[This Transcript is Unedited]

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

SUBCOMMITTEE ON STANDARDS AND SECURITY

Hearings on HIPAA Code Set Issues

May 30, 2002

Dept. of Health & Human Services
Hubert Humphrey Bldg., Room 705A
Washington, DC 20020

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

Contents


P R O C E E D I N G S

DR. COHN: Good morning. I want to call this meeting to order. This is the second of two days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee is the main public advisory

committee to the U. S. Department of Health and Human Services on national health information policy. I am Simon Cohn, a physician, and chairman of the subcommittee. I am the national director for health information policy for Kaiser Permanente.

I want to welcome fellow subcommittee members, Health and Human Services and staff, and others here in person. I also want to welcome those listening on the Internet. As I say every morning, we need to make sure, and I would remind everyone, that when you are making comments or making presentations, we would ask for you to speak into the microphone so that those on the Internet can hear, as well as we have recording of our testimony.

The focus today, this is our second day, is on the HIPAA medical data code sets and whether there is a need for possible expansion to the list of codes or need for replacements. Today, we are looking at issues that we have identified from previous medical data code set hearings. We will be talking further about them this morning and into the early afternoon. I want to thank Donna Pickett, Betsy Humphreys, Vivian Alt and Karen Trudel for their work putting this day together.

With that, let's have introductions around the table and, then, around the room. For those on the national committee, I would ask that if, as part of your introduction, if you would note if there are any issues coming before the subcommittee today for which you need to recuse yourself. On that note, I want to publicly mention that I am a member of the CPT editorial panel. As I think you all realize, CPT is a HIPAA named medical code set. Because of this, I will be recusing myself from any votes on procedural coding issues today. Indeed, I have asked Kepa Zubeldia, one of our committee members, to lead the session. I will, however, with the agreement of the subcommittee, participate in the discussion and question periods for the morning.

Jeff, would you like to continue the introductions?

MR. BLAIR: You betcha. Jeff Blair, vice president of the Medical Records Institute, vice chair of the subcommittee on Standards and Security. There is nothing that I need to recuse myself from.

DR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for information technology at the Agency for Healthcare Research and Quality. I am liaison to the national committee and staff to the subcommittee on Standards and Security.

DR. YASNOFF: Bill Yasnoff, Centers for Disease Control and Prevention, staff to the subcommittee.

MR. BEEBE: Michael Beebe, American Medical Association.

MR. GUSTAFSON: Tom Gustafson, Centers for Medicare and MedicAid Services.

MS. BEBEE: Suzie Bebee, NCHS and staff to the subcommittee.

MS. GREENBERG: Marjorie Greenberg, National Center for House Statistics, CDC and Executive Secretary to the committee.

DR. ZUBELDIA: Kepa Zubeldia, Clarity Corp and member of the subcommittee and the committee.

MS. TRUDEL: Karen Trudel, Centers for Medicare and MedicAid Services, staff to the subcommittee.

MS. SQUIRE: MaryAnn Squire, NCHS.

MS. SCALA: Virginia Scala B

MS. PICKETT: Donna Pickett, NCHS and CDC.

MR. ORLEON: Jeff Orleon, Insurance Associate for B

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

MR. STINEDELL: Steve Stinedell, Centers for Disease Control and Prevention.

MR. MARTIN: Peter Martin, Acupuncture and Oriental Medicine.

MS. GORDON: Dena Gordon, Legal Medical Information B

MR. EMERY: Jack Emery, the American Medical Association.

MR. MILLEN: Bruce Millen, American Association of Naturopathic Physicians.

MS. HANDY: Pat Handy, McCethlan Corporation.

MS. SMITH: Gail Smith, McCethlan Corporation.

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

MS. KLAUS: Linda Klaus, American Health Information Management Association.

MS. PROPHET: Sue Prophet, American Health Information Management Association.

MS. BONNELL: Claudia Bonnell, Blue Cross and Blue Shield Association.

MR. McCORNEY: Frank McCorney, American Dental Association.

MS. KEMPF: Tamara Kempf, American Dental Association.

DR. FEINBERG: Lori Feinberg, CMS.

MR. RUDOLPH: Paul Rudolph, CMS.

MS. FIEBERK: Elizabeth Fieberk, independent consultant.

MS. GILFULLY: LeeAnn Gilfully, Gilfully Consulting.

DR. COHN: Well, Kepa, I want to thank you for your willingness to lead these hearings and let me pass the gavel to you for this session. I guess we should comment that, based on our discussions yesterday, the schedule has changed a little bit in the sense that we have planned to take an abbreviated lunch break and will, likely, be finishing before the scheduled adjournment time. Kepa?

DR. ZUBELDIA: We will be trying to work through lunch. Maybe we can finish before. We had a very interesting discussion yesterday, and great presentations. We talked about the use of ICD-9 and ICD-10 for diagnostic purposes. Today, we would like to hear the follow-up on the discussions we had in April on the use of ICD-9 and ICD-10 for procedure coding, and other procedure coding systems. We have a panel with two members and I would like to invite Michael Beebe to start. Then, some discussion.

MR. BEEBE: Thank you very much. Good morning. My name is Michael Beebe. I am the director of CPT Editorial and Information Services at the American Medical Association.

I would like to talk to you today about some additional information that was requested by the subcommittee, based on, I think it was my presentation from February 6th. I guess I can only assume that I was not very clear in that presentation. So, I apologize for having to be here again. My statement, I weighed and served three questions on which the subcommittee requested additional information: The CPT update schedule, the CPT licensing and cost and the CPT editorial panel meeting process, itself.

First of all, the CPT update schedule. The subcommittee has expressed some concern about the proposed semi-annual early release of CPT category 3 codes for new and emerging technology and the lack of coordination between CPT and the healthcare procedural

coding system, HCPCS and their newly adopted quarterly update schedule. Since the February 6th meeting where this problem of the semi-annual updates was discussed, the CPT editorial panel discussed the issue of the category 3 code release and implementation dates with several of the payers on the panel, the Centers for Medicare and MedicAid Services, the Blue Cross Blue Shield Association and the Health Insurance Association of America.

The panel, and the payers on the panel, believed that a six month time period is sufficient to implement the new codes. They agreed on the following schedule of a January 1 release of the new codes, the new category 3 codes, for July 1 implementation and a July 1 release for January 1 implementation. That will give payers the six month window to incorporate those sets.

The CPT editorial panel chose to develop the category 3 codes to address the concerns of the healthcare device and pharmaceutical industries. The CPT editorial panel code proposal criteria required that services receive full FDA approval for any devices or drugs used in the performance of the service. It is also required to demonstrate that a service or procedure is performed by many physicians or non-physician healthcare professionals throughout the country. These criteria, often, have the effect of delaying the development of CPT codes for new and emerging technologies. To respond to concerns expressed by this delay on the part of pharmaceutical and device manufacturers, the panel developed category 3 codes to provide standard descriptor language and codes to facilitate tracking and research on new and emerging technologies.

The CPT editorial panel is able to offer early release on category 3 codes because the services are not part of the Medicare fee schedule and do not go to the AMA specialty society of the RVS update committee or the RUCK for relative value recommendations to CMS. As you know, CPT is used in connection with the Medicare physician fee schedule and the panel has made every effort to accommodate the statutory requirements for annual updates to the schedule. Unless Congress acts to change the updates, the panel will only consider early release for codes that do not need to go before the RUCK for relative value recommendations.

In addition, the AMA and the CPT editorial panel view the possibility of more frequent updates to medical code sets as potentially disruptive to the claims process. Since payers on the panel recommended a six month implementation period for systems to accommodate the category 3 codes, we are concerned that more frequent updates could disrupt the claims processing system that currently causes delayed payments to physicians.

On the issue of coordination between CPT and HCPCS code set release schedules, the AMA and the CPT editorial panel both agree on the need for greater communication and cooperation between the developers of the two code sets. We believe it can only be achieved if the HCPCS alphanumeric editorial panel expands its decision making process. The work of the HCPCS alphanumeric editorial panel could benefit from the input of physicians, physician groups and recommends that the CPT editorial panel be provided a seat and an opportunity to serve on the HCPCS editorial panel. Tracy Gordy, Dr. Gordy, the chair of the AMA editorial panel, recently wrote a letter to Tom Grissom, director of Center for Medicare Management, voicing similar concerns, and also asking for greater physician and non-physician participation in the HCPCS panel.

On the licensing and cost issue, the subcommittee indicated that the pricing of CPT is a concern, particularly related to the cost of acquiring information on CPT from the Internet, as well as the cost of CPT assistance. Concern was also expressed regarding a rumor that the AMA had new licensing prices and policies for use with CPT. To begin, AMA licensing prices and policies for the use of CPT has not changed. The AMA has no intention of changing these policies and prices.

CPT electronic data files are licensed directly to end users, internal use license, and to product developers who wish to incorporate CPT in their products, distribution licenses. Royalties for internal use and distribution licenses are the same, $10 per

user, per product, plus the initial cost of the data file itself, which is roughly $55. This is the same rate and the same policy that was referenced in the preamble of the August 17, 2000, the final rule on transactions and code sets. Volume discounts to the $10 per user fee are available.

CPT pricing has, historically, been developed and based on individual users. Some software programs are now priced based on the number of concurrent users. Either approach is sound. We believe that the individual user price structure has the advantage of being simpler to implement and administer since it does not require a computerized user counter function to monitor the number of concurrent users. Also, the modest CPT royalty is, in part, reflective of the broader user base of individuals, as opposed to the more narrower base of concurrent users.

The AMA encourages fair use under U. S. copyright law. Fair use is limited use that must meet specified requirements and does not require license. The AMA does not require CPT license for CPT codes used in connection with superbills, patient bills or incidental viewing of CPT codes. The scenario of a hospital that provides patient access to their medical records would likely fall under fair use and the patient would not have to pay. The hospital would pay for its use of CPT as CPT is incorporated into the software that facilitates the development of the patient access tool or the development of the bill. But, the patient, again, would not have to pay.

Internet pricing and policy is the same as the above distribution licensing policy with some additional security features to help protect our copyright. The AMA has recently signed two amendments with CMS to allow the free use of CPT on the CMS website and on their carriers' website to communicate Medicare policies.

The AMA has also recently developed a public access site where users can look up CPT codes and Medicare fee information for free on the Internet. Users can search by code or keywords in the long descriptors and the search will return long descriptors of the CPT service and the Medicare fee information by geographic area.

The subcommittee also expressed interest in the pricing of CPT Assistant. Currently, descriptions of CPT Assistant is $169 for non-members or $115 for AMA members for one year, which is 12 issues. A two year subscription can be had for $299, or $205 for AMA members. The CPT Assistant is a monthly newsletter that provides accurate, up-to-date information on the application and interpretation of CPT codes. The newsletter is targeted toward the continuing education of CPT users to assist them in their day-to-day tasks often associated with using CPT.

The CPT editorial panel meetings. CPT panel meetings are open to all participating specialty societies and the healthcare professionals advisory committee. This means that any or all of the 112 member CPT HCPCS advisory committee, and their staff, can attend panel meetings throughout deliberation and voting on coding changes, including the development of code language and guidelines. Individuals and organizations who request coding changes are welcome to present their views to the panel and can stay throughout deliberations and voting.

Panel voting is conducted electronically to maintain the confidentiality of panel decisions. We believe confidentiality is important to preserve the integrity of the editorial process where reconsideration and refinements are part of the process for developing a quality product. The Centers for Medicare and Medicaid Services, the Blue Cross Blue Shield Association, Health Insurance Association of America, the American Hospital Association, the American Health Information Management Association, representatives from the managed care industry and representatives from the healthcare professionals advisory committee, along with rotating representatives from the different medical specialty societies all participate in the CPT editorial process.

Panel decision making is conducted in open by secret ballot and payers and physicians and non-physicians are all permitted to vote. Although panel meetings are not open to the public, as ICD-9-CM meetings are, panel decisions are made in the open.

Although the ICD-9-CM maintenance process was identified as the most workable approach in the preamble to the final rule for transactions and codes sets, the AMA believes it is only one model for code set maintenance, with the CPT editorial process as another desirable alternative. The ICD-9 coordination and maintenance committee conducts open meetings where anyone is welcome to speak on an issue and committee agendas are posted in advance on a CMS Internet site for anyone to view. However, no decisions are made at the committee meetings and the final group that makes decisions is not specified and contains no representation outside the government.

Alternatively, CPT editorial panel meetings are open only to participating physician and non-physician healthcare professional organizations, not to the public. However, decisions are made at panel meetings by a specified group that contains representation from physicians, hospitals, payers and non-physicians.

The AMA views the process for maintaining ICD-9 and CPT as two different approaches that achieve similar results with respect to openness and the opportunity for inclusion. The two processes both meet the intent of HIPAA for open update process and for all adopted standards. The AMA believes that openness is achieved by providing access to the editorial process by all interested parties by giving stakeholders a voice in deliberations and by broadening decision making to include as many and diverse group of stakeholders, perhaps on a rotating basis, as is practical.

Certainly, the demands of a rigorous and thorough editorial process place constraints on the number of individuals involved in making decisions. The AMA is currently exploring ways of using the Internet to post agenda material and to allow comment on that agenda material by the public.

In conclusion, the AMA takes responsibility to maintain and distribute CPT very seriously. As such, policies surrounding the release of CPT codes, the licensing of CPT and panel process, are always developed to maximize the public interest. This commitment will continue to shape CPT editorial and business policies as the panel and the AMA work to meet the challenges of HIPAA.

Thank you for allowing me to present the views of the AMA and the editorial panel. I would be happy to answer any questions you have.

DR. ZUBELDIA: Tom?

MR. GUSTAFSON: Thank you very much. Tom Gustafson, Centers for Medicare and Medicaid Services. I am happy to be here again. I was with you for the last meeting to talk about ICD-9 and 10. My subject this morning relates to HCPCS. I am going to operate from a set of slides that copies of which are available for all of the panelists at their desks and there are some additional copies, I believe, over on the side table for anyone who did not pick one up on the way in. There is, also, a printout there of information from the HCPCS website that may provide some background information for those who are unfamiliar with this.

The topics I was going to cover this morning related to several that had been identified to me as subjects of interest to the committee. I certainly hope I have this right because I do not claim to be the expert on all aspects of HCPCS. Let me proceed with this and, then, obviously, I will be prepared to answer questions on these subjects, or others to the best of my ability.

I am accompanied this morning by Dr. Lori Feinberg, who is one of our coding experts. She is a member of the CPT editorial panel and represents CMS on that panel. As a rehabilitation specialist, also works very extensively with the folks concerned with updating HCPCS.

The three subjects I was going to treat this morning are composition of the national panel for HCPCS, the update schedule and an issue related to implementation guides. Just to summarize here, I was going to provide a little bit of background information on the nature of HCPCS. I think that the panel may have heard some of this before, but on the premise that repetition is the mother of learning, bear with me as I go through this.

HCPCS. The initials now stand for Healthcare Common Procedure Coding System. The words used to embody the term Healthcare Financing Administration, HCFA. But, of course, that is a past organization. It changed its own name, so we changed the name of the code set, keeping the initials the same.

These codes are used for ambulatory procedures. There are three levels of codes. Here is something that may not be readily apparent. CPT 4 is considered part of HCPCS, what we refer to as level 1 codes are the CPT 4 codes that the American Medical Association editorial panel maintains. There are, then, two additional levels of codes, one which I will label here, simply, alphanumeric. Then, a third step, which I will refer to as local codes, used largely by state Medicaid agencies and some local carriers. They are on their way to extinction. We have a definite schedule for phasing them out over the next while. I won't dwell on them further.

What we are mostly talking about, when people say HCPCS, they usually refer to the level 2 codes. These codes include codes for drugs, durable medical equipment and so forth. Just to give some flavor of this, I have displayed on this slide some of the various series. There are, actually, two or three other series, I think, that I may have left off because they were so, they appeared to be so small. They cover a gamut of different things, as you can see here, outpatient pass-through items, durable medical equipment, medical supplies and other items which, by and large, are not part of the CPT set. Here is an additional slide which provides further information.

The number of codes here varies very substantially in individual series. Radiology transportation, for instance, has its own series because under Medicare, radiology transportation, is reportable x-rays, is carrier priced. I believe there are three codes, perhaps four, there or something on that nature. Some of the other series, Q for instance, is quite large. This apparatus is described in greater detail in the handout I was referring to earlier.

The national panel, we have, yet, a third model here of how these things operate. The national panel consists of three organizations: the Centers for Medicare and Medicaid Services, Blue Cross Blue Shield and Health Insurance Association of America, representing private insurers. We also have a number of formally designated consultants which are displayed here. The American Medical Association; Department of Veterans Affairs, the federal agency; one of our durable medical equipment contractors, of which we have four around the country; and then, there are two particular private insurers. I am not sure exactly whether they serve on a long period or rotate around. Just one note here because I know this question has arisen in the past, but what about Medicaid? The answer is, in our view, we represent both Medicare and Medicaid. You will notice our title, the name of our agency includes both of those organizations. I will go into that a little bit more in just a minute.

The consultants, in this case, receive the full information on the panel agenda and provide comments to the panel as a whole. Anyone who is familiar with these kinds of meetings knows you, usually, get a very large binder of information for any given meeting. The consultants receive all of that, we mail them to them. They provide comments to them, they provide comments to the committee.

The CMS organizes its own HCPCS activities in a fairly formal way. We have a work group that consists of representatives from, if you will, both sides of the house. So, Kay Riley, who I know may be familiar to many of you, sort of honchos this and is the principal Medicare person on there. We have a representative from the Center for Medicare and State Operations. A person named David Greenberg, who maintains a website for communication with states. And, we have a state representative, Alan Schutgard, if I am pronouncing it right, from the State of Maryland, who is designated to the work group by the state Medicaid director's association.

Now, this work group comes together for various purposes and makes recommendations on behalf of CMS to the national panel. This provides a channel for development of those kinds of activities. The panel, itself, receives applications on an annual basis from interested parties. Each member makes recommendations related to those applications. This is detailed in the handout I described earlier. We believe it is fairly well known in the wider community. Typically, an application, the application date,

as I understand it, is April 1st. Deliberations happen over the summer and new codes arise the following January.

Meetings are a little less formally organized than in the other systems that we have just heard about, where interested parties have an issue they wish to bring to the attention of the panel by other than written means, they can request meetings. I understand the individual members meet frequently with various interested outside parties. There is a formal machinery for doing that related to durable medical equipment. The panelists, in turn, may also meet jointly, although this is not a frequent occurrence. The panel, then, convenes itself three times a year in order to determine codes for the national cycle. It is, basically, taking three bites in the course of a process that operates on an annual basis. It is too much work to do all in one meeting, as you can well understand.

Individual members have the opportunity to establish codes on their own motion, and do so to a greater or lesser extent. There are several of what I refer to as temporary series within the code sets. I will come into those in greater detail. G codes are created by the Medicare program relating to its programmatic interests. Others can use these codes, but they are Medicare's in that sense. S codes, as noted here, are created by the private insurance members. These codes respond to the particular payment policies of these payers. I will have another slide on that later on.

So, what causes us to establish a code? Well, it is very typical, very similar to what you would expect in the maintenance of any code set. You see something coming along that may be unique or different or inadequately described by the existing codes. Where there seems to be some important difference between the existing codes, and where there is use of the item in sufficient volume to warrant a code. There are examples where folks have come along to us and said, gee, we need a code for our product. We have looked at it and discovered, well, they have only sold 35 units of this thing around the country. That may be just because it is starting up and we expect to have 100,000 units next year, in which case you would really want to look seriously at a code. On the other hand, if it looks like they might inch their way up to 40 by next year, you might not do it.

In instances where a specific code for a particular item is not available, payer systems permit the use of unlisted codes. The implication of that is, at least in the Medicare system, that claim involving that code will kick out for review on a by-hand basis at the carriers. Medicare processes about a billion claims a year. Almost all of these are untouched by human hands and unseen by human eyes. The coding system is vital to maintaining automatic code processing. But, in instances where there may only be 35 claims a year, rather than set up the elaborateness of a special code, it may be perfectly appropriate to continue to do that on a by-hand basis.

The updating question. As I described earlier, the introduction of new codes typically happens on an annual basis. There are provisions for quarterly updates in certain circumstances. G codes and S codes I already have described to you very briefly. C codes, another similar kind of thing, it is a specialized code series used only in the Medicare, or, at least, designed to be used for the Medicare hospital outpatient perspective payment system. There are special payment provisions there for what I refer to as pass through drugs and devices. We have to be able to identify those and we have a quarterly updating system to permit newly arriving drugs and devices to receive this transitional pass through payment early in their life cycle.

There is a trade off here that we need to recognize. Again, there is nothing unique about HCPCS in this, trade off, whether you do quarterly, annually or some other cycle, between the speed with which we can move and the administrative burden on various stakeholders in the system of proceeding more quickly. More frequent updates, just to note for the sake of those here who are interested, particularly, in research and epidemiological concerns B sometimes clouds the data picture. If things change in the middle of the year, your analysis becomes more complicated. But, the administrative burden that is of most moment to us as a payer is the administrative burden in our systems and in provider systems. Basically, the land here is that, as we understand it and I think you received some testimony from various provider groups, providers tend to favor long cycles. Annual seems to be fine as a general proposition. Suppliers to those providers, device manufacturers and others, tend to like things to move very quickly so that things can move into a more explicit payment status more quickly.

Let me come back to payer-specific code series here for just a moment. I have a slide here entitled Why G Codes? A similar sort of a story relates to the S codes, but since I am with the agency responsible for G codes, I will speak to that. Others may have some other observations on S codes. The G codes are established by Medicare for professional services that are used within its system. The reason we may need to do this, a couple of reasons. One is we may need to add a code lickety split because Congress says this benefit will start happening April 1st. If there is going to be a lot of whatever it is, we do not want to be in a position of doing hand processing on a very large volume of claims, but we cannot wait for a longer coding cycle. That would be a perfect example of something which might, then, migrate into a level 1 code at a later phase, once the CPT editorial panel had had a chance to consider it, although that is not a necessary consequence. In fact, there are some hypothetically temporary codes in the G series that have been there for a good long while.

There may be needs, on the other hand, where we need for our programmatic and policy purposes, or what the private sector might describe as business needs, to maintain distinct codes from those that are in the CPT series. I have given an example here on the slide of routine vena puncture. The CPT code for this includes vena puncture with finger and ear sticks, but Medicare does not cover these. It does not pay for them. So, we need a more specific code that goes to those particular items.

The question, the final question, that I believe I was asked to address related to coding guidelines, or what are sometimes referred to as implementation guides. There is an implementation guide, there are several different implementation guides around.

There is one available for ICD-9, principally on the diagnosis side, as I understand it. I am sure there are many experts here in the room who know this better than I. Similar rules have not been adopted under the HIPAA apparatus, at least, for other code sets. There is no general implementation guide, as I understand it, for HCPCS.

Our answer to this concern is, essentially, that the kind of information you would find in such a coding guideline is, generally, contained within the operating instructions from payers. We provide very extensive manuals and program memoranda that guide the behavior of carriers, intermediaries and providers. That is, we believe, the appropriate place to look for this kind of guidance. We, as payers, have to insist on maintaining our control over payment policy. In the case of Medicare, we are driven by statute and have to be able to code appropriately for that. So, that is the general rule.

I said I was going to describe the situation relative to public meetings for durable medical equipment. I seem to have dropped a slide here somewhere along the line. So, let me just point that out very quickly.

A lot of the action on HCPCS is in durable medical equipment. As a result of statutory change a year and a half ago in BIPA, we have now introduced a system where we hold public hearings. There are three of them scheduled for this year. It is our expectation that we would hold three such public meetings each year going into the future. The schedule for these and the apparatus by which this happens was announced in The Federal Register in a bulletin that went out last November. This is an opportunity for manufacturers of equipment to come and make a formal presentation. The formal presentation is, basically, to the CMS work group. Agendas are announced in advance. Everyone gets to look, we draft proposed recommendations. Those are, then, the subject of discussion at this public meeting. CMS may revise its recommendation as a result of that meeting. The recommendation is, in turn, forwarded to the HCPCS panel for its consideration. I should note, in connection with the HCPCS panel, that anyone can request a code. That is obvious already. The panel meetings are not open to the public. However, their agendas are posted in advance on the web. That is described in the web material I referred to earlier. Anyone can make comments that are, in turn, reviewed by the panel in the course of its deliberations. We publicly invite comment on that.

I will stop here. That is the end of my formal presentation and I would be happy to answer any questions.

DR. ZUBELDIA: Thank you. Thank you, very much, both of you for the clarifications. I would like to start with a question for Tom on what is the process for making some of the temporary codes permanent?

MR. GUSTAFSON: I would ask my colleague, Dr. Feinberg, to come up to the table and, perhaps, elaborate on that for you.

DR. FEINBERG: Temporary codes are established for programmatic reasons. If the work group decides that it meets the needs of all payers, not just Medicare, which is, when do a temporary code, it only applies to Medicare, although we also have the capacity to do temporary codes for Medicaid, as well. We may do more of that in the future. We have not done much of that in the past, but we have a code area for that. The proposal goes to the committee and it is put on our agenda. The public gets to comment. It, then, gets voted on and is adopted and updated during the regular update cycle.

In other words, are you saying that we decide to or someone in the community wants one of our temporary codes to be permanent? Can you give me a little bit more of a scenario? I can walk you through it in more detail.

DR. ZUBELDIA: In the April meeting, there was some concern from the Blue Cross Blue Shield, and some of the other private payers, that they would like to have some of these S codes as permanent codes and remove the wording temporary out of it.

DR. FEINBERG: Actually, if you look in the CPT book, there already are several of those home health kind of home infusion codes that have become a part of the CPT code set. We will be doing more of that in the future so that as we find a need, those things are brought to either the CPT or the HCPCS panel and are brought into the permanent code set.

MS. HUMPHREYS: Can I follow-up on that? When we heard from the home infusion people, I think they felt that codes that were in, now the S codes in HCPCS, were exactly what they needed and wanted. They, definitely, did not want them ever to disappear.

They thought that it was very, it was unsettling to the people who use them to have them attach this rubric temporary.

DR. FEINBERG: As we said, many of the temporary codes are awfully permanent.

MS. HUMPHREYS: Is there any problem with calling them permanent then? The ones that are?

DR. FEINBERG: If someone wants to write to the national panel and request that they be moved into a permanent position, you would follow the same basic application procedure which, actually, is in that long HCPCS, I put a HCPCS handout on the table which is, basically, a HCPCS primer. If there are not enough of them, I have more. There is an application to fill out. It would be, actually, quite short when you say I would like to see the S code of so-and-so put into a permanent category. It would be a fairly simple application and the committee will consider it.

MS. HUMPHREYS: Would it change the code?

DR. FEINBERG: Not necessarily.

MS. HUMPHREYS: Okay.

DR. COHN: First of all, Michael and Tom and Lori, thank you both, all, for coming. Obviously, I think the work of HCPCS is very important, especially as we move towards administrative simplification in October of 2003. As we move to get rid of local codes, it is very important that the work of the HCPCS national panel not be impeded because there is a lot of work to be done. Having said that, the subcommittee and full committee has heard testimony from HCPCS, Kay Riley and others over the last several years. I think we have been relatively concerned about what we perceive as the lack of coordination between the HCPCS alphanumeric codes and the CPT HCPCS level 1 codes. I am, actually, hearing, maybe I am just being more attuned to it, but, I seem to be hearing more concerns and more issues coming up over the last six months to a year than I have heard previously.

I was hoping, Tom and Michael, that you were both coming to explain how you were going to better coordinate. What I hear, Tom, is a rendition of what is and what was a year ago which, as you said, the subcommittee has already written a letter to CMS about. I am hearing from Michael, I think, a request for greater coordination. I think. Can you both describe plans for improved coordination between these two coding systems?

DR. FEINBERG: Can I address something?

DR. ZUBELDIA: Sure.

DR. FEINBERG: I know that the agenda materials for every HCPCS in the past went to CPT. Now, they did not, they were not, because they did not seem as immediately important as other things. I am not sure how much feedback we got from them. Now that there is a move towards more coordination, the materials are now going to Michael. I believe we can use the same vehicle to get better coordination. We do not have to, really, implement a new vehicle, we just have to say this is now a more important task than it was in the past.

MR. BEEBE: I think, definitely, by way of putting, yesterday, before I came to this meeting, I got two, two, Fed Ex packages each this big from Kay Riley. So, I think it is one of those situations that maybe we ought to be careful about what we ask for. But, I think that part of coordination is not only participating as a commenter to the process, but also participating as a decision maker on the process. As you saw, the folks who make the decisions at HCPCS are all payers. I think that it would be a more fair process if there were providers involved in that decision making process. I think that would, also, help tremendously with the coordination between CPT and HCPCS.

MR. BLAIR: Tom and Lori, I remember some of the recommendations that we made. It was several years ago. Maybe you could give us an update, or refresh my memory a little bit, as to what has happened. There were a couple of things. One of them was that we had made the suggestion that the HCPCS board, and I may not remember the name of it exactly, be expanded for greater representation from Medicaid agencies. To the best of my knowledge, I do not think that that has occurred because you just mentioned that it is, the three entities are still the same three entities, Health Insurance Association of America, CMS and I forget the third. Apparently, there must have been some reason why that did not happen.

The other piece was, if I recall correctly, we had also made the suggestion that the policy that is in place of considering new codes, one of the criteria was that the volume of usage be there in order for you to designate a new code. I think that our suggestion was for you to consider the fact that if you do not create a new code, in many cases, it will stifle a new procedure from being used and that you look for a new way, a new policy, a new criteria, so that things could be more open. I do understand that you do not have a crystal ball. But, maybe you should not try to have a crystal ball. Maybe you should try to see if you could make it more open because once the codes are in place, then, it gives opportunities for new procedures to, or, procedures or durable medical equipment or other medical supplies, other reimbursements, to be able to find their own level more naturally.

Could you give me some feeling as to what thoughts you have had on these things and whether these recommendations are still being considered or not?

MR. GUSTAFSON: Let me try to comment on that. This is Tom Gustafson. Perhaps Dr. Feinberg may fill in. On the question of Medicaid representation, we believe that there is adequate Medicaid representation at the national level and at the work group level, as well. I described that earlier in my presentation. We have a representative to our work group which has been designated by the appropriate association of state Medicaid officials who provides input, works regularly with our work group. Our understanding is that our agency, which sponsors both programs, represents both programs, at the national level. We do not believe there is any significant concern in the Medicaid community on this issue. We may not have been hearing it if there is. But, we believe that there is, in fact, adequate representation at the moment.

Let me say, in general, that the question of who ought to be on the national panel is one for the national panel to determine, as we understand it. We are, certainly, open to considering the possibility of expanding the panel in various ways, but I have to represent myself as CMS's representative on that. This would have to be a joint decisions with the other parties.

As to the question of volume and how that plays, I attempted to describe that earlier. We do not have a hard and fast rule on this which says, you know, if you do not sell 100,000 units, we are not paying any attention to you, but, it is a judgment call as we currently deal with it. The judgment involves, in no small measure, anticipation so that we do not have a crystal ball, but we hear what people say about is this likely to be an important and widespread item or service that may be added or not. We have no problem with permitting items that are coverable under the Medicare program, at least, from being covered and being paid for. It is important to emphasize that when we talk about whether an item receives a code or not, that is not tantamount to whether it is paid for or not. Because of the existence of unlisted codes, items that are thought likely to be in small volume can be paid for, they just do not have their own specific code. Now, you can be assured that manufacturing interests are very keen on having that explicit code identified because, then, they can tell hospitals, well, if you code it this way, here is what the answer will be. Medicare will pay for it, it will be paid at this price. It is less certain in the small volume kind of circumstances. We do appreciate the fact that that may have some effect on folks' willingness to adopt technology and we are very mindful of that.

Our goal, CMS's goal at least, in any of this is to provide access, to ensure access, of our beneficiaries to quality medical services. Insofar as new items come along that do a better job, we actively want to get them into the hands of physicians, and so forth and so on. We have to balance that general thrust with, obviously, the administrative concerns that go along with that and the possibility of substantial elaboration of a large number of codes for very small volume items which would, in turn, have some administrative burdens, both on us and providers, and make the fat code books all the fatter and that sort of thing. Dr. Feinberg?

DR. FEINBERG: There is, actually, a converse case that people sometimes do not think about. We, sometimes, split out a code because we want to non-cover it. There was a recent non-coverage decision, actually, that had to be implemented with a G code because they had been hiding this service under an existing CPT code, but it was sufficiently different that we said we are giving it a G code so we can identify it and not pay for it. Sometimes, coding really helps us discriminate services, two types of services, one that we want to pay for and one that we do not. We use it that way, so that I think that the coding system offers us some flexibility in better identifying the product that the beneficiary gets, but the beneficiary can get products for which there is no code.

There are, certainly, by the number of new codes we add which is very large in the HCPCS system, I think there are hundreds of codes that we change or modify every year. We do that in response to these applications, basically, applications from the world. We did have, though, here is an example of a code we did not accept. People had an ID bracelet for this is Mrs. So-and-So. She has diabetes. They wanted a different code for the diamond studded one, the ruby studded one, the emerald studded one. I could not have made this up. But, you know, the answer is those we do not care, really, about coding about. They are just not of medical distinctions. Anyway, that gives you an idea, hopefully.

MR. BLAIR: Thank you.

MS. HUMPHREYS: I wanted to follow-up on the issue of the coding guidelines or lack thereof. I understand the distinction between payment guidelines. I understand that, obviously, the payment policy approach is somebody else's. But, first I would like

to know, I mean, Medicare itself, Medicare, Medicaid, is a big payer. Do you have official CMS coding guidelines for HCPCS for Medicare and Medicaid?

DR. FEINBERG: Can you give me an example of what you mean, what question you want answered by a guideline?

MS. HUMPHREYS: Basically, the issue here is not, it is, maybe, let's get right back to your example of the rule out, the fact that you broke out something.

DR. FEINBERG: Yes.

MS. HUMPHREYS: A guideline is, you have to use that code for this service. You may not use it up here. What we are hearing from the field is that different payers, actually, take the same service, the same procedure, and have slightly different ways that they want you to code it. This is what administrative simplification was supposed to get around. But, if every payer can give you a guideline and the guidelines is we want you, in these fuzzy cases, we want you to code it this way, then the provider is sitting there with the requirement to code one way for Blue Cross, one way for Medicare, one way for payer B. So B

DR. FEINBERG: For example, I will give you an example, at least the way Medicare does it. There was a code called care plan oversight, 99275, I do not remember the number, but on that order. It is care plan oversight. We used to cover it. It was worded to match our payment policy. A professional organization came along and said we think this code would be better if you added this to it. We said you can add that, but that is not according to what we pay and that now encompasses that code for a bunch of services that we think are included elsewhere in ENM. So, the code was adopted by the CPT panel, no problem. In our database, we marked that code as non-covered. There is a little N there. We have a G code that goes back to the exact old text

of the code and people know that when they see an N in our database, they have to code it with a different way. Really, it is communicated in a fairly clear manner that is published annually in our Federal Register notice.

MS. HUMPHREYS: I think that the issue here is that B

DR. FEINBERG: Usually, the coding books, actually, pick it up in the colors when they print them, although they are not completely B

MS. HUMPHREYS: You are not quite getting at this. Maybe somebody else can help me. The issue is that people are submitting claims to Medicare, and everywhere else, and for the same service they are being, whether it is paid or not, they are being required to describe it a different way. Michael, maybe you can B

DR. ZUBELDIA: Let me for a second. Initially, when the CPTs and HCPCS came out as two distinct code sets, maybe 50 years ago or something, the instruction was that if there is a code in the CPT, you use the CPT code. If there is not a CPT code, then you look for a HCPCS code. That has somewhat migrated to, and depending on the payer and depending on the code, that if there is a HCPCS code, you use the HCPCS code in preference to the CPT code. But, it is not consistent. It is not consistent from payer to payer. It is not consistent from code to code. I think that is what Betsy is referring to, are there guidelines on how to do, which code to use?

DR. FEINBERG: I think that the issue here is that although we can publish the rule that says you must use these codes, we have not solved the problem of providers and provider organizations having to maintain a whole set of independent rules until we have some greater consistency in this area.

MR. BEEBE: We see that it is a big problem. The AMA spends a lot of time helping people understand how to code. We draw a very hard and fast line due to something called anti-trust between payment policy and coding policy. We do not get involved in payment policy. We do and are very much involved in development of coding guidelines and coding rules. CPT has several different levels of coding rules to help people understand and to uniformly apply CPT codes, conventions, guidelines. We, truly, believe that without the adoption of those rules, for example, what is an add-on code in CPT? How are add-on codes to be applied and used with respect to other codes in the code book? Conventions like that, without the adoption of rules and guidelines,

are meaningless. It does not create for an administrative simplification plan.

MR. GUSTAFSON: I have to take the payer perspective on this. That is that we can only pay for what we are supposed to pay for.

MS. HUMPHREYS: That is not the issue.

MR. GUSTAFSON: No, I think it is the issue because insofar as you create a uniform set of coding guidelines for CPT that would apply to all payers, that could lead to situations where Medicare, Medicare's payment policy, is being directed by coding guidelines, not by coding, but by coding guidelines created by another organization.

MS. HUMPHREYS: I can easily believe that this could be the case. But, I think that is the issue that we are trying to address here because I can also believe that it would be possible for there to be uniform coding guidelines. Then, to have Medicare have its own set of rules, as you say, and we do not pay for this. Somebody else to say, yes, yes, yes, we do pay if it is Medicare Plus Choice, or whatever. But, the, and, I agree that this is, probably, a complicated issue, but I participated in discussions when there was a discussion about whether there were uniform coding guidelines that could be recommended as part of the original standard. The answer was that there was not because of the issues you are describing. But, it seems that we are hearing from the field that it would be tremendously valuable if there were such things.

MR. BEEBE: If you take CPT modifiers as an example, CPT modifiers allow the physician or non-physician professional to modify the circumstances under which the service or procedure was performed. It does not change what they actually did, just the circumstances surrounding it. Modifiers were accepted under HIPAA. As a result of that, all payers have to be able to accept CPT modifiers. That does not mean that they have to change payment policy based on CPT modifiers. I think that is the kind of example and the kind of thing we are talking about with guidelines. It is that you accept the guidelines and the guidelines have to be applied. That does not mean you have to pay for the add-on code. It does not mean you have to pay X amount of money for the add-on code. You have your own policy surrounding that. But, you have to be able to accept the add-on code.

DR. FEINBERG: Actually, I think, in some sense, HCPCS is a transaction system. You can send us a code that we have turned off and we will say, thank you, this does not describe a covered service. You have to look elsewhere. I will give you an example. For PET scans, there is one PET code in the CPT book. We have very prescriptive limits on what we pay for PET. Therefore, we have created G codes for PET for solitary lung nodules, PET for breast cancer staging, PET for, but, we cannot accept a claim for PET because it does not give us information about whether we can pay the claim. We send that claim, we get a claim like that, we accept it and we send it back and say it has to be coded in a different way. It is not as though it is not acceptable. It can come in, it can be processed, and it goes back to the payer. Yes, the payer who does PET, presumably, knows that, presumably understands. We put all of these things up for, at least we do, for public. We put them out in public pronouncements. They are available on our web. In some sense, what you are saying what you need is a compilation of our program memorandum on our codes. That would be doable. We could make that more easily accessible. But, I think it is important, every provider would love to have uniform payment policies for insurers, that is really what they are saying. I think that payers cannot B

MS. HUMPHREYS: I guess that I understand that everyone would love to have uniform payment policy. But, in the absence of uniform payment policy, they would like to have uniform coding approaches. Then, the payment policy added on top of a uniform approach. It seems to me that, as I understand it, HCPCS is now not, as of HIPAA, is not just designed to meet the needs of CMS. It is a national coding system for certain types of services. It does not matter if the claim ever comes to you. If it goes to a third party, if that service is supposed to be covered by HCPCS, then there has to be a HCPCS code for it and some approach to describing when that code is used. That is my understanding of the whole purpose of HIPAA.

DR. FEINBERG: Well, I think that there is a couple of things that we could do. We, certainly, could make an effort to organize our program memoranda to deal with, at least from a Medicare perspective, the HCPCS coding better, and put that on our HCPCS website, like all the materials, which I think ought to be very helpful that we, the HCPCS website, actually, has a wealth of material that I am not sure how much people use. We xerox the subset of it for people to read. I think that it, probably, is very reasonable if we were to, essentially, use what we call our program memoranda. I think that other payers, probably, have the same, they probably have bulletins and things that could be considered coding guidelines. But, I think in this case, the coding guidelines may be specific. For example, all of those S codes are S codes for home health that people like so much because Medicare does not use them. Although we are willing to have them be permanent codes, our payment policy is based on a completely different theory for paying for those kinds of services. So, those codes are, if you sent us one, we would deny it.

MS. HUMPHREYS: Yes, I guess that they did not want to send them to you. They just wanted to use them in the same way and they want them somewhere in an official HIPAA code set, listed as being permanently available so they are not worried that they might get dropped in the future.

DR. ZUBELDIA: Lori, actually, I think you are trying to, what I am hearing is that you are trying to enforce, through the code set, your payment policies.

DR. FEINBERG: But, really, that is the only information we get about the service.

DR. ZUBELDIA: But, you can easily tell the provider, do not bill for vena puncture if it is done through an ear prick.

DR. FEINBERG: But, then B

DR. ZUBELDIA: I would like B

MR. GUSTAFSON: But then, you would have a CPT manual that contradicts that payment policy.

DR. FEINBERG: Yes, you cannot do that. That is, exactly, what we do not want to do. We want the code to describe the service.

DR. ZUBELDIA: I would like to give Dr. Yasnoff a minute to talk about B

DR. YASNOFF: I am going to try to restate what Betsy said in a different way. It seems to me that the purpose of codes is to represent what happened, what the provider did. Insufficient detail so that all the decisions down the line that need to be made, including payment, but there may be other decisions, can be made. If the coding system, if the purpose of the coding system is only to facilitate payment, rather than to represent reality, what services are really being given, then you end up with a coding system where you are not, you cannot have this uniformity that we are trying to get to. Let me give an example. If a particular set of medical providers are painting patient's toes red, then, I would argue that there should be a code for painting patient's toes red. Probably, no payers will be covering that service since, to my knowledge, there is no evidence that that is medically necessary or beneficial. But, it would represent the reality that these providers are painting patient's toes red. Frankly, I do not care whether there is any evidence. What I think the codes need to do is to represent what the providers are doing. Then, you can take, if you have a good representation of what the providers are really doing, then you can make payment decisions. Let's go to that example, the vena puncture example. If you have a code for vena puncture that includes services that you are not paying for, to me, the problem is not that you have a payment problem, the problem is that the code

does not represent reality. Therefore, there should be codes that represent reality carefully. Then, you can sort them out as to how they are paid. But, I think it is important to think separately about whether the code set represents reality because if you do it that way, then presumably, everyone can agree, or, potentially, potentially, there is more potential for agreement on representing reality than there, certainly, is on agreement on payment policy. I think there are, obviously, going to be a plurality of payment policies, and that is going to change over time.

DR. FEINBERG: But, at some point, though, you have to, for example, let's take your example where you have a code for painting the patient's toenails red. Is there another code for painting the patient's toenails blue? Yellow? Orange? Well, what about fire engine red versus dark red? Are those separate colors? At some point, a distinction has to be made of where you want to stop describing the service in detail. I think that is always a tension in a coding system. I think that if somebody pays for it and somebody does not, then those are two good things to distinguish at the code level, I would say. That is one of the things, that is often the reason why we have to create different codes.

DR. YASNOFF: Right. I think if there is a clinical reason why you would paint someone's toes yellow versus red, you would want to have different ones. Also, if you were getting 100,000 claims a year with painted toes, that you might treat it differently than if you were getting one claim a decade for painted toes.

MS. HUMPHREYS: I think this is what you are doing and we understand that. But, it does seem to me that if the principle is that we are describing procedures that are done, that someone is submitting on a claim to anyone, we can even say if, this is an administrative coding system, so if we are doing things and no one is sending a HIPAA transaction about this, then you do not have to worry about. But, if someone is sending a HIPAA transaction, not to you, but to somebody, then it has to be covered.

It seems to me, therefore, there is an independent thing. What are the discrete things that people are sending and want to? Or, reasonably send? Then, the issue is who is paying for them?

DR. COHN: I think we can spend all of our time on these issues. I am well aware that at this table there are many coding experts. You have just heard from a couple of them. I may or may not be a coding expert, but I am humble enough to know that these are difficult issues. I doubt that we are going to solve them in the next 10 or 15 minutes, how you go about doing things. I have also been involved in this process enough to know that it is very imperfect. It is sort of where the world of coding

hits the real world of billing. I guess from my humble view of the world, really, what I am asking for and wanting is better coordination. I am not going to solve all of your problems today or at this table. But, I am, at the end of the day, very concerned as we move towards HCPCS 2 becoming a national code to be used by everybody, including the S codes, including the G codes, including everything there, that we need to take a look. It is not so much we, you need to take a look at overlaps, redundancies, areas of confusion.

I think we are going to be in a situation soon just to talk about home infusion where there is going to be a likelihood that people could be able to build on either through CPT or through S codes, at least as I understand. I hear, once again, from my view, I won't say on a weekly basis, but certainly on a bi-weekly basis, concerns from various groups about, gee, we are having trouble because we could use either of these two ways to do things like influenza injections. I mean something very basic, very public health related, and in the new world of HIPAA, people will have the ability to send codes either way.

I guess I am looking for some sort of a process, as well as I would like to follow this up with the subcommittee, about how you all are going to start coordinating better. I think that is, really, the fundamental question we keep sort of circling around about. Be it guidelines, be it the fineness and distinction of code sets. I think we have brought this issue up before. I think we need to bird dog this and follow it.

DR. FEINBERG: Can I make one suggestion?

DR. COHN: Yes. If you have a solution, please.

DR. FEINBERG: It would be useful to know the sort of situation in which coders have difficulty with the HCPCS codes so that we could understand what kind of guidelines are needed. If people can send that to our HCPCS website, which is listed with us, that way we will have, it, certainly, seems to me, for example, that from a Medicare perspective, and, I will talk to the Medicaid people, that we will make the programmatic coding information as accessible as we can. I think that if we do it, it can be a model for other payers, as well.

Now, Aetna may have a different one than Cigna than somebody else. But, I think that if you let us try to do a model of what you are looking for, and know the kind of information that you consider would be helpful, then we can, potentially, produce a guide that is helpful to the coders to use.

MS. HUMPHREYS: Well, I think there is some people in this room that can easily help you with that. I guess we just get back to the basic question of if the same service is provided, why would Aetna tell somebody to code it differently than somebody else, than Medicare would? If it is the same service, then it should be the same coding. Therefore, one guideline ought to fit both in terms of the description of that service.

DR. FEINBERG: Can I give you an example? For example, we were recently approached in a very informal setting by a group of surgeons who said there is one code for a shoulder replacement. It is really harder to do a redo of that shoulder replacement than it is to do the initial surgery. Now, that can be coded with the shoulder replacement code and a 22 modifier. But, that leaves the surgeon, which is a perfectly acceptable way to code that, 22 means it is a complex case, which is a perfectly acceptable way. But, the surgeons, some of them, would prefer to have the two codes broken out to initial shoulder replacement and replacement shoulder replacement. In other words, a redo. But, on the other hand, there are the bulk of surgeons who want to do it and like it just the way it is because, presumably, that will change the price of both services. So, some of these codes get a certain amount of inertia when there are provider interests involved. It is, actually, a rather complex situation. Aetna might come along and say, you know, I know that there is five surgeons doing these in my area that I want to pay more to. They might say, I am going to create a special code for them. They should be entitled to do that if they let B

MS. HUMPHREYS: That is the problem, they are not anymore. When HIPAA goes in, they will not be able to do it which means B

DR. FEINBERG: They can with notice, by saying that they will create an S code that says this, we think, is a distinct enough service. When it is promulgated and publicized, then people will know that that is the case. I am just giving you an example of something that I can see, potentially, in the future.

MR. BLAIR: How is that different from the process that you are already using right now? I am not a code expert. I would tell you that I just listened to the comments. I remember the testimony that we received before we made our recommendations several years ago. It sounds as if there is a widespread sense of frustration, a widespread sense of frustration that either new codes are not being dealt with in a quick way, in a responsive way, that the perspective is focused on payment rather than coding. I do not know the answer. I think that you, probably, know the, you are experts. But, I think that the processes that you have been using for determining what new codes should be added has to reflect a broader responsibility then you used to have, now in the HIPAA world. I think that that is kind of what I am hearing from a lot of folks now, your scope has increased. Therefore, you have to, I think, look at your processes for adding new codes and modifying and updating codes in terms of the broader role that you play.

MS. GREENBERG: I just want to reinforce, I guess, maybe what everybody is saying and give an example. I think the pre-HIPAA world was a payer-specific world when it came to data. The post-HIPAA world is not a payer-specific world. That does not mean that payers do not have separate policies. I do not think any of us disagree that there is nothing in HIPAA that prevents people from paying. But, from a public health point of view, from an outcomes point of view, from a, you have got to have uniform data across all of the payers and across all, hopefully, settings. I think that is what HIPAA is about. I happen to represent the Public Health Data Standards Consortium on the national uniform billing committee. The UB-92 used to be a very payer, it still is, but to some degree payer-specific claim. There were all sorts of codes that were payer-specific. They have recognized now that they have to move away from that. Their goal is, that does not mean that if Medicare needs a code for some legislative reason they are not going to put it in. Then, it is a code that everybody can use. If Blue Cross needs a code for the same thing, then it is going to have to be, they are going to have to harmonize the same code. It is just like we are doing with all of the Medicaid. We just took thousands of codes, state Medicaid codes for abortion, because every state has a slightly different way, what they can pay, what they cannot, but, we have created a set of national codes. I think this may have fit the pre-HIPAA model with CPT having non-specific codes and HCPCS having specific codes. But, that does not really work now, I think.

Another thing is a code set. A classification. I would agree, it just does not work without guidelines. If I were a coder, I would refuse to use a classification that did not have guidelines. I just think that it is very much of a different world now.

We have to think how we can collect uniform data and then let the people have their own payment policies, et cetera. I do not think it is going to be solved here. I agree. But, I think that we have to get out of the current framework of payer-specific data sets, payer-specific classifications.

One aspect of a classification, one of the criteria, maybe that has been articulated by this committee and maybe we need to put it out there again, is that classification should be hierarchical. If you have a non-specific code and you have a more specific code, if you have that specificity, you are supposed to use a more specific code, even if the payer is willing to pay on the non-specific code. That is the essence of a coding guideline. That is how ICD works, that you would have to use more specific codes. Certainly, if we want to do anything other than just pay, we want to look at outcomes and we want to look at resource utilization, then we want the more specific codes. So, amen.

DR. COHN: I think, Tom, I just want to make a comment. I think just to follow that up, obviously, Tom, you started out the conversation by talking about the HCPCS coding system and recognizing there is level 1, level 2. It would be nice to have a set

of guidelines, but it would be really nice if there were a set of guidelines alphanumeric and HCPCS level 1, and that vis a vis there was enough coordination between the various parts of HCPCS that came up with a single set of guidelines. I think that is what Betsy was asking, so that everybody understood. Anyway.

DR. FITZMAURICE: I want to kind of switch, if you do not mind, to another topic. That is, I was going to ask a question and a follow-up question, but I think I know the answer to the first question. The first question was are codes ever lumped or split or services, devices, supplies, added or subtracted from the definition of code retirement? I think the answer is yes and we have seen some examples of it.

I heard Tom say in his testimony that Medicare has nearly a billion claims, most of which are never touched by human hands or seen by human eyes. Yet, if there are changes in the code over time, how do we know about it? I inferred, and I am not sure that Lori did say this, that she could write a compendium history of a code that talks about those changes, for any code change. I suppose it could be put on the web. It is important in this day and age when computers are running through these things that they have consistent meanings over time or that we know when we change them. I am asking, have you considered, this is both HCPCS and CPD-4, have you considered having a unique addition to the code that is a number that never changes, but is

replaced when the meaning of the code is changed, when you add to it or subtract from it? The computer, in searching through this, can say here is a different unique number. That means we are now on this definition, not the old definition. Over time, there may be four or five different definition changes, but each one of them has a unique number associated with it so that as you go through any kind of historic file, you know what that code definition was intended at the time it was submitted or the time it was paid or the time it appeared on another record than a claim.

This is important not only for payment and research, but for drug alerts, device recalls, product recalls, reverse genomic studies, quality improvement, patient safety, medical areas. It is important for reducing miscoding, coding errors and misinterpretations of codes. I am asking, have you considered adding a unique code to the existing code structure so that that one code refers to one definition. The national drug code does it for labeling. Same drug, but they change the label, different code. Computers can keep track of all kinds of things with very little increase in costs. Have you considered it?

DR. FEINBERG: Actually, we feel somewhat constrained by the five field character structure that we have now because they are implemented in so many places. There is over 750,000 physician offices and they are used by physical therapy offices, OT offices, I could go on and on. There is, probably, well over a million of these outpatient kind of places, essentially, all of whom transmit Medicare claims to us electronically. But, when we make, we, actually, at least at the work group level, one of

the things we consider when we look at a, someone comes in with a product. They might want their own code. We feel that it is included in a code. Sometimes, to make that clearer, we may change the language, but not change the, so, make people know that. If we feel, if we do any substantive change to an existing code, our rule is that we change its number. At least, the version of HCPCS that we use internally has a stop-and-start date for every code. The deleted codes, at least in our book, stay in there until when it was active. Maybe, actually, that is a code book that everybody needs, not just us, because I know that when I help my people look for historical data, that is the code book I use. There is no reason why everybody should not have it. It is just that it does not seem like when the paid people publish it, that they put that kind of information in your code book. Maybe that is a mistake. Maybe that is part of what you say by coding guidelines that would be helpful to you that we have accessible to us. I believe, actually, that the code book I use is now loadable from the web, so it is already up there. It is just that it is a big file. People have to remember to download it. Buying these nice printed ones is, usually easier.

DR. ZUBELDIA: Only the last three years. I got it from the web. There is no start-and-stop date. You go to the web, the HCPCS codes you can download are for the last three years.

DR. FEINBERG: Okay. Well, then we can do something.

DR. FITZMAURICE: Lori, I am talking about adding something to the coding system. Now, whether or not people use it is another story. If they want to incur the costs of doing this is another story. But, until you put a unique number for each definition that you have, people won't know that it has changed. You will never know when Tom's computer goes searching through them, which one they used on a claim.

DR. FEINBERG: We do, right now, have a field that says when it was activated and when it was discontinued. What you are saying is we should reduce that to a machine-readable form, start-and-stop date of that code.

DR. FITZMAURICE: I am saying keep that. Add something new. Add a unique code that changes every time you change the definition that could cause people to code something differently, to include something more, reduce something from what it covers.

MS. TRUDEL: What I think Lori is saying is that when that happens, we already give it a new number.

DR. FITZMAURICE: You would run out of numbers with only five digits.

MS. TRUDEL: And, that when we tinker with the language just to make it a little bit clearer, then we do not give it a new number.

DR. FEINBERG: We think that everything, for example, if there is a word that people say, well, what does this word mean and we clarify it. We do not think it changes anything about the code. That is the only situation in which we do not change the number.

DR. FITZMAURICE: But, do you expect that it causes some people to take an action as a result of that change?

DR. FEINBERG: No, we do not. We hope that it just makes it clearer for people saying, well, I do not know what this, I mean, there is a, I am thinking of B

DR. FITZMAURICE: But, there are other lumping and splitting that goes on that will have an effect.

DR. FEINBERG: Yes. But, those are not lumpings and splittings. They are sort of clarifying changes. I think CPT does them sometimes, we do them, sometimes. People say, well, I do not know what this word means. Can you explain this word? If enough people ask, we explain it in the code.

DR. FITZMAURICE: I am saying that there are an infinite number of numbers. If you attach a unique number to every change that you make, then there is no question about it. Then, over time, you can see did it cause a change in quantity and how people used it.

DR. FEINBERG: I guess I cannot promise to do that because I do not know enough about the HIPAA record structure. Is there a place in the HIPAA record structure for that kind of information?

DR. FITZMAURICE: I do not think we are talking about something that is cast and permanent. You can never change a HIPAA record structure. I am just asking to consider it so that whenever you make a change in the HIPAA record structure, that you put it

into your coding system. If people want to use it, want to incur the cost of expending fields in their computerized patient records, their billing records, they can. The cost of not doing it is all these errors that could possibly come up. The have to make the benefit cost analysis.

DR. ZUBELDIA: I think, we are running out of time. I think we need to come back to these issues. I do not think we have resolved all of the issues.

MR. GUSTAFSON: Could I make just a closing comment, if that is where you are aiming is closing on behalf of my agency. This has been a, I think, particularly interesting and fruitful discussion. We are very conscious of the kinds of frustrations that are being reflected by members of the panel. The point, I would like to make a couple of points here. One is that the agency attempts to understand these and would like to be receptive to solving them to the extent we can. We believe that coherent coding policy is a good thing and that we should attempt to work more enthusiastically, more creatively, than we perhaps have in the past with the coordination of CPT versus HCPCS. We will have some discussion with Mr. Beebe about ways we can, perhaps, do that more fruitfully, because undoubtedly there are ambiguities and overlaps in the coding systems now that are not necessary and could fruitfully be pruned to the advantage of all. I say that without have any specifics in mind, but I am sure others can point out circumstances of that sort.

The discussion has focused on wouldn't it be nice to have a uniform coding system that everybody could use for all purposes. I would just caution the committee that this, indeed, may be a very desirable goal, but may be a very substantial achievement to aspire to all at the same time. What HIPAA did as we, or does, as we understand it, is create a situation where transactions, electronic transactions, have to be communicable across networks between providers and payers in a uniform and understandable fashion so that if somebody sends us a code, we know what it is and can do something appropriate with it. That appropriate thing may be to send it back to them saying we do not pay for that code. But, that by itself, is a comparatively limited achievement.

Part of the aspirations I hear voiced here today relate what I would describe as a next level beyond that. Wouldn't it be nice if all could agree that what the coding rules are. That will depend on how granular, I believe a term that coders frequently use, one wants to make the payment system and how speedily it can be updated to reflect needs for change in granularity. That is not, just how far one can go with that is not entirely obvious. I think we need to acknowledge merely that, I do not mean to be discouraging, but I do wish to think we all need to acknowledge the reality that that may be a goal. It may be a goal that will take us a long while to move toward. We need to make progress, but it is not an easy thing.

DR. ZUBELDIA: Thank you. That was an excellent closing statement. I think that there are some issues that have been identified. I would like to, maybe, set some homework for a follow-up discussion. Obviously, some of the topics were very clear, the coordination of the codes, coding guidelines. It was pretty evident that we need to have coordinated coding guidelines.

We also talked about temporary codes and how to make them permanent. Maybe what we have to do is remove the label temporary.

This distinction between specificity of codes and the enforcement of payment policy. That needs to be addressed at some point. I think there, even though you expressed that Medicaid is adequately represented, I think that we have seen in the past, and, maybe this has been corrected, but the proliferation of local codes by the different state Medicaids was, perhaps, a reflection of them feeling that they were not properly represented. They need to do their own thing. Something that, maybe it is a combination of other factors, including payment policies and payment guidelines in the different states.

We also need to look at the structural limitations of the HCPCS codes and is that an appropriate technical structure to support what needs to be supported. Or, is it a straightjacket that prevents further granularity of the codes?

I think that these are topics that are, probably, going to take more than just one hour for the next meeting.

DR. COHN: It sounds like there is a whole variety of issues you have.

DR. ZUBELDIA: Yes.

DR. COHN: I guess from my view, and I will just speak personally, I think the biggest concern I have had as I have listened to all of this has been the apparent lack of coordination. I would, personally, rather than solving the entire problem with HCPCS by August, I would be very satisfied if there were a report back on a plan for coordination between the two, with some actual achievements or plans for achievements.

DR. ZUBELDIA: But, keeping all of these things into perspective. That is not just good for the nation. I think that the overall framework needs to be the HIPAA framework where the HCPCS codes are no longer private and proprietary to a payer or to a series of islands that constitute a multitude of payers that have their own local codes. This needs to be something that encompasses the entire healthcare industry. That is a HIPAA requirement, that there be no more local codes. When is the next meeting, August?

DR. COHN: Yes, end of August.

DR. ZUBELDIA: End of August. Do you think that you could look at these issues and come back at the end of August and continue with this discussion?

MR. GUSTAFSON: We can, certainly, look at these issues. I would rather not promise appearance in August right at this moment. I would like to be able to confer with my colleagues back at the office and see if we think we can have something meaningful to say by that time. If you could let us get back to you on whether August seems pertinent, or whenever the meeting that is immediately following that. I do not wish to delay this unnecessarily, but we are moving into a period where staff availability is a little bit questionable. We may seem like a behemoth, but we, actually, have only a small number of staff working on these problem areas.

DR. ZUBELDIA: And, the plate is very, very full. We would understand that. So, let us know when.

DR. COHN: And, as you know, Karen Trudel is our main staff who, I am sure, is not far from, her office is not far from yours. I, actually, just want to take a minute and thank all of you for participating in this conversation. Tom, I really, especially you, from CMS, having you here. Kay Riley has been very valuable in previous conversations. I think your presence brings a level in terms of the conversation. We want to thank you. Obviously, Michael, you have been, you must feel like you live with us in terms of the amount of time we have had you testifying on issues. So, I want to thank you. Lori, and obviously, Paul Rudolph, who is sitting back there, I am sure listening. He has provided input. Thank all of you for your work.

DR. ZUBELDIA: Thank you very much. And, Michael, do not go away.

MR. BEEBE: I have to go to the bathroom.

DR. ZUBELDIA: Let's take a 10 minute break. Then, we will continue after the break.

[BRIEF RECESS]

DR. ZUBELDIA: Let's proceed with the meetings this morning. We now have a panel with a follow-up from the April meeting on the coordination between Alternative Link codes, ABC codes and the AMA codes to see how this is progressing. I would like to invite Michael Beebe to start. Then, Melinna Gianinni.

MR. BEEBE: Good morning, nice to see you again. My name is Michael Beebe, American Medical Association. The AMA, I would like to talk today about the inclusion of alternative therapy services in the current procedural terminology code set. The AMA accepts the responsibility for updating and maintaining CPT and is committed to working with all healthcare professionals to include codes for unique and clinically effective services provided to patients. I thank you for the opportunity to demonstrate our efforts and to explore the inclusion of codes for alternative therapies.

At the April 10th meeting of the subcommittee, several presentations were made by groups which demonstrated certain gaps in the nationally designated code sets. Among the identified gaps were codes to describe services provided by alternative therapy providers. The subcommittee, at the time, recommended that the AMA and Alternative Link, Incorporated, work together through the CPT editorial process to develop codes to facilitate the reporting of alternative therapy services under HIPAA. My statement

will describe the CPT editorial process, the AMA's view of its obligations as a maintainer of a HIPAA-designated code set and the panel's plans for developing codes and descriptors for alternative therapy services. I will also review our efforts at working with Alternative Link in developing codes for alternative therapy.

The CPT code set is maintained by the American Medical Association through the CPT editorial panel. The panel employs a process that is well-established, publicized and documented. Anyone can submit code change proposals for a new or revised CPT code. Instructions and a code change proposal application is available on the AMA CPT Internet site, along with a schedule of panel meetings and deadlines. In order for any code to be included in CPT, a well-established CPT editorial process must be followed.

By requiring all organizations and individuals to follow the same process, the AMA and the CPT editorial panel are able to guarantee the consistent application of the same criteria to code proposals to maintain clinical accuracy, relevance and consistency with generally accepted healthcare practices and develop uniform codes that are internally consistent, mutually exclusive and functionally integrated into the overall CPT code structure.

The CPT editorial process is an essential component of the development of the CPT code set and can, under no circumstances, be bypassed or shortcut. Circumventing the CPT editorial process would lead to internal inconsistencies, structural defects and inferior descriptions. Moreover, to allow an individual or group to go around the CPT editorial process, or to be treated differently, would not be fair to others who are interested in changes to CPT. Adherence to the CPT editorial process is an important part of CPT's integrity as a HIPAA-designated code set, as well as a definitive characteristic of CPT codes themselves.

The CPT editorial panel is supported in its work by the 112 member CPT-HCPCS advisory committee. The committee members are nominated by the National Medical Specialty Societies and the Healthcare Professionals Advisory Committee, which is our non-physician healthcare professional group. Since its establishment in 1992, the HCPCS has allowed for the participation of organizations representing limited license practitioners and allied health professionals. These groups include the American Academy of Physician Assistants, the American Chiropractic Association, American Dietetic Association, American Nurses Association, occupational therapist, optometrists, Physical Therapy Association, podiatrists, American Psychological Association, American Speech Language and Hearing Association and the National Association of Social Workers. As a result of the efforts of these organizations, CPT contains creative descriptions of services and procedures performed by non-physician healthcare professionals, including some services that may be considered alternative therapy services, including therapeutic massage, acupuncture and chiropractic manipulation.

The AMA and the CPT editorial panel recognize that CPT's position as a designated national HIPAA code set may require the development of additional codes to describe other services provided by alternative therapy providers. It may also be necessary to expand the membership of the HCPCS to include professional organizations representing additional alternative therapy providers. The AMA is committed to making these changes, but any activity designed to expand or change the CPT code set must follow the CPT editorial process.

The CPT editorial panel has been working recently on a process to include more codes for alternative therapy services. Based on the panel's experiences with the HIEC home infusion folks and home infusion coding, the editorial panel has adopted a work group approach to the evaluation and development of descriptions for alternative therapy services for possible inclusion in CPT.

The chair of the CPT editorial panel has appointed an alternative therapy work group consisting of national organizations representing providers of alternative therapy, non-physician healthcare professionals from the CPT HCPCS, members of the editorial panel and members of the payer community, as well as Alternative Link, Incorporated. The work group has been charged with evaluating the reporting needs and existing claim requirements of alternative therapy payers and providers; the development of a framework, including criteria for review of descriptions of alternative therapy services by the CPT HCPCS advisory committee and the editorial panel; the selection of discreet fields of alternative therapy services to begin the development of code proposals; and finally, the development of CPT code change proposals for alternative therapy to be presented to CPT advisors and the editorial panel.

By bringing the relevant stakeholders together under its leadership, the editorial panel can resolve issues and problems more quickly and with better results than by following a more independent code development process. Using a multi-disciplinary work group will also allow the panel and the advisory committee to have access to the most current information on alternative therapy and will also serve to internally scrutinize code change proposals.

The AMA CPT staff has begun to assemble the membership of the alternative therapy work group and is working on a schedule of meetings. Alternative Link has been invited to participate in the panel's work group, but has thus far not accepted. As for our cooperative efforts with Alternative Link, Incorporated, the AMA has made serious and deliberate attempts to work with Alternative Link. Since April 10th, we have had one meeting, one lengthy conference call and exchanged several letters and e-mails.

The AMA has expressed our willingness to work with Alternative Link through the CPT editorial process to develop code change proposals. We have invited the company to participate in the alternative therapy work group the panel is assembling. Although the meetings have been productive from the standpoint of developing an understanding of one another's positions, they have not produced an agreement on how to develop CPT code change proposals for alternative therapy.

Previously, the subcommittee recommended that the AMA and Alternative Link work together through the CPT process to develop codes to facilitate the reporting of alternative therapy services under HIPAA. The subcommittee request was not for the AMA and Alternative Link to explore options for incorporating Alternative Link codes into CPT. There is enormous difference between creating codes for a service and importing codes for that service developed by another group or company. This is a significant difference because the editorial panel process guarantees a critical level of consistency in procedure coding, code application and clinical decision making as to what constitutes appropriate descriptions of healthcare services. These functions would be eroded by the wholesale inclusion of another group of codes. Moreover, a wholesale inclusion of another group of codes would undermine the core benefit of having a rigorous editorial board maintain the integrity and uniformity of CPT.

Alternative Link has argued that the CPT editorial panel, by developing codes for alternative therapies, is appropriating Alternative Link's intellectual property without remuneration. This is simply not the case. AMA has no intent to utilize Alternative Link's pre-existing codes. Rather, we intend to create new codes that meet CPT editorial panel standards and that are an integral part of a coherent work of coding.

Alternative Link, Incorporated, has developed a coding work and database for alternative therapy. This work links providers with state licensing requirements. However, Alternative Link is not a professional organization and does not represent any element of the alternative therapy provider community. In this sense, providers of alternative therapy services have not voiced the concern that their services will not be recognized under HIPAA and that their business needs will not be met. Rather, Alternative Link has raised this concern. Alternative Link may be a company that has developed a product that is jeopardized by the HIPAA transaction standards.

The AMA has made a proposal to Alternative Link to assist them with their needs under HIPAA. Once the alternative therapy work group has established a functional framework and alternative therapy codes have been developed by the AMA through the editorial

panel process, the AMA has offered to work with Alternative Link on the development of a crosswalk, or a mapping, from CPT alternative therapy codes to alternative therapy codes that exist in the ABC coding system of Alternative Link and vice versa.

Such a crosswalk would enable Alternative Link to utilize its databases to link services with providers and state licensing information, thereby providing the claims processing functions that are an important part of the business need of Alternative Link, Incorporated.

In conclusion, the AMA takes its responsibility to maintain CPT very seriously. The AMA and the CPT editorial panel recognize that CPT's designation as a national HIPAA code set for electronic healthcare imposes an obligation to be responsive to the needs of healthcare payers and providers. The AMA and the panel accept this obligation. However, we must request that individuals and organizations who want changes to CPT be required to follow the established process. CPT may have been selected as a HIPAA-designated standard due to its general acceptance, but we believe it was generally accepted due to respect for the CPT editorial panel, the CPT editorial process and the substance of the CPT code work.

Thank you very much for your time and I would be happy to answer the panel questions whenever you have them.

MS. GIANINNI: Good morning, Mr. Chairman, members of the NCVHS Standards and Security Subcommittee. My name is Melinna Gianinni and I am the president and founder of Alternative Link. We appreciate the invitation to report on recent interactions with

the AMA. Those interactions were mandated by the designated standards maintenance organizations and the subcommittee and facilitated by a staff member of the Centers for Medicare and Medicaid Services. Our understanding from the April 10th public hearings, and especially from a separate meeting with NCVHS staff, CMS staff and the AMA later that day, was that this mandate had two distinct elements. The AMA was to review the functionality and value of the market ready ABC codes and establish a business agreement on a mutually acceptable approach to the situation and any relevant intellectual property issues. On the basis of that business agreement, collaborate to integrate the functionality of ABC codes and CPT codes in a manner that supports public health, health industry business needs and congressional intent under HIPAA.

During this testimony, Alternative Link will describe the challenges of trying to collaborate with the AMA, even with expert facilitation by subcommittee and CMS staff; review the AMA's mixed history of public health achievements and political behavior; stress the urgency of the code set situation, emphasizing the life saving potential of the ABC codes and report on the hundreds of thousands of human lives that could be lost as a result of further delays in code set availability; highlight benefits and functionality offered by ABC codes for alternative medicine, nursing and other non-physician interventions; and use an analogy from the grocery industry to illustrate why stakeholders benefitting from an existing supply chain infrastructure should not have control over coding for new technologies.

Alternative Link found the AMA to be unreliable, self-serving and predatory in its approach to the mandated collaboration. The AMA's newly proposed alternative therapy CPT coding initiative establishes the AMA as a direct competitor to, rather than a collaborator with, Alternative Link. Although the AMA may, at this point in time, have some legitimate intentions in the monopolistic role it is proposing for itself, this stance will also position the AMA to delay code set availability and keep alternative medicine, nursing and other non-allopathic physician practitioners disenfranchised from mainstream healthcare; manipulate code assignment to make difficult head-to-head scientific comparisons of conventional physician and non-conventional, non-physician interventions; reverse engineer Alternative Link's intellectual property; and enhance the political strength of allopathic physicians by dominating a critical element of the healthcare infrastructure.

In our view, the DSMOs, the NCVHS subcommittee and DHHS, as a whole, did not intend to give the AMA the authority to behave as a monopoly. The AMA's stance is, however, an unfortunate by-product of the mandate to collaborate. This is particularly disturbing because DSMO and subcommittee leadership assured Alternative Link that DHHS believed the AMA would be collaborative than it had in the past interactions. We were told that the AMA had been counseled to be cooperative, transparent, impartial and socially responsible, clear duties of a designated standard.

In a separate meeting on April 10th, following the subcommittee's directive to the AMA and Alternative Link to try to work together, subcommittee and CMS staff advised the AMA to address two things in collaborating with Alternative Link. First, seriously consider the immediate functionality and value of the 4,000 market ready ABC codes and, depending on the significance of these codes to public health, health insurance business needs and congressional intent, come to an agreement about how to best make use of the codes and establish an appropriate relationship, including an acceptable approach to any relevant intellectual property issues. Second, with the code set merits and intellectual property issues settled, collaborate on a code set integration process. The AMA agreed to follow this directive. Based on the DSMO and subcommittee assurances, as well as the AMA's own statements about their new leadership and collaborative approach to the industry, Alternative Link laid aside a long history of negative experiences and agreed to collaborate with the new and improved AMA.

In the past six weeks, in marked contrast to its presentation in the April 10th hearing and its commitments in the separate meetings that followed, the AMA exhibited aggressive, competitive behavior. In particular, they withheld a non-disclosure agreement, they proposed a crosswalk from ABC codes to non-existent CPT codes and asked Alternative Link to refocus our business and claims edits scrub application. They showed virtually no interest in examining the ABC codes. They cancelled two meetings that were jointly scheduled on April 10th. They flatly stated that the AMA would establish an alternative therapies work group and develop competitive CPT codes with or without Alternative Link's involvement.

Disregarding its duty and pledge to be cooperative, the AMA is now in a position to delay code set availability and keep non-conventional, non-physician practitioners disenfranchised, manipulate code assignment, reverse engineer Alternative Link's intellectual property and use a critical component of the healthcare infrastructure to exercise a monopoly and advance allopathic physician interests. Prior to this integration process, and really from the mid-1800s, the AMA has protected physician interests, both legitimately, by supporting meaningful public health initiatives, and illegitimately, by suppressing potentially competitive providers under the guise of protecting public health.

While the AMA has undertaken many inspiring public health initiatives, it is undeniably a political organization. The AMA's commitment to its allopathic physician membership is common knowledge in the healthcare industry and is referred to on the AMA's own website. With only a few bad apples deviating from a largely civic minded mission, a trade association that serves allopathic physicians and is a designated code set authority could easily withhold or continue to introduce biases into code development to limit the scientific collection and analysis of healthcare data needed for head-to-head quality and cost comparisons between conventional physician and non-conventional physician interventions and to restrict public access.

Alternative Link recognizes that the AMA's Board of Trustees is committed to the art and science of medicine and the betterment of public health. That notwithstanding, the AMA itself has expressed proprietary interest in maintaining control over coding of allopathic care and gaining greater control over the coding of alternative medicine, nursing and other non-physician interventions. For example, in a presentation to the AMA Board of Trustees on December 4, 2000, the Chair stated, AYou may have never realized the huge investment physicians have in coding, not in terms of dollars, but an investment in physician autonomy. AMA administration of a physician-driven process, coding, has given us a cohesive voice in healthcare delivery. A voice that makes us stronger and louder than we are as individuals.@ In an age where physician autonomy is in danger of slowly being chipped away, how did the AMA secure a physician-driven standard use to describe medical services not only for payers, but also for all of the healthcare industry? Certainly, physician control of a uniform code has not always been the norm.

The AMA is a politically astute organization. Its members are politically active and strategically placed. The AMA has been well represented on the DSMOS, with the AMA permanently chairing on of the standards maintenance organizations and sitting on the

National Uniform Claims Committee and holding a seat on the National Uniform Billing Committee, excuse me, I had that, the permanently chair NUCC. Conventional allopathic physicians have been serving in DHHS and on the NCVHS subcommittee. Allopathic physicians are also in leadership positions in the Healthcare Insurance Association of America and other association and organizations with significant influence on code development.

With this level of advocacy, the AMA has maintained a position of control over this critical component of the healthcare infrastructure, despite well known weaknesses in the CPT code set and the editorial process. As early as 1993, the NCVHS reported that the AMA's code development process was flawed and was widely believed to favor AMA membership. That notwithstanding, the AMA CPT code set was named a designated standard under HIPAA. Since that time, there are eight codes in CPT for alternative medicine. The AMA CPT editorial panel is almost exclusively conventional medical doctors, as is the CPT advisory committee. There is a handout that shows the makeup of that committee. The healthcare professional advisory committee and the newly formed alternative therapies work group include some other practitioners, but both fail to include more than 90 specialty associations, not including over 50 specialties of nursing. Despite the advisory bodies within the AMA, final decisions are still made by a decision making body that is almost exclusively allopathic physicians.

Our intention is not to vilify the AMA. The AMA has supported some of the greatest public health initiative this country have ever known. Our intention is to say that even under the best of circumstances, a political organization with an allopathic physician agenda will be hard pressed to divorce itself from self-interest and demonstrate cooperative, transparent, impartial and socially responsible behavior in code development for alternative medicine, nursing and other non-allopathic physician interventions.

There is an urgent need for these codes. According to the Journal of the American Medical Association, over 100,000 patients die in the U. S. each year as a direct result of hospital and physician errors and not the disease for which they sought treatment. That number, again, die from negative effects of appropriate conventional treatments. In total, nearly a quarter of a million individuals die from these causes, including an estimated 12,000 from unnecessary surgery, 7,000 from medication errors in hospitals, 20,000 from errors in hospitals, 80,000 from infections in hospitals and 106 from non-error, negative effects of drugs.

For this, and many other reasons, American citizens are increasingly turning to alternative medicine, nursing and other non-allopathic physician interventions as a primary source of care. In fact, according to subject matter experts, complementary and alternative medicine has a compounded annual growth rate of 38 percent and more visits are made each year to can practitioners than to primary care practitioners.

If the AMA were granted coding authority over alternative medicine, nursing and other non-allopathic physician interventions, public health may suffer tremendously. Scenario number 1, the AMA is politically motivated in the development of codes for non-conventional medicine. Codes are defined with insufficient granularity or interventions are intentionally bundled and coded in such a way as to preclude the demonstration of superior outcomes for alternative medicine, nursing and other non-physician interventions when compared head-to-head with conventional interventions. Sub-optimal care patterns result in a 10 percent in a decrease in unnecessary hospitalizations, physician visits and other types of conventional care. The set back in actuarial capabilities costs no fewer than 320,000 lives, more than 100 times the number of lives lost in the 9-11 attacks. There is two other scenarios that I hope that you will read.

The point is that the functionality of ABC codes is needed immediately to support cost effective, evidence-based and integrative healthcare. The cost of delays is staggering in terms of potential loss of human lives. If we, also, consider the dollars wasted as a result of unnecessary administrative insufficiencies, dollars that could be reallocated to generate greater prosperity or to cover the uninsured, the human toll is even more devastating.

We would like to help in any way possible solve the coding problems. We have offered the coding hierarchical structure to the AMA. We have offered to work with them in whatever way we possibly could to assure that the codes were adopted quickly. This has not worked out well. We have existing materials that other people in the healthcare industry think are viable. They are published. This is the caman nursing manual, published by Delmar Thompson, Relative Values for Complementary and Alternative Medicine, published by Relative Value Studies, Incorporated; and the state legal guide to complementary and alternative medicine, also published by Delmar.

In the same time Alternative Link developed 4,000 market ready codes, the AMA has developed eight. A coding analogy from the grocery industry, I am going to have you read that because I am running out of time. As suggested by this analogy, which compares withholding UPC codes for cheese products and what would happen to the supply industry, medical codes are to the healthcare industry what universal product codes are to the retail industry. That is, codes are a vital part of the industry's infrastructure. They support electronic communications and transactions and are essential to proper functioning of the industry.

ABC codes are urgently needed to design healthcare benefits, manage utilization, process claims, as well as run clinical trials and conduct health services research. With regard to public health, about a quarter of a million Americans die each year for causes related to conventional medicine. This may offer a solution and it won't be known unless it is measured.

We have, I know I am running out of time and everybody is getting impatient, we have developed a non-profit organization in 1999 to hold the ABC codes and to offer a venue for alternative care associations and practitioners and other interested parties to continue to develop and review the ABC codes. We did start this in 1999 in anticipation that this was going to be a needed element to make sure that the code set went forward with total cooperation from the practitioners.

Public demand for alternative medicine, nursing and other non-allopathic intervention, continues to escalate. The industry needs a code set now to help manage care claims and outcomes. We ask for your help in supporting the Secretary of the DHHS in making a rational decision based on public health interests, critical industry needs and congressional intent under HIPAA. For a more detailed comparison of code set development, please refer to the additional handout. We can, also, supply a five year time line of each step Alternative Link has taken in order to become a HIPAA named standard, and our repeated interactions with the AMA from inception of the company until May 21st. Thank you.

DR. ZUBELDIA: Thank you. I am sorry, we were distracted trying to go over your written testimony that we just received.

MS. GREENBERG: I think, maybe, you had just put it down there. In any event, we did not, actually, have copies of people's places, so we are making more copies because we have now run out of it.

MS. GIANINNI: I am sorry.

MS. GREENBERG: So, everyone, we will have additional copies made up.

DR. ZUBELDIA: Thank you for both of your testimony. From what I can hear of the conversations did not go very well, huh? How would you like to proceed? What would you like to do?

MR. BEEBE: I think from our point of view, the editorial panel currently does have codes for alternative medicine. We do not have a lot. I can explain the reasons why I think we do not have a lot. But, from our point of view, we see that we have an obligation to work with providers of alternative therapy services to see what their demands, their needs and requirements are under HIPAA to expand the codes that we currently have and to explore their current needs for reporting under HIPAA. That is what we have formed the work group to do and that is our intention to move forward under those premises.

DR. ZUBELDIA: Ms. Malina?

MS. MALINA: Cynthia Malina, I am the CEO of Alternative Link. Our desire from the beginning has been to work with AMA at the highest levels in the organization to try to re-think the situation. We think there has been a fundamental shift not only in consumer demand around healthcare, but also in code set needs under HIPAA. In our view, there is a tremendous opportunity for Alternative Link to assist the American Medical Association at the highest levels in re-thinking its code development process. One of the nice side effects of the time frame in which the alternative, the ABC codes, were developed is that they were developed for the sole purpose of meeting HIPAA intent, congressional intent under HIPAA. So, they have a hierarchic structure. They have a lot of features that CPT codes do not have. At the same time, they were designed to create a minimal burden on health industry stakeholders. So, they fit into the existing fields that are used for CPT codes and can fit into the information systems of payers and TPAs and provider organizations, et cetera.

What we would like to do is raise the level of discussion out of the CPT editorial process and try to do discuss this as a business process re-engineering to, again, assist the industry in getting the code sets that it needs.

I should add if that is not possible, then we would like to be a designated standard separately. The need for these codes is immediate. There are over 629,000,000 visits to can practitioners right now. The AMA made a specific point earlier today, talking about how much effort they have gone to to separate code assignment from payment. Yet, all of us who are familiar with coding understand that no assignment of codes equates almost directly to no payment. So, through non-coding, it is possible to

violate anti-trust, as well. We want to ensure that that possibility does not exist.

We admire many of the things the American Medical Association has done. At the same time, it has to raise questions to look at 4,000 codes for complementary and alternative medicine that were developed in the last half decade and compare it to eight that

were developed under the CPT editorial process. There is, clearly, a problem with the process itself. That is why we would like to raise the level of discussion.

DR. ZUBELDIA: From what I remember of what we discussed in the meeting in April concerning the process, there are several options. One of the options would be for the ABC codes to be a separate HIPAA standard. For that to happen, the transactions would have to have a qualifier for the ABC codes. We discussed that a qualifier is not present in the current state of the transactions. It would not be present until version 4050, for the transactions, which means that since the 4050 implementation guides are still being drafted, they could not possibly be used for at least four or five years. I think we discussed that point.

We also discussed the fact that you cannot just merge two different coding structures into one without great disruption. I believe that the way we left it was that you guys were going to work together to see what alternative therapy, alternative medicine, alternative non-allopathic codes, could be included in the CPT to resolve the immediate needs of the industry and look for a longer term solution.

Maybe that is where we left it, I thought that is where we left it. I am not sure that you are going in that direction now.

MS. GIANINNI: If I may, I think one of the things that stalled the conversations most was that the AMA has a stance, whether it is right or wrong, that the CPT editorial process is the only process that there is to create any terminology. We do not think that that process is going to be quick enough or fast or open enough right now to adopt the need that exists today for these codes.

The best solution in our minds is to put these into HCPCS, where there is not all of the problems and intellectual property issues that existed with the AMA. Although they said that we are being, that we were not cooperative, we have millions of dollars

invested in this work and to not even have it recognized as having any value was not only insulting, but it also negated work that was done over the last seven years within the guidelines of HIPAA, within the standards development organizations and within every single thing that HIPAA was trying to accomplish since 1996. We feel that there is some superiorities to this coding system that CPT does not have and they have not been open to that either.

DR. ZUBELDIA: Could you clarify for the panel what do you mean to say to put these codes into HCPCS?

MS. GIANINNI: One of the things that Kay Riley and I discussed was that she would take, she would look at, with their IT department, if it was possible to include these codes into HCPCS now.

DR. ZUBELDIA: Is the structure the same?

MS. GIANINNI: Yes. It is a five character structure. HCPCS are part alpha, part numeric. This is all alpha.

DR. ZUBELDIA: Okay.

DR. YASNOFF: I just want to ask a clarifying question. You mentioned there are only eight codes in CPT for the things that are represented in your code set.

MS. GIANINNI: Right.

DR. YASNOFF: Are there any codes in HCPCS now that relate to things that are in your code set?

MS. GIANINNI: There is, probably, a few crosswalks. We have not looked at the supplies and seen if there was an exact, where there is any duplications. If there are, they are very minimal because we have looked at that when we first started to make sure there was no duplication.

DR. YASNOFF: I am assuming from what you said before that your codes do not overlap in their numerical designation in any existing HCFA codes.

MS. GIANINNNI: No, they do not.

DR. YASNOFF: Thank you.

MS. GREENBERG: To pursue this a little, how would they be maintained, updated, et cetera, and secondly, how would that address your concern about intellectual property?

MS. GIANINNI: The main issue is much like the American Dental Association. They have dental codes that are maintained by the ADA. A licensing agreement is built with CMS for special use of those codes. We thought that we had an appropriate, similar B

it was similar enough in situation that there was an existing code set, there was a way to deal with us that was similar to the way that is dealt with the American Dental Association codes, whereby not Alternative Link, eventually, but the non-profit organization that will grow out of Alternative Link when the ABC codes are disposed of, wherever they go, that that organization will be the maintenance organization and Alternative Link will take responsibility for that until that can be accomplished.

DR. BLAIR: Let me see if I understand what you are proposing. I think I hear you proposing that in order to get the code set available as quickly as possible, not just for billing purposes, but also, so that meaningful research can be done to validate the efficacy of these different alternative medicine procedures, you are making a proposal whereby the investment that you have made in the development of this code set would not be recovered. In short, you are about to make a proposal which is a significant financial sacrifice in order to try to get these code sets out where they could be used. Is that what you are saying?

MS. GIANINNI: Correct.

DR. ZUBELDIA: Can I ask a technical question? Do all of your codes begin with a letter that is currently not used in HCPCS?

MS. GIANINNI: There is repetition. We have, HCPCS has an A code. We have a code that begins with A. We think that this is a database issue that is relatively easily solved. Our IT person said that if he could work with the HCPCS IT department, he felt that there would be an easy solution for making rules that would keep the codes from having any problems with crossovers from the B

DR. ZUBELDIA: But, as they are, the alternative medicine codes will be sprayed through multiple HCPCS categories because of the first letter. Is that correct?

MS. GIANINNI: We do not know the answer to that. I think that that just bears exploration to see how best to preserve their structure and HCPCS structure and not have any problems with them.

DR. COHN: I do not think I have any questions. I was just observing that what HCPCS decides to do with its code set is really an issue having to do with decisions made by the HCPCS national panel, I think. It really is not an issue for the national committee. The thing is, I am listening to this. This is something where we are, obviously, not going to be dictating to the national panel what they do.

DR. BLAIR: I would be interested to know if, Lori, if you are in a position to make a comment whether this offer from Alternative Link is something that HCPCS would be receptive to.

MS. TRUDEL: This is Karen. I would like to raise a threshold issue and that is that it seems to me that the inclusion by reference of a completely different code set is, potentially, something that is well above and beyond what was intended by the term code set maintenance. The evolution of a code set, the addition of HCPCS codes, periodically, the addition of CPT codes, that evolutionary process is a very evolutionary process. It is not something that significantly changes the nature of a code set in a large way. Just as the change from CPT-4 to CPT-5 would be a major issue. I would want to check with our general counsel as to whether this even constitutes a code set maintenance or whether this is significant enough that it, basically, it pushes it into the new version territory. We are talking about, what, Cynthia, 11 million codes?

MS. GIANINNI: The possibility of an all alpha code structure offers 11.8 million code possibilities. When you expand that out to the possibility of numeric and alpha in a five character space, you have 45,000,000 possibilities. I think that with that number of coding possibilities, there is a solution here for everyone.

MS. TRUDEL: I think my point is that that is more codes than we have in HCPCS now by an order of magnitude.

DR. BLAIR: There is 4,000 codes.

MS. GIANINNI: Right.

MS. MELINA: We have 4,000 codes. Let me, if I may interject for a minute and just describe a range of possibilities. We, obviously, have an interest in getting some kind of return on the investment that our investors make. We have many different business models that could help us accomplish that. That is beyond the scope of the people in this meeting. What we are trying to express here is that we are so adamant about the need for these codes right now for health services, research, clinical trials, all of those different needs, that we are willing to bend over backwards to find a way to make this fit. That can be anything from integrating the functionality of the code set into existing designated standards to being named as a designated standard. From my perspective, a good follow on action from this would be to get some kind of sense that there is going to be serious consideration given to the code set functionality, the development process, the maintenance process, the real need out in the industry, and that we would have an opportunity to come back to the table with that information and suggest some very specific solutions. We did not come to the table with those solutions today because we were giving our best effort to trying to interact with the AMA. Frankly, we have not given up that possibility. I just want to know, one of the things that puts organizations out of business is their inability to recognize when there has been a fundamental shift in the marketplace. In our view, there has been a fundamental shift in the marketplace. We have tremendous respect for the AMA. We have respect for the other coding authorities, as well. We think that because of the timing of our code development, there are some brilliant solutions embedded in our code set that can solve some of the problems that were spoken about earlier today.

I felt like, frankly, getting a little personal, I felt like the kid in the class who knows the answer to the question and the teach won't call on him. We have some challenges with trying to make sure that under HIPAA, when HIPAA is fully implemented, the industry can function. Not just that the code sets work, but that the industry can function. My background is in reimbursement. I understand what the challenges are. They are enormous. There are enormous areas of healthcare that do not have codes. Without codes, and with a mandate that only approved codes will be used, the industry is going to be at a standstill. We have part of the solution and we would like to be seriously considered.

MR. BEEBE: I would like, for a moment, to address what I believe is the reason why CPT has eight codes for alternative medicine. From that, move on to why I believe that there is not more of a demand despite what Cynthia suggests is a stream change in our healthcare culture.

I think that, currently, CPT does only have eight codes. But, the CPT process is predicated on the idea that providers of healthcare services, physicians and non-physicians, and payers of healthcare services, come to the panel for services they need to

describe for payment purposes, for claims processing purposes, for just as HIPAA states, for financial and administrative transactions. We have eight codes because the American Chiropractic Association came to us and said we need codes for chiropractic care. So, we gave them, I think there is five codes for chiropractic manipulation in CPT. The American Medical Acupuncture Association came to us and said we need acupuncture codes. So, we worked with them to develop acupuncture codes. We respond to the demands of providers for claims. The fact that we do not have more codes, to me, indicates that there is not a business need on the part of healthcare providers to submit claims at this point. There may be in the future. Maybe Cynthia is right, that there is a stream change, but at this point, that tremendous demand is not out there. When there is, I suspect that more alternative medicine providers would come to the editorial panel and ask fro additional codes.

DR. ZUBELDIA: I do not want this to turn into a debate. We are way over time. Let me see if I heard this correctly. I think that you want to introduce the functionality of the coding structure into HCPCS now. Is that correct? Not necessarily the codes themselves.

MS. MELINA: If there is a viable business model for us under that, yes, we would be interested in doing that.

DR. ZUBELDIA: I think that HCPCS could, perhaps, look at dedicating one letter and, perhaps, even changing all the codes to introduce new functionality into HCPCS that would represent the needs of other providers that are not represented today. Is that what you want to do?

MS. GIANINNI: Yes. I think that we have a lot of structural intelligence in this set that we could offer as a solution to the growth problems.

DR. ZUBELDIA: Understanding that HCPCS structure today is one letter and four numerics and in order to introduce that functionality, you may have to renumber all your descriptors.

MS. MELINA: If there is a viable business model for us, and we can integrate and implement this code set promptly, we would be interested in doing that.

DR. ZUBELDIA: I think we need to hear from HCPCS on this, but not today.

DR. COHN: Right. They have not even considered the proposal yet.

DR. ZUBELDIA: I think that they need to look into the possibilities. You need to look with them into the possibilities and see what happens. We also need to hear from providers and payers, which we have not heard from yet, on this very issue. That is something that we need to put into it.

DR. BLAIR: Could I ask this, Kepa? If, in the subsequent, is there any reason why we even need to render a judgment or verdict? If those codes are acceptable to HCPCS, and they work out an agreement, do we even, they do not have to wait for us for approval for that.

DR. ZUBELDIA: It would be a major change.

DR. COHN: I think the question is is that, I mean, we need to let this process go on and let them explore. Our role here has to do with HIPAA mandated standards and updating HIPAA mandated standards. If this becomes part, I have no idea what is going to happen with this, but I think the next question after all of this is, as Karen was bringing up, is this enough of a sea change that it needs to be in a proposed rule? I think at that point, it comes back to us about whether it should go as a proposed rule. I have no knowledge about that.

MS. HUMPHREYS: I agree with your assessment of that and I think that Karen's concern is reasonable. But, I do feel that if there is a major gap, and we have set up a Catch-22, go work with a code set maintainer, but the inclusion of all the codes that you think are important, or their field thinks is important, is too big a change to deal with an existing code, then we have to get out of that loop. We either have to designate another standard or we have to say that this is, that a major expansion of an existing code set to cover a whole other area is acceptable. We cannot say neither one is acceptable.

DR. COHN: Well, I think we need to hear, I agree with you, something from the national panel is, probably, a subject, we talked recently about coordination in the HCPCS area. At the end of the day, we want to make sure there is not a whole lot of redundancy and overlaps with whatever we do. We probably need to hear from them.

DR. YASNOFF: I think this gets back to the issue of codes and the representation of reality versus codes and the payment of claims. If the purpose of codes is solely to decide what claims are paid, obviously, that is one of the purposes of codes, but, another purpose of codes is to represent reality. If you do not represent the reality for things that are happening, which are not being paid for, how will you ever know whether they should be paid for? You have no representation of them to look at, to evaluate whether there are any positive outcomes from those things occurring.

DR. BLAIR: My thought is that if Alternative Link works with HCPCS, I do not think there is any need for us to ask Alternative Link to wait or HCPCS to wait. If they could explore this, then maybe by the next meeting, they can both report whether there

is any difficulties or not. If there are difficulties where they need our help or assistance, then we could address that.

DR. ZUBELDIA: I think that they need to explore a possible solution, then it would be up to the subcommittee to recommend whether that possible solution gets moved under HIPAA or not. Is that what you are saying?

DR. BLAIR: Well, let's see what the two, both organizations come up with as a recommendation after they have mutually explored it, rather than us be an impediment to that exploration. Let's let the exploration go forward and let them come up with the recommendations. HCPCS is able to wind up saying whether or not it is a major change or not, or whether they could accommodate part or all of these things. I do not think that they need to wait until we make a determination before they go ahead with that exploration and their assessment.

MS. MELINA: Is there a question in the panel? I see a book floating around. It looks like concern.

DR. ZUBELDIA: The concern is duplication. But, it is just looking at one page of the book. There is, on that page, I think already exists with different codes under CPT. It is just one page. We do not know.

MS. GREENBERG: I do not disagree that if the HCPCS editorial panel and Alternative Link can have a productive conversations, they should go ahead and have them. But, I do not think we want to leave the impression that it is in the eyes of the code set maintainer, developer and maintainer, whether this represents something that would require a rule. If that were up to people who maintain 9-ICM, we would probably say 10-CM is just an update. There was something about the way Jeff, the way you phrased that, it was sort of like, well, let them figure out whether this is enough of a change. I think that it is not the, I do not think it is solely the role of the maintainer of a code set to decide whether something requires regulation under HIPAA or is just updating of their code set.

DR. BLAIR: Let me rephrase it a little differently. I think that HCPCS is probably better able than we are to determine whether or not some additional codes can fit into their structure with, and make an assessment of the impact. They do that all the time with their adding codes. So, if they look upon this within their normal process and structure of adding codes, then why should we ask them to wait?

DR. ZUBELDIA: I think they, probably, should start exploring that, have a report from HCPCS national panel for the next meeting. In the meantime, in the next meeting, we should probably bring some providers and payers to talk about this, so if there is, or, when there is a solution to what is the proper home for this coding structure, we will have a better opinion as to whether to recommend that it be adopted or not.

MS. MELINA: We would also like to encourage the panel to invite academics and, perhaps, folks from NCAM to the next meeting, as well, so that we are not only representing the need to establish payment, but the need to measure outcomes.

DR. COHN: I guess I would agree with you, Kepa, but the, I am just sort of trying to think of the process we are describing here. I do not know that, pending the outcome of whatever discussion occurs, or recommendations by the national panel, or otherwise, that we need, at that point, we need to hear from them, first, before we start mobilizing to hear from the constituency just because there may not be a need. That is, really, the only issue. But, I think we need to explore. As you know, we are trying to figure out what the answer to the next processes are and we are just going to have to see what happens.

DR. ZUBELDIA: So, that is some more homework.

MS. GIANINNI: Thank you, very much.

DR. ZUBELDIA: If we can help in any way, let us know.

MS. GIANINNI: Thank you, very much. We appreciate your open-mindedness to this and the long process this has been.

DR. ZUBELDIA: Let's move on to the next testifier. Carol Bickford, from the American Nurses Association, is going to talk to us about the impact on the elimination of local codes for nurses.

MS. BICKFORD: Good morning, Mr. Chairman and members of the subcommittee. I am Carol Bickford, registered nurse, and senior policy fellow in the Department of Nursing Practice and Policy of the American Nurses Association. Thank you for the opportunity to address the impact of the elimination of local codes on claims processing for nursing services.

The American Nurses Association is the only full service association representing the nation's registered nurses, or RNs, through its 54 constituent member associations. Our members include registered nurses, working and teaching, in every healthcare sector across the entire United States. Numbering more than 2.7 million, nurses are the largest healthcare workforce in the nation. From the nurse midwives who attend delivery to geriatric nurses practitioners and clinical specialists who manage end-of-life care to staff nurses who care for us doing times of acute injury or illness, nurses are integral to healthcare across the human life span. Nurses touch patients and manage teams of healthcare professionals and hospitals, clinics, community health centers, offices, nursing homes and patient homes, always seeking to have better outcome. We are the ones who most often care for patients for extended periods and manage the technologies incorporated into their healthcare experiences.

I have been asked to speak on the impact of the removal of local codes for reimbursement for nursing. I had to do quite a bit of research on this because it was not an issue that we had thought was of importance to us in nursing, but as I did some digging, we had some very interesting stories.

Local codes permit reporting and reimbursement for new services under state Medicaid services and other reimbursement structures. This allows payment promptly, pulling funding from the proper account and appropriately logging the service for reporting purposes. In light of the over 50,000 local codes that existed, NMEH, the National Medicaid EDI-HIPAA work group, took a look at those codes and tried to collapse, resolve, reconcile, harmonize, reduce, what they could. They identified the appropriate CPT-4 codes that were considered neutral to the practitioner type. They added non-CPT-4 codes to the ones that could not be supported by CPT-4 into the 2002 HCPCS level 2 codes.

In essence, the problem is resolved because there are not any local codes. Unfortunately, as I was doing the research to answer this question, there are very substantive issues that do remain. I would like to use this opportunity to address them in this

discussion. In light of the events that have occurred in the last two days, and some of the testimony, nurses are partners in this discussion.

It is important to understand that nursing comes to healthcare delivery with a different view. We look at nursing as encompassing the prevention of illness, alleviation of suffering and of protection, promotion and restoration of health in the care of individuals, families, groups and communities. This is a very different practice model from the existing pathology-based, diagnostic and procedure HIPAA code sets.

Nurse's work involves considering the patients and their environments in context. It involves under served, indigent and vulnerable populations. We look at problem solving and patient education. Nursing work demonstrates advocacy for the patient and their informed decision making. Nurse's work often incorporates complementary and alternative care modalities. It involves in identification and ongoing evaluation of patient outcomes. As a result of our considerations, we have standardized code sets that permit linkage of the diagnosis or problem, expected outcomes, interventions and actual outcomes for evidence-based practice.

Our nursing languages are being incorporated in this Nomad CT. The first release includes NANDA, taxonomy 2, and the nursing diagnoses problems from home health care classification, the Omaha system and the perioperative nursing data set. Nomad CT, second release, in July of 2002, will be including the interventions from the perioperative nursing data set. The third release in December of 2002 will include more interventions reflective of the home health care environment and the home health care classification, the Omaha system for the visiting nurse environment and the nursing interventions classification, or KNOCK. Nomad CT, in 2003, will include outcomes from the home health care classification, Omaha and the nursing outcomes classification.

We are trying to get our languages and our code sets integrated into information systems environments that will support our description of clinical practice. We have not been concerned about reimbursement. Our focus is the patient and describing the reality, the point that has been discussed regularly in the last two days. We have been long time participants in standards and code set development. ANSI, ASTM, HL-7 and, also, at the international level. We have been working on ICD-10-CM. We have participated in CPT-4 and worked on the CPT-5 discussion for the proposed revision. We are not yet seated on NCVHS and CPT-4's editorial panel.

I refer you to the consistent themes that are identified on page four of the testimony that I have provided for you in written format. These are comments that were provided to me by the various nurses in the specialties that I consulted in trying to tease out what local codes were for nursing and what issues were surrounding code sets in light of the HIPAA activity. Codes do not capture the essence of the care that is delivered. Codes are missing all the teaching components, which make a significant difference in outcomes. Codes do not accurately reflect the time spent with a patient. Codes do not allow identification and differentiation of practitioners and their practice. Codes are inconsistently applied in various states. Disease and illness are not the same thing and current codes only reflect disease.

Prevention, coordination and case management, palliative care, transitional care, rehabilitation, pain relief, complementary and alternative modalities are missing in code sets. Incident 2 for Medicare, does not permit correct recording and tracking of who completes the activity or intervention. High risk, high need patients fall outside the average code and CMS cannot track where the money is spent. Innovative interventions and care delivery solutions cannot be tracked. Areas where nurses are demonstrating significant influence in reducing costs. Multiple reporting requirements by differing payers requires submitting claims as HCPCS, for one, and CPT for the other, an undue information management burden. Excessive reporting requirements for multiple entities is extremely burdensome when one designated core data set could suffice embracing the right ones and read many times principal(?).

You have asked us to provide solutions or recommendations, not just talk about the problem. From nursing's perspective, it would be valuable to implement ICD-10-CM for diagnoses as soon as possible because our nursing diagnoses are incorporated into that

structure. We would encourage consideration that the code sets and systems must reflect nurses and other non-physician provider's work. We, also, would like to have a designation of a permanent nurse seat on NCVHS and one on the CPT editorial panel. Another recommendation is include attachments to HL-7 messages as an automated solution to tease out the clinical items that are being argued about in the code set definitions.

That completes my testimony. In essence, local codes going away has nothing to do for nursing because nursing does not exist in the code sets as they are right now. I am ready for questions. I have my flak jacket on, it is underneath my sling.

DR. ZUBELDIA: Thank you. I have a couple of questions. The last bullet on the slide that you have there, to include attachments to HL-7 messages. Are you talking about attachments to the extra messages or are you talking about something else?

MS. BICKFORD: I am referencing that as a solution to get around the discussion about are things included in the code sets as we are moving forward with the HL-7 content component. I am not the expert in this arena. I am not our representative to HL-7.

This was one of the recommendations that came forward as I collected the stories that reinforce the need to have a single code set or some guidance on how to apply for payment. That was just one recommendation I put out there for consideration. Where you go with it is your option.

DR. ZUBELDIA: In your written testimony, on page 3, it talks about the ABC codes. Could you tell us, obviously, you do not use local codes now. So, it does not matter if they go away. Could you tell us about your use of the ABC codes?

MS. BICKFORD: The American Nurses Association, in its effort to try and articulate what nursing does and provide a reporting mechanism, continues to be strongly supportive of the development of standardized languages code sets. NANDA is the nursing diagnosis entity that first began. We have the home healthcare classification. The American Nurses Association, also, recognized the ABC codes as a nursing language that supports nursing because they have integrated the nursing interventions classifications into that structure. That is why the code set is called Alternative Billing Codes because it includes nursing and non-physician providers. That was an important piece for us to be able to quantify, to count, to mark against, as any of the these code sets are integrated into practice.

The ANA recognition program is looking for innovations in how do we begin to describe our reality. The worker that is responsible for reviewing each of the code sets, language that come forth, was very impressed with the ABC codes in that it included the

alternative therapies, which become part of nursing practice in many cases. It reduces the redundancy because you do not have to then move it in to a nursing intervention code. There is a mechanism to identify which provider was doing the activity embedded in the structure. Then, there was a costing piece, and that is critical as we are moving into more and more throes of the nursing shortage and our aging population with increasing healthcare consumption, it is important to talk about what nurses do and how do we cost it out, if we could ever be reimbursed for it.

DR. ZUBELDIA: Are you using those codes today, and how?

MS. BICKFORD: I cannot speak to that because as a professional organization, we do not have any coding activities. I would have to defer to Alternative Link and who they have licensed their products to.

DR. ZUBELDIA: Thank you.

MS. GREENBERG: In regard to your last recommendation, Carol, I just wanted to clarify it just for the participants, that the National Committee on Vital and Health Statistics, unlike perhaps, the CPT editorial board, which has representation of particular constituencies, the membership of the national committee, each person on the committee is selected for their expertise, generally, in a variety of areas. There is absolutely nothing that would preclude a nurse. I think we have, probably, had some nurses over some 50 years, although I would be the first to admit we have, probably, had a lot more doctors on this group than we have had nurses. But, the way, there are some advisory committees that have designated seats for particular organizations. This is not an advisory committee of that type. Everyone is selected. Even if you happen to be, for example, a member of AMA, when you serve on this committee, you do not represent AMA. It would be the same if we had a nurse or a background in informatics or a variety of areas. That is, certainly, an option. But, there is no process for having designated seats on the national committee.

DR. ZUBELDIA: But, in this subcommittee, we have a nurse, Carol Bickford.

MS. BICKFORD: That is me.

MS. GREENBERG: I am talking about as a members of the committee. We do not have slots for different professions.

DR. COHN: I was, actually, just going to change the focus here a little bit. I, first of all, wanted to thank you for coming and talking about the nursing issues. I think that the subcommittee and, indeed, we all sort of struggle with the boundaries of what our HIPAA mandated code sets and HIPAA transactions versus clinical terminologies and clinical transactions. I think the nurses terminologies, actions, diagnoses, are an area that sort of fits, it is sort of a gray zone, sort of in between the two in many ways. I really want to thank you for bringing the issues up. I do suspect that as we begin to move into more terminology discussions later on this year, I am sure that we will be paying a lot more attention to this sort of area to try to figure out how best to handle it. I do not know where, this is like a chicken and the egg in the sense of things that we have been focusing on so far with the HIPAA transactions are things, obviously, that are transported often in 837 transactions, which are claims which are payment based. I think, as you commented, there is not a whole lot here that is part of that. You do not often times get paid specifically for the work that you do. Yet, the work you do is very important.

MS. BICKFORD: There is increasing concern for those who are in nurse managed call centers, nurse managed home health centers, that, indeed, there is not a mechanism to reflect their care delivery that they are doing. There are alternative care delivery processes because of the structuring that we currently have in place. So, it is sort of like if you cannot count it, you cannot get reimbursed for it because you do not exist.

I would like to bring to your attention that nursing has done significant work in the outcomes arena. So, we have the diagnosis piece, we have the interventions, but we have outcomes. I do not know of anyone else that has been doing work in that arena.

I would like to bring that to your attention, to be thinking about, as we are looking at evidence-based practice and informed decision making on resource consumption and allocations and innovative solutions.

DR. BLAIR: My thinking is that as we begin to investigate medical terminologies within the domain of recommendations for patient medical record information standards and code sets that the nursing terminologies would fit in there. Simon, do you agree?

DR. COHN: I think that was what I was sort of indicating, that we would, obviously, be talking about more. I do not know exactly where it fits, but it is, certainly, an area that we are going to be looking at, I think, pretty hard.

DR. BLAIR: That is still within the HIPAA domain. But, it is not within the financial and administrative transactions. It is more within the HIPAA PMRI standards. Does that make sense to you?

MS. BICKFORD: Yes, sir. That is why we have been participants in the standards work all along the way, trying to assure that that is included.

MS. BEBEE: In the PMRI report from July of 2000, there is a figure called healthcare terminology domain areas. The nursing codes are a big part of that. I have a copy right here.

MS. BICKFORD: There is one thing that I would like to speak to and it was not part of my testimony because it just emerged. It is sort of the reality. We just heard a significant discussion about the incorporation of the alternative therapies, the cams, into existing code structures. If we were to do the same thing for nursing, we would have the same difficulty because we have our already existing structures. How would you bring in one diagnosis at a time when you have a different framework and different perspective? How would you bring in a different intervention structuring, framing, when we have a whole set of, body, of work. We have that same issue, that ABC codes, we have a whole chunk of intellectual work. How could it be integrated into an existing code set? We are in the same predicament as ABC codes.

DR. BLAIR: I think the way things have evolved, it is a little different because if you may have noticed, when we listed the candidate terminologies under the PMRI graphic that Susan Bebee just referenced, we failed to include complementary and alternative medicine there. One of the aspects, I think, that Alternative Link has been bringing to our attention is two issues. One is with respect to the billing issues for complementary and alternative medicine, excuse me?

MS. GREENBERG: It is on the chart.

DR. BLAIR: It is?

MS. GREENBERG: Under diagnoses and procedure codes. I guess because of alphabetical, but it is the first one.

DR. BLAIR: Let me make my point differently then. That is that I think there is a sense of urgency that Alternative Link has brought up now. It was first tied to the billing issues, but it is also tied to the need to have the code sets out there for research. It, almost, seems as if, I get the sense of urgency that they have expressed is one where it is happening before we have gone into a thoughtful, methodical process of evaluating the terminologies for PMRI standards.

DR. ZUBELDIA: Okay. Let's conclude this panel. Instead of breaking for lunch, we are going to have a five minute break, very quick break, then we will conclude with a discussion, a subcommittee discussion, on this morning and whatever additional carryover issues we have.

DR. COHN: Yes. I think we will, hopefully, hear a brief report from the dentists about progress in that area and talk about a couple of other issues.

[BREAK]


DR. ZUBELDIA: Let's open it up for subcommittee discussion on what we have heard today. Maybe we can do that for 20, 25 minutes. Then, I will turn it over to Simon for the additional issues.

DR. COHN: I think I want to start out by thanking our acting chair. Kepa Zubeldia, you have done a great job of chairing the last day and a half. I think we have had a number of very difficult issues. Much to my surprise and pleasure, I think we, actually, made some progress on them.

DR. ZUBELDIA: Nobody fought anything.

DR. COHN: I do not think I have a whole lot, I mean, I do not have a whole lot to say about, I think this morning, the various pieces, have been sort of moved forward on all fronts. So, I do not have a whole lot to say about that. I am more, probably, concerned about the additional carryover issues to make sure, see where we are on those. Do others have issues or comments they want to make about this morning?

DR. ZUBELDIA: I would like to, maybe, bring back the discussion from last night on the recommendation and to put together, to move forward with ICD-10-CM, and PCS, for the same uses that we are using ICD-9 now. I think that is, probably, the best conclusion of the meeting. From what we have heard this morning, it would not, that would not change. The recommendation would still be to move forward with ICD-10.

DR. FITZMAURICE: Excuse me, Kepa. Are you talking about diagnosis and procedures?

DR. ZUBELDIA: Yes, and procedures for the same uses that we are using now, the IC-9 procedure codes, which is institutional use.

MS. HUMPHREYS: Has Karen left us, or just temporarily?

DR. COHN: Gosh. I sure hope not.

DR. ZUBELDIA: She is coming back.

MS. HUMPHREYS: I think the action item from yesterday was, perhaps, not in committee, but, there she is. Sorry. There is Karen returning. My understanding, Kepa just brought up the issue of the general conclusion yesterday that the subcommittee would recommend to the committee to recommend to the Secretary to move forward. It sounds like we should all be part of the mikado or something. To submit a recommendation regarding moving forward with an NPRM related to ICD-10-CM and ICD-10-PCS. But, I guess that, was not the conclusion yesterday that there was going to be some draft prepared and then circulated, rather than having us, are you over commas today?

SPEAKER: Yes.

DR. COHN: Yes. That will be a couple weeks from now.

DR. ZUBELDIA: I am not sure that yesterday we concluded on moving forward with the PCS part. And, the waiting until today. That is why I want to move forward with PCS part.

SPEAKER: No, I do not think so.

MS. GREENBERG: Michael is raising his hand.

MR. BEEBE: Michael Beebe, American Medical Association. I was not here yesterday and I apologize for that. But, one of the thoughts that I had was that I thought that the committee on the PCS issue was interested in collecting additional data on the impacts of PCS.

MS. HUMPHREYS: Yes. Just to sort of summarize what came out of yesterday, I think that where, I think, the committee was going with this was that the current situation is quite broken in in-patient care, both on the diagnosis and on the procedure side, in terms of the not very useful approaches to these, that, probably, there is much more input that could be gathered on this issue, but if the committee recommends to the Secretary that they move forward with an NPRM, which is just what it is, a proposal to say this is what we are intending to do and this is what we heard and this is what we say. Now, provide comments, that we are, probably, talking a minimum three years before, well, the committee was saying, based on all the, yesterday, that, probably, a recommendation would be we should move forward with an NPRM and after the NPRM is, whatever comes out of it, is finalized, then there should be a two year implementation process. Whether this is only on the diagnosis side or only on the procedure side, or both, and that given that the situation is so bad, both from the point of view of the current ability to describe what is, actually, wrong with patients and what is, actually, being done to them in the in-patient setting, that it would be better to move this process along which would make everybody sit up, take notice and really provide their input. Otherwise, this committee could hold hearings for the next 10 years and they would still not get the same level of comment on these important issues that they would get by publishing an NPRM. That was the gist of the conversation yesterday.

MS. TRUDEL: Here are the recommendations as I got them. Any revisions or corrections are gratefully accepted. The first recommendation would be recommending ICD-10-CM and ICD-10-PCS for in-patient only. The implementation would be at the same time. This would be recommended by a proposed rule. There would be a two year plus implementation period after the final rule. That effective date would be no sooner than October, 2005. The effective date should be an on-cycle, like an October or a January B

something where coding updates are currently expected and well coped with. There is a need for a date certain. The point that CM and PCS are broken. There is a need to add some of the, I just have a note that says add history. I am not sure what that means.

DR. BLAIR: I think that describes the fact that things are broken, I think.

MS. TRUDEL: And, a recommendation for corresponding coding guidelines. Did I get it all?

MS. HUMPHREYS: Yes. And, I think that the history issue related to the fact that the NCVHS is on record going back to 1993 that the existing code sets are broken in terms of being able to collect data. Of course, yesterday, we heard a lot about the procedure ones in the previous hearings. Yesterday, we obviously had some very compelling examples about the problem as it exists on the diagnosis side, as well.

MS. TRUDEL: I also have a question mark next to something else. We said effective date would be no sooner than October of 2005. I wrote a note to myself no later than December, 2006, because I was hearing people say a lot, we do not want to wait until 2007 or 2008. But, I do not know whether the subcommittee wants to, actually, put an end date on the recommendation.

DR. ZUBELDIA: I think that the message was pretty strong that this should not be floating forever, years delayed for a long term.

DR. COHN: I guess I have a slightly different feeling on this one. I do agree that we heard, I think, a lot of testimony of people throwing out dates that, depending on what hypotheticals you gave them, the dates seemed to change in three to five minutes, basically. I think the critical piece is that there be enough time from the effective date to allow for a successful implementation. I cannot guarantee when a final rule might come out, nor can anyone in this room. I think it is dangerous to start giving people end dates. Now, what I did hear, let me just say this, is that I think in our testimony from our last session and this session, I have heard that both the ICD-9, Volume 1, Volume 2, Volume 3, they are all broken. I heard an urgency, but I did not hear an emergency. It is not going to be like things are going to fall apart tomorrow. So, if things go six months later, or things go a year later, it is not going to cause the entire system to crash.

MS. HUMPHREYS: Well, we will have to see. I guess the issue that I think was brought up yesterday is given that these are complex and controversial issues, that a statement from the committee going forward to HHS that there should be a rule and implementation should be two years later, without some strong statement up front about something needs to be done about replacing these within our life times or within some time frame, might mean that everybody would say, well, good, there is only a rule and it needs to be changed, and two years later, let's just keep putting that monkey on somebody else's back. In the meantime, it is very difficult to describe what is going on in hospitals, both in terms of what the patients are suffering from and, of course, in the case of the diagnosis portion of this, it does not just affect, it affects everybody. A lot of office space practitioners, as we heard, as well as B

DR. COHN: It seems like there ought to be some way to wordsmith exactly what you are saying because I, actually, agree with you. We do not want to give people a sense that there is no urgency.

MS. HUMPHREYS: Yes. Presumably, we can work on a draft for the committee to review.

DR. FITZMAURICE: Karen, I had a question about what effective date means. If we say effective date of October, 2005, are we talking about a mandatory compliance date, as opposed to here is an effective date, then it becomes mandatory two years later?

SPEAKER: Compliance date.

DR. FITZMAURICE: So, we are talking about a mandatory compliance date of October, 2005.

MS. HUMPHREYS: Yes. Her point was that I do not think anybody was advocating that it could be possible to do this in an effective way before that date.

DR. FITZMAURICE: I think you are right.

MS. HUMPHREYS: Maybe that is not true. Maybe there were a few, but I think the preponderance was definitely in the other direction.

DR. FITZMAURICE: People that have been immersed read effective date and say, oh, 24 months from the effective date it becomes mandatory. Instead, we are talking about mandatory compliance date of October, 2005.

DR. COHN: I was, actually, going to suggest that maybe we add something to the letter that indicates, I heard the terms implementation planning, I am trying to think of what other terms were used, but all fall into the fact that I think we need to inform the Secretary that, as this moves forward, there really is a responsibility on the part of HHS to develop a national implementation plan and to assist with successful implementation.

MS. HUMPHREYS: Yes. I heard some B

DR. COHN: That may be obvious, but B

MS. HUMPHREYS: I heard some people recommending really getting wheaty snip into the act and having seen, at least from my perspective, how reasonably effectively they have worked related to HIPAA issues, that sounded like a good recommendation to me. These poor people are, probably, going to say forget it. But B

DR. ZUBELDIA: They also have to go into some milestones in the implementation. I do not if that is wheaty snips role or how that would be achieved.

DR. FITZMAURICE: Are you suggesting milestones in the final rule? Or, are you suggesting in implementation?

DR. ZUBELDIA: In the implementation plan.

DR. COHN: I guess the steps for this document would be drafting, or try to circulate it, or word smithing prior to the NCVHS meeting. Go through our usual process of B

MS. HUMPHREYS: Additional word smithing.

DR. COHN: , additional word smithing, exactly. We will provide some time on the agenda during the June breakout for, hopefully, final word smithing. We are all familiar with this process. Is that comfortable and agreeable to the subcommittee? Okay.

DR. FITZMAURICE: Simon, are you proposing, then, in August, we have something that should be semi-final with all this word smithing?

DR. COHN: No. I was expecting June.

DR. FITZMAURICE: Okay.

MS. HUMPHREYS: The full committee June meeting.

DR. COHN: I was, actually, going to ask Donna Pickett to come to the table only because I think that she is the keeper of the open items, the carryover issues, I think. We just need to look through them and see what is still open, pending and otherwise, at this point. I do not know which order we want to take them, but is the, if I remember from yesterday, we had this open issue about what we were trying to recommend about DSM, whether it is a crosswalk, or whatever. Is that something you want to even address today or bring up later?

MS. PICKETT: No. Actually, I wanted to ask that we move that to either the June agenda or a subsequent agenda. Based on the additional discussions that we heard yesterday, and the testimony provided by APA, and some of the additional discussions that the subcommittee had, I think there are a number of issues that probably need to be additionally rolled into the white paper. That could be ready for the June meeting, but certainly, it is not ready today.

DR. COHN: Okay. Now, I see two other issues here. We just need to, I think that they, perhaps, have at least been discussed already today. But, one is version control. Do you feel that that is still an open issue or B

MS. PICKETT: It is an open issue. It was raised by previous presenters at the February and the April meeting. The topic there is that, for instance, using ICD-9-CM or CPT as an example, ICD-9-CM is, the new version becomes effective October 1 of every year. For CPT, I believe it is January 1st of every year. But, you do have some that do not, actually, do that so that some payers or other providers are using previous code sets after a new code has, the annual change has been implemented. Either AHA or AHIA, they might be able to provide more detail. But, it becomes an ongoing issue and it continues to be a burden to the providers because they have to worry about which code set can they send, which ones should they send. Sometimes, they will send in new codes that have not become effective, based on a particular time frame, but the claims are rejected anyway because someone had not revised their systems to accept the new codes. I am aware, I believe, of some state DRG programs that are, actually, using older groupers which do not allow for the acceptance of any of the new codes. Some of the groupers are, actually, two to three years behind. But, I would defer to AHIA and AHA to provide you with additional detail on that. But, that is an ongoing problem.

MS. HUMPHREYS: The issue, I think, too, is whether everyone is clear that according to HIPAA, as stated, we definitely have a problem, we still have the problem and we have it legislatively, about October, January. We have to resolve what is going to happen. I am sorry I had to miss some of the discussion this morning about the quarterly and whether everybody is quarterly or two times a year or three times a year are going to be, maybe this is following up on the coordination with CPT and HCPCS, whether we could end up with, really, mini issuing of new deadlines throughout a year. If everybody was doing it twice a year, but not on the same date. Or, three times a year and not on the same date. There are those issues. But, I guess that one of the questions is like the local codes. Does everybody really understand HIPAA? Do they, actually, know that there two year old group is, theoretically, going to be an item of the past when HIPAA is implemented?

MS. PICKETT: That is an excellent question because I do not think we have the answer to that question.

DR. COHN: I think there has, also, been issues around this that have been brought before. Even just about how long of a period, like the old codes are used versus the new codes, which is just another view of this piece.

MS. HUMPHREYS: That is right. I think that the issue is HIPAA, I remember some long conversations about this, there does not seem to be much, the way HIPAA states that you are submitting things as of, with the code set that was in place when you are preparing your record, at the time that the service was delivered, there does not seem to be a way around this. People cannot be running back, renovating all of their health records. Therefore, there is a built-in, natural requirement to be able to process the old things because we know that the claims are not going to be submitted by midnight at the date when it switches over. I mean, not all of them. This is, definitely, a requirement. There is no way to get around it.

DR. COHN: But, it probably ought to be standard.

MS. HUMPHREYS: Standard in what sense? If it is going to be standard, then we better hear from everybody about what is the rough lapse time, whether it is B

SPEAKER: The statutes of limitation differ.

MS. HUMPHREYS: Whether it is this month, that month, whatever. I do not even know what is common in the various segments of this multifarious industry in terms of when bills are submitted.

DR. ZUBELDIA: One of the problems that we have now is that the common way of acting is following Medicare's instructions. Medicare's instructions today is that the procedure code follows the date of the service. The diagnosis code follows the date the claim was filed.

MS. HUMPHREYS: No.

MS. PICKETT: They both follow the date, it is the date of service or the date of discharge. That is for diagnosis and procedure.

DR. ZUBELDIA: For professional claims.

MS. PICKETT: Oh, you are talking about CPT?

DR. ZUBELDIA: I am talking about CPT B

MS. PICKETT: Well, it is the date of service, but B

DR. ZUBELDIA: , and process codes on professional claims is the date the claim was filed.

SPEAKER: No.

DR. ZUBELDIA: On professional claims?

SPEAKER: It is the date the service was provided.

DR. COHN: It sounds like we need to have an off-line discussion on this or, at least, pull out the books.

DR. ZUBELDIA: I believe that Medicare is doing it the date the claim was filed. That is going to have to change. What I am saying is what is happening today, not what HIPAA requires, but what is happening today.

MS. HUMPHREYS: No. But, I think these people are in charge of what is happening today.

DR. COHN: Did one of you want to clarify what the rule is in relationship to this?

MS. PROPHET: Today, the proper protocol is supposed to be that the codes are effective on the date the service was rendered. Or, in the case of in-patient discharge, the date of the discharge. I am not aware of Medicare having a different requirement for any particular claim. Now, the problem, as Donna was pointing out, is that some payers do have grace periods in which you are allowed to submit, continue to submit, the old codes for varying lengths of time after the effective date because either the provider system or the payer system has not been updated to reflect the new codes. That can vary anywhere from 30 days to 90 days, it is all over the map.

DR. ZUBELDIA: This may have changed recently, but when Medicare carriers update their CPT tables, they have an expiration date on each code that says when each code ceases to be effective. When they update the ICD-9 tables, they do not. They update the ICD-9 tables on October 1 and that is it. As of that day, you cannot file a claim that has an old code because there is no expiration date associated with the codes in the table, as there is for the CPT codes. It may be that it is just a practical reality. Maybe it is not in the instructions, but just a practical reality says that when they update the ICD-9 tables, as of that day, if you file a claim with a diagnosis for services rendered the week before, with a code that has been eliminated, the claim will not fly.

MS. PROPHET: Well, that is technically not correct. As Donna can verify, when the official addenda comes out, it clearly says on it that this is effective for services as of October 1st.

DR. ZUBELDIA: I understand how it is going to work under HIPAA.

MS. PROPHET: That is the current instruction now.

MS. PICKETT: That is the current instruction. That is not a HIPAA instruction, that is the current instruction.

DR. ZUBELDIA: Okay.

DR. COHN: Kepa, is there an action item around here, around this?

DR. ZUBELDIA: I am concerned that that is not how the vendors have their systems working. We may have to find the reality. Maybe it is just an education process.

DR. COHN: Well, I guess the question I would ask is is this something where we would want to get a couple of either vendors or payers, others, come in and identify if there is any version control issues that they are aware of and try to get straightened

around?

DR. ZUBELDIA: I think that if we make it very up front that this may be a change over the way you are doing it today. Let them be aware that this could mean over the way it is being done today. I think that should be enough.

MS. PICKETT: This is an action item?

DR. COHN: I am not sure that this is an action item.

DR. ZUBELDIA: No. Just a matter of indication. I think Willie can take care of that education.

SPEAKER: Sure.

MS. PICKETT: Okay.

DR. COHN: It sounds like that is one we need to follow along. The other issue is standard use of code set guidelines. I think we talked some about that this morning, as well as the existence of code set guidelines. I do not know that we need to belabor that for the moment, but is there an issue with this?

MS. PICKETT: Just the additional issue that it, really, does go beyond just CPT and HCPCS. This is an across-the-board issue where various payers interpret the use of the code sets differently. Even if it was standardized by CMS, and the use of the alphanumeric HCPCS, there are still others that may have a slightly different interpretation and reporting requirement for a given service. It is a much larger issue, though, obviously, since everyone uses HCPCS, it looms very large. But, that is only part of the picture. Again, I think AHA or AHIA could provide additional information on how that plays out when you have the burden of a provider being told, well, for this particular payer, I have to report the service this way with this combination of codes, while for another payer, they may say, we want it with this combination of codes, or some payer may not really care about the specificity and say a very unspecified code is perfectly appropriate. For the provider that has to sort that out, in the absence of guidelines, or the absence of definitive guidelines, as an example, I believe the AMA mentioned that they have guidelines for the use of CPT. Now, whether all payers accept the use of those guidelines may be a different issue.

DR. COHN: Is that an actual question you are asking? Or, is that more of a B

MS. PICKETT: Well, I think there are, probably, others in the room that could verify whether that is or is not a problem.

MS. HUMPHREYS: The issue, it seems to me, we have two issues. We have HIPAA code sets that do not have what anyone would call definitive guidelines for coding. Then, we have one that does have definitive guidelines, but then, it is possible that individual payers have their own local things which they are telling people to do, even though there is a national set of guidelines for the disease part. Then, there may be conflicting guidelines that payers are used to providing. So, it is this issue of, it is, basically, Marjorie's issue, of do payers, actually, grasp that in the post-HIPAA world, the whole intent is to get rid of these local variations or not. Do they understand this?

DR. COHN: You know what I am going to suggest on this one? Because this sounds the same way as the earlier one with version control and things like this. I think that, maybe, we need a letter, not for June, but maybe for the September NCVHS meeting which is a letter stating concern about a variety of issues and recommendations the Secretary needs to highlight and communicate these to the industry so that they are aware of all of these things. This is not really something we can fix, but these are the stuff of which we need to alert the Secretary that these look they are issues that people need to be aware of. They need to be working on it as they do HIPAA implementation. That would include version control and this issue about the standard use of

codes. Have guidelines, where they exist B

MS. GILLFOYT: This is Helen Gillfoyt. Simon, the only problem with waiting until September is testing has to begin by April. I am assuming that everybody has filed for an extension or will have filed for an extension. That is cutting a lot of this stuff pretty slim when you are going to, actually, be changing systems to accommodate the results of whatever the letter is.

The other thing that I would like, when you are considering these items that need to be considered, is the issue of the 837 institutional and the 837 professional being required for the same service by different payers.

DR. COHN: You mean the form related to site of care?

MR. GILLFOYT: Not the form, the format and the content. The same two payers for the same service, one will require the 837 institutional format and content. The other will require the 837 professional with the format and content. That is a major issue for providers because we had thought we were going to be able to get out that thing of filing 400 different versions of the claim. That is number one. But, number two, if we ever hope to get to payer-to-payer coordination of benefits, that is going to be an impossibility if I send the institutional content to payer A, but payer, is going to want the professional content. Payer A is not going to have the professional content to send on to payer B. This is something that really needs to be addressed by the committee and sooner rather than later.

DR. COHN: I do not know that we are going to be able to deal with this one before August, but it does sound like a topic for an August.

MS. GILLFOYT: Wheaty snip is addressing the issue from a work group. But, basically, what they are doing is looking at what occurs today, as opposed to making, well, hopefully, some recommendations will come out of that, but they are doing a study as to what the current status is.

DR. ZUBELDIA: They have prepared a beautiful spreadsheet that shows that there is no consistency.

MS. GILLFOYT: Right. If, the only consistency is the inconsistency. It is a major, major issue for providers. But, as I said, the extension of that, while it is a major issue for providers today, the extension of that is we just do not have any hope of getting to payer-to-payer COB with that problem in existence.

DR. ZUBELDIA: Not just payer-to-payer COB. COB period.

MS. GILLFOYT: Well, COB period. Right.

DR. COHN: I think this is an issue we have heard before. I am reminded that we, actually, meet, but, I do think it is, actually, something we should spend a little while on hearing both from wheaty and others about the problem, as well as possible solutions. I think it would be very useful in this letter if there were some solutions that we could offer.

DR. ZUBELDIA: I can tell you a little bit of what I know about the problem and solutions. The problem is that the payers today are using whatever they are using, NSF or UB-92. HIPAA does not require them to change their business practices. So, if their system, today, needs the NSF or home health, they are going to continue requiring the 837 professional for home health because that is what they are doing today. It is very difficult to convince those payers, today, that home health should be billed with the 837 institutional because that is what the 837 institutional was designed for, unless there is mandate spelled out somewhere.

DR. COHN: Okay. Well, Kepa, without trying to solve the problem at this session, we are unearthing an issue. Is this something that you believe is worthy that we should take a look at further and see if we can make some recommendations?

DR. ZUBELDIA: I think we need to, as quickly as possible.

MS. GILLFOYT: Just to follow-up, just one brief thing on what Kepa was saying. The data elements for home health are spread across both the institutional and the professional claim. That is part of the real problem. I agree with Kepa that it should be out of institutional, but the problem is that the data elements are in both forms. They are not the same data elements in both formats, so it makes it, as Betsy said, the only consistency is inconsistency.

MS. TRUDEL: I have one concern that I am just going to mention that is that, the fact that the subcommittee is going to take this up is fine, but if we telegraph that we are looking for a short term solution by October, 2003, that is very different from saying we realize that there is a need to address this eventually. I think, if health plans, for instance, are suddenly given the impression that they are going to have to do something about this by October, 2003, that is going to complicate many, many people's implementation plans. I think we need to be careful what kind of intention we are telegraphing to people because, believe me, they do watch and they pay attention. If there is an implication that we are going to attempt to make some sort of a solution to this, by solution, I mean requiring people to use one or the other, by October, 2003, that will be all over the list service by tomorrow morning.

MS. GILLFOYT: One of the things that I found after this whole process was brought to my attention is that, at least, Minnesota has had a law on the books since >96, or >94, I forget which, that says if you are an institutional provider, you will send either the UB or the EMC. If you are a professional provider, you will send either the 1500 or the NSF. They make a clear definition in their legislation as to what is an institution and what is a professional, what is a dental, and it goes on down the line. I am trying to find out if any other states have the same kind of legislation in place. But, the Minnesota legislation is clear and it is in place and has been for quite some time. So, payers, my point is that payers in Minnesota are already, or should be already, used to doing this kind of processing.

MS. TRUDEL: But, payers in the other states are not ready.

MS. GILLFOYT: There is 49 other states.

MS. TRUDEL: And, they are going to want to know whether we are planning on doing something that is going to make them have to do that by October, 2003. That is B

MS. GILLFOYT: I hear what you are saying, Karen, but let me just point out that from the provider side, this is not administrative simplification because I still have to have the ability to generate two formats. That is both the professional and the institutional provider.

DR. ZUBELDIA: It is not the role of the committee to design the standards. This is, maybe, something that we have identified that there is a flaw or a hole in the design of the standards. Maybe it should be back to the standard's designers to close the hole and have better instructions in the standards as to what has to be used when.

MS. GILLFOYT: I think the flaw was in the description of the use of the standards, as opposed to, because the regulation clearly states what standard is to be used in what situation. It just did not define that.

DR. ZUBELDIA: I think that we need to look at it soon. I do not think we need to come up with a solution immediately.

DR. COHN: Yes, exactly. That was my comment, also. I, certainly, do not want to solve the problem right now. We do not have all the right players in the room to even understand all aspects of it.

DR. ZUBELDIA: We need to look at it.

DR. COHN: Yes, exactly.

MS. GILLFOYT: You might want to hear from both the wheaty group and the DSMOs because the DSMOs, I know, are addressing this also. I know it has come before. And, UBC and then, UCC. I think it is for them to resolve in a sense. Or, to come forward with a proposal.

DR. COHN: Yes.

MS. GREENBERG: When do you, when are we hearing next from the DSMOs, in any event?

DR. COHN: Well that, actually, almost moves on to the next issue. But, I think that it is, I mean, I should comment even before you bring that issue up. I do want to acknowledge receipt of letters from NCPDP related to professional supply, excuse me, to supplies as well as professional services. I think we were B

MS. GREENBERG: And from, I think, NADP. NACP?

SPEAKER: NADP.

DR. COHN: No, no. You are talking about the National Association of Community Pharmacists, I think.

MS. GREENBERG: We have gotten two letters. One wanting to have two formats for retail pharmacies. One not wanting to have two.

DR. COHN: Thank you for including that. I am just acknowledging that the issue has been brought forward. I think we are hoping to get some input and guidance from the DSMO group about what their recommendations are around all of this stuff. To my view, brings up when we will be talking to the DSMOs next.

MS. GREENBERG: Is that issue dealt with in the NPRM that is going to be, I did not think so. There was something on the wires or whatever, saying that it was. I did not think it was. Okay.

DR. ZUBELDIA: The final transaction draw describes what to use when in that area. They are not happy with it.

DR. COHN: Yes. But, anyway, I think that this issue has been brought forward to the, as I understand it, to the DSMO group. I think we are, I would imagine it would be part of the discussion we would have with them. I think at this point, they had asked about meeting with us in October. Once again, not for necessarily the 2003 implementation, but for the yearly process. I think one of the questions we will have to talk to them about is whether there may be some issues that they want to share with us and have us discuss in August. That begins to reflect, also, on the previous issue. Once again, we need to see what their time line is and their availability. Now, Donna, did you have a comment? Then, Nelly.

MS. PICKETT: I will defer to Nelly.

MS. LEON-CHISEN: If we could just come back for a minute to the issue of version control and guidelines. I know you had suggested writing a letter recommending that this issue be addressed. I would suggest that you split out those two issues. The issue of version control is very problematic, especially with Medicaid claims, where a hospital may have to deal with Medicare claims, and other payers, where they have the current code sets, especially for ICD-9-CM, but the grouper for the Medicaid system may be two, three, years back as Donna mentioned. Some states are even older than that. So, I think that can be taken care of separately and much quicker. Putting people on the alert that if you did not understand that this was what was meant by HIPAA, you better start working on it.

The second issue with the guidelines, I think, is a little more complex. It, probably, will take longer to work out, especially since the HIPAA code set only mentioned the official code guidelines under ICD-9-CM. From what we heard today, there is no set of guidelines for HCPCS. We will, probably, have to work with CMS in terms of giving examples and working with them in terms of how to develop those guidelines.

I would hate to lump the two issues together because one can be resolved much quicker than the other. We would be willing to work with CMS and AMA and anybody else in terms of developing guidelines.

DR. COHN: For version control?

SPEAKER: No.

MS. LEON-CHISEN: For guidelines. For version control, you could just B

DR. COHN: You meant that as a long term?

MS. LEON-CHISEN: Yes, especially where there are no guidelines existing today.

DR. COHN: Okay, that is fine. I thought you were going to develop guidelines for the version issue.

MS. LEON-CHISEN: Well, if you will let us.

DR. COHN: Oh, no.

MS. LEON-CHISEN: I do not think you want that.

DR. COHN: No.

MS. PROPHET: I was just going to make the same point and, also, say I am not sure exactly what the letter on coding guidelines would say for those code sets that have rules, like CPT, but HIPAA currently does not require adherence. To require people to do something that they are, really, not regulatorily required to do, I think is kind of a problematic issue that needs to be addressed. So, there is the issue of developing guidelines for those code sets that have them, and then B

DR. COHN: Yes. Just to be clear about this one, I think we had already divided that issue into two issues. One is lack of guidelines, which it is hard to tell people to follow a guideline when there is not a mandated one. I think what we were talking about was when there actually is the guideline that is required that people need to be aware of, that they need to follow it.

MS. PROPHET: But, my point is that for the code sets that have existing guidelines, other than ICD-9, HIPAA does not require B

DR. COHN: Yes, I agree. We agree with you.

MS. HUMPHREYS: So, I think that, but, I think that the division, or whatever is being done here, there is a notion of does everybody understand that before ICD-9-CM, volume 1 and 2, there are guidelines. Guess what? You have to follow them. Also, does everyone understand that it is, really, no longer going to be acceptable to the state Medicaid agencies, and whatever, understand that these two or three year old groupers have got, they have got to stop doing that. It does seem to me that those two issues get addressed different ways because you have a broad education issue vis a vis, hey, you know, the diagnosis coding guidelines, you really have to follow them. You have, I would assume, that CMS could be more directly involved with whatever the Medicaid group is in terms of these old groupers.

DR. COHN: Thank you. Are we okay so far? Okay. I think we had mentioned that we will have to talk to the DSMOs to see if they only want to come in October or they want to come in August, instead, to begin to discuss some of these issues.

Now, the other piece I just want to bring to fore, actually, there are two pieces. One is called responding to the NPRM, which I have been informed by Karen Trudel is, actually, on the, has been released and is one the website now?

MS. TRUDEL: It is on the CMS website in PDF format, www.cms.hhs.gov/hipaa.

DR. COHN: We just need to aware of that. A letter, if the NCVHS is to send a letter on this issue, we have a 30 day period, just like the entire industry does, to comment. I think we will all be reviewing the NPRMs. I suspect, since they should likely mirror many of the recommendations we made and other things that we have held testimony on, that the letter may not be a lengthy letter and it may be generally supportive. Without having reviewed it, I cannot say for sure. But, I think the intent, assuming the subcommittee agrees, is that we will try to draft a letter and have it for discussion at the subcommittee and full NCVHS meeting. Is that agreeable to the subcommittee? I see Jeff nodding his head. Kepa?

DR. ZUBELDIA: Are we going to have time? It will be published on the 31st. So, we have until the 31st. There is barely enough time.

DR. COHN: Yes, you are right. Just barely enough time. But, barely enough is enough. I just means that we cannot send it back for further revision another week or two after the full meeting. It is a tight time frame, but at least we have a full meeting upon which to fix it up and have it approved. Everyone okay with that? Okay. We have gotten pretty good at this, actually.

Now, the final issue on my agenda is just, unfortunately, Brady is not here today. But, for the June meeting, we are going to have some major discussions around the Administrative Simplification Compliance Act and our responsibilities related to reviewing a sample of the compliance delay request. I think Brady is beginning to put some thought into an approach and methodology for how we should be evaluating it. Hopefully, we will receive some drafts of that between now and the June meeting.

With some reviews going on with the idea that we can have a more thorough discussion about that in June.

DR. ZUBELDIA: Do we have a sense for how many have been filed so far? Ball park?

MS. TRUDEL: Not too many. I think a little over a thousand.

DR. COHN: Okay.

MS. HUMPHREYS: Compared to comments on the privacy rule, it is a mere bagatelle.

MS. TRUDEL: Interestingly enough, though, we are getting them seven days a week. The statistics show we are getting requests filed electronically seven days a week.

SPEAKER: 24-7?

MS. TRUDEL: Yes.

DR. COHN: Great. That will be, I am sorry that Brady is not here, but he would, I think, probably have talked a little bit about some of his early thoughts about that. But, we will, hopefully, be spending some time and trying to reach some agreement about how to approach that.

MS. GREENBERG: Is everything that is being filed electronically in the format that was provided?

MS. TRUDEL: That is the only way you can do it, it is web-based.

MS. HUMPHREYS: Okay. Keep them coming.

DR. COHN: Now, that is sort of the end of my agenda, other than to ask the subcommittee if there are other items that we need to be putting on future agendas? We talked about June specifically, but also, certainly, for August.

MS. GREENBERG: What is the main focus of the August hearing? I have had some people ask me about the August hearing.

DR. COHN: Marjorie was asking about the main focus of the August meeting. I do not think it is has been completely determined. My hope was is that we would get back to issues specifically around HIPAA implementation. So, some of the discussions that

we have had around, the carryover issues, I think, are pertinent to that, as well as understanding from the industry about other issues that are occurring. We may hear from DSMOs, if they are prepared to begin the discussion in August. There is a hope

that sometime in the last half of the year, and I do not know whether it is going to be August or later, that we begin to talk some about lessons learned so far from the implementation and if there is any suggestions for how we can learn from the experience so far and make recommendations to the Secretary on how to improve the process.

MS. GREENBERG: That is related to the sample. We will also be reviewing the sample and recommending best practices or ways to overcome problems.

DR. COHN: Well, I think there is a variety of issues, some of which are, that may, certainly, be related.

MS. GREENBERG: What about, when are you going to get back to PMRI and, I guess, the next topic begin vocabulary standards?

DR. COHN: Well, I think that is a topic that we will, maybe in June we will be able to lay out the plans for the fall hearings at that point. I do not know. I am trying to figure out how all this stuff fits together in the jigsaw. I will tell you quite honestly that I do not have the answer at this point about how it all plays. Jeff, do you have any comments about that one?

DR. BLAIR: No. We have so many things on our plate. Let's just see how it folds in together. One of the other, if it is possible, it would be nice to know what kind of industry response, excuse me, well, let's just see if by August or October whether there is an HHS letter that comes out as part of our initial recommendations on PMRI message format.

MS. GREENBERG: We just got one.

DR. COHN: There, actually, was one on May 1st.

DR. BLAIR: Yes, but that was not the actual incentives for guidance to the industry. It was an acknowledgment and indicating that they would be working with us during this summer to craft the industry guidance and the incentives.

MS. GREENBERG: Yes. I see.

DR. COHN: Okay. I guess I should announce that, obviously, the full committee will be meeting on June 26 and 27, across town.

MS. GREENBERG: Not in the Humphrey Building, the Windham Hotel on New Hampshire Avenue?

SPEAKER: Yes.

DR. COHN: Our date?

MS. GREENBERG: Open meeting, of course.

DR. COHN: Our date in August, the August subcommittee meeting, which will be the next subcommittee hearings will be August 28th and 29th.

MS. GREENBERG: No, not in August. I believe we intend to be in this building again. The June meeting, the June full committee meeting will be in the Windham Hotel.

DR. COHN: Is that here?

DR. ZUBELDIA: August what, 19 and what? What did you say was the August date?

DR. COHN: Okay. Let me give you the fall dates for the subcommittee hearings. The subcommittee will be holding hearings on August 28th and 29th, on October 22nd and 23rd, and then the final one for the year is December 10th and 11th. These hearing dates are, obviously, dates that are being held. We do reserve the right, if there are no issues coming before the subcommittee, to cancel them, or one of them. But, so far, that does not seem to have been much of an issue for the subcommittee. Are there any final questions, comments, from the subcommittee? Any other issues that we need to discuss today? Well, I want to thank the subcommittee, as well as the staff. I think it has been a very interesting and useful day and a half of hearings and meetings. I will look forward to seeing you in June.

(Whereupon, the meeting was adjourned.)