Washington, D.C.
The Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics met on February 21, 2001, at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public.
The Subcommittee on Standards and Security met on February 21, 2001. Ms. Trudel and Mr. Nachimson briefed the Subcommittee on issues and progress related to the regulatory process for proposed changes to the financial and administrative transaction standards.
Ms. Weiker reported on the process formulated by the Designated Standard Maintenance Organizations (DSMOs) at the Accredited Standards Committee X12 meeting, outlined the fast-track change process, and discussed ways the industry can be kept informed as this process evolves. Mr. Beatty noted errata had been reclassified as corrections to the guides and would be differentiated as modifications and maintenance. He noted X12N had approved a process for the publication of addenda containing corrections to the guides, and he outlined issues and a time line.
The group reviewed a draft of a letter to DHHS arising from the February 1-2 hearings on barriers to implementation. Stating NCVHS believes further evaluation is needed, it recommended: (1) retracting the adoption of National Drug Codes (NDCs) as the standard for drugs and biologics for use in standard transactions other than retail pharmacy and (2) that HHS work with X12N to ensure that HCPCS codes, as well as NDC codes, could be used in the standard institutional and professional claims transactions. The letter also proposed that HHS develop criteria to be met by a drug coding system, usable throughout the industry, and evaluate proposed drug-coding systems against those criteria.
The group discussed upcoming hearings that Dr. Fitzmaurice and Mr. Blair are leading regarding PMRI issues and next steps. They discussed working drafts of materials to be sent to testifiers for comment at the March 19-20 hearings: criteria for selection of PMRI Message Format Standards, a questionnaire to PMRI standards developers intended to assist NCVHS in selecting standards, and a proposed list of candidates for PMRI transactions. They also considered other potential users of standards to contact for broader testimony.
Based on recent hearings and what they had heard in the meeting, the Subcommittee updated the draft of the annual report on HIPAA to Congress, which they will recommend tomorrow to the full Committee.
The group reflected on code set activities they might incorporate later this year in a work plan for the full Committee.
Mr. Nachimson outlined the process adopted by the Secretary in the final rule for Standards for Electronic Transactions published in August 2000 for making changes to the standards. A modification can be adopted any time during the first year after a standard is adopted, if the Secretary deems it necessary to permit compliance. Subsequent changes can be made once per year at any time. The compliance date for a modification can be no earlier than 180 days after adoption; ensuring a minimum of six months implementation time. All covered entities, except small health plans, are required to use the initially adopted standards by October 16, 2002. If a final rule adopting modifications to the initial standards is published by February 2002, it could be effective April 2002, allowing the required two-month window for Congressional review. The compliance date could be October 2002, allowing the required six months implementation time. Mr. Nachimson said he was confident that the date could be met fairly easily. He noted that going through the rulemaking process with reasonable time frames for clearance, a notice of proposed rulemaking would have had to be published by the beginning of February. But he said DHHS was trying to make the regulatory process as short as possible, and that he was hopeful proposed changes would be published sooner, giving the industry as much time as possible for changes. He noted the Department was working with the Office of General Counsel to find a quicker regulatory process; possibly these rules could be issued as interim final rules, or final rules with comment, so there would be only one clearance process. Mr. Nachimson said DHHS needed to know what the industry wants in this first set of changes to the standards no later than May 1.
Ms. Trudel emphasized that trying to expedite the DSMO process was not a reflection of the February deadline, but of the importance of ensuring that the industry had as much advance notice as possible of proposed changes so they could appropriately allocate energy and resources. She said DHHS recognized many people felt the need for the certainty of a final rule and wanted to make them aware of the changes and publish as quickly as possible.
Dr. Braithwaite asked if the proposed and final rules for changes would meet the $100 million requirement to be classified as a major rule, eliminating a two-month delay. Ms. Trudel replied that, without knowing what the changes would be, they could not do an analysis. Dr. Zubeldia asked what the chances were (if the DSMOs had changes to facilitate compliance that generated more than $100 million savings and those changes occurred before May 1) of the Department adopting these modified implementation guides in the first year. If the process happened in the first year, only changes required to facilitate compliance could be put through the process--but if the rule-making process took longer, the DSMOs could work on changes that could be more productive and end up with greater savings. If the DSMOs came up with the recommended quick changes, was the rule-making process flexible enough to pass that final rule by the first-year deadline? Ms. Trudel said these were some of the things they were discussing with the general counsel and others familiar with the Administrative Procedures Act, which guides this process. She suggested, at this point, the DSMOs should address any issues before them.
Ms. Weiker reported on the process formulated by the DSMO chairs with X12N TG2 management at the recent X12 meeting. She noted this process was also discussed by one of the chairs at the recent joint National Uniform Billing Committee (NUBC) / National Uniform Claim Committee (NUCC) meeting, with the Dental Content Committee (DECC) present. There had been open communication among the DSMOs about the process, and their feedback was incorporated into the guidelines
She said the first step had been to establish a clear definition of modification versus maintenance of the standard based on, and consistent with, definitions in the Transactions and Code Sets Final Rule. The definitions Ms. Emerson provided at the February 1 hearings were used. Maintenance is defined as a technical correction: correcting a typographical error or another non-substantive change. DSMO action is not necessary; maintenance goes through the defined SDO process. Modification is a substantive change in the implementation specification, data content or format: e.g., additions or removals of data elements or segments, changes in situational requirements for data elements, changes in maximum length of data elements, allowable qualifiers for external code sources, incorrect definition or note, or changes in number of repetitions of a loop or segment. DSMO action is required for modifications. If X12N Work Groups or DSMOs cannot decide, the default is modification, enabling further consideration.
Step two is to advise X12N TG2 Work Groups and management of the need to address errata and DSMO requests opted in on at the February meeting. The third step is to define categories of Requests to change the HIPAA Implementation Guides. All items entered as errata must be redefined as either maintenance or modification. Maintenance items follow the X12N process for updating a guide. Modifications enter the DSMO process via the Change Request System (CRS) by February 28, 2001. X12N will select modifications at the February meeting, securing additional time to enter all modification requests into the DSMO CRS. Any DSMO CRS requests already entered will be handled in the same way. Requests for additional code sets and claims attachment development (which will not affect the version 4010 implementation guides) will not be fast tracked, but follow established DSMO process time frames. DSMO CRS requests not yet entered that are modifications meeting these criteria continue the fast track process for the March 2001 batch. After that, original time frames for processing requests resume.
Ms. Weiker outlined the fast track change process: (1) On the first (modified from the fifth) business day of each month, excluding federal holidays, organizations will be notified of any change requests. (2) Organizations will have five (modified from 10) business days to decide whether to collaborate in the analysis and development of the change request. (3) Organizations collaborating in the analysis have until April 9 (modified from 90 calendar days) to complete a business analysis and develop a preliminary recommendation for the disposition of the change request. (4) Within seven (modified from 15) business days after the analysis is completed, all collaborating organizations will review and compare recommendations for disposition of the change request in an informal consensus process. If there is consensus on a recommendation, it is forwarded to the appropriate SSO for changes. The collaborating organizations will try to resolve any disagreements; if consensus cannot be reached, any collaborating organization may invoke the appeal process. Appeals go to the Steering Committee for resolution. Each organization has one vote, a two-thirds majority moves the disposition forward. (5) The SSO will communicate to collaborating organizations the proposed changes and confirm that the solution satisfies the disposition recommendation. Collaborating organizations will have 15 (modified from 30) calendar days to review the proposed solution. SSO changes confirmed to satisfy the recommendation will be incorporated into the appropriate documentation. Any SSO changes not satisfying the recommendation will be referred back to the SSO for further development. Collaborating organizations have seven days to reach consensus. If deadlocked, they may invoke the appeal process. Since changes must be made within the first year of implementation, DSMOs will strive to avoid the appeals process.
Ms. Weiker reiterated that all DSMOs participating in a change request for a modification will follow the fast-track process for batches through March 1, 2001. If a DSMO cannot complete the work in a fast-track time frame, it will provide an explanation and submit alternative proposals for completing the task. Five requests were received for the December 2000 batch. Two were received for the January 2001 batch, 20 for the February 2001 batch. As of February 20, 109 requests had been received for the March 2001 batch. X12N, NUCC and NUBC opted in on 26 requests. The DECC opted in on 19. The National Council for Prescription Drug Programs (NCPDP), four. And Health Level 7 (HL7), zero.
Ms. Weiker noted the importance of considering when and how to communicate what they are doing to the public. Many health care organizations had already conducted a gap analysis and begun implementation planning, which for some included coding requirements for implementing these transactions based on current implementation guides. Most affected organizations did not know what was being planned. Ms. Weiker emphasized that the industry should be kept informed as this process evolves. Incorrect statements were already being made. Once they proliferated, it would be difficult to put out fires and convey accurate information. The DSMOs recommended that notification and messages be communicated through the Administrative Simplification and WEDI listservs and AFEHCT's and DSMO's communication processes.
Ms. Weiker affirmed each DSMO’s commitment to operating within the expedited process. She expressed their concern over whether the Department can meet the October 16, 2001 deadline.
Mr. Beatty expressed the group’s commitment to the continued maintenance and revisions of the X12N implementation guides in keeping with the needs of the health care industry. He said X12N welcomed the change requests as opportunities to improve the guides and gain additional industry input. He reported that at the last X12 meeting the change requests, initially referred to incorrectly as errata, were reclassified as corrections to the implementation guides and would be differentiated as modifications or maintenance. He said X12N is determining what changes are necessary for the industry to comply with the regulations, which could wait until the next version, and those that are maintenance items to the implementation guides.
Mr. Beatty noted that at the February trimester meeting, X12N approved a process for the publication of addenda containing corrections to the already-published implementation guides. Corrections include both modifications and maintenance items; only modifications need to be sent to the DSMO CRS. He said that, based upon discussions with HHS, the group might be able to publish corrections that allow the industry to comply with the regulations, although not all modifications and maintenance items will be identified through the June X12 trimester meeting.
He said X12N will provide recommendations for the change requests it has elected to participate with in the DSMO collaboration by April 9. Technical solutions for approved DSMO change requests will be provided to the collaborating DSMOs no later than May 18, satisfying the disposition recommendation of the DSMO collaborating organizations. X12N will hold informational forums for any addenda to the implementation guides at the June trimester meeting. The noted forums will be informational, not a time for introducing changes or issues to the addenda. X12N has approved project proposals for the next version of the HIPAA implementation guides, which could be available to HHS and the health care industry as early as February 2002.
Mr. Beatty noted that regardless of how efficient the DSMO and SSOs make their development process, the industry is bound by the federal rule-making process, which has proved to be slow. He laid out a time line. By June, X12N will complete the addenda for consideration in an interim final rule. HHS is targeted to publish the interim final rule in February, with a comment period. April 2002 is the effective date for the interim final rule, after a 60-day Congressional comment period with no substantive comments received. October 2002 would be the end of the 180-day minimum implementation time line. (If 180 days minimum is acceptable to the industry.) Twelve months later, April 2003, would be the next opportunity to change the transaction standards. If no addenda are adopted for the guide, the next version could be adopted any time after October 16, 2001. He noted it was still unclear when the 12-month period begins for the next version.
Issues included: (1) changes received after February 2001 to the HIPAA implementation guide with addenda do not become effective until at least April 2003, (2) the process may lead to version issues; some implementation guides with addenda may spawn one version, while those without addenda may trigger another, leading to transaction interoperability and implementation cost issues, (3) what happens if any changes received after February 2001 are required for compliance with the regulation?
Mr. Beatty noted that the HIPAA implementation guides were not perfect and that there still were health care stakeholders who did not realize or acknowledge that HIPAA would affect them. He reiterated that X12N is working to identify changes necessary for the industry to comply with the regulations, but stressed the need to deal with the change management process everyone was bound by and how it might be adapted to better meet the needs of the health care industry.
If HHS cannot adopt, by October 16, the X12N HIPAA implementation guide addenda, Mr. Beatty said X12N recommended not adopting them, but immediately beginning to develop a rule for the next version of the implementation guides based upon version 4050. Even if the addenda are adopted, he encouraged HHS to immediately begin developing a new rule for the next version of the guides. He urged the Department to develop a fast track for its interim and final rule-making process. He also said the Department needs to re-evaluate naming X12N implementation guides down to the release, sub-release and implementation date. He proposed only naming the SSO and its currently published implementation specification and not publishing it more frequently than once-a -year. He said X12N needed consistent direction and guidance from HHS and NCVHS.
Ms. Weiker noted all the DSMOs agreed to the fast-track process. Ms. Ward reported all of the DSMOs had a fast-track process in place to deal with these requests and the data content, except possibly the Dental Committee that had just created their process. Mr. Beatty explained that the gap in his time line between June 2001, when X12N completes the addenda, and February, when HHS publishes the interim final rule, was the time they were told it would take to develop the interim rule, move it through clearance, and approve it for publication in the Federal Register. Ms. Trudel clarified that February is the last possible date--not the target. The gap was not expected to be that large.
Dr. Cohn expressed appreciation for Mr. Beatty’s participation and asked him to clarify his understanding of the fast track. Mr. Beatty replied that the task was to evaluate which issues were required by the industry to comply with the final rules and the transaction standards. He said they were sifting through the corrections trying to identify what they were told were the only addenda that could be published, if they tried to do so within this first year--modifications necessary for the industry. He suggested they might all gain clarification as they went through this discussion that seemed to be changing to a broader scope.
He cautioned that, given what he heard, they couldn’t achieve this by October 16, 2002. The questions were did they publish addenda or the next version of the guides--and what could be put into the corrections? Noting he heard different things from this Subcommittee and HHS, he asked for directions on what could be published in the addenda.
Dr. Cohn reflected on what they had heard in the hearings. In November, a variety of testifiers, including representatives from WEDI, expressed concern that some data elements in the X12N standards needed to be evaluated to ensure that there was a business rationale for their existence. In February they began seeing data elements brought forth by coalitions and individuals questioning the business needs. Dr. Cohn observed that, according to the industry, much of the fast track process was not to make the standards bigger--they already were adequately sized—but to verify there was a business case for all the elements, both required and situational, in the guides and standards. He noted that some of Mr. Beatty’s recommendations aimed at doing addenda and moving forward with a new guide, probably made sense. As the industry finished off their gap analyses and planning, they wanted assurance that what they had to implement as the first HIPAA required standards really met business needs and were not beyond what the industry needs to function. At this point, many people dealing with implementation and buying or re-developing software would not appreciate their continuing without making any changes. And the next implementation guide suddenly is pulling back, not requiring a number of the data elements that were there. Noting that, as of that morning, 137 issues were being evaluated, Mr. Beatty remarked that part of that analysis involved trying to balance out the payer's need for information and the provider's ability to supply it. He predicted there would be more issues; many organizations had not yet begun to look at the guides or do gap analysis. He said the process had to be managed succinctly, so everyone understood what was happening. Dr. Cohn remarked that this reaffirmation process was essential for business.
Dr. Zubeldia observed that the implementation guides were not NCVHS’s or HHS’s, but industry implementation guides written by X12N and NCPDP, and adopted by the Secretary as HIPAA standard implementation guides, following NCVHS’ recommendation to adopt them. NCVHS had heard substantial testimony indicating something was wrong with the current guides, or at least that testifiers sought changes. The Committee had asked the authors to consider how to correct deficiencies. In doing so, the guides might need modifications that required the intervention or decision of the DSMO process. Dr. Zubeldia said he expected the modified guide to be presented as the industry recommendation for NCVHS to recommend to the Secretary for adoption, probably along with a recommendation for an expedited process for adoption of the modifications. He said the DSMOs were “driving the train.” He believed NCVHS would recommend the modified guide for expedited adoption. Dr. Cohn noted that there were still hearings and, possibly, some contentious data elements.
Mr. Beatty noted they were not looking at publishing new implementation guides, but addenda to the current guides (along with working on the next version of the guide, as part of their normal process). The question was what could they publish in the addenda. They initially heard they could only do corrections required by the industry in the first year. Today they heard maybe they could do all modifications and maintenance. He agreed that they were in control and moving forward with the implementation guides. But he said whatever the Department and the industry adopted had to be addressed by the Subcommittee’s and the Department’s recommendations.
Ms. Ward pointed out two distinct processes and issues. She noted the fast track was not negotiated in the MOU, but was based on the Subcommittee’s observation at the last meeting that people were testifying about issues and something needed to be done this first year. The process the DSMOs agreed to is a longer process that refers to future iterations for future versions of implementation guides. She reported the DSMO Steering Committee met yesterday, and each organization was scurrying to make the necessary changes. But they needed assurance from the Department that these would be adopted as addenda or changes to the 4010 in time. She needed to know when they left today, that they were on a fast track with the understanding and intention from the Department that something would be done by October.
Ms. Beebe said she appreciated Ms. Ward’s thoughts; having participated in the X12N process, she wasn’t really sure she understood how the DSMO process fit into the fast track. She said, in her public health data standards consortium role, she had submitted a letter that day addressing these issues based on testimony from the provider industry. As a result of the fast track, she questioned whether the consensus process at X12N was still working--If the same rigor used to take out a data element was applied to adding one. She noted that the 30-day comment period set for May would not be possible because the DSMOs would discuss this as early as April. And the decision-making forum had become only an educational forum. She said the consensus process built into the HIPAA process had changed. Mr. Beatty replied that the fast track process was essentially the same process they had defined for the emergency changes to the implementation guide. There would still be a comment period as a result of the addenda; the interim rule process provided an opportunity for a 30-day comment period after the release in the Federal Register of the interim final rule. The time frames had been shortened to make the dates, not to preclude anyone from the consensus process. All these efforts were being facilitated within the various discussion groups within the X12N implementation guides. All change requests were available on the web site. Everybody knew which DSMOs expressed interest in those changes. They were trying to keep everything as open as possible; everything was just accelerated.
Ms. Ward gave another view of consensus. She noted that X12N had always been an open group: “inviting, welcoming, and sometimes begging” people to help write these guides. She pointed out that what X12N now brought to the table was one recommendation among many. She suggested one might argue there is even greater opportunity for consensus within this expedited process, because it is open beyond X12N.
Ms. Weiker asked for clarification. Were they saying, forget October 16 and look beyond; or did they think they could meet the October 16 date and categorize compliance and modifications? Ms. Trudel said the important thing for the DSMOs to keep in mind is that 137 items were on their plate and had to be addressed. She encouraged the DSMOs to move forward and address them. At that point, they would have a list of items and know what various groups recommended. That would give the Department a better idea of the magnitude of the problem. She added that it would be helpful to have their sense of whether this would significantly affect people's ability to comply. Ms. Trudel clarified she was only talking about modifications. The maintenance items were not part of the DSMO process.
Ms. Helen Gilfoy, from Phoenix Health Systems, remarked that she had watched the implementation guides through all their iterations and seen data elements “come and go.” In November, she had testified about losing marital status as a data element. She said people wanted to avoid gearing up to collect data elements that would not be in the next iteration of the guide. She asked for a look at those things the DSMOs thought would be eliminated in the next two years, so that vendors “don't deliver a product that, in two years, nobody needs.”
Ms. Weiker noted that fast tracking was based on what was necessary or would prevent compliance if it was not addressed. She remarked it almost bordered on being unreasonable to think that, given constraints of resources and time, they could do it all by April 9.
Dr. Zubeldia said it was up to X12N or DSMOs to determine whether a change was maintenance or modification and, if it was modification, whether it was necessary for compliance. He agreed with Ms. Trudel that they had to address everything put through a DSMO, either through the fast track or normal process, within DSMO time frames. What went through the fast track and what went through the normal process were decisions DSMOs had to make. He emphasized that the industry needed to know this now. The sooner DSMOs could make a recommendation (either addenda or implementation guides) publicly available, the less confusion the industry would have and the less money they would spend doing this.
Ms. Trudel observed that it was somewhat misleading to say the fast track process was inextricably linked with the first-year authority. The fast-track process was linked to the industry’s need to know as soon as possible. Whether this was done by first-year or first-update authority was irrelevant. The point was that people needed to know soon. Mr. Nachimson reiterated that, as the law stated, these are industry standards--not Department standards. They needed to rely on the recommendations of the industry regarding the initial standards and any changes. He noted they also had to keep in mind the October 16, 2002 first deadline. They needed to know which changes were absolutely necessary, and that the industry was willing to implement in that time frame. And he emphasized that, in discussions with the Office of General Counsel on an interim final rule versus the proposed rule, they needed to make sure that the industry and anyone interested had an opportunity to see these changes and participate in the process.
Ms. Gilfoy pointed out that the data elements were not an issue of compliance. But with the vendors who were going to enable her to collect those data elements in limbo, compliance issues arose. She said she was not going to tell the insurance industry, “You can't have the newborn's birth weight because I don't think you need it.” The issue was that everyone needed to know what he or she needed to have. It was very difficult to comply when what one thought was hard and fast suddenly changed.
Dr. Zubeldia pointed out that people working at X12N and the other DSMOs were all volunteers. They didn't have unlimited time, but they would make the most reasonable recommendation for the industry. He added that they might not have time now, because they were doing their own implementations, and might have to postpone this for next year. Dr. Cohn responded that the reality is, they need to do it all—and, clearly, that involves prioritization. The Subcommittee was asking the DSMOs for their knowledge and expertise to help wade through this. He said he believed everybody was trying to recognize that there are HHS rules and regulations beyond any of their control, and that the whole point was to review and prune the requests and move this through as quickly as possible. Mr. Beatty said that they heard from the Department that they had to go fast, but the industry told them they were going too fast. The Medicaid groups and others needed more time to do the appropriate review.
Dr. Zubeldia noted that Mr. Beatty had mentioned before the meeting that some of the X12N transactions identified a few issues that must be changed to permit compliance. Dr. Zubeldia recommended fast tracking only those issues and having some simple addenda that could be fast tracked by the Department. He suggested making those publicly available as soon as possible, maybe in the June 3 X12 meeting. And then, he said, everything else could be worked on through the normal process for the next release. Ms. Ward and Mr. Beatty said that was their plan. Dr. Zubeldia emphasized the need to let the industry know what they were planning to change. Ms. Ward pointed out that they touched on communicating this in their testimony.
Ms. Weiker reported that the DSMOs were going to gather consensus on recommendations on April 18 and 19, which would be posted on the DSMO web site. (Anything they couldn't agree on would be tabled.) That would allow X12N and NCPDP to go forward and make the necessary changes to create an addendum. She said she heard what wasn’t necessary for compliance should be set aside for the next version. They should go through with compliance to the 4010 guides, but provide the entire list to the Department. Dr. Cohn concurred. He said they should meet before the implementation guide is revised and make sure everyone agrees with what is happening with the data elements. A week to 10 days after they have that consolidated list they should meet. Dr. Cohn observed that “requirement for compliance” was a term they had all used and suggested another with a softer edge: “helps smooth compliance.” He asked everyone to think about smoothing compliance and implementation as they went through this.
Dr. Braithwaite explained that the DSMOs were getting a fuzzy response from HHS about time lines for issuing rules for good reason. HHS had never done this before. Where there was a process for rule making (i.e., Medicare), it happened with great efficiency. But HHS, too, was going through “growing pains” and had to get detailed recommendations from the Office of General Counsel. That was why the DSMOs were not always hearing a precise answer. The Subcommittee wanted to be flexible and would do their best. Ms. Ward cautioned the Subcommittee not to be surprised if they heard parties were not pleased with the fast-track process. People were feeling it circumvented a process that should be in place. She said they had to strike a balance, and that was what they would do--They had done that for years in X12N standards development. Dr. Cohn said they had received two letters; everybody had copies of them. He observed that what the Subcommittee had heard from the DSMOs was a reaffirmation of the quality of the process that they had put together. Clearly, it was a process that was demanded because of the time frames they had to deal with. He encouraged people with issues to testify or provide written documentation. As the recommendations “came down the pike,” the Subcommittee would provide an opportunity for people to make their concerns known early enough in the overall process that they could reflect on them. He said the group appreciated the ongoing process the DSMOs developed. Recognizing they were dealing with an industry limitation, he thanked them for coming up with a faster version. He clarified that time was held open in the May 1-2 hearings, if the DSMOs were ready to begin the discussion then. Time was also available on May 31 and June 1 and they could do either or both. He noted another set of hearings on PMRI in mid-March. Hopefully, they would not have to deal with this issue then, but if there was a need for further discussion, there was also this opportunity.
Ms. Trudel summarized the main points of the four-page letter that was a product of the February 1-2 hearings on barriers to implementation. It mentioned the letter from the National Uniform Billing Committee outlining concerns about adoption of the National Drug Code (NDC) for institutional and professional claims as well as retail pharmacy, especially with respect to institutional claims. The American Hospital Association testified that NDC are not used in the clinical setting or included in patient's medical records, patient accounting or billing systems; complying with the requirement could cost a minimum of $200,000 per facility. On the physician side, there was testimony that HCPCS codes are used almost exclusively to report drugs and biologics on the professional claim. Practice management systems would have to be expanded and significantly changed in order to report NDCs. Also, using NDCs to report drug dosages could be problematic: often what was dispensed was different than specified in the package-size code. Vendors said their product lines would be directly and significantly impacted by the move from HCPCS codes to National Drug Codes.
There was discussion at the hearings that industry cross walks or cross references would be needed right away in order to program to use the NDCs by the October 2002 compliance date. In addition, deficiencies were identified in the NDC maintenance process that could result in re-use of NDCs or the change of an NDC for a particular drug over time. HHS staff associated with reviewing the comments for the proposed rule discussed issues raised in that process, assessed points raised at the meeting, and indicated that problems arising from using the NDC warranted a more thorough investigation. The Subcommittee charged staff with preparing this letter and providing recommendations to the Department.
Ms. Trudel read the recommendations. The NCVHS believed further evaluation was needed before a standard code set for drugs and biologics could be implemented in standard transactions other than for retail pharmacy. The NCVHS recommended that the requirement be modified, retracting the adoption of NDCs as the standard for drugs and biologics for use in standard transactions other than for retail pharmacy, but stating that NDC should remain the standard for these in the retail pharmacy (i.e., NCPDP) transactions. The NCVHS also recommended that HHS work with X12N to ensure that HCPCS codes could continue to be used in the standard institutional and professional claims transactions, and that the institutional and professional claims transactions should also be able to accommodate NDCs in any case where these codes are useful or needed.
The letter noted that no single drug coding system fully met all the needs of the health care industry. It proposed that HHS develop criteria to be met by a drug coding system, usable throughout the industry, and evaluate proposed drug coding systems against those criteria. It stated that such a drug coding system must be effective for use throughout the industry for drug inventory, pharmacy, patient care and billing, and recognized that design and development of a new coding system for drugs went beyond the scope of HIPAA but not beyond the scope of NCVHS.
Noting that the Subcommittee had recommended to the Secretary that it would be appropriate to have a drug reference terminology that encompassed the full scope of what the letter listed, Mr. Blair doubted they could say this went beyond HIPAA. The group discussed that they had not presented a criteria for a drug terminology, but had specified two things. They encouraged the FDA to work with the existing standard development and terminology organizations and drug knowledge-based vendors in order to develop a drug reference terminology that would handle both the clinical and billing as well as the inventory requirements. And they recommended that the FDA make available its existing drug knowledge base, making it more accessible and easier to use. Dr. Zubeldia said they could make recommendations or consideration for the design and development, but they should not be deciding on developing a new drug coding system. The consensus of the group was to say “NCVHS recommends that HHS develop criteria that should be met by a drug coding system that could be useful throughout the health care industry and evaluate any future proposed drug coding systems against these criteria.”
Ms. Ward noted that certain segments of the industry (e.g., home infusion market) needed to use NDC to bill their claims electronically; without NDC, they would be forced to revert to paper. Ms. Trudel clarified that current practice could continue. The group agreed to revise the letter to read, “NCVHS recommends that HHS work with X12N to ensure that HCPCS codes, as well as NDC codes, can continue to be used in the standard institutional and professional claims transactions.”
Noting the importance of advising everybody as soon as possible that they do not have to use NDC codes in certain situations, Ms. Ward asked how this should be communicated. Mr. Beatty suggested adding clarification notes. Dr. Cohn commented this would have to be referenced in a revised final rule. Hopefully, if HHS agreed, they would help communicate this. Dr. Zubeldia suggested a broadcast message to everyone on the mailing list saying that NCVHS recommends to the Secretary that the NDCs not be required for medical and professional claims. Once the Committee has agreed to recommend it, Ms. Ward encouraged communicating it so health plans and providers could digest that and make decisions based on it. Ms. Trudel said that, as a matter of standard procedure, the letter would be posted on the NCVHS web site. Dr. Braithwaite said he would consider the matter of getting wide distribution throughout the industry. Dr. Cohn reiterated that, if HHS approves, there would be communication between HCFA and others referencing this in advance of a final rule.
Dr. Fitzmaurice provided background on hearings scheduled for March 19-20. The hearing seeks industry comments on a process whereby the National Committee looks at PMRI standards as proposed in the recommendations of the July 6 report to the Secretary. He noted that this does not presume that the standards would become mandatory HIPAA standards; the Secretary could decide among many alternatives.
Testifiers will receive in advance materials for review. The Subcommittee invites comments on the criteria for selection of PMRI Message Format Standards for recommendation to the Secretary and on a draft of a questionnaire to PMRI standards developers, intended to assist NCVHS in selecting PMRI standards. Testifiers will also receive a proposed list of PMRI transactions to be considered in the first phase. Testifiers will be asked if these (or any others) should be included among “the low hanging fruit” identified for special consideration for industry adoption. There also will be a section for additional comments on a process to determine which standards to consider next on the clinical side for improving the health care system. Mr. Blair clarified that this first phase of the selection of standards for PMRI was focused on “the low hanging fruit" for message format standards.
The group noted testifiers would include SDOs, vendors of electronic clinical systems, the public health community, academia, and others with comments on the process. Members discussed other potential users of standards to contact for broader testimony. Dr. Fitzmaurice suggested the American Hospital Association, the American Medical Association or the American Nurses Association. Dr. Zubeldia said they might identify other users by going through the list of the standards that could be considered as candidates. Mr. Scanlon suggested an industry overview and economic framework from firms that follow the industry. Mr. Blair noted that vendors rapidly moving to develop Internet web-based solutions and application service providers held a different perspective on communications of PMRI information. Dr. Fitzmaurice asked to be e-mailed or called with further suggestions.
The group wordsmithed the annual report. Based on what they had heard in the meeting, Dr. Cohn suggested adding a sentence or two to the executive summary about the Committee continuing to evaluate, absent issues, and providing recommendations. The group discussed referring the draft to the Privacy Work Group in the morning. Dr. Cohn said the paragraph on local codes could be simplified. He suggested the report observe that HIPAA affects Level three local code implementation issues. Noting that only a few codes that are actually registered with HCFA as Level three codes are affected, Dr. Zubeldia cautioned this could create confusion. Dr. Cohn suggested a footnote clarifying this would be useful. Mr. Scanlon said it might be better to just address it in the body. Based on the briefing heard today, he said they could deal with the timing on implementation of the privacy regulation. If there is a new date, they could probably get rid of the temporary postponement issue, at least for now. Dr. Fitzmaurice said he would insert the recommendations for the standards for PMRI in the body of the text.
Mr. Scanlon noted the addition of information about the industry’s response, including the fact that HIPAA implementation ranks among the top IT priorities in health care and descriptions of efforts by WEDI, AFEHCT, Washington Publishing Company, and the regional data consortia. Another insert summarizes the situation, noting problems remain for many participants and concern in the industry over the cost and adequacy of the two-year implementation time frame and affirming that the Committee will monitor these issues throughout the year and provide advice and recommendations. The Subcommittee will recommend the draft to the full Committee.
Dr. Cohn noted that the group was tasked to consider what action the full Committee ought to take this year regarding code sets and classifications. There was a briefing the next day on ICD-10 CM. There was ongoing work on IDC-10-PCS; in June there might be an opportunity for an informational session on that and other procedure coding system advances. Dr. Cohn remarked that a number of code sets were mentioned in the comments to the final rule on Standards for Electronic Transactions. Based on the work they were already doing around the administrative and financial transactions, he said it might make sense for the full Committee to see if any of these merit recommendations. He noted the DSMO process was booked up for a couple of months, but remarked on this opportunity to understand better what value they might have for electronic transactions. Dr. Fitzmaurice proposed they might look for gaps where there were no codes and get testimony about codes needed. Since there was a recommendation from the Committee to develop criteria or messaging standards, he suggested there might also be consideration of developing criteria for choosing code standards and the roles they serve. Mr. Blair recalled that a couple years ago they had testimony from a developer of alternative billing codes for alternative medicine. He suggested they might revisit and see if that would be helpful to the industry. Dr. Zubeldia said that group had been very vocal about needing those code sets and that the Subcommittee ought to understand what was involved. He also suggested looking at the home infusion EDI coalition codes; some were saying the HCPC codes were not sufficient to bill for vision services. Mr. Scanlon reported that the Population Subcommittee was finishing up their report on the ICIDH as a standard code set and would recommend in their report that the Standards Subcommittee look at code sets and standards as a longer-term issue. Dr. Zubeldia suggested looking at the impact of ICD-10 from a financial as well as technical perspective; they could commission an economic study of the switching between ICD-9 and ICD-10 and have testimony on the economic impact. Dr. Cohn said he was not sure that was what the full Committee intended when they asked them to think about strategies around coding. But he agreed it needed to be done sooner or later, if not by NCVHS, as part of government’s evaluation of moving eventually to ICD-10. He acknowledged there was an issue: providers wanted to do transactions electronically but couldn't because they did not have code sets sufficient to their needs. But he advised the group that they also needed to think about timing. They wanted to be careful, as well as respectful, talking about code sets that relate to transactions and make sure DSMOs were “at the table” providing input and guidance.
Dr. Cohn said he was not convinced they were ready to articulate a work plan for the code sets for the rest of the year. After they heard about ICD-10, they could see if the issues around the economic study might be pertinent to explore with the full Committee. Another piece was a status update or educational session around the status of the ICD-10 procedure coding and other procedure systems. But, for the next several months, it was probably premature to go full steam into administrative transactions and other code sets. The calendar seemed to be full up until the summer. Thanking everyone, Dr. Cohn adjourned the meeting at 4:45 p.m.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
/s/ Simon P. Cohn, M.D. 5/31/01
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Chair Date