination.

DR. GREENBERG: And provider taxonomy.

DR. ZUBELDIA: And provider taxonomy, definitely.

DR. GREENBERG: And it could be a long term solution.

DR. ZUBELDIA: And a combination of other things. I mentioned before, maybe they need to do time billing and say how many minutes. I don't know if that is a need in their business or not, but if the codes incorporate time in the code, maybe they need to do that. It is something they need to study.

MS. MOLINA: What sort of time frame and objective criteria is the subcommittee using to assess whether the relationship between AMA and Alternative Link is working effectively, so that we know how to continue to protect public health and address these business needs, and assure that there is in fact a level playing field?

DR. ZUBELDIA: The criteria is that you will let us know.

MR. BLAIR: On the 29th and 30th, at the next subcommittee meeting, both Alternative Link and the AMA would report back on both of your perceptions of progress you have been able to make. Hopefully it will be good progress.

MS. MOLINA: I appreciate that. I just want to again remind the committee that we are existing because of a benefactor, the philanthropic donations of an individual. So time for us is of the essence. I daresay I would be very concerned for the complementary and alternative medicine community and the nursing community if for any reason this takes too long.

DR. ZUBELDIA: We are asking you to come back and let us know if it is working or not in a month and a half. May 29 and 30 is not a long time.

MR. BLAIR: Cynthia, is that a reasonable time frame for you?

MS. MOLINA: Any distance between us and getting the code set implemented for constituencies is a challenge, obviously. We have been trying to implement this for six years, and the organization has gone through many rounds of contributions from this individual. I feel we are tapping into his resources very heavily, and I am concerned about what this means for public health.

DR. COHN: I guess I should respond a little bit in terms of time frames, just in terms of setting expectations. Even if today the subcommittee made a recommendation, there is a whole long HHS process that would have to occur to even get it to a point where it was a final rule.

MS. MOLINA: We understand that.

DR. COHN: So just be aware that fast in terms of government process is, as I think we have all learned, not very fast. So you should set the expectations of your philanthropic sponsor -- at least if we were to take this path, it could take awhile.

MS. MOLINA: We understand that. The challenge is one of having a very well-defined direction. We do have many stakeholders in the health industry who have said they will mobilize immediately behind the codes once there is a firm direction identified. The lack of direction is what keeps us from being self sustaining.

DR. ZUBELDIA: Maybe as guidance for the time frame, version 4050 for the implementation guides are not even out in draft form yet. They will have to go through draft comment for the industry. I would not expect that to happen until end of 2003, 2004. Then they will have to be going through an NPRM process to be adopted as a standard by the Secretary, and then an implementation period. So you are talking about 2004 at the earliest, 2005.

MS. MOLINA: I understand.

DR. ZUBELDIA: The opportunity of going with CPT and HCPCS now is a real opportunity and it is fast. It may seem slow to you, but it is fast.

Also, let me point out another thing. You don't have to wait for the Secretary to adopt a code set, especially in a case like this, to start using it.

MS. MOLINA: The insurance community --

DR. ZUBELDIA: There are sections that, most of them, are not being billed for insurance. You can start using them for whatever public health purposes, you can use it for actuarial services, you can use it for other purposes. You could start using that today.

MS. MOLINA: Understood. Many of the stakeholders, in fact, most of them, are looking to this subcommittee and the recommendations of the DSMO to help them assess whether an investment in this code set or in the capabilities of the code set is appropriate for their organizations. They already have a significant financial burden in implementing HIPAA, and they want to make sure they make good business decisions.

So we do need some kind of direction as quickly as possible, so that we can assure them that some aspect of this code set is actually going to make it, either in CPT or HCPCS or some other area.

DR. BEEBE: I would just like to help the subcommittee with its expectations regarding the progress report in May.

We are not going to have new CPT codes for alternative medicine in May. We will be working with them on CPT code change proposals, and we hopefully will have demonstrated progress on developing those code change proposals for probably distinct portions of alternative medicine codes as we work them through the CPT process.

I think that is the type of thing that can be expected from our cooperation, and that we can bring back to you in May.

MS. MOLINA: Thank you.

Agenda Item: Issues Regarding ADA Raised at February 6-7 2002 NCVHS Meeting

DR. ZUBELDIA: We are only a half an hour late. If we can get the discussion on the ADA, Frank, maybe you can start this discussion among the members by bringing us an update on the ADA issues that were raised in February.

MR. POKORNY: On the ADA --

DR. ZUBELDIA: On the coding and the response from the ADA. I think you were sent with some homework to do?

MR. POKORNY: That's right. This is Frank Pokorny with the American Dental Association.

After the meeting on February 6, I returned to our offices and prepared a response to the various issues raised by representatives from the National Association of Dental Plans, the Health Insurance Association of America and the Delta Dental Plans Association. This rather long letter and attachment as a matter of fact was conveyed to the subcommittee on the 13th of March, i believe.

In it, we tried to address all of the issues that were raised singly, or those that were held in common by the various organizations. I am feeling a little bit slow in my language here; I wasn't expecting to be talking about the actual letter itself, but I think the overriding tone of the letter was very much appreciative of the issues that were raised at the meeting on February 6, tempered a bit by a bit of disappointment.

We had hoped that these sort of issues would have been raised by the various members of the code revision committee, including Health Insurance Association of America and the Delta Dental Plans Association, during the meeting that was convened on January 28 and 29 of the code revision committee, which unfortunately was foreshortened due to bad weather and concerns over travel.

There is I believe, as the subcommittee knows, a meeting that has been planned by representatives of the leadership of the National Association of Dental Plans and of the American Dental Association to discuss one of the issues that was raised in common by the respondents, which was the NADP having a seat on the code revision committee.

It would be premature for me to address the outcome of these discussions, because these discussions are but one step in the modification of the settlement agreement which defined the procedure and the participants that gathered together on the 28th and 29th to come up with a revision to the code of dental procedures and nomenclature.

I would be a little more comfortable at this point if there are any specific questions that the subcommittee had concerning either the response that the American Dental Association had put forward in view of the testimony that these other organizations gave, or if there are any other general questions that the subcommittee would have about where things stand now in the code revision process, as we lead towards the publication of the next version of the code of dental procedures and nomenclature, which is to be effective January 1, 2003.

MS. TRUDEL: I have an idea, Frank. The previous testimony raised what you categorized as four key issues. One was the participants, second was the meeting protocol, third was process for future code review and revision, and a fourth comment that talked about access costs for the CDT.

I know you responded to all four of those issues. Then we had additional responses to your responses from Delta and from NADP that I think you have had a chance to read this morning.

MR. POKORNY: Scan would be more appropriate.

MS. TRUDEL: Scan, okay. Are there folks from those organizations in the room?

MR. POKORNY: There are representatives from the Delta Dental Plan Association.

MS. TRUDEL: How about we just get everybody up at the table?

DR. ZUBELDIA: And you fight it out. No.

MR. POKORNY: I think, Kepa, fighting it out was not the appropriate word.

MS. TRUDEL: Since I recklessly started off on this bent, I would suggest that we look at each one of these items and see where we stand, and see if there are any still remaining concerns. Then the subcommittee can note what appears to be the current position, and any possible future activities.

MR. POKORNY: I see my colleagues from the Delta Dental Plan and National Association of Dental Plans sitting across the room here. One of the things that I would like to point out is that when we did have our meeting of the coding committee, by design we interspersed members of the payor sector of the dental community and of the provider sector of the dental community side by side, so we didn't have a we versus them situation.

I am assuming this is not a we versus them; it is just a function of where the microphones are located in this room.

DR. ZUBELDIA: Could you introduce yourselves?

MR. O'BRIEN: Yes. My name is Phil O'Brien. I am general counsel for Delta Dental Plan Association.

MS. OSHENSKY: I am Janice Oshensky. I am director of provider and plan relations at Delta Dental Plans Association.

MR. GRANT: I am Jay Grant, National Association of Dental Plans, Washington counsel.

MR. MUSCO: Tom Musco with the Health Insurance Association of America.

DR. ZUBELDIA: Who wants to start?

MS. TRUDEL: Let's start with an easy one, hopefully. Let's talk about meeting protocol. As I understood it, there was a discussion about what protocols were to be used to conduct the sessions. I think the ADA had a recollection that there had been a vote to not use Roberts rules and to operate more on a consensus basis. Some of the people in the room didn't remember a vote being taken. Does that characterize -- was that one of the issues?

MS. OSHENSKY: That was one of the issues. My name is Jan Oshensky and I did attend the meeting. I sat in the back. They went over some of the protocols. They didn't go over all of the protocols. To my recollection, there was no unanimous vote on that procedure.

MR. POKORNY: When you are working with recollections, I can only go by the notations that I made of the actions taken by the committee. On the discussion of the proposed operating procedures, that we would follow the two day session and perhaps beyond, but also a record of all the votes taken on the 84 change requests that were reviewed and acted upon. Comparing my notes with those of my colleagues and others within the association and the ADA's representatives, we all noted a unanimous vote.

That may again sound like a we versus they, and I would be more than happy to entertain hearing what NADP's recollection or HIAA's recollection is, but I think more importantly, there was discussion of how we should proceed. There was also discussion that this was going to be an evolutionary process.

We had to start somewhere, and we wanted to start somehow in order to move ahead on a backlog of numerous requests. Are we fixed in time? I would say no. I think the whole spirit of a collegial environment which was mentioned several times during the discussion of the operating procedure -- and as I scanned the responses, I noticed an endorsement of the concept of working in a collegial environment. It says that we will look to improve the way that we work together to become more understanding of what our various needs are in terms of approval processes and things of that nature.

For example, I learned from Janice just a little while ago that there is a board meeting of Delta USA, at which there is a need to review and approve the code changes. I regret I did not know this before. This is an important piece of information that needs to come forward. Is there an equivalent need for review and approval by HIAA, is there the need for review and approval by BCBSA or CMS? I haven't heard of that. But these are the kinds of things that we need to have come out to insure that the protocol that we have works well.

I am opening the door. I need more feedback like this, to make sure that we work together.

MS. TRUDEL: I would really like to quote something that Maria Ward said earlier this morning about the DSMO process with respect to code sets. I thought it was very well put. She said, this process couldn't be any more new. I think the same can be said for your process.

The question is, how are you going to work it out? I'm not sure we want this to be a recurring agenda item on this subcommittee's agenda.

DR. ZUBELDIA: No, and it is something that you need to address in your next meeting and just take care of it.

MR. POKORNY: I agree. One of the obligations that the ADA took on because we could not begin the conversation on January 29 is to come up with an overall scheme of how we are going to be moving ahead, timing, activities, who does what, public notice, a process for solicitation of changes for the next cycle, coming up with a good timetable.

One of the obligations that I have is to craft that. That is one of the things I will be doing. My first objective though right now is to be sure that we have an agreement on what we did on the 28th and 29th. We have already gone through a report of the actions taken by the code revision committee that was circulated to all of the participants. That included not only a recap of the introductory comments where we set the stage and some of the initial agreements about the operating protocol, but more importantly, a complete recitation in detail of every motion, every vote, the tally on each vote, and the resultant action or what will be seen in the next version of the code of dental procedures and nomenclature, either deletion, change or an addition.

This has been circulated to all members with request for comments, and we have received several comments that the subcommittee on the code is going to be reviewing next week on April 18. The intent is then to go back and make sure that we all have an agreement on what was said and what was agreed on.

Our intent is not only to have a new version of the code on January 1, 2003, but abide by our commitment which we discussed in January to have a final version of the code set available for use by the payor sector of the dental community by the beginning of the third quarter, meaning on or about July 1 of this year.

MR. MUSCO: I would just like to comment on what Frank just said. I am very appreciative for the comments Frank made in terms of trying to put together what this process will involve. But by the same token, that is in essence one of the problems now. There is no next meeting of the code revision committee. There is no time frame for submitting code change requests or what the eventual composition of that committee will be. So a lot of the process, I won't say needs to be modified; a lot of the process needs to be put into place. It is not there now.

MR. POKORNY: Tom, you are right and as I said, that is one of the things I am working on. I wish I could have done it sooner, but I am first concerned with getting what we have done out, to satisfy the information dissemination needs, for lack of a better term, so everybody knows what is coming and prepare for it.

But I agree; it is critically important for all of us to know how we are going to be moving ahead from here. That has not fallen off the plate. It is there, it is at the top of the plate right now.

MS. TRUDEL: Is there any way that some of the other participants in this process could take on some of the load of drafting some of these procedures for the group to look at?

MR. POKORNY: Frankly, we haven't talked about that. Being the secretariat, we assumed it was our responsibility to come up with a draft, to offer a discussion topic on how to make it work.

That being said, I have had several conversations with the member organization representatives on what ought to be in that process. We have had some feedback already. I have had some feedback already, which has been very valuable. The next step is to take that and put it into something in black and white that people can look at and respond to, rather than just talking hypothetical.

MR. MUSCO: I agree. We have had some verbal conversations with the ADA to make this a continuing process, to keep code revisions at the forefront. So as needs arise, either through technological change or new treatment methodologies, there is a way to suggest code revisions to the ADA, to have this process maintained, and to actually keep the communication going. As representatives might change, we also feel the need to keep in close contact with the people who were actually on the code revision committee.

MR. POKORNY: I think that is a very important point. Tom Marsden as a matter of fact brought that up in a conversation I had. I consider that for lack of a better term the social glue, something that makes an organization work over time.

As the NCVHS has members that roll in and roll out, there is continuity provided by staff. My hope is that Janice and Tom and I are going to be around for a long time, but we all know that the people that we will be working with, the official representatives, may change. So we have to get acquainted. We have to become more comfortable working with each other, and have that translate into a better working relationship amongst the representatives too, because they will have the confidence to know that staff is working together. We have to find ways, and I think we will find ways, to talk more frequently. We are beginning to do that.

MS. OSHENSKY: In answer to your question, I know that DDPA would certainly be more than willing to participate in helping develop some kind of time line. I'm sure that HIAA would as well to help the ADA.

MR. WARD: And NADP would certainly like to volunteer to do that as soon as they become part of the committee. I know that they are looking forward to their first meeting with Dr. Bransom.

I just think the fact that there is some dispute on what happened at the meeting and what procedures shows a lack of structure, and that is what we need. One of the first things that needs to happen in this new enterprise is to get the procedures down and to make sure it is we working together.

MR. POKORNY: I would like to add too that I did have a conversation with Evelyn Ireland, and Evelyn volunteered to the NADP's in-house communication mechanisms to spread the word about what has happened and what is going to be happening, so NADP's members know about the upcoming changes and eventually what the process will be. That was independent of whether or not NADP or anybody else has a seat on the board.

It seems a separate issue, which I think is very telling. It recognizes that we all are working toward the same goal here, which is having a code set that is current and usable and widespread.

I have also taken the opportunity of the relationships that have come out of the meeting back in January to talk about another issue that the ADA is dealing with, which is the revision of the paper claim form, to bring it up to harmonize the data contents of the electronic and paper claim form. All of the organizations on the other side of the room have agreed that this is something that is very important to do together.

So we are having -- I think this is an example that we can work together, even though this is outside the code. It demonstrates that we are starting to move together. I fully expect this to carry forward into the code revision process.

But as you point out, Karen, Maria did say it very well: this is the start of a new process. People say, but you have met together before. Yes, but the circumstances are different now. We can build from that.

MR. MUSCO: I would like to make one other comment. Since we did bring up representation on the code revision committee, HIAA would also welcome additional input from representative organizations, that being NADP.

I would also comment though on the representation from CMMS and perhaps this has to be addressed to CMMS, that the representative from CMMS was supposed to represent a payor perspective. But in my opinion, my association's opinion, the representative chosen was from the Medicare side of CMMS, and Medicare does not pay for dental benefits.

Additionally, the individual was a dentist, but not in practice. So I don't truly believe that the representation at the time of this initial meeting was truly representative of both payors and providers.

DR. ZUBELDIA: Are other of your representatives practicing dentists?

MR. MUSCO: The official members at least as I understand it from the payor side, either the representative or an alternative representative, are practicing dentists.

MR. POKORNY: Kepa, are you looking for a response to that particular --

DR. ZUBELDIA: No, I am not. It is interesting. I am kind of surprised that payor representatives would be practicing dentists. I would consider that provider representatives would have to be, but payors?

MR. MUSCO: At least for the HIAA's part, our designated representative is not a practicing dentist, but we have alternative advisors who are and who can address from the payor perspective the consequences or the benefits and so forth of code request changes.

DR. ZUBELDIA: I think that would be probably an unrealistic expectation, to expect that practicing dentists also work for Medicaid and represent CMMS at the table.

MR. MUSCO: Perhaps someone from the Medicaid perspective, where Medicaid does actually look at and reimburse for dental services, might have an additional perspective on the codes from a payor perspective.

MS. TRUDEL: Your concern is noted. I don't think this is an appropriate place to discuss the issue, but it is noted.

MR. O'BRIEN: I would just comment that I was obviously involved extensively in discussions with ADA to bring our litigation to a conclusion. The settlement agreement we did end up reaching took a lot of effort, but I want to say that we very much support that settlement agreement. We worked long and hard on it.

I recognize that the process is not going to be perfect from the outset. We do need to work together. But as stated, we do need a process. We do need to have rules of protocol to govern the meetings. I think a lot of these issues would be minimized.

We are very much open to changing the fifth payor rep on the committee, because the national purchaser representative which is called for in the settlement agreement has proved to be not very workable. I have been having dialogue with ADA's general counsel on that issue. I presume they are open to discussion of that. We certainly would not oppose NADP as that representative.

MR. POKORNY: Fortunately, Mr. Spicus is not keeping his confidence -- I have no doubt that you and he have talked.

MR. O'BRIEN: Yes.

DR. ZUBELDIA: And of course NADP is willing to participate as the fifth representative, right?

MR. GRANT: Yes. We have asked for quite some time.

DR. ZUBELDIA: So that may be something that we would like to maybe hear if it is resolved, when it is resolved one way or the other. Just let us know.

MR. GRANT: We would welcome that.

MR. POKORNY: I would be happy to provide a report to the subcommittee periodically on progress, if that would be beneficial. I get the feeling it might be.

DR. ZUBELDIA: At least until the issues are settled and the group is working in harmony.

MR. POKORNY: Would this include coming to the May meeting also, Kepa?

DR. ZUBELDIA: You can report by letter, by e-mail, whichever way you feel is more convenient.

MR. BLAIR: As I have been listening to the testimony back and forth, it sounds to me as if the issues are less of a substance issue on issues as opposed to governance issues, when the meetings are scheduled, who gets to attend, when the votes happen, those types of things.

One thing that you might consider is, if there is some way to identify a third party, an independent secretariat, that both sides feel comfortable or that all sides feel comfortable with. Then maybe the governance issues might be less contentious.

MR. POKORNY: Jeff, when you say independent secretariat, would that also embrace an independent chair?

MR. BLAIR: Actually, I would almost leave it to all of you. It is a mechanism to try to achieve some additional degree of harmony and confidence in the mechanisms of your working relationship.

MR. POKORNY: I appreciate your thoughts. Looking at Mr. O'Brien, it sounds like that might be a settlement issue with you, too.

MR. O'BRIEN: That is certainly something we would be wi;ling to discuss.

MR. POKORNY: I seem to recall there was a statement that the ADA would be secretariat in the agreement.

MR. O'BRIEN: The settlement agreement can always be modified.

DR. ZUBELDIA: It is a suggestion. I hope it won't be necessary. You may be able to just work out the friction that you have when you are starting something. It is starting to move, work out the friction items. I think it just takes a little more collaboration. If you can work out that friction, that would be great, but if you can do it among yourselves, I think it can be easier.

MR. MUSCO: We would like to ask one question of the subcommittee that wasn't mentioned in Karen's list of issues, but was raised in some of the comments at the last subcommittee meeting. That was the comments on the accessibility and availability of the code set at a reasonable cost.

DR. ZUBELDIA: The problem with that is, what is reasonable.

MR. MUSCO: I think you have heard testimony at your prior meeting and testimony today about some of the costs of obtaining these code sets, some at no charge via website downloads and so forth. I am just interested in hearing any comments you might have.

DR. ZUBELDIA: Well, it is a very interesting question. We have heard today the DSM sells their book for $50. CPT's are somewhere between $35 and $45, whether you are a member of the AMA or not. Some of the developers have incurred a certain cost, and there is intellectual property in the codes.

From what I understand, the CDT code set is in that same range or even lower. So I'm not sure -- maybe I don't understand what the problem is quite.

MR. MUSCO: My understanding is that you purchase a copy of the CDT in printed form, it is at a level equivalent to some of the other code sets. But in addition to that, there is a licensing arrangement which costs quite a bit more. Maybe Frank can address that.

DR. ZUBELDIA: In addition to the paper copy?

MR. MUSCO: In addition to the purchase of a paper copy, yes.

MR. POKORNY: There is a license agreement for use of the code of dental procedures and nomenclature. The license for a licensee would normally be a third party payor organization, it might be a vendor of a practice manager software system. The code is a feature to facilitate office operations. The fee for, as I believe was included in my letter, for a third party payor, commercial carrier, would be $1000 fee for a license to use the code. A practice management system vendor -- and I am going by memory here -- I believe is at ten dollars per seat. So depending on how many systems a vendor has sold would depend on what their fee would be.

Right now though, we are beginning to compare apples and oranges. We compare copies of a printed document or even a flat file for use, versus a licensing or royalty, and perhaps a more appropriate level comparison would be the licensing fee or the royalty fee that AMA charges for the CPT.

I don't have the numbers for that, but from what I have read, it involves -- it could be on a fee basis also. I don't see Michael here anymore, so I guess he can't talk to that.

DR. ZUBELDIA: I don't think it would be fair to compare two code sets one to another. I think we need to look at the fees; it is reasonable for a dentist to pay ten dollars to license the codes. I think it is reasonable, I don't know. Is it reasonable for a payor to pay a thousand dollars to license the codes? I think it is reasonable. If you are asking for $100,000 or something like that from a payor, I would say that is high, but a thousand dollars to license the codes for a payor that is going to base their payment system on those codes, I don't think that is very unreasonable.

I buy the CPT electronically every year, and it is a lot more than ten dollars. So is the problem that the ten dollars per seat is not reasonable, or that the thousand dollars for a payor is not reasonable? Is that the problem?

MR. WARD: We felt that a thousand dollars was unreasonable. We have some very small plans that work in very small areas, and we did feel the thousand dollars was unreasonable. We don't have a problem with ten dollars or fifty dollars, but we did object to the thousand dollars. Just from NADP, I believe there are about 85, 90 members.

DR. ZUBELDIA: There must be really small plans.

MR. WARD: There are some small plans.

MR. BLAIR: Are you able to accommodate that by having a separate fee schedule for payors that are smaller than a certain designated size?

MR. POKORNY: Jeff, what I can do right now is bring back these comments and discussions to those within the ADA who can make the decision. I'm not in a position to talk to the ADA on this point. Thank you very much for bringing it up.

DR. ZUBELDIA: I believe that there is also another potential buyer of the code, which would be the vendor. Very small vendors could be strapped financially, but I believe the vendors get it for free.

MR. POKORNY: The practice management system vendors?

DR. ZUBELDIA: The practice management vendors. They get it for free, and they have to pay ten dollars per dentist. But the vendor itself doesn't have to pay for it.

MR. POKORNY: The vendor may elect to either pass the fee on to the individual practicing dentist, or bundle that as part of the overall cost for the system. That becomes the business decision of the practice management system vendor.

DR. ZUBELDIA: So the issue is that a thousand dollars per payor, whether that is reasonable or not. I think it is reasonable. It is up to the ADA to see if there is any consideration for small payors. But if a payor cannot afford a thousand dollars to pay for the code system on which they make the payments, I think that payor needs to consider another business. My personal opinion; it is not NCVHS' opinion, okay?

MR. MUSCO: One of the issues we raised was the equitable nature of the cost differential between payors and providers. Both having to use the code sets to transmit their information back and forth, yet the large differential in terms of -- I won't even say the cost of purchasing the code set, because that can be accommodated with a printed version or a website version, that is fine. It was this issue of licensure just to be able to use the codes to process claims.

DR. COHN: Maybe I should just comment, because there are obviously many ways the ADA can do this. They can charge you per seat as a biller and consider every one of your claims adjudicators as a seat. I think you would find it to be about the same number of dollars probably at the end of the day, at least for many of your plans.

I guess it is a question of how you define all of this stuff. Like Kepa, I'm not sure this is really an extensive discussion.

DR. GREENBERG: Isn't this really a broader issue that is part of the ongoing review of the committee? I don't think it is probably appropriate to pursue this any further here, but it is not that it isn't an issue that has been raised. It was raised with several of the code sets. It was raised with the NPRM process. I think it is something the committee should stay on top of, but I don't think it can really be resolved here.

DR. COHN: It is not the answer, but maybe this is a broad investigation and database with all the code set developers that are charging a license fee, because certainly it seems to be an ongoing issue. I don't have any way to make anything free for anybody, but we ought to --

DR. GREENBERG: Isn't it on your list?

DR. COHN: Yes, I think it is on the list. Cost, Jeff added that from yesterday. So I think maybe we will just have a whole panel devoted to feelings about that, and if there are any great solutions.

MR. GRANT: I wish I was better prepared to articulate that. I think what I will do is ask NADP's executive director to get back to the letter. Maybe she can state it in a more succinct manner.

DR. ZUBELDIA: Is there anything else?

PARTICIPANT: What about the next meeting?

MS. BEEBE: Maria Ward before she left wanted to offer, if she needs to be on the agenda, that she could carve out time for the next meeting, if the subcommittee wanted to have her back here.

DR. ZUBELDIA: I don't know if we need it.

DR. COHN: At this moment, we have to do a little more agenda planning, but I don't think there is going to be a discussion about DSMOs.

DR. GREENBERG: Isn't it about the time that we have the annual review with the DSMOs?

DR. COHN: That was actually an e-mail that I received from Maria about the yearly review. She was proposing October. I sent that e-mail along to Karen and asked for her thoughts, because I think we need to be looking at the timeliness. Obviously we are at the beginning of a process that results usually in a notice of proposed rulemaking. The question gets to be figuring out how that all works in terms of timing. So I was going to ask her for her guidance. But I think that would be the only reason we would need a DSMO representative here in the next meeting.

Anything else? Any final comments? I want to thank you all for coming. We will keep a close eye on this one.

DR. ZUBELDIA: And we are adjourned.

DR. COHN: We are adjourned.

(Whereupon, the meeting was adjourned at 12:30 p.m.)