Public Health Service

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Subcommittee on Standards and Security

February 6-7, 2002

Washington, D.C.

- Minutes -


The Subcommittee on Standards and Security of the Natl. Committee on Vital and Health Statistics held hearings on February 6 and 7, 2002, at the Hubert H. Humphrey Building in Washington, D.C.

Subcommittee members:

Staff and Liaisons:

Others:


EXECUTIVE SUMMARY

February 6-7, 2002

The Subcommittee on Standards and Security held hearings February 6 and 7, 2002 in an ongoing process focused on administrative simplification provisions of the Health Insurance Portability and Accountability Act (HIPAA). During the first day, the Subcommittee heard fifteen presentations and talked with three panels representing code set developers, designated standards maintenance organizations (DSMOs), and industry representatives about issues with current HIPAA medical data code sets, some non-medical code sets and local codes; the second day, six presenters reported on industry activities to develop the model compliance extension plan required by P.L. 107-105, and members undertook this year’s annual report on administrative simplification

Panel 1: Code Set Developers

Dr. Beebe reported improvements in the code set, the CPT editorial process, and distribution of the CPT code set and associated licensing information. AMA issued the new CPT version in November, accommodating release of the Medicare Physician Fee Schedule. CPT Category III codes will be updated semi-annually. CPT code change proposals, instructions for submission, and the panel's schedule are available on the AMA CPT Web site. Anyone can submit code change proposals; panel meetings are open to participating specialty societies and healthcare professionals’ advisory committees. Dr. Beebe commented on medical data code set distribution mechanisms, formats and prices. AMA worked with the Centers for Medicare and Medicaid Services (CMS) to allow use of CPT in Local Medical Review Policies posted on the Internet. The CPT Editorial Panel worked with CMS to revise CPT and delete G Codes. AMA didn’t see an increase in code proposals and expressed concern that payers and providers hadn’t reviewed coding needs related to eliminating local codes.

Mr. Pokorny said ADA believed the current process and schedule for updating the Code on Dental Procedures and Nomenclature (the Code) worked well. In January, ADA's Code Revision Committee completed deliberations on changes to the Code that will be incorporated into the next version, effective January 1, 2003. ADA anticipates a biannual code revision cycle. Mr. Pokorny said distribution mechanisms, formats, and prices were acceptable and that use of local or "proprietary” codes was diminishing. He noted a survey indicated in late 2000 that at least 68 percent of the Blue Cross/Blue Shield Association (BCBSA) plans accepted claims submitted with the current version of the Code and that none of the respondents to ADA's 2001 survey expected problems electronically accepting claims with the current version by October 16, 2002. He said ADA had already adjusted its Code revision process to reflect timely needs of the dental profession, the third-party payer community, and federal regulation promulgated under HIPAA, but that it served no one if evolutionary changes led down a dead-end to extinction.

Ms. Brooks reported on three changes in the ICD-9-CM process. Meetings were now held in April and December and procedural topics considered in April might be included in the October addendum as code changes. She said CMS was trying to be more responsive and was discussing some proposals that might not get FDA approval or come out during this year. The ICD-9 Coordination and Maintenance Committee (C&M) was trying to add codes, but the book was full and everything that wouldn't fit elsewhere was fitted into an open section and would be indexed. CMS would discuss going to 10 PCS at the April hearings. Ms. Brooks said there hadn’t been any changes in the distribution mechanisms that had always been in the public domain. The addendum was put up annually. Ms. Brooks said, because technology was changing so rapidly, there probably were gaps in ICD-9-CM.

Ms. Riley said the current established maintenance process and schedules for updating the Alphanumeric Healthcare Common Procedure Coding System (HCPCS) Code Set worked well. The permanent national codes were updated each January and interim codes were announced quarterly. Ms. Riley reported the number of requests for national codes to replace local and non-standard codes increased less than expected. Some 658 alphanumeric codes were added, 14 reactivated and 319 changed.

Mr. Shugart said current processes and schedules for updating HIPPA medical data code sets generally worked well, but converting 25,000 Medicaid local codes slowed the process. Specific concerns were expressed over CPT changes taking three or more years, unique issues facing Medicaid programs with federally approved waiver programs, and a request for standardized timelines for updating multiple code sets. The general consensus was that the code set distribution mechanisms and formats were acceptable. Every state reported progress and difficulties in eliminating reliance on local codes. Mr. Shugart noted specific concerns, especially the lack of standardization regarding implementation guides and the paper forms. He said most gaps in the coverage of medical code sets could be addressed by updates to existing code sets. Consensus was that ICD-10-CM shouldn’t now replace ICD-9-CM Volumes 1 and 2. Concern was expressed about the creation of code sets for alternative medicine. State Medicaid programs concurred that current processes and schedules for updating the non-medical data code sets either weren’t working well or couldn’t be evaluated without a final decision on taxonomy. General concern was noted over costs.

Panel 2: DSMO Perspective

Ms. Gilbertson provided an update of change requests the DSMOs had seen and their recommendations and reported on the code set request procedures the DSMOs were creating to guide submitters requesting adoption of a new code set into the HIPPA regulations.

Mr. Arges said NUBC and other DSMOs had reviewed many change requests for the implementation guides, but after careful deliberation, couldn’t support adopting HIEC codes to report home infusion services or the ABC code set for the reporting of alternative care services. Submitters were asked to present their need to the CPT and HCPCS coding groups. Mr. Arges hoped every effort would be made to avoid bundled services, especially those facilitating reimbursement. Noting the UB-92 data set was a unique, integral component of the electronic transaction standards for institutional providers, NUBC recommended users stay current with the maintenance of the entire code set. NUBC was comfortable with the existing medical code sets as outlined in the final HIPAA rule and anticipated adopting upcoming changes and redesigning the UB-92 data set. NUBC also looked at closing major gaps that might exist between the paper UB and the electronic transaction standards. NUBC surveyed to identify areas needing improvement and hoped to have solutions that could be approved by NUBC as early as August.

Update Regarding Non-medical Code Sets

Ms. Hawk defined “non-medical codes” (non-procedure or service codes that refer to claim status, adjustment reason, or payment remarks) and described two types: external codes named and described in the HIPAA implementation guides that didn’t describe “medical” events and code sets defined (named and included) within each implementation guide. She noted issues (e.g., same concept codified differently, same value different meanings, and version control and “communication flow”) and that some code sets were actually identifiers (provider, employer and plan ID) and should be deleted or moved. Ms. Hawk stated that codes used should be those in effect when the transaction was initiated. And she raised questions and suggested next steps.

Ms. Narcisi summarized NUCC's role as maintainer of the Health Care Provider Taxonomy Code Set. NUCC worked with WPC on development of a web-based system, similar to the DSMO change request system, for handling new code submissions and change requests. Guidelines NUCC developed for submitting change requests will be posted on the Web site. NUCC developed criteria to evaluate requests and currently reviews code requests monthly, publishing them upon approval.

Panel 3: Industry Representatives

Mr. Murphy said NADP: was deeply concerned about a lack of open, fair process for the maintenance of the Code on Dental Procedures and Nomenclature (CDT), opposed licensing requirements imposed selectively on dental benefit plans that severely limited use of CDT, and found CDT usage fees demanded of dental benefit plans to be out of line with those for other healthcare specialties. He said the CDT Code Revision Committee’s actions didn’t encompass basic principles of an open public process as required by the rule. Mr. Murphy urged the Subcommittee to review ADA's actions and procedures and undertake any changes necessary to ensure that appropriate interested parties had an integral role in the code set development process.

Ms. Oshensky said DDPA and ADA recently settled a longstanding litigation and entered into an agreement to implement a consensus approach to code maintenance that would provide for DDPA’s continued participation and the provision of industry input. But she said procedures in place prior to implementation of HIPAA continued as the process for updating CDT. DDPA asked the Subcommittee to recommend establishing federal “mileposts” to objectively judge the openness of the update and maintenance process for all standard setting organizations (SSOs). She urged that these explicit “mileposts” be drawn from the Secretary’s recommendations and DDPA’s observation that, to be an open process, SSOs must: consider only science-based code changes; impartial consideration of changes; adequate notice of change submissions; and appropriate, timely implementation of changes.

Ms. Leon-Chisen said the important issue for hospitals and health systems was whether the code development process incorporated: sensitivity to all users’ needs, easily accessible and widely understandable instructions on code usage, and maintenance through a clearly defined organizational structure capable of high-level coding integrity. American Hospital Association (AHA) supported the current ICD-9-CM update process and was encouraged by AMA's CPT Editorial Panel’s efforts to address members’ needs and consider the interests of non-physician stakeholders, but was troubled by the lack of institutional provider input into the HCPCS Level II update process. Ms. Leon-Chisen expressed AHA’s concern about the lack of progress toward standardization in the application of current code sets. She noted ongoing problems and confusion related to the frequency with which various code sets were updated and uncertain implementation dates. To reduce administrative costs, AHA recommended updating code sets no more often than annually and on the same date.

Health Insurance Association of America (HIAA) called for: early and periodic communication of code changes and suggestions, open discussion of issues, ability to suggest alternates based on submitter suggestions or in addition to original requests, an open process inviting comment from interested parties, easily found information on meeting schedules and agendas, and recognized rules of order. Payer participants should be selected for their familiarity with dental claim payment processes and perspective on dental issues. While understanding that DSMOs should be able to recover reasonable costs associated with maintaining the data set, Mr. Meyer said HIAA believed price should be equitable.

Ms. Prophet said the American Health Information Management Association (AHIMA) believed that: all payers and providers should be required to adhere to existing code set rules, definitions and guidelines; coding guidelines should be part of the standard code set and all users must abide by them; every accepted standard medical data code set organization must have an organized process for development and maintenance of the codes, rules and guidelines that includes and ensures broad access, input and representation from a full range of stakeholders; and all these processes should be placed under the supervision/oversight of a single entity that objectively balance needs of the stakeholder groups. AHIMA believed four principles should guide code set maintenance: the maintenance process should be streamlined with more frequent system updates; the interim between proposal and implementation should be minimized; the process for developing rules and guidelines should be open and coding system rules and guidelines should be updated on the same schedule as the code set as part of the official version; and all requisite materials should be most recent versions in formats available for government and private entities.

In order to maintain delivery of care (products and services) to the patient, NCPDP recommended that the Department of Health and Human Services (HHS) recognize NDC, UPC and health related item (HRI) codes, in addition to HCPCS, as valid identifiers for supply billing transactions. Ms. Gilbertson urged that these codes be permitted via NCPDP standards for the billing of supplies and that HHS clarify that NCPDP standards were acceptable for the billing of supplies. NCPDP also recommended that HHS recognize NCPDP standards for the billing of professional pharmacy services.

Review of PMRI Recommendations Letter

Members reviewed and refined this seventh draft of the Committee’s recommendation letter to the Secretary on PMRI message format standards. In January, a number of industry reviewers were asked to critique the latest version and their feedback shaped this working session. Members voted to send the letter off to the full Committee.

Panel 4: Industry Activities to Develop a Model Compliance Extension Plan Required by P.L. 107-105

Mr. Tennant said the model compliance form (MCF) drafted by the Workgroup for Electronic Data Interchange’s (WEDI’s) Compliance Task Group (CTG) should be viewed as a tool to assist covered entities in developing their compliance plans and for raising issues for the National Committee on Vital and Health Statistics (NCVHS). Consensus was to keep MCF simple and easy to fill out. Numerous critical issues were unresolved. There was a short window of opportunity for NCVHS to analyze a sample of the forms to identify key implementation barriers and develop solutions, and for this information to be useful, it needed to get out as quickly as possible. Mr. Tennant said WEDI stood ready to help fulfill this legislative directive.

Observing that physicians understood compliance to be a more complex, burdensome undertaking, AMA proposed calling the MCF an extension form. AMA believed the WEDI model should be adopted to the maximum extent possible and urged CMS to conduct focus groups with all types of covered entities. Noting small physician practices were already overwhelmed implementing HIPAA, AMA encouraged HHS to promulgate the remaining rules, so physicians knew what would be required under remaining HIPAA regulations and where requirements overlap, before making costly administrative and technology changes. Because modifications to the transactions rule weren’t finalized and there was uncertainty about whether others physicians exchanged covered transactions with would be compliant, Ms. Narcisi anticipated most, if not all, physicians would submit extension forms. She cautioned HHS to be prepared to establish a simple, effective process to receive and acknowledge a very substantial number of forms.

Mr. Wilder emphasized that MCF wasn’t the important part of this legislation: what mattered was the additional period of time to get ready to implement the transactions and code sets rule. Noting both the Department and the industry had to step up their educational efforts, Mr. Wilder encouraged the Committee to help entities educate members. Mr. Wilder encouraged the Department to post MCF on its Web site and publish all the rules as soon as possible; AAHP’s member plans were concerned that they still didn’t have final rules on security, enforcement, claim attachments or plan, provider and employer identifiers.

Given that HHS's modification of the final rule had been further delayed, Ms. Doyle cautioned that there was little, if any, possibility that modifications would go into effect so covered entities could implement them along with the original standards by October 16, 2002. She offered BCBSA’s comments and recommendations. While additional time would improve compliance and afford organizations an opportunity to achieve through administrative simplification, rather than compliance with “band-aid” solutions, Ms. Doyle noted that providers and state government had to understand the requirements of the transaction code set rules so they could assess their need and the regulations’ impact on day-to-day operations. Ms. Doyle encouraged CMS to integrate aspects of the BCBSA commissioned PricewaterhouseCoopers report Jeff Fusile presented at the December hearings into their provider education program.

Mr. Arges noted punitive measures in the legislation only applied to healthcare providers and plans and that clearinghouses could wreck havoc on providers and plans if they weren’t ready. While H.R. 3323 provided additional time for those who might need it, Mr. Arges said it also threatened to harm those that believed they were ready, only to find that their application of the transaction standard failed with some trading partners and that they faced harsh sanctions. Mr. Arges said AHA would probably recommend that all providers file for an extension. Mr. Arges noted many of the Department's rules on the administrative simplification provisions that support the final electronic transaction and code set regulations hadn’t been issued, even in proposed form. He said there appeared to be little or no forward movement on other critical decisions and urged HHS to address these unresolved implementation issues.

Mr. McLaughlin expressed concern regarding the release of the pending NPRM for transactions and code sets, noting he wasn’t confident NPRM would be released in time to satisfy the 180-day modification requirement imposed by the legislation. He said the clearinghouse might have to file for an extension because of trading partners or payers who weren’t ready by the initial compliance date. Mr. McLaughlin urged the Subcommittee to clarify the testing level covered entities were expected to begin on or before April 16, 2003. And he emphasized further guidance from HHS was necessary to lead the industry toward early external testing and provide clarity and direction to covered entities that internal testing should take place as early as possible in 2002.

Agenda Item: Model Compliance Extension Form and NCVHS Procedures

Participants discussed ways in which the form could help people think about what they had to do to become compliant--Then plan and work toward it. They’d decided to mention common compliance barriers and try to include more on vendor/contractor assistance. It was agreed that an entity could submit a single form covering other entities for which it had a legal obligation. The form would be SSO-enabled and any electronic submission would result in immediate acknowledgement. The Post Office offered registered and certified mail; HHS would not make a separate effort to acknowledge forms sent in by mail. CMS didn’t want to interpose this process in ongoing communications providers and plans should be having with trading partners and didn’t anticipate making a registry available. Ms. Trudel said this was a handshake between two parties, and the status would change over time. She said the form and instructions would be announced in a Federal Register notice that listed required data elements and values and told how to obtain facsimile document and instructions.

Review Annual Report to Congress on Administrative Simplification

Members discussed a first draft of the 2001 annual report to the Congress, agreeing they would present a revised draft for the full Committee’s review at the February 26-27 meeting. They would take comments and seek approval with flexibility to incorporate further changes. Noting agenda books went out to the full Committee on February 18, members agreed to submit comments to Mr. Scanlon within a week. A key issue for the year was getting the rules out; another was that the delay in the rules made it inevitable that all parties would have to request a compliance extension, undermining potential success of the final implementation. The finalization of the privacy rule was a milestone and there were notable accomplishments on the administrative simplification side with the BSML process and the fast track changes. No proposed or final rules relating to these standards had been issued and the report’s emerging tone was that the delay seemed to be responsive to what industry wanted, but unless the final requirements were known, it was an empty delay and year. Members discussed quoting industry surveys indicating strong support for the administrative simplification provisions, despite all the frustration and inconveniences of the delays. They would reference the national health information infrastructure (NHII) report and comment on the $44 million authorization, reminding Congress that the appropriation would be welcomed and was needed. Implementation issues included the need to have the remaining HIPAA standards, particularly the fast track changes, and the modifications to the privacy rules. Members noted that the Subcommittee held hearings to determine what its final recommendations would be for PMRI; a separate letter released in advance of the report could convey that NCVHS was considering a strategy which didn’t require a final rule or mandate for PMRI standards, but looked instead for HHS industry guidance and incentives.

2002 Issues

Dr. Cohn noted analysis of a sample of the compliance plans and publishing reports on effective solutions to compliance problems were new issues for the year. Code set issues from yesterday’s hearings would take up much of the April 9-10 meeting, but, if they could make time, members also would talk to WEDI and others about best practices that could be posted on the Web sites. Ms. Greenberg said limited contractual funds could be available.

Members will be e-mailed ranges of dates for three sets of two-day hearings July through December. Noting the Committees and industry’s concern about the overall HIPAA process of getting the regulations, improvements, and updates out, Dr. Cohn proposed a summer or early fall hearing focused on the federal process and recommendations to make to the Secretary or Congress about ways things might work smoother. Members noted aspects of due process, commenting and responding take time and there were changeovers in administration. They discussed finding a way that was constructive, actionable, and drew lessons from these five or six years. Mr. Blair suggested that Ms. Greenberg, Mr. Scanlon, Dr. Fitzmaurice, and Ms. Trudel consider who within HHS might provide suggestions or guidance for process changes that could help ameliorate these situations in the future.

Ms. Greenberg noted their responsibility to analyze the sample compliance plans required some part of the Department (she assumed CMS) to do prior analysis and time for the Committee’s analysis and processing. She wanted to make sure they had a process; National Center for Health Statistics (NCHS) wasn’t in a position to do the tabulation. Mr. Augustine said he would take the lead in developing a recommendation for how the analysis might be structured. NCVHS will work with him.

A two-hour breakout session on February 26 will focus on PMRI, the letter, and review. Ms. Trudel said WEDI would be ready with the report on code sets. Dr. Cohn said WEDI might also talk about the COSA report. Ms. Greenberg said the discussion of government e-health initiatives would be ready in June. Dr. Cohn expressed appreciation to everyone and adjourned the meeting at 12:30 pm.


DETAILED HEARING SUMMARY

Dr. Cohn welcomed everyone, especially the newest member, Brady Augustine, to the first of two days of hearings of the Subcommittee on Standards and Security of NCVHS, noting this is the main public advisory committee to HHS on national health information policy. He explained this was the first of several hearings planned for 2002 on code set issues. Today's focus was on the current HIPAA medical data code sets, as well as the non-medical code sets used in the HIPAA transactions, and on progress in dealing with the local code set issues. Future code set hearings would address hospital expansions of the list of codes and the need for new versions of HIPAA code sets. Today, members would also review the patient medical record information letter that, hopefully, would go to the full Committee later this month. The next day would focus on new responsibilities for the full Committee and Subcommittee resulting from the passage of the Administrative Certification Compliance Act, beginning with providing input to HHS on the development of the MCF. Member would also begin crafting NCVHS’s annual report on the implementation of administrative simplification.

Panel 1: Code Set Developers

Dr. Beebe said AMA had made significant improvements in the code set, the CPT editorial process and distribution of the CPT code set and associated licensing information over the Internet. He said these changes validated selection of CPT as a national standard and demonstrate the willingness of AMA and the editorial panel to support CPT in this role.

Dr. Beebe said the process and schedules for updating CPT as one of the medical data code sets worked well. January 1 of each year is the statutory date for updates to the Medicare Physician Fee Schedule. Because CPT is associated with the Resource Based Relative Value Scale, AMA strives to accommodate that release schedule, issuing the new CPT version early in November. This year CPT codes came out in mid-October, giving users more time to update.

CPT Category III codes (a new category for new and emerging technology) will be updated and made available semi-annually on the AMA CPT Web site. More frequent updates for these carrier-or-payer-priced codes that don’t go through the AMA specialty society relative value update process will allow researchers collecting data on services performed to apply and begin tracking earlier. AMA and the panel are enhancing the CPT maintenance process: CPT code change proposals, instructions for submission, and the panel's schedule are available on the AMA CPT Web site. Information can be downloaded and code change proposals e-mailed, expediting coding changes. Anyone can submit code change proposals and AMA encourages users to work with the panel to correct code set deficiencies. AMA is updating its Web site so anyone can view panel agenda schedules, electronically comment on agenda issues, and download and track code change proposals. CPT advisers will be able to electronically comment on agenda items, expediting the panel process.

Panel meetings are open to participating specialty societies and healthcare professionals’ advisory committees. The panel is reviewing options to further open panel deliberations and the advisory input process, weighing considerations of openness with a need to maintain confidential and rigorous peer review editorial process. Confidentiality of panel decisions is vital to the integrity of the editorial process and maintaining the integrity of the industry-wide update schedules.

CMS, BCBSA, HIAA, AHA, and AHIMA, and representatives from Health Care Professionals Advisory Committee and the managed care and medical specialty society communities participate in the CPT Editorial Panel process. AMA believes collective input improves the quality of the CPT code set and suggests that adding a member of the CPT panel in the HCPCS maintenance process would help maintain national coding consistency and eliminate duplicate codes.

Dr. Beebe commented on medical data code set distribution mechanisms, formats and prices. AMA made a concerted effort to provide easy, low-cost access to CPT data files that can be purchased and downloaded from the AMA Web site (webstore.amaassn.org/index.jhtml.) Single users can purchase full data sets (short, medium and long descriptors) for $67.95 (members $54.95) and two-ten users for $187.95 (members $174.95). Single users can purchase individual data files for $54.95 (members $44.95) and two-ten users for $174.95 (members $164.95). Internal use of CPT beyond ten users is $50 per legal entity, plus $10 per user. The CPT code book is available on line at the AMA and other Web sites. CPT 2002 Standard Edition is $49.95 (members $39.95). CPT Professional Edition (with illustrations, color coding and cross references to educational materials) is $74.95 (members $64.95). AMA mails a catalog twice a year to physicians and CPT users and resellers offer CPT books through catalogs and online. CPT licensing information, including royalty rates, are available on the AMA Web site. Distribution license royalty is $10 per-user per-product license. Print publication is 7.5 percent of sales price and not less than $10 per distributed copy.

AMA has worked with CMS to allow use of CPT in Local Medical Review Policies posted on the CMS Internet to communicate Medicare policies with carriers and providers. AMA recently developed a public access site where users can look up CPT codes and Medicare fee schedule information for free. Users search by CPT code or key words in the long descriptor; the search returns long descriptors of the CPT service and Medicare fee information by geographic area. AMA intends the site to be used for personal healthcare purposes; searches are limited to ten per day.

Dr. Beebe reported on AMA’s progress in eliminating local codes. The CPT Editorial Panel worked with CMS to transition HCPCS Level II G Codes into CPT or otherwise rectify duplicate codes by revising CPT and deleting G Codes. Anticipating an influx of new code proposals with the elimination of local codes, AMA invested in a document management system, but hadn’t seen an increase in code proposals. Dr. Beebe expressed concern that payers and providers hadn’t reviewed coding needs related to the elimination of local codes.

The Final Rule discusses standard data content for adopted standards that facilitate consistent and identical implementation. Although this includes data dictionaries, implementation specifications and modifiers for code sets, the final rule explicitly excludes guidelines and instructions for code sets and adopts only the official ICD-9-CM guidelines for coding and reporting. AMA believes the standard implementation guidelines for code sets are essential for uniform national application and that CPT guidelines and instructions should also be specified as a national standard implementing CPT Code Set. The CPT panel and advisers consider CPT section guidelines, specific code level instructions and definitions in the application of modifiers while the language for CPT code descriptors is developed. Proper use of CPT codes is based on associated material in the CPT book. Usage of codes and descriptors without this information limits the functionality of CPT, its uniform application, and contributes to improper coding interpretation. AMA encourages NCVHS to recommend including CPT guidelines and instructions for applying the codes as a national standard.

As a result of the CPT-5 Project’s recommendations, CPT incorporated improvements to the structure and function of CPT codes. In August, Dr. Beebe told the Subcommittee of efforts to develop a CPT data model to enhance interoperability in anticipation of electronic medical records and other advanced computerized functions. Today he discussed changes in CPT that add specificity and enhance clarity, integrate services not previously described, and supply tools for researchers and managed care. Changes in CPT 2002 were a direct result of AMA’s efforts to make the code set easier to use and straight forward. General instructions were changed to emphasize usage of unlisted procedure code when no other exists to describe a procedure/service. This change was made to prevent miscoding of new services and facilitate their tracking and eventual inclusion in CPT, as well as encourage use of Category III codes.

Other changes in CPT eliminate ambiguity and enhance clarity of code descriptions. As part of the CPT-5 Project, AMA began an effort to standardize CPT terminology and choose amongst synonymous terms. The National Library of Medicine's Metathesaurus was used to analyze CPT descriptors and develop lists of synonymous terms. The CPT Advisory Committee and Editorial Panel determined the most clinically appropriate terms for given circumstances. Similarly situated codes were changed. The panel made exceptions for different contexts and nuances. The CPT Editorial Panel and Advisory Committee adopted a pragmatic approach, to implementing changes to eliminate ambiguity and improve specificity while trying to avoid unreasonable or unnecessary changes that could cause problems for users. It intends to gradually phase in changes, so users aren’t overwhelmed and the claims processing function isn’t disrupted.

For CPT 2002, the panel focused on clinically appropriate elimination of ambiguous terms. The panel and advisers develop parenthetical lists of methods or techniques clinically appropriate to the service, including them in the code descriptions. Ambiguous terms that don’t affect the meaning or intent of the code or cause problems for the users are maintained.

Another initiative from the CPT-5 Project was an attempt to prepare the CPT Code Set for the elimination of local codes. AMA conducted a survey to determine why private payers develop local codes and to capture a set of local codes for possible inclusion in CPT. Survey results indicate payers use local codes for data collection, new technologies, screening/counseling and non-physician provider services. CPT Editorial Panel and Home Infusion EDI Coalition, working with payers and the home health community, developed and will continue to refine new codes for home health services and home IV infusion services. The survey results also supported a major new CPT initiative to develop Category II codes (for performance measurement) and Category III codes that will allow CPT to meet new coding demands caused by the elimination of local codes and increased integration of CPT with clinical and administrative computer systems. AMA believes CPT must expand its scope to accommodate the increased need for information contained in the administrative record, provide data in capitated settings where no bill is generated but there is need for enrollment data, and to provide data for encounter, outcomes, and quality.

Panel 1: Code Set Developers

The underlying HIPAA legislation designated ADA a consultant to the Secretary of HHS on national standards for healthcare. The Final Rule on Transactions and Code Sets named ADA's CDT as the medical code set for reporting dental procedures and the Secretary named ADA's Central Content Committee as one of the six DSMOs charged with reviewing and making recommendations on changes to the HIPAA standard transactions.

In the mid-1960s ADA' developed and promoted the national standard for tooth numbering, for paper claim form submission and the Code. Both the paper claim form standard and the dental procedure codes evolved with revisions on a five-year cycle. The most recent versions were published in 1999 with a January 1, 2000 effective date. ADA publishes both in a manual titled cdt-3/version 2000.

To fulfill its role as a consultant to the Secretary and as a DSMO, the association established the Central Content Committee (DeCC) as a voting body with balanced membership from the payer, general interest (e.g., WEDI), and provider sectors of the dental community. DeCC is concerned with the data elements that comprise all standard transactions, but is not involved in changes to the Code, which has been identified as an external code set conveyed by a data element in a standard electronic transaction. ADA’s Council Dental Benefit Programs is responsible for code maintenance and the Code’s evolution has followed a path that incorporates changes arising from within the profession and third-party payer community.

Mr. Pokorny said ADA believes the current process and schedule for updating the Code works well and that the door to improvements is open. During the last decade, review and publication of revisions to the Code occurred about every five years. The current version was disseminated in the ADA publication titled cdt-3/version 2000. Responding to implied expectations in the regulatory preamble to the final rule, ADA anticipates that Code revisions will be periodically reviewed and published biannually. A biannual revision cycle supports a more timely accommodation of the needs for new or revised dental procedure codes to reflect improvements and changes to the practice of dentistry. The cycle also enables deletion of codes for procedures that are no longer considered current, appropriate or in widespread use. On January 28-29, 2002, ADA's Code Revision Committee completed deliberations on additions, deletions and changes to the Code that will be incorporated into the next version, effective January 1, 2003.

The call for Code change requests was made when the current version became effective and a page on ADA’s Web site was established to allow direct electronic submission. (Instructions are also included for submission on paper.) The recently concluded review of the requested changes was undertaken by the Code Revision Committee, which has a balanced, equal-voting representation from the ADA representing dentistry as a whole and the third-party payer community (CMS, BCBSA, Delta Dental Plans Association [DDPA], and HIAA). Planning for the next review and revision cycle is underway and ADA welcomes thoughts and recommendations from NCVHS and other members of the dental healthcare community.

Mr. Pokorny said ADA also believed that the distribution mechanisms, formats and prices were acceptable. Over 84,000 publications containing the latest version of the Code have been purchased. ADA's Department of Salable Materials offers cdt-3/version 2000 for $59.95 (members $39.95). A quick reference guide containing a subset of frequently used codes, without descriptors and other pertinent information, costs $11.95 (members $7.95). A CD-ROM with the Code and other functionality costs $149.95 (members $89.95). An ASCII text delimited file is available for entities that choose to license the Code. Licensing fees for practice-management system vendors are based on the number of installed sites at a rate of $10 per site annually; the licensing fee for third-party payers is $1,000 per annum, without limitation on the number of users within an organization. ADA's pricing policy arises from a business decision to apply an administrative fee that recoups some development and maintenance costs. The intent is that all users within a category (e.g., member dentist in practice) are treated as uniformly as possible. ADA members have paid for their copies of the Code since 1990.

Noting a history of some third-party payers creating and using dental procedure codes that weren’t found in or perhaps designated by a different code in the Code on Dental Procedures and Nomenclature, Mr. Pokorny suggested that "local codes" might be better termed "proprietary codes." AMA believes such exceptions are becoming less frequent. One action that reduced the number of dental procedure code sets was noted in the Regulatory Preamble: "The ADA will change the leading '0' to a 'D' as proposed. Many organizations are already using the 'D'Codes, which contain the leading 'D,' without difficulty and we expect others to make this transition without difficulty. Although we did not receive comments that specifically addressed the removal of the dental codes from the HCPCS, generally comments about the desirability of more consolidated access to all HIPAA codes have led us to revise our position on the inclusion of 'the Code' in HCPCS. Thus, the dental codes will be available from two sources: the ADA and through a licensing agreement between HCFA and the ADA."

Mr. Pokorny reported a survey indicated in late 2000 that at least 68 percent of the BCBSA plans accepted claims submitted with the current version of the Code. Information from HIAA, reported on an aggregate basis, indicated member carriers who had already adopted the current version provided dental benefit coverage to 45 million individuals. None of the 20 respondents to the ADA's 2001 survey (13 BCBSA plans and seven commercial carriers) expected problems electronically accepting claims with the current version of the Code by October 16, 2002.

Mr. Pokorny noted that Dr. Lumpkin’s letter, dated June 29, 2001, to Secretary Thompson acknowledged, "It is clear that the current HIPAA code sets do not cover all procedures and diagnoses. This will always be a problem due to the evolving nature of healthcare." Mr. Pokorny said Dr. Lumpkin's letter and ADA’s testimony both recognize an evolutionary environment where stasis serves no one in the healthcare community. As noted, ADA has already adjusted its Code revision process to reflect timely needs of the dental profession, the third-party payer community, and federal regulation promulgated under the auspices of HIPAA. Further refinement of the Code revision process should be expected to ensure that all sectors’ current and future needs are incorporated into the Code. However, Mr. Pokorny said it served no one if evolutionary changes led down a dead-end to extinction.

Panel 1: Code Set Developers

Ms. Brooks reported on the ICD-9-CM process maintained through C&M. She described three changes in ICD-9-CM and noted that the timeline of events related to updating ICD-9 and committee reports were posted on the www.hcfa.gov Web site.

Overall, Ms. Brooks said the process had been well received and the public didn't want many changes. But she said a number of organizations felt it took too long to get ICD-9-CM code and the timeline was changed. Meetings were now held in April and December. Procedural topics considered at the April meeting s might be included in the October 1, 2002 addendum as code changes. This would only be possible if there were no unresolved issues; other topics would be held over for study and considered for implementation the following year. Ms. Brooks remarked that the time frame was challenging and that a drawback of holding this meeting after the proposed notice announcing the final codes was that everyone would read the code titles in April, see the proposed DRG assignments and comment, but won't know which titles made might go out in October. Noting many manufacturers submitted codes in November and the agenda had been quite full, Ms. Brooks said there might not be any last-minute burning submissions. She said CMS worked closely with the industry to make sure that the codes made sense and that the process was simple and understandable.

Ms. Brooks said CMS was trying to be more responsive in bringing issues to discussion. CMS had encouraged people to obtain FDA approval or actual use of the codes before submitting topics to C&M. However, C&M was discussing some proposals that might not get FDA approval or come out during this year.

Ms. Brooks said they were trying to add codes and fit more things in, but the book was full. In order to make the current book work better, everything that wouldn't fit elsewhere was being fitted into an open section in front of the neurology. The new addendum utilized this new section (00) and held another in reserve. Codes in this section would be indexed. She said CMS would discuss the issue of going to 10 PCS at the April hearings.

Ms. Brooks said there hadn’t been any changes in the distribution mechanisms for ICD-9-CM, which had always been in the public domain. The addendum was put up annually in late spring or early summer. NCVS coordinated efforts between the two agencies to produce the CD-ROM that contained the entire book, was a searchable document, and sold for under $20.

Ms. Brooks said there probably were gaps in ICD-9-CM, because technology was changing so quickly, especially on the procedure side. A new diagnosis could be squeezed in, but new approaches in procedures occurred daily and were difficult to update, given the book’s current structure.

Discussion

Dr. Zubeldia expressed concern about the Category III codes being released on a semi-annual basis, which was out of sync with the rest of the CPT codes. He asked if there was a version control system so people knew which code set was being used and the method for retiring old Category III codes and the version control. Dr. Beebe explained that the new codes were released semi-annually. The full body of codes was still released on an annual basis in the CPT book. Whenever codes were deleted or revised, the revisions appeared with the semi-annual updates. But deletions would be noted in the CPT book with the rest of the CPT files; the code set and migration of Category III into Category I was controlled. He said AMA was still working on the release schedule with BCBSA and other payers so it could be readily incorporated into quarterly tape updates, helping them comply with HIPAA requirements.

Dr. Cohn said he understood that the ICD Volume 3 procedure codes were updated annually. CMS was trying to create a four-or-five-month period when everything got handled. He asked how that would work for insurance companies and software vendors trying to modify their systems. Ms. Brooks said, in theory, CMS didn't have any more time than the others. CMS still had to have the addendum up by early May/June and make the same timeline for the CD-ROM. Publishers and vendors would notice no difference.

Ms. Brooks clarified that the ICD-9 code set could be read at www.hcfa.gov by clicking on meetings, events, workgroups, ICD-9 Coordination and Maintenance Committee. An addendum showed how things changed. The home page lists the option of buying the whole ICD-9 code book with index and tabular with search capability on a CD-ROM. Ms. Pickett explained there were three versions of ICD-O: ICD-O-3 (the current version used by NCI) will be a component of ICD-10-CM, ICD-O-2 is part of ICD-9-CM, the typography codes are Chapter 2 of ICD-9-CM and the morphology codes of ICD-O are in an appendices of ICD-9-CM.

Dr. Mc Donald asked about AMA’s pricing for a hospital with 2,000 stations and ten people entering CPT codes in medical records. Who had to have licenses—the ten in medical records or anybody checking people in? Dr. Beebe said a hospital with 2,000 stations would get a volume discount that depended on whether CPT was the core of what they were using or incorporated into a larger billing or payment context. Participants discussed definitions of per user and concurrent user and distinctions between a simultaneous count as opposed to 2,000 overall users. Dr. Beebe said if there were ten stations, which 2,000 people could possibly use, it would be a per-station charge. Dr. Mc Donald remarked that usually it worked the other way: there were more stations than people at any one time in most hospitals. And most stations weren't used for coding. He said it was easy to manage and count in medical records, but application programs in clinics couldn’t uniformly report back to AMA how many people peaked out at one time. Dr. Beebe said the reality was CPT was just a data set software developers incorporated into their software system, which they sold to the large clinics and hospitals and charged, per-user or per-station, paying AMA a portion based on licensing.

Mr. Blair remarked that over the last several years the Subcommittee heard general concern about the license fees for code sets. He asked if a hundred percent of license fees for CPT codes went into continued updating and maintenance of CPT code or was some used for other AMA purposes. Dr. Beebe said the CPT licensing operation was a small proportion of AMA’s income. Some went to offset activities of the panel process, some went to overall AMA operations. AMA accounting didn’t attribute income from fees and the percentage that went toward continued updating and maintenance of CPT codes would be difficult to extract. AMA’s CPT licensing was about $4 million per year; Dr. Beebe estimated that in excess of 50 percent went toward the editorial process.

Noting the Subcommittee would hear testimony later in the year on the growing usage of complementary and alternative medicine, Mr. Blair asked if there was an attempt to include coding for complementary and alternative medicine within ICD and CPT code sets. Ms. Brooks and Dr. Beebe both said their policy was to include and expand code sets to include complementary and alternative medicine.

Ms. Brooks clarified there wasn’t an official crosswalk between procedures included in the ICD-9 and those in CPT. Sometimes one got a procedure code a year earlier than the other; it depended upon need.

Recalling that in his written testimony Mr. Pokorny quoted from the final rule that the dental codes would be available from the ADA and through a licensing agreement between HCFA and ADA, Dr. Zubeldia asked if the dental codes would be available free to all Medicare or Medicaid providers. Ms. Kaye Riley, HCPCS coordinator, explained that the dental codes were part of the Alphanumeric HCPCS and would be included as the D section in the HCPCS, identified as copyrighted by the ADA. ADA had encouraged HCPCS to make the codes in the agreement that were posted on the Web site (the same codes published in the CDT-3) available free to everyone. The number and wording of the code was available. HCPCS wasn’t posting the ADA guide with instructions, definitions, bells and whistles. Those were available and endorsed by ADA.

Dr. Zubeldia asked if a vendor could download and redistribute those codes as part of their system to dentists without paying a license fee. Ms. Riley pointed out that dentists could go to the hcfa.gov Web page and view or download the entire set of HCPCS codes. The code numbers and wording were publicly available. ADA had the entire documentation and guidelines. Mr. Pokorny said he would check the terms of the licensing agreement with HCFA and send the Subcommittee a letter. Dr. Beebe said AMA had an agreement with CMS that allowed CPT codes to be printed as part of the Medicare fee schedule, but AMA didn’t allow anyone else to download the codes and use them for their systems, which would be an infringement of copyright. Dr. Beebe confirmed that AMA kept deleted codes in a file to avoid reusing them.

Dr. Yasnoff asked about the historical integrity of the three code sets: could one always go back and figure out codes or were deleted codes intentionally reused? All three testifiers said in the past empty numbers were sometimes reused and created confusion, but they no longer reused codes. However, Ms. Brooks explained CMS modified meanings, adding or deleting a concept and splitting it out and making another code. These could be trailed out in conversion tables published annually.

Panel 1: Code Set Developers (con’td)

Ms. Riley said the HCPCS data set was maintained jointly by BCBSA, HIAA, and CMMS. Responding to Mr. Beebe’s testimony, she said that, since inception, an AMA representative had been invited to participate as a consultant to the HCPCS National Panel, received all information related to the code requests, and comments were encouraged.

Ms. Riley said the current established maintenance process and schedules for updating the Alphanumeric HCPCS Code Set worked well. The permanent national codes were updated and made available each January 1. Annual HCPCS updates were posted to the Internet each October and could be viewed or downloaded free at www.hcfa.gov/stats/pufiles.htm#alphanu. Private publishers also made copies of the HCPCS available. Noting it was sometimes necessary to add HCPCS codes during the year, based on internal operating needs of the private sector, Medicare or Medicaid, Ms. Riley said information on interim codes and their quarterly effective dates were available on www.hcfa.gov/medicare/hcpcs.htm. The HCPCS Web page also contained background information on HCPCS coding process, coding request information, and a list of HCPCS code corrections.

Ms. Riley said the HCPCS National Panel worked with various professional groups and Medicaid state agencies to assist with the elimination of local and non-standard codes by responding to requests for the establishment of national codes.

Ms. Riley reported the number of requests increased, but were less than expected. For the 2002 HCPCS update, 658 alphanumeric codes were added, 14 codes reactivated and 319 changes made through existing HCPCS code long descriptions.

Information about the Medicaid-established process for the states to submit requests for the HCPCS code modifications was available by clicking on HCPCS Medicaid on the Medicaid Web site. CMS also published a notice in the November 23rd, 2001 Federal Register announcing Medicare establishment of procedures that permit public consultation under the existing process for making coding and payment determination for new clinical laboratories and DME.

Ms. Riley said three public meetings regarding coding and payment for new DME were scheduled for March the 11th, May 13th, and June 17th, 2002, beginning at 8:00 a.m. at the CMS auditorium in Baltimore. Comments regarding the procedure identified in the notice published November 23, 2001 had been requested by c.o.b. January 22, 2002. Ms. Riley said she hadn’t yet received them, but understood there were few. January 28, 2002, had been the first meeting’s deadline for registration to attend, present comments or submit new DME HCPCS coding requests through the HCPCS review process in order to appear on the agenda. As of the deadline, only one request for coding new DME had been received and only four people had registered to attend the March 11th meeting.

Code requests for review and consideration for the 2003 HCPCS update had to be received and reviewed during the current review cycle. The review cycle for the 2003 HCPCS update began on Tuesday, April the 3rd of 2001 and ends c.o.b. on Monday, April 1, 2002.

Panel 1: Code Set Developers

Mr. Shugart said current processes and schedules for updating HIPPA medical data code sets generally worked well. However, because of the massive undertaking of converting some 25,000 Medicaid local codes, the process was slower than most would like. State Medicaid programs worked collaboratively through NMEH over the last two years to eliminate local codes. Specific concerns were expressed over CPT changes taking three or more years, unique issues facing Medicaid programs with federally approved waiver programs, and the need for a standardized timeline for updating multiple code sets. As they’d heard, the effective date of changes to ICD-9 is October, CPT is January with interim updates, and CDT currently is every five years, but is moving toward a two-year process.

The general consensus was that the code set distribution mechanisms and formats were acceptable. Comments included there should be free Internet access, concern over AMA charging for inquiries about the meaning of code descriptors, and a call for a notice of postings on the various Web sites.

Every state that responded said progress was being made toward elimination of reliance on local codes. However, the process was very labor intensive, slower than anticipated, and in some cases required extensive workarounds.

Mr. Shugart said specific concerns were expressed about: AMA’s decision to use a new format 9999T for technology codes, instead of all numeric, conflicts over whether certain services defined in multiple code sets should be billed through the professional or institutional guide, a lack of mental health codes, and a request for a clearer definition of what was considered a medical code under HIPAA (e.g., non-emergency transportation isn’t, sales tax is). Mr. Shugart said he was especially concerned about the lack of standardization regarding which implementation guide and paper form to use: this failed to meet the goals of administrative simplification and made coordination of benefits harder and more expensive. He noted a positive sign was collaboration between the state Medicaid, mental health, and substance abuse services.

Mr. Shugart said generally there weren’t gaps in the coverage of medical code sets that couldn’t be addressed by updates to existing code sets. However there was some consideration of using universal product numbers for medical equipment and supplies and the use of National Drug Codes instead of the HCPCS J Codes.

He said the consensus was that ICD-10-CM shouldn’t replace ICD-9-CM Volumes 1 and 2. Mr. Shugart suggested this wasn’t a strong position about long-term coding, but a result of everyone working on implementing all the other current HIPPA code sets. Discussion of a replacement code set shouldn’t be tackled now, but after the HIPAA extended implementation date. Mr. Shugart noted this would also impact on the Medicare inpatient prospective payment system and its use within the DRGs, and that Maryland also used it for validation of bills submitted by hospitals.

Mr. Shugart said the majority of state Medicaid programs also thought PCS shouldn’t replace ICD-9 Volume 3 as a standard. Some commenters weren’t familiar with PCS. Others thought ICD-9-CM Volume 3 should be allowed for outpatient claims or CPT/HCPCS should be allowed for inpatient claims. State systems operated differently and had different perspectives.

He reiterated that the biggest concern about replacements or additions to the list of HIPPA medical data code sets centered on the creation of code sets for alternative medicine.

Consensus among state Medicaid programs was that the current processes and schedules for updating the non-medical data code sets weren’t working well. Some states said all code set maintainers should be required to update on a regularly scheduled basis for efficiency and cost effectiveness. Others called for an announcement of release dates or considered the process cumbersome and hard to follow. Still others said that question really couldn’t be answered until final decisions were made on taxonomy.

Mr. Shugart said there was no consensus about whether distribution mechanisms, formats and prices were acceptable. There was general concern about costs and one request for free Internet access. Concern was expressed that states might have limited opportunities for participation as a result of state budget issues and travel restrictions. Concern was also expressed over the loss of specificity of Adjustment Reason and Remark Codes and the uniqueness of Medicaid programs compared to health insurers and Medicare.

Discussion

Mr. Shugart said interfacing between NMEH and the HCPCS code panel and NMEH’s effort to come up with national codes that replaced the existing local codes had been a mammoth undertaking, but was working. Several national meetings had been held. Forty states had participated at national panels. Forty different areas of coding were identified. CMS worked with the NMEH to develop a process to expedite the creation of the codes and that, obviously, had worked. Some 30 of the 33 codes addressed had been essentially submitted or completed. Work continued on DMS and DME, which had many local codes. Substance abuse and mental health had worked together to resubmit, after realizing some of their coding was similar, yet distinct. One reason the states were concerned about the original HIPAA deadline was these codes weren’t yet available; the ability to apply for an extension was welcomed by all states. It might be three-to-four months before everything was out.

Ms. Riley said reverse crosswalking to the national code sets had been tremendous, but the majority of the codes identified by the Medicaid state agencies were already identified in the existing standard code sets. In one area they narrowed 3,000 codes down to 300. After eliminating duplication, variation and wording, they asked the HCPCS workgroup for three codes and that had been established. From 3,000 to three codes was a tremendous effort. The national panel met with the Medicaid state agencies to help formulate guidelines to move forward and submission to the workgroup for final review was expected in February for the March agenda. Ms. Riley said they wished that they could go faster, but they were responding to requests received. She said she was truly surprised that they weren’t receiving more (especially for DME) from private industry. Dr. Cohn said he shared Ms. Riley’s concerns about issues related to private industry and he wondered, based on prior work, if private industry and health plans might be in for some rude awakenings as HIPAA came closer and they suddenly realized local codes were no longer appropriate. Ms. Riley said they had to keep reminding them.

Dr. Cohn remarked that Mr. Shugart made two comments that resonated in conversations Dr. Cohn had with others in health plans and other medical organizations. He’d talked about standardized time frames for publication of code sets; something Dr. Cohn heard from a lot of private payers concerned that everybody was on different schedules. Mr. Shugart had also commented on redundancy and not being sure which code set to use. Dr. Cohn asked if Mr. Shugart had any suggestions for solutions based on all they’d heard so far. Mr. Shugart said he thought solutions were to be found in ongoing work establishing the standards. He suggested the next step was the implementation guides. There was a large matrix of “who bills what on which HIPAA electronic record” and those decisions were the next step toward administrative simplification. Consensus needed to be developed and the actual billing format identified.

Noting Mr. Shugart had expressed concern about lack of standardization regarding which implementation guide to use, Dr. Yasnoff asked if that problem could be solved by designating a single implementation guide as a standard, along with the code set itself. Mr. Shugart said he thought the separate implementation guide would work, given a caveat about which guide different providers should be using for various billings. He emphasized that was what actually was missing. He said his state had created a number of unique home health and nursing home codes, but the UB-92 guide stated home health and nursing homes should bill on the UB-92. Mr. Shugart’s position was that the default should be to bill under that code set, especially with the elimination of local codes. There should be clear direction who to bill and with which guide. Dr. Zubeldia observed that it was a difficult question. If a hospital owned an ambulance company, would that hospital bill the ambulance services with an institutional claim? There was no easy answer. Mr. Shugart’s perspective was that the ambulance company would be identified as a separate provider owned by a hospital that they would need to bill--in that case the hospital wasn’t authorized to bill the ambulance service. Asked if the multiple implementation guides served an important function that should be continued, Mr. Shugart said they needed to maintain a separate implementation guide for each different transaction set.

Dr. Cohn expressed concern about standardized time frames for release of code sets: they’d heard everything from two years for the dental codes to quarterly for HCPCS. People in the private sector were concerned about so much variation and afraid they wouldn’t be HIPAA compliant because of issues that arose with so much variation. There was also the issue of redundancy and overlaps that left people uncertain about which code to bill. Dr. Cohn asked how Ms. Riley would solve these problems. She said she believed electronic access through the Internet would be their saving grace. Everything would be posted on the Web and people could identify it. People wanting to use them could find them, and insurers and claims processors could check the Web pages periodically to update their systems.

She said they weren’t talking about a large number of interim codes during the year. In order to help Medicaid and other organizations, there were more S, T, and G Codes than usual on record. Generally there were only a few and it wasn’t an excessive amount of work to enter two-to-six codes into your system. Now there might be as 30-40 per quarter, but it was only because of this crunch to make codes available so organizations could get their systems ready for implementation of the HIPAA regs.

Ms. Humphreys commented that both the October and January dates were legislatively established. When the original NPRM was published they’d sought legal counsel within HHS about this issue of lining things up and whether HIPAA trumped any of this legislation, but it didn’t. NCVHS would have to propose a legislative change.

Ms. Riley said the national code set actually was published in October to allow time to update the databases for the effective date of January 1. All “interim” codes would be included in that annual update and be part of the publication.

Panel 2: DSMO Perspective

Ms. Gilbertson provided an update of change requests the DSMOs had seen and their recommendations. One: The addition of HIEC codes for home infusion. The DSMO recommended that X12N work through Level 2 HCPCS and CPT-4, removing the HIEC code qualifier from the implementation guides. If the code set is still incomplete, they should submit a request through the DSMO. Ms. Gilbertson noted there were two parts to this request: HIEC requested their code set named as a HIPAA code set and they requested their qualifier remain in the X12N implementation guides. HIEC worked with CPT to have their code set needs addressed. CPT believed that, eventually, they could accommodate them. X12N had left the HIEC code qualifier in the implementation guides and, as part of the addenda process, they noted in the implementation guide that the use of the HIEC codes wasn’t allowed under HIPAA.

Two: The addition of ABC code sets for complementary and alternative medicine practice. After considerable review, the DSMO requested the submitter to review and specify why HCPCS, NDC, CPT codes were not meeting their business needs and demonstrate support for health plans supporting/paying these categories. A follow-up request had been recently adjudicated by the DSMO; noting information provided about working with HCPCS and the need for further information about CPT.

Three: The support of local HCPCS J Codes for an additional year. The DSMO decided that this was a policy issue and submitted it to HHS. (Granted additional time, this is a past, processed request.)

Four: The support of clinical nomenclature codes to classify mental disorders. The DSMO noted that ICD-9 codes were mandated in the final rule.

Five: The support of temporary procedure or diagnosis codes for each code set. The DSMO recommended that the diagnosis and procedure codes were part of the “medical code set” as defined by HIPAA. Neither the DSMOs nor the X12 implementation guide had the authority to include any non-designated medical codes or code sets in the HIPPA implementation guides. X12N recommended that the requester work with the maintainers of the medical code sets (i.e., CPT, ICD, HCPCS, CDT and NDC) to request any necessary codes. Ms. Gilbertson said it was the DSMO’s understanding that all the code set maintainers either had or were developing processes for requesting new codes and at least several were contemplating including temporary codes. The Subcommittee had heard more testimony on this that morning.

Six: The support of vision code sets. The DSMO recommended that the requester work with existing code set bodies and become involved in NCVHS Committee hearings during 2001. If requesters didn’t reach consensus they could reapply to the DSMO outlining actions and consequences of outcomes. The dialogue indicated that the vision industry hadn’t come to consensus on their business needs and were petitioning the SDOs for assistance. The DSMO recognized that after reaching consensus the vision card industry would need to submit a request that represented their industry. Ms. Gilbertson noted the industry had since been active in the X12 environment, gaining consensus and input.

Ms. Gilbertson reported on the code set request procedures the DSMOs were creating to guide submitters requesting adoption of a new code set into the HIPPA regulations. A draft outlined the steps, organizations available to help, and questions submitters should answer before entering a request in CRS. Ms. Gilbertson said the DSMO would e-mail or present to the Subcommittee the finished code set procedures at the next appropriate hearing..

Panel 2: DSMO Perspective

Mr. Arges noted that NUBC was one of six Designated Standards Maintenance Organizations responsible for the maintenance of changes to the implementation guides on the HIPAA electronic transaction standards and code sets. He thanked the members for holding the May 31-June 1 hearings on the National Drug Code and correcting the potentially costly reporting requirement for developing non-retail pharmacy claims.

NUBC and other DSMOs had reviewed a large number of change requests for the implementation guides. Most dealt with usage of a particular data element or segment, but several groups had asked to expand use of medical code sets beyond those in the final rule. After careful deliberation, NUBC couldn’t support adopting HIEC codes to report home infusion services or the ABC code set for the reporting of alternative care services. Many of the codes in these code sets weren’t necessarily medical codes, but a way of bundling medical services to accommodate special payment or reimbursement arrangements. Members cited a lack of evidence that the code sets identified in the final rule couldn’t accommodate their medical service. They also noted that CPT-4 and HCPCS codes already existed for the same types of services. NUBC suggested that these organizations present their need to the CPT and HCPCS coding groups. Mr. Arges said he hoped that in seeking new medical codes, every effort would be made to avoid bundled services, especially ones designed to facilitate reimbursement.

Mr. Arges said all DSMOs had similar views on these code sets; they were still uncertain whether the remaining services were medical codes or external codes established to accommodate a niche of healthcare reimbursement. NUBC needed to know which codes describe a package of services and if they were intended to identify specific types of caregivers. He noted that the UB-92 data set and the electronic transaction standard for the corresponding implementation guide pertained to the institutional provider setting. Consequently, if the intended services relate to the professional component of care, then the institutional implementation guide (which represents only the facility fee portion) wouldn’t apply. If the intent was to represent the institutional component, the NUBC needed to know: what type of institutional provider would utilize these medical service codes, and what type of health benefit plan currently covered these services. NUBC would also like to know about the coordination and maintenance process associated with the development of these code sets.

NUBC was responsible for the maintenance of the UB-92 data set that includes a number of external codes, referenced in the electronic transaction standards for institutional providers. The institutional implementation guide for claims reporting includes references to external codes that are the responsibility of NUBC: Bill Type and Frequency Codes, Patient Discharge Status Codes, Condition Codes, Occurrence Codes, Dates, Value Codes and Revenue Codes. Because these codes were a unique and integral component of the electronic transaction standards for institutional providers, NUBC recommended that all users of the institutional guide stay current with the maintenance of the entire code set.

Mr. Arges said NUBC supported and followed a deliberation process that was inclusive, broad-based and sensitive to the user community. The codes developed were easily accessible and widely distributed. And a clearly defined structure of review and communication promoted integrity and usage. He emphasized that the DSMOs supported the approach outlined in the final rule for data maintenance bodies and he urged the Subcommittee to keep in mind the importance of the deliberation process as they examined the requests. Everyone contributing to the DSMO process was aware of the attributes outlined in the final rule, and he emphasized that they strove to follow these precepts with each change request.

Mr. Arges said NUBC was comfortable with the existing medical code sets as outlined in the final HIPAA rule. NUBC anticipated the possibility of adopting these upcoming changes and redesigning the UB-92 data set. He said NUBC also looked at closing any major gaps that may exist between the paper UB and the electronic transaction standards. NUBC undertook surveys to identify areas needing improvement, as well as use of local non-medical codes established to accommodate many state reporting requirements, including Medicaid and public health data reporting. They hoped to have solutions that could be approved by NUBC as early as August. Solutions include establishing new NUBC codes within existing code set elements and changes decreasing the paperwork burden (e.g., business rules on procedures for reporting sterilizations, abortions). Mr. Arges said NUBC would seek NCVHS’s viewpoint and assistance in carrying out these recommendations.

Discussion

Responding to questions, Mr. Arges explained NUBC met quarterly and had public calls between meetings. NUBC generally had two scheduled implementation dates for modifications to particular codes: April and October. NUBC tried to give the industry at least six months lead-time. In terms of version control, NUBC indicated within the implementation guide the start date associated with a particular change (normally April and October). Mr. Arges said the committee generally had open meetings. Anyone could come and follow developments. Meeting minutes and agenda covered outcomes and actions, describing the nature of the change. Minutes were sent to various state associations and NUBC organizations as part of that process. The NUBC Web site listed when meetings took place, issues that came before the committee, and deliberations. NUBC made copies of the full UB-92 manual available. The hard copy is $75. There is a $50 annual subscription fee, with updates on the Web site.

Dr. Cohn asked the DSMOs’ views on how well the process was moving in terms of updates and getting issues related to non-medical code sets resolved. Ms. Gilbertson said she didn't have much experience with the public and code sets, but hopefully submitters were getting their responses quickly. Ms. Narcisi said this was a whole new process and DSMOs learned as they went along. The fast track process put them in a spin dealing with change requests to the implementation guide. A few code requests had come in and they were developing guidelines. She said Ms. Gilbertson had outlined things that needed to be done before the DSMO change request process. She suggested the process would get better within a few months. Mr. Arges said the DSMO’s first order of business was making changes that made the implementation guide workable, but he thought the DSMO process worked appropriately. Guidelines were needed to help requestors better understand the information they had to provide, so DSMOs could deliberate with some certainty about the nature of the request. Ms. Gilbertson added that DSMOs were learning that their responses had to be clearer; both X12 and NCPDP were more active in talking to submitters than a year ago.

Dr. Zubeldia noted NUBC intrinsic codes and CPT Category III codes changed twice a year. HCPCS and temporary codes could change quarterly. He asked about the impact of the requirement under HIPAA that the Secretary not adopt a new standard more frequently than once a year. Mr. Arges said a difficulty NUBC always faced, trying to hit the April and October dates, was changes that required them to act a month or two earlier than anticipated. But the code sets were designed to augment the format of the electronic transaction standard; NUBC wasn’t altering the transaction standard. Code sets were just another way of conveying information to be implemented within a year. Mr. Arges said he’d like to hold to no more than twice and, ideally, once a year. But he wasn’t sure they could always accommodate legislation or regulations.

Mr. Blair commended the DSMOs on their approach to examining non-medical code sets and their ultimate criteria. There was great value in extending existing code sets, because those SDOs were already in place and had experience meeting industry needs. But he said he wasn’t sure about the equity of two criteria for new code sets. Industry acceptance as a criterion put a heavy burden on a new code set. And if a primary purpose of reimbursement was a deciding factor with a new code set, he suggested it ought to apply as well to code sets that were already part of the DSMO process. Mr. Blair applauded the work the DSMOs had done and the way they’d made it easier for people to look at adopting HIPAA standards.

Mr. Arges agreed. NUBC wasn’t trying to preclude another code set from being considered; but he said they had to understand the circumstances that required reporting of a particular data element. NUBC had indirectly expanded its usage in code sets by allowing Medicare program changes in the post acute care setting that went to prospective payment where an MDS RUG category was reported. They could move forward understanding the provider’s setting, nature, and obligations.

Dr. Mc Donald commented on the understanding derived from talking to people in different areas and he applauded the human effort that took 24,000 codes and boiled them down to a tiny number.

Dr. Zubeldia noted that the Subcommittee had received written testimony from Alternative Link and the National Home Infusion Association.

Update Regarding Non-medical Code Sets

Ms. Hawk explained she was a medical librarian by profession who volunteered to help identify issues related to the non-medical code sets. She defined “non-medical codes” as non-procedure or service codes that refer to claim status, adjustment reason, or payment remarks. She described two types. Type A were the external codes named and described in the HIPAA implementation guides that didn’t describe “medical” events. Type B code sets were defined (named and included) within each implementation guide.

Ms. Hawk commented on different types of issues she’d begun to identify. One was the same concept codified differently. Marital status “separated” was codified four different ways in four different established standards: UB92 captured it as an X, X12.837 as an S, HL7 as an A, Minimum Data Set as a 4.

Another issue was same value, different meanings. In X12, marital status “S” meant separated. But in UB92 and HL7 “S” meant single.

Ms. Hawk noted that not only context, but also timing was essential. Codes used should be those in effect when the transaction was initiated. Delays between initiation and submission of a claim could be significant. Claims with incorrect codes were rejected.

Another issue was version control and what Ms. Hawk termed “communication flow.” Even material available from a single source (i.e., Washington Publishing Company [WPC]) didn’t have true version control; users must read X12 minutes to discern the appropriate version.

Ms. Hawk noted that some code sets were actually identifiers and should be deleted or moved. She noted three different sets of identifiers: provider, employer and plan ID (formerly PayerID). NPRMs had been issued for the first two, which were final. Payer ID didn’t yet have an NPRM.

She questioned that HL7, which was the messaging standard for claim attachments, had the same non-medical code sets as X12.

Ms. Hawk raised other questions: were the criteria for evaluating medical code sets applied to the non-medical code sets--did the same issues of maintenance, updating and responsibility that were a primary concern for the medical code sets also apply here? Would it be useful to evaluate non-medical code sets with each criterion? Were there gaps in the non-medical code set that needed to be addressed? If so, should they be discussed with the medical gaps?

Ms. Hawk suggested ideas for next steps: (1) noting the definition of non-medical code sets wasn’t yet stable, she suggested bibliographic control; (2) have all the different lists of HIPPA-related code sets available in one place, e.g., WPC Web site; (3) try to obtain the non-medical code sets and implementation guides; (4) look inside the implementation guides for the code sets within.

Update Regarding Non-medical Code Sets

Ms. Narcisi summarized NUCC's role as maintainer of the Health Care Provider Taxonomy Code Set, an external non-medical data code set designed for an electronic environment. Its original purpose was to code provider type/area of specialization for medical related providers. The code set was originally developed based upon a combination of medical specialties, fields of scientific study, services, and age of the patient. In testimony last year identifying problems with some of the non-medical code sets, Ms. Narcisi reported this code set was inconsistent and a former maintenance process wasn’t effective. The code sources were classified as external to ANSI ASC X12 and maintenance was the responsibility of volunteers from the X12N community. There was no formal governing protocol for maintenance of the taxonomy and participants couldn’t attend meetings on a regular basis.

Ms. Narcisi explained that X12N and the National Provider System Workgroup from CMS had identified and coded an external provider table for coding provider type and provider area of specialization for all medical related providers and in April 1996 a single taxonomy was proposed that both CMS and members of X12N found meaningful, easy to use and functional for electronic transactions. The list incorporated all types of providers associated with medical care and the amount of research required to validate and classify them using the hierarchical structure was enormous. A broad definition of "areas of specialization" was used, which included nationally recognized specialties, provider self-designated specialties, areas of practice focus and any requests by any agency or trading partners submitted before the first taxonomy release. This level of detail captured specialty information in categories detailed enough to support those trading credentialing information, yet broad enough to support those wishing to trade directory-level specialization information.

In 2001, X12N asked NUCC (membership includes representation from key provider and payer organizations, state and federal agencies, SDOs and NUBC) to be the official maintainer of the code set. NUCC developed procedures for processing all outstanding and new taxonomy change requests and updates the taxonomy list and definitions. NUCC’s Web site and updated list will be available soon. The current code list can be accessed at the WPC Web site.

The taxonomy represents a one-to-many relationship to the individual provider. Many occurrences of the taxonomy might apply to a single entity or provider (e.g., a provider trained in internal medicine and specializing in cardiology might appear with both specialties).

There are about 800 ten-digit Provider Taxonomy Codes. The hierarchy of provider categories incorporates four areas of provider classifications, creating the capability to sort providers into broad and specific categories: (1) provider type--a 2-byte alphanumeric code that identifies a major group of services or occupations of healthcare providers (e.g., dental service providers), (2) classification code--a 2-byte alphanumeric code that identifies more specific services or occupations within the healthcare provider type, based on licensed provider classifications (e.g., dentists, dental hygienists or dental laboratory technicians), (3) area of specialization--a 5-byte alphanumeric code that identifies the provider's specialization or any other descriptive characteristic about the providers practice (e.g., physicians could specialize in internal medicine or limit their practice to endocrinology), and (4) a place holder--1-byte alphanumeric code. Many of the provider types and classifications also include definitions.

NUCC was working with WPC on the development of a web-based system similar to the DSMO change request system. The process for handling new code submissions and requests for changes to current codes was patterned after that system. The NMEH Workgroup coordinated the large number of code proposals related to Medicaid and participates in NUCC's provider taxonomy meetings. HL7 expressed interest in working with NUCC and other SDOs were encouraged to participate.

NUCC developed guidelines for submitting change requests, which will be posted on the Web site: (1) Was there a proven business need for acceptance or a change--Because this is a national list, requests should help solve needs on a national level, (2) Would an existing code suffice in place of the perceived need for a new code, (3) Did the organization code presently exist within the code set--Was there consistency between the list and current place of service code list? Every new Taxonomy Code request must be accompanied by a definition.

NUCC developed criteria to evaluate requests: (1) existence of a nationally recognized specialty board or specialty defined by a subspecialty certification or certificate of special competence issued by a board or nationally recognized accrediting body, (2) existence of an American College of Graduate Medical Education accredited residency or subspecialty training program, and (3) in exceptional circumstances, other healthcare fields would be considered if need to identify providers in that field was determined. Determination would be based, in part, on: (1) a significant number of providers limit their practice to that specialty because of demand for services, (2) the specialty was based on major new health science concepts with broad professional support, (3) the specialty was a distinct, well-defined new field concerned with problems of a specific patient group, organ system, disease entity or healthcare procedures.

NUCC currently reviews code requests monthly and would publish them upon approval.

Ms. Narcisi remarked that with the DSMO change request process reviewing code source requests, non-medical code sets NUCC had been dealing with that had been strictly billing applications would be utilized more in the medical record applications.

Discussion

Dr. Zubeldia noted that Ms. Narcisi had mentioned that one guideline for the change request was whether the organizational code currently within the code set retained consistency between the list and the current place of service code. He asked what place of service had to do with the Taxonomy Code. Ms. Narcisi noted there were codes that list organizations or certain facilities that might or might not be in the place-of-service codes. She said NUCC had talked with CMS, who currently maintain the place of service codes: it might not make sense to have them in two separate places. Dr. Zubeldia questioned if that wouldn’t be only for provider taxonomy codes that specifically represented not only the specialty but also a place of service. Ms. Narcisi explained that the specialties were included in the Provider Taxonomy Code Set. Organization codes were added because there weren’t codes for reporting those different facilities in a place-of-service code. Medicaid agencies added different codes because they had different reimbursement methodologies. Several local codes were used.

Dr. Zubeldia asked if there were guidelines for when to use the Taxonomy Codes with HIPAA. He expressed concern that, if it was left up to the payer to request the Taxonomy Code, different payers would request Taxonomy Codes in different circumstances and providers wouldn’t know whether to send a Taxonomy Code. Ms. Narcisi said NUCC didn’t have guidelines because this wasn’t a required element in the X12 implementation guide. However, it was added to the addenda as a situational element and would be included in the guide. Dr. Zubeldia pointed out that the implementation guide said “required if necessary for adjudication”: a determination made by the payer.

Dr. Cohn remarked that, based upon what they’d heard, the Subcommittee continued to be concerned about non-medical code sets. He suggested they needed to find out the status of USHIK’s activities. Noting they’d heard about two-year updates for the dental codes, one year for CPT, quarterly for HCPCS and monthly for the provider taxonomy, he asked Ms. Narcisi what made sense. Ms. Narcisi agreed that updating monthly was generally too often, but she noted the Provider Taxonomy Code Set hadn’t been updated since 1997 and there had been many outstanding requests. Some 50-60 codes would be added to the next version. However, there were very few new code requests for the provider taxonomy list.

Ms. Humphreys commented on proposed code sets related to alternative procedures that had combined the provider with the service, potentially creating a number of codes for identical procedures or services. She said these submitters should also be advised to talk to the Provider Taxonomy. She also cautioned that this national requirement might be problematic because the states had very different laws about licensing of alternative practitioners; having to be national might exclude many legal procedures. Ms. Narcisi said that was an excellent observation. NUCC worked with the NMEH group, which had been looking at those issues and trying to do it on a national basis, but they were limited by certain state codes. Hopefully, they could help. HL7 had offered to work with them and NUCC welcomed input from anyone.

Ms. Humphreys remarked that the code sets had to represent legal sets of providers doing a licensed procedure in a particular state and submitting a bill to a payer. Ms. Narcisi said NUCC had a good listing of physician providers but non-physician providers weren’t adequately represented in that code list. Dr. Zubeldia noted that materials Ms. Hawk provided indicated Code List 139 was maintained by an ad hoc group that met the Sunday before the X12 meeting and had no structure, updating process or version control. Ms. Narcisi said Provider Taxonomy would have a more rigorous version control system.

Dr. Mc Donald said finding the medical codes was good, but cautioned that the border between medical and non-medical wouldn't always be clear. He clarified that, in terms of the attachment Ms. Narcisi mentioned, clearly HL7 had different non-medicals in equivalent fields but that particular field wasn’t included because the X12 component it contained superseded it. He said complications in the attachments should be sent to Ms. Ward so they could be fixed. Dr. Zubeldia said X12’s position was that the actual code was irrelevant because it was up to a translator to determine the way it needed to go. Dr. Fitzmaurice clarified that while, as Ms. Hawk said, NPRMs had been issued for the provider and employer identifiers, the final rules weren’t out yet.

Panel 3: Industry Representatives

Mr. Murphy said NADP members provided more than 70 percent of all network-based dental benefits and a full one-third of all indemnity dental benefits in the United States. He said payers had invested tens of millions of dollars to incorporate the CDT coding system into claims systems and benefit literature. And state governments used this code set to build benefit schedules and for utilization monitoring and standard reporting systems between insurers and state government agencies. He said NADP had three significant problems with the HIPAA non-medical code set development and maintenance: (1) NADP was deeply concerned about a lack of an open, fair process for the maintenance of the CDT as recently outlined by the ADA, (2) NADP opposed licensing requirements imposed selectively on dental benefit plans that severely limited use of CDT, and (3) NADP and other national organizations found the CDT usage fees demanded of dental benefit plans to be out of line with costs associated with more widely used codes designated by the rule for other medical and healthcare specialties.

As the DSMO for the CDT, the ADA had the responsibility and the requirement within HIPAA to ensure that principles of modifications, specifically including open public access to the process, were met and the process for code revision was fair, equitable and inclusive. Mr. Murphy said the process recently announced by ADA didn’t incorporate these principles. As early as 1993, NADP requested to participate as a member of the CDT Code Revision Committee. In December of 2001, ADA sent "Overview of the Code Revisions Process" to three organizations that historically participated in the Code Revision Committee; BCBSA, DDPA, and HIAA. Mr. Murphy said NADP received no notice of the new code revision process or any response to its repeated requests for participation. He added that NADP understood that DDPA and HIAA were included on the committee as a result of litigation.

The invitations outlined the new Code Revision Committee and process. The committee was to consist of five dentists representing and appointed by the ADA and five representatives from payer entities (BCBSA, DDPA, HIAA, CMS, and an “employer representative.” Mr. Murphy remarked that CMS and the “employer representative” weren’t truly payers but purchasers with little knowledge of detailed CDT usage issues. He said the process ensured ADA a majority vote on all issues (unless all five other representatives agreed on a particular code revision or addition), veto power, and the ability to carry out its position on any issue of dispute without the support of any other participant.

Mr. Murphy said the committee’s actions didn’t appear to encompass the basic principles of an open public process as required by the rule. ADA chaired and provided all of the committee’s staff and participants had observed that the staff failed to present recommendations in the format presented by members of the committee. Mr. Murphy said the public didn’t receive adequate notice of the location of meetings and agendas, and supporting documentation wasn’t available for review. Observers weren’t provided with copies of the agenda or materials and no process was apparent to allow for comments from observers unless directly related to specific issues on the agenda. While the rule required open public process, during the January 28th and 29th meeting the committee discussed moving to executive session if there were too many observers present.

NADP suggested the Subcommittee review the procedures used by other DSMOs and direct ADA to set up a process that was equitable and clearly allowed participation of all interested parties. NADP also suggested that a neutral representative (e.g., a member of HHS) be designated chair.

Mr. Murphy emphasized that CDT was the primary means for communication between a dental office and NADP members who paid for the benefits. The use of CDT to facilitate the payment of claims was critical to providers, the industry, and consumers. In the publication of the final Transaction Code Rule, several commentators raised the issue of using existing proprietary code sets during the rule's public comment period. HHS responded by saying that HIPAA allowed HHS to select an existing proprietary code while requiring all standard code sets to be updated as needed and "that there are efficient, low cost mechanisms for distribution, including electronic distribution, for the code sets and their updates." HHS further states that the selection of a code set did not remove any copyright protections from code sets selected by the rule. The rule made it clear that HHS intended any copyrighted material to be easily available to those mandated by HIPAA to use those designated code sets.

Mr. Murphy said in December dental benefits plans received letters requiring them to sign a Dental Insurer License Agreement with ADA that threatened the possibility of litigation. The agreement grants a dental benefits plan the right to (1) install the code set on their internal computer systems to process claims, develop contracts, and design employers’ benefits plans; (2) retrieve codes and descriptions via CDT commands for the exclusive use of the licensee; and (3) develop utilization data using the CDT. The agreement clearly outlines that the plan would only have the rights mentioned; all others were owned by the ADA. A plan was specifically prohibited from reproducing or distributing any part of the CDT via global computer networks, including the Internet. Any change to the CDT, as outlined by the agreement, would necessitate completion of a separate license for the revised CDT with the ADA maintaining the right to revise the agreement.

The restrictive provisions of this agreement could severely limit the effective and efficient operations of dental benefit plans and add costs to the process. While the current list of allowed uses for the CDT appeared to encompass the process used by most dental benefit plans to process claims, NADP was concerned that ADA could unilaterally modify this limited-use agreement.

NADP believed the agreement failed to contemplate many current uses of the CDT and created serious, substantial questions for plans. Mr. Murphy said no other significant portion of the dental benefits industry was being asked to sign a licensing agreement that so severely restricted their commerce. And apparently agreements weren’t uniformly required of all dental plans. Many small regional or single state carriers and some DDPA plans hadn’t received the demand for licensing.

Dental benefits plans could be restricted from placing a schedule of benefits using CDT on their Web site. Many employers were contractually requiring dental benefit plans to make electronic copies of benefit materials available via the Internet; this agreement would block dissemination of information to consumers. Mr. Murphy said few members had acquiesced to signing ADA’s agreement.

ADA members could order the code for $40. Non-ADA dentists were charged $60. Dental benefit plans were asked to pay $1,000 annually for use of the federally mandated CDT. Mr. Murphy said NADP believed that amount was well above what would normally be considered “low-cost distribution” and represented an effort by ADA to profit off the HIPAA mandate that dental benefit plans must use CDT. NADP’s research hadn’t shown any other DSMO that had different pricing structures based on which segment of the industry a purchaser belonged. NADP urged the Committee to either specify a specific dollar amount that reflects the intent of the law or call on ADA to standardize its charges for the code to amounts in line with what other DSMOs charged for use of HIPAA mandated code sets. Mr. Murphy asked for assurance that income from these fees didn’t support general ADA expenses. And he asked the members to review ADA's actions and procedures and undertake any changes necessary to ensure that appropriate trade organizations, dentists, the government and employers had an integral role in the code set development process.

Panel 3: Industry Representatives

Ms. Oshensky said DDPA, as the nation's largest dental benefits organization, provided coverage to 75,000 employer-sponsored group dental programs serving 39 million workers and their families. DDPA and the ADA recently settled a longstanding litigation and entered into an agreement to implement a consensus approach to code maintenance that would provide for DDPA’s continued participation and the provision of industry input. She noted that the dental code system maintained and distributed by ADA had become a national standard and, as the principal means of communication between dentists and dental benefit payers, the code was central to DDPA and member plans’ core business.

On January 28-29, DDPA and other dental payers had the first meeting with ADA since the settlement agreement. Ms. Oshensky said it appears that procedures in place prior to implementation of HIPAA continued to be the process for updating CDT. No formal procedural format was followed and the ADA representative chairing the meeting determined the agenda arbitrarily. Ms. Oshensky said DDPA’s first recommendation was that the federal government require SSOs to follow specific rules of order. The code set was now a national standard and public participation had to be facilitated in a fair, orderly way.

The preamble to the final rule noted concerns about ADA's process and that ADA had assured the Secretary that "a workable open updating process" would be in place. DDPA has played an integral role in the development and maintenance of CDT and was represented as a voting member on the CPT Editorial Panel responsible for maintenance of AMA’s CPT codes, HCPCS Alphanumeric Editorial Panel responsible for maintenance of the HCPCS code system, and ADA’s Code Consensus Panel--the governing body for CDT. Ms. Oshensky said the participation of dental benefit payers in these SSOs with voting responsibility was key to providing industry input to continue these systems as communications tools for efficient processing and reimbursement of dental and all healthcare expenses. Full representation and input from appropriate payer organizations was crucial to the update and maintenance process for these standards, balancing competing goals of fair payment, affordability and cost management.

Ms. Oshensky noted that, unlike many other standards, the code standard for dental services was maintained and distributed by ADA for a charge. She said that, while DDPA recognized organization’s ability to claim copyright for its work, it was incumbent upon those whose work defined the standards by which the healthcare industry communicated to facilitate easy access. Organizations should be able to recover reasonable costs associated with the production and distribution of their work, however, such charges must not impede access to public codes. The subcommittee must ensure that SSOs that impose a fee do so fairly (e.g., charging a fee for every update may become burdensome and impede access to these now “public” code sets).

Ms. Oshensky said the current process was a continuation of the practices employed by SSOs when HIPAA standards were adopted. No new process was required by law, and the Secretary defined no specific open process model. DDPA recommended that the Subcommittee consider adopting a model format for use by all SSOs to ensure consistency and fairness for all interested parties.

The preamble to the final rule noted elements of an open updating process: a committee of experts composed of a broad cross-section of relevant stakeholders, voting privileges for all members, recognition of all submitted proposals from any interested parties, open meetings announced in advance, and posting of coding changes. The Secretary suggested in the preamble that SSOs should hold biannual meetings with public attendance and without payment of registration fees, establish a central contact for public input, and provide meaningful opportunities for participants to voice concerns and suggest changes.

Noting the code set standard was now incorporated by federal law into a national standard to facilitate uniformity, Ms. Oshensky said DDPA believed objective mileposts should be established by the Secretary to provide a uniform, objective marker for judging whether the updating and maintaining of these standards met the goal of an open process. In defining that open process for updating and maintaining the code set standards, Ms. Oshensky urged the Subcommittee to remember that an open process must, in practice, take into account the concerns of payers as well as providers.

Code set changes should be designed for efficiency and cost management. When possible, changes should be objectively science-based. They shouldn’t be designed solely to enhance provider payment opportunities, without increasing services to patients through code splitting or unbundling. Provider-sponsored code changes should be more than thinly veiled attempts to manipulate coverage controversy.

Ms. Oshensky said an open process balanced the needs of providers and payers. These concerns were expressed in the preamble and the Secretary noted the need to continue to monitor the process and ensure that the code sets meets the industry’s needs. The impact of unbundling could greatly increase the cost of healthcare; once a change was established, it shouldn’t readily be changed or modified, absent a scientific basis.

Code set changes proposed by payers and providers must be given equitable consideration. An open process ensured that all timely submitted proposed changes were widely circulated and considered in open, public deliberation and in a timely way that allows equal, fair review prior to the board's gathering.

An open process had an objective protocol by which proposed changes were judged fairly, not arbitrarily. All stakeholders had a voice in development and determination of objective criteria, facilitating impartial consideration of changes. SSOs spend more time on substance, than on procedure, in debating proposed changes.

Open process ensures that all interested parties receive adequate written notice of the time frame for submitting changes. The notice must be conspicuous and the submission process clear. All changes proposed timely in proper format must be considered by the SSO.

Open process also ensures that implementation of adopted changes occurs fairly for both payers and providers. The process must balance the desire to utilize new code set changes against the time needed to address administrative and physical modifications required to execute changes.

State departments of insurance must approve changes for DDPA plans. Frequent changes were disruptive and time consuming to implement. Biannual updates would make this process more manageable, although the state regulatory process was unpredictable. DDPA plans aimed to implement simultaneously in all 50 states to ensure national consistency and uniformity.

DDPA asked the Subcommittee to recommend establishing federal “mileposts” to objectively judge the openness of the update and maintenance process for all SSOs. These explicit “mileposts” would stem from recommendations of the Secretary noted in Ms. Oshensky’s testimony and DDPA’s observation that, to be an open process, SSOs must: consider only science-based code changes; impartial consideration of changes; adequate notice of change submissions; and appropriate, timely implementation of changes.

Panel 3: Industry Representatives

Ms. Leon-Chisen said AHA worked with CMS and NCHS, for more than 30 years to ensure the appropriate interpretation and application of ICD-9-CM codes. With the addition of the AHIMA, they were collectively known as the cooperating parties. AHA also provided a clearinghouse function through its central office on ICD-9-CM and published Coding Clinic for ICD-9-CM. AHA worked with HHS, the American Medical Association (AMA) and the CPT Editorial Panel to ensure that the same level of integrity and quality was achieved in the hospital application of CPT-4 and HCPCS.

Ms. Leon-Chisen said AHA members relied on the reporting integrity of clinical codes that were a key data component used for benchmarking, quality assessment, public health research and reporting, strategic planning, as well as reimbursement. Accurate, comparable data was required to achieve these objectives. For hospitals and health systems, the important issue was whether the code development process incorporated: (1) sensitivity to all users’ needs, recognizing organized delivery systems shifts from inpatient to outpatient procedures and from physician offices to outpatient treatment facilities; (2) easily accessible and widely understandable instructions on code usage; (3) maintenance through a clearly defined organizational structure capable of achieving high-level coding integrity.

Ms. Leon-Chisen said a well-defined maintenance and implementation process complemented these principles. The maintenance process should include broad-based input and coding system changes should take into account all users’ needs. The process should be predictable, recognizing users' capabilities to adapt to coding changes. It should have routinely scheduled meetings, allowing providers opportunities to review changes, and identify the implementation date. Ideally, coding changes should happen no more than annually. Providers should be able to utilize the same code set version over a given period with a consistent implementation date across all users, including payers. She emphasized that it was important for healthcare providers to have clear, unambiguous instructions and consistent coding and reporting guidelines. Guidelines should be readily available and widely accepted by all payers. Consistent guidelines allowed for the development of comparable health information that provided a better basis for establishing an equitable payment system. Ms. Leon-Chisen added that, While AHA was pleased that the HIPAA code sets included official ICD-9-CM guidelines for coding and reporting, there were no comparable official guidelines designated or under development for the HCPCS or the CPT-4 code sets. AHA recommended that official guidelines be developed.

Ms. Leon-Chisen said AHA supported the current ICD-9-CM update process. ICD-9-CM had a well-defined, broad-based maintenance and implementation process that tried to consider all users’ needs. It was predictable, proposed changes were well publicized, and public comments accepted. Meetings were routinely scheduled to review coding changes and there was a set annual date for using approved changes. AHA was encouraged by AMA's CPT Editorial Panel’s efforts to address members’ needs and consider the interests of non-physician stakeholders. But Ms. Leon-Chisen expressed AHA’s concern about the lack of institutional provider input into the HCPCS Level II update process. She said she was encouraged to hear Ms. Riley announce an open meeting. The panel was comprised of representatives from payer organizations; proposed changes were posted on the CMS Web site and public comments were accepted, but Ms. Leon-Chisen noted this wasn’t the same as having provider representatives involved in the development process.

Ms. Leon-Chisen noted ongoing problems and confusion related to the frequency with which various code sets were updated and uncertain implementation dates for new or revised codes. She applauded HHS's decision to update ICD-9-CM codes no more than annually--more frequent updates would be burdensome to hospitals. AHA members struggled with the quarterly changes in the HCPCS Level II codes. With implementation of the outpatient prospective payment system (OPPS), C-Codes were developed to allow the reporting of devices, drugs and biologicals that qualify for additional transitional pass-through payments. The code set became so fluid that some devices had several different C-Codes in the first year of OPPS implementation. Members have difficulty keeping up with excessively frequent changes to chargemaster and billing systems.

AHA is concerned about implementation issues regarding recent improvements in the CPT-4 code set. Current practice has been for annual updates, however AMA had begun early biannual electronic release of certain new codes on the AMA Web page (implementation dates haven’t been set). Ms. Leon-Chisen cautioned about disparate implementation dates at individual payer's discretion that confuse coders (no code books will be published mid-year) and increase costs to hospitals.

AHA members also struggled with challenges of different implementation dates for the 2002 CPT-4 and HCFA changes. Traditionally, hospitals update HCPCS codes on January 1. This year, CMS instructed hospitals to delay submission of updated HCPCS codes until further notice. Some payers updated the HCPCS codes on January 1, creating operational burdens for hospitals with information systems that couldn’t differentiate between the 2001 version for Medicare patients and the 2002 version for non-Medicare patients. Hospitals that opted not to upload the 2002 version manually separate and process those non-Medicare claims.

To reduce administrative costs, AHA recommended updating all code sets no more often than annually. AHA recommended that all covered entities update their code sets on the same date, preferably October 1st for ICD-9-CM and January 1st for CPT and HCPCS, following current Medicare practice. AHA also recommended that HHS’s regulations clarify the specific version of the code sets adopted and develop transition rules for switch over. Transition rules should require covered entities to maintain and work with the older version for claims for services provided until the new version is released.

CPT-5 improvements call for CPT to address the needs of clinical and health service researchers for coded data. Category II codes were created to capture performance measurements and Category III codes were meant to provide a temporary set of tracking codes for new and emerging technology procedures and services. New categories of codes contain an alpha character as the fifth character in the string, preceded by four digits. Current CPT instructions are that if a Category III code exists, this code must be reported instead of a Category I (traditional) unlisted procedure code. AHA was concerned that a number of state Medicaid programs already indicated that their information systems weren’t capable of accepting the new code structure. Providers were forced to choose between disregarding CPT instructions and violating HIPAA standards or following Medicaid guidance by submitting a CPT unlisted procedure code. Ms. Leon-Chisen said AHA hoped all Medicaid programs were able to update systems by the October 16, 2003 deadline. AHA recommended that HHS declare a moratorium on structural changes to the standard code sets so stakeholders could make necessary changes to ensure compliance.

AHA was also concerned about the lack of progress toward standardization in the application of current code sets. Because existing CPT evaluation and management (E/M) codes correspond to levels of physician effort rather than non-physician resources utilized, CMS had allowed each institution to develop its own system for coding clinic and emergency visits. Widely disparate mapping systems developed with each hospital grading the visit according to its own classification system. However, all use the same CPT code numbers to report physicians’ services. These mapping systems were expected to be a temporary solution until a logical, standardized method for evaluation could be developed. AHA worked with CMS and hoped a standard method of reporting facility E/M services using separate, unique HCPCS or CPT codes be developed before HIPAA implementation in 2003.

AHA recommended that HHS clarify that HIPAA compliance meant codes should have a single meaning to clearly identify what service was being provided and should be assigned in a standard manner with clear guidelines that instruct coders on the proper use and evaluation methods to drive E/M assignment.

Ms. Leon-Chisen noted members concerns regarding reasonable pricing of CPT use, while emphasizing that AHA didn’t want to preclude private sector or copyrighted systems. The private sector played a key role in developing many of these systems and availability of a copyright could be an important incentive to useful development.

Ms. Leon-Chisen said AHA felt progress had been made in reducing local codes; AHA hoped payers continued to work diligently to eliminate them completely.

Discussion

Dr. Zubeldia addressed the discrepancy: ADA believed the dental codes were copyrighted, giving them the right to issue a license, and the panel considered them within the public domain. He asked how the panel proposed to handle licensing, copyright issues, and payment for the development of the codes. Should the codes be in the public domain or were people willing to pay a reasonable fee? He suggested that paying a thousand dollars a year didn't seem unreasonable, and he asked the panelists to define the problem. Mr. Murphy said it was the arbitrary nature of the licensing fee; NADP didn't know what they’d be told to pay in five years. NADP objected to the exclusionary nature of the process.

Mr. Murphy described NADP’s size. United Health Group was a $25 billion health and dental insurance payer. Cigma, Aetna and Guardian Life were members. NADP members paid the bills on behalf of employers, but couldn’t sit at the table. Noting DDPA had a ten-year, renewable royalty-free use of a license, based on settlement of their lawsuit with ADA, Ms. Oshensky said their interest was in ensuring the process was fair and equitable for others. Ms. Leon-Chisen said AHA didn't have a problem with copyrighted systems, but meant to make sure the fees were reasonable. Mr. Augustine said he understood AMA and ADA wanting to charge for work they did, but said that as these code sets moved toward the public domain, he expected give-and-take on both the financial and development sides.

Dr. Yasnoff followed up on the process issue, asking if the ADA Code Revision Committee had a role in setting prices or defining the codes licensing terms. Mr. Pokorny explained that the committee was responsible for maintenance of the code; other ADA divisions handled licensing and maintained the copyright. Dr. Yasnoff queried how resolving everything NADP asked for with respect to additional participation and open process would address issues relative to the licensing provisions or cost--if they were done elsewhere. The issues seemed separate. Mr. Murphy responded that, as payers, NADP’s focus was, in fact, more on the process; if the payer community had to go inside ADA again to discuss fees, that was a secondary issue.

Mr. Blair pointed out that the administrative simplification provision’s guidance to NCVHS in selecting standards was that preference be given to SDOs accredited by ANSI because the institute required those SDOs to conduct their determination of standards and updates in an open consensus-based manner. He noted ADA was a regular member of the ANSI Health Informatics Standards Board. Mr. Pokorny said Robert Owens, ADA’s CIO, was HSBE chair. Noting that Mr. Blair referenced standards development work unrelated to the Code on Dental Procedures and Nomenclature, Mr. Pokorny said these technical standards related to dentistry are within ADA and have nothing to do with ANSI.

Dr. Mc Donald commented that he’d heard "public domain" bounced around a number of times and he thought the word was either misused or misunderstood. He reflected that they didn't want public domain, where nobody had discipline and there could be 5,000 variations. He suggested they wanted copyright with pre-use or very broad use, so there was a control mechanism. He further petitioned what he’d heard. One set of complaints was about bumpy process that he considered easily fixable. He encouraged ADA to fix that process so it didn't confound other issues. The other issue was code sets, and he acknowledged that it might be harder to make that a fully democratic process. A standards organization had to let everything come in, so it didn’t end up with irregularities. Code sets presented more of a challenge with consensus than technical message standards. Dr. Mc Donald asked the testifiers to define their domains of dispute.

Mr. Murphy said the issue for the payers was that the trade association that represented the majority of the dental insurance payer transactions wasn't at the table. Given a fair and open process and dialogue between payers and organized representatives of the dental community with one organization/one vote, most issues could be smoothed out. He said payers didn’t want to make it anymore difficult for a dental care provider to submit procedures and be efficiently and accurately paid. It was their objective to do that as rapidly as possible to lower costs. The key thing was enough cycle time to implement. Mr. Murphy doubted they’d get that time, if payers weren’t at the table and part of the process.

Ms. Oshensky noted some codes were put forth by specialty organizations (e.g., oral surgeons, periodontists) and involved science-based new technology everyone could support. Other proposals collapsed codes (e.g., so work done on primary and permanent teeth were given the same code). There wasn't any scientific basis for that and there were issues with the coding.

Dr. Cohn stated that he found the testimony received from the dental and payers' associations to be relatively serious allegations. He said he hoped ADA would provide a written response addressing these allegations. Noting he was taken with Ms. Leon-Chisen’s first principle (the code development process should be sensitive to needs of all users), Dr. Cohn said they probably couldn’t have complete happiness, but that responsiveness was a desirable part of code development the Committee encouraged.

Dr. Fitzmaurice continued along the vein Mr. Blair had introduced. ADA was accredited and knew and followed the ANSI process, but in the case of the CDT codes had chosen not to follow that process. Mr. Pokorny took exception: The code set had never been put forward as an American National Standard--ANSI process didn't apply.

Panel 3: Industry Representatives

Mr. Meyers summarized written comments from HIAA, the trade association for the private insurance industry, reflecting claims, processors, and data users perspectives on the CDT code system for dental services developed by ADA and the process, participation and access to CDT.

Mr. Meyers said HIAA strongly believed there should be: early and periodic communication of code changes and suggestions, open discussion of issues, ability to suggest alternates based on submitter suggestions or in addition to original requests, an open process inviting comment from interested parties, easily found information on meeting schedules and agendas, and recognized rules of order. Payer participants should be selected for their familiarity with dental claim payment processes and perspective on dental issues. While understanding that DSMOs should be able to recover reasonable costs associated with maintaining the data set, HIAA believed price should be equitable.

Mr. Meyer said licensure of the ADA code set was implied in the copyright when purchased by the provider parties; payer organizations signed a formal licensing agreement and paid a fee to access the code. The agreement stated that ADA reserved the right to modify or change the code, implying a unilateral right to change the code without previous announcement or schedule of code changes, language Mr. Meyers suggested was prohibited by the responsibilities conferred upon DSMOs.

Mr. Meyers asked the Subcommittee to consider these facts in deliberating on responsibilities of DSMOs. By law, all users must use these designated national standards for the efficient electronic transmission and processing of health claim information. HIAA believed that to do so, there had to be a formal process with scheduled events for meeting review, communication, implementation, appropriate representation from both payer and provider communities and, most importantly, equitable access to the code set at reasonable cost for all users.

Panel 3: Industry Representatives

Ms. Prophet said AHIMA was a professional association representing more than 40,000 members, who manage patient medical and clinical information in the form of health records and databases and provider health plan, government research and other private organizations, facilities and practices. AHIMA was an advocate of its members overwhelming desire to see consistency, uniformity and best practices for coding in all standard government regulations and industry practices and an active participant in numerous coding standards groups including the ICD-9-CM Coordination and Maintenance Committee and the CPT Editorial Panel.

One issue AHIMA identified with CPT was that these codes were primarily designed for physician billing and the requirements of the Medicare Resource Base Relative Value Scale and not for health research, data tracking, quality, analysis, and electronic patient record systems and databases.

HCPCS was divided into three levels: Level I were the familiar CPT codes; Level II were the codes developed by CMS, HIAA and BCBSA; and Level III were the local codes. Ms. Prophet noted there was considerable room for duplication of codes across the CPT and the HCPCS Level II code sets and constant potential for misunderstanding. AHIMA members daily faced the problems of lack of coding specificity, required use of duplicative or overlapping code sets, inability to compare coded data meaningful, and conflicting code requirements for different individual payment policies, including government payers. AHIMA testified in May 2001 to the ICD-9-CM Coordination and Maintenance Committee about the need for a study of the procedural coding systems currently in place and the conflicts that exist. A copy of the testimony and a newly revised Payer's Guide to Health Care, Diagnostic and Procedural Data Quality is available at www.ahima.org.

Ms. Prophet said several problems inherent in the code sets wouldn’t be resolved until the industry addressed their replacement or modifications necessary to recognize current and future needs. Each medical code set process in use was different. Like the code it maintained, each was established in a different era. Ms. Prophet said they had to judge how these processes met the goals and objectives of data and information consistency (now and in the future), administrative simplification and use in a mandated HIPAA system, and user integration.

Ms. Prophet said AHIMA shared concerns AHA addressed in its testimony regarding code set effective dates and distribution. AHIMA members were concerned that some private health plans were using effective dates outside of HCPCS Level II codes’ quarterly schedule. These issues needed to be addressed.

Regarding code set costs, Ms. Prophet said products utilizing medical code sets in the public domain were more readily available and affordable than those utilizing a copyright, wherein delays occurred because of licensing issues. They’d heard in other testimony that it was unclear whether costs related to code sets with a copyright were excessive. The issue had to be explored. Complaints were raised by members about costs associated with obtaining official advice from the code set maintainers or other organizations designated responsible. Ms. Prophet remarked that, again, they didn’t have a sense of fair cost and until the process was reformed and a coordinated and funded coding effort in place, someone had to pay for maintaining codes.

Ms. Prophet addressed AHIMA's recommendations. One: AHIMA believed that all payers and providers should be required to adhere to the existing code set rules, definitions and guidelines as developed by the code set maintenance organizations and published as part of the code set. HIPAA regulations should be modified to require users and covered entities to follow a code set's rules, definitions and guidelines in line with other recommendations. Two: Coding guidelines should be part of the standard code set and all users must abide by them. HIPAA regulations should be modified to reflect this requirement. The coding system rules and guidelines should be updated on the same schedule as the code set. Three: Every accepted standard medical data code set organization must be required to have an organized process for development and maintenance of the codes, rules and guidelines for correct, consistent use of their code set. The process for developing codes, code set rules and guidelines should include broad access and input and representation from a full range of stakeholders, including coding and clinical experts, practitioners and users. Input should be solicited prior to finalization of a new or significantly revised rule or guideline and meetings should be open to the public or, at a minimum, to primary stakeholders. Notice of meetings should be posted at an appropriate time in at least the Federal Register. The agenda and information on submissions should also be posted.

Four: All these processes should be placed under the supervision/oversight of a single entity or authority who (acting similar to ANSI) should: provide oversight and authority to the guideline development process for each medical code set, ensure consistency in processes, and ensure that the various standard code sets complement one another and work in tandem without duplication or overlap. Five: Given multiple uses of coded data, this lead authority shouldn’t primarily focus on the needs of any one healthcare provider or plan, but objectively balance the various needs of the different stakeholder groups. This authority must be given sufficient resources to manage this new responsibility. AHIMA believed the logical choice for this central authority would be an expanded and appropriately funded NCHS. NCHS already served as the principal health statistics agency in the United States and was charged with providing statistical information that would guide actions and policies to improve the health and health systems of the American people. NCHS was also the U.S. link to the World Health Organization on coding issues.

Ms. Prophet said AHIMA believed four principles should guide code set maintenance. One: due to rapid advances in medicine and technology and the immediate need for codes to describe them, the maintenance process should be more streamlined, with consideration given to the feasibility of more frequent system updates. Two: length of time between proposal of a new code and its implementation should be minimized. Three: an established process should be in place for developing rules and guidelines for the correct application of the coding system. The process should be open and permit broad input from all stakeholders prior to finalization of a significantly revised or changed guideline. The coding system rules and guidelines (and consequent payment system changes) should be updated on the same schedule as the code set and made part of the official version. Four: All requisite materials (code sets, guidelines, definitions and other directives) should be in formats available for government or private entities, ensuring unfettered access to official, most recent versions and interpretive materials.

AHIMA believed the responsibility for ensuring maintenance and coordination of these coding systems and development of the associated rules and guidelines should be the domain of a single agency, so decisions balanced the needs of users, payers and providers to ensure data integrity wasn’t compromised. Noting medical code sets and their maintainers suffered from abuse of the codes, Ms. Prophet outlined AHIMA's recommendations for proper coding use authority. No healthcare entity should be permitted to change these rules to accommodate an adjudication process or revenue systems. The “official” source of coding advice should be clearly identified and readily accessible so all users could readily procure “official” coding advice. Coding support services, newsletters and educators should be required to stay abreast of and provide direction consistent with official rules, definitions and guidelines. She noted the need for a lead authority to designate the source of “official” medical coding information and ensure conflicts were resolved by appropriate sources.

Due to issues with overlapping and duplicative code sets and the use of multiple procedural code systems, AHIMA made the following recommendations. One: a single procedural coding system be developed and adopted for use across all healthcare services sites. Two: a federally funded examination of the feasibility of moving to a single system that evaluates (a) the efficacy of alternative systems across all healthcare settings, for all payer types and services (addressing the need for uniform data to fulfill the needs of a national healthcare and public health infrastructure, healthcare research and other non-treatment use of healthcare data); (b) the implementation and long-term cost and benefits of a single system compared to multiple systems; and (c) a recommended strategy for implementation that accounts for implementing future systems (e.g., ICD-10-CM). Three: The HCPCS coding system should be revised so that this single procedural coding system is recognized as the exclusive coding system for procedures and services. HCPCS should then become a coding system with a more open development and maintenance process, representing only products, technology and supplies that weren’t procedures and services. The HCPCS coding system processes should continue to be reformed to eliminate HCPCS Level III codes and the process for this new coding system and timeline should be published so entities using local codes knew how to secure a new code.

Ms. Prophet said AHIMA recommended that code set maintenance organizations should consider refining processes to minimize lag time between code proposal and implementation. A single standardized process should establish temporary HCPCS Level II codes. The process must ensure that a duplicate code wasn’t anticipated in another coding system and codes should be for all parties, but not dictate payment policies (ensuring that overlapping or duplicative temporary codes weren’t created). A standard time frame for implementing changes in temporary codes should be adopted.

AHIMA also recommended that payment or reimbursement systems accept proper coding practices. Temporary codes shouldn’t be created for procedures, services, items or supplies that could appropriately be reported with existing national HCPCS or CPT codes. A process and time frame should be established for transitioning temporary codes to permanent codes in the appropriate standard code set. An appropriate lag time between release of the new CPT Category III codes and their effective date should be required and it should be made clear that these codes were part of the CPT standard code sets and implementation and use was mandated. Ms. Prophet noted there might be a need for greater lag time between release of the annual CPT code changes and the January 1 effective date, so systems changes could be made and all payers could implement reporting. Vendors and payers should be asked for input. AHIMA suggested a central authority could establish a standard time period between release of code changes and the effective date for all medical code set developers. Ms. Prophet said AHIMA would discuss ICD-9-CM and its potential replacement in subsequent hearings.

Panel 3: Industry Representatives

Ms. Gilbertson said in order to maintain delivery of care (products and services) to the patient, NCPDP recommended: (1) HHS recognize NDC, UPC and HRI codes in addition to HCPCS as valid identifiers for supply billing transactions, (2) these codes be permitted via NCPDP standards for the billing of supplies, (3) HHS clarify that NCPDP standards are acceptable for the billing of supplies, and (4) HHS recognize NCPDP standards for the billing of professional pharmacy services.

Currently, pharmacies and pharmacy claim processors supported the 11-digit NDC, UPC and HRI codes for billing millions of supply claims per year, using NCPDP standard. Most pharmacies and pharmacy claim processors had supplies in their databases identified via the NDC, UPC and HRI codes. Ms. Gilbertson said costs for programming and database purchases would be significant to switch solely to HCPCS, which wouldn’t provide the specificity required for the current level of patient care.

Ms. Gilbertson noted the final rule didn’t name a standard for billing of supplies, but inferred a default would be to use the X12N 837 implementation guide. Noting that NCPDP standards were designed for this purpose with pharmacy industry consensus, she asked for clarification allowing the use of these standards for the billing of supply claims consumed or used during, or as a consequence of, administration of a drug therapy, or commonly dispensed via a pharmacy. (The X12 837 implementation guides should be used for billing of other medical supply claims.)

Noting the final rule incorrectly stated that the NCPDP standard couldn’t support the billing of professional pharmacy services because it “did not support HCPCS J-Codes,” Ms. Gilbertson pointed out that, in another section, the final rule listed support of professional pharmacy services as a quality of the NCPDP standard. Noting pharmacies and pharmacy processors support the NCPDP standards for the online, real-time billing of professional pharmacy services via HCPCS J-Codes, Professional Pharmacy Service Codes and numerous other identifiers, Ms. Gilbertson asked that, in addition to the X12 standard, NCPDP be recognized for this billing.

HHS already recognized the NDC code for drugs and biologics and the HCPCS for medical supplies. Many supplies were identified by an NDC. Over-the-counter drugs and supplies didn’t have a valid NDC code; manufacturers utilize a UPC or HRI code. HCPCS codes assigned to many of these products didn’t permit individual manufacturer-specific pricing. One of these databases contained more than 19,000 products with no associated NDC code. While these items might have HCPCS codes and associated maximum-allowable-cost (MAC) pricing, as defined by CMS, billing and payment on most non-government sponsored payers was based on individual manufacturer costs. HCPCS couldn’t be the only identifier and associated MAC-based pricing via HCPCS might not apply.

Ms. Gilbertson also noted that the pharmacy industry currently supported the drug utilization review (DUR), and professional pharmacy services codes in support of patient care and billing of professional services. After professional consultation with other medical personnel, these codes were used online, real-time, to automatically justify the dispensing of potentially conflicting drugs. These codes were part of the NCPDP standard, but weren’t supported in the X12 standard. The NCPDP standards for the billing of professional services supported about 20 fields used as identifiers for reason for service, results of service, professional fee information, and level of service rendered. Ms. Gilbertson said the industry supported the use of these fields to describe the professional service and to facilitate information sharing for patient care.

Discussion

Noting that the Secretary adopted standards based on the type of claim (e.g., institutional, professional, dental, pharmacy), Dr. Zubeldia said Ms. Gilbertson seemed to be advocating a carve out where pharmacy would be based on provider/payer and that, for pharmacy benefit managers and payers, the claims would be in NCPDP formats even though they might be for services generally billed in the 837. Ms. Gilbertson tweaked that interpretation: what was part of the pharmacy benefit should be billed using NCPDP standards; X12 standards were perfectly acceptable for the medical benefit. Pharmacies billed on HCFA 1500s to help customers who needed to build those types of claims. The pharmacy industry wasn’t against supporting both standards, but wanted to use transactions developed with pharmacy consensus for the pharmacy benefit.

Dr. Cohn expressed surprise that this hadn’t surfaced last year in discussions about changes to the NPRM processes. Ms. Gilbertson explained the issue wasn’t identified until somebody innocently asked how to bill supplies: the answer came back, bill insulin as the drug using NCPDP and syringe as a medical supply. The NPRM was already in progress; there were no modifications at that point. Ms. Gilbertson reiterated that pharmacies weren’t opposed to using both X12 and NCPDP transactions; there had been give-and-take and they understood it made sense to bill certain benefits X12. Dr. Mc Donald rephrased the query: Was this a good precedent? He said he wasn’t opposing, but trying to explore, the issue. What worried him was how they’d ever achieve unity if, in the first round, they were already carving out dualities. Ms. Gilbertson replied that this wasn't carve-out; it was clarification of current business being done via NCPDP standards. Dr. Mc Donald countered that the same argument could be made for the Medicare hospital bill. Ninety percent of the hospitals used an electronic standard. That was historical reality and the agreement was they’d get to one standard. Ms. Gilbertson responded that there was a big difference with this currently done online, real-time and drug and supply could be split. Dr. Mc Donald acknowledged that professional billing and supplies were different; he could see the argument more clearly with supplies. Ms. Humphreys said she didn’t recall any comments from NCPDP about this happening every day in an NCPDP standard when they’d asked for input on code sets.

Asked the percentage of pharmacies that billed supplies using NCPDP codes and transactions, Ms. Gilbertson said there were 3 billion pharmacy claims and they were talking about millions of supplies. Professional services was a small portion, right now. Wisconsin Medicaid program had a very successful professional service program going under the NCPDP standards for pharmacies, but these services were smaller in perspective. She said she’d provide the actual numbers to the Committee.

Ms. Humphreys noted the professional pharmacy services taxonomy was a good system, but hadn’t been in use and “on the table” when the original collection of information about standards and uses for various services was compiled. Dr. Mc Donald observed that, if he understood what Ms. Gilbertson was saying, all the receivers and maybe all the senders would have to support both. Was that really what she wanted? In response, Ms. Gilbertson noted two things. One: concerns about providers and payers needing to really look at the types of services and the point that met the business needs, And two: members’ dilemma with the DUR: having to get two different prior authorization answers (from whoever controlled supplies and whoever controlled the drug) for a prescription--each within its own cycle, because one was online, real time and the other a batch transaction. She said it was more about patient care than which standard.

Remarking that he was echoing the confusion around the table, Dr. Beebe said the CPT Editorial Panel received a letter from APA requesting participation on the Health Care Professional's Advisory Committee (the basis was the need to code professional services under the 837, using CPT), which advises the Editorial Panel on non-physician issues. He said the panel, like everyone else, was mightily confused about “which will be used where, how, when, why.” Anything the Subcommittee could do to help would be greatly appreciated.

Ms. Gilfoy expanded upon Ms. Gilbertson’s thoughts. SNP was doing a survey, asking providers what they expected to send and payers what they expected to receive. The version of the 837 submitted appeared to be payer dependent, which Ms. Gilfoy pointed out was exactly what they tried to get away from. Provider and payer communities had different views on which portions of the ambulatory surgery were institutional or professional claims. Ms. Gilfoy said Mr. Shugart touched upon this earlier, but she didn’t think people realized how much guidance was actually needed. She cautioned that all the efforts of administrative simplification could be undermined at this level. Mr. Arges said NUBC was hearing the same sort of issues from the hospital community. NUBC was putting together a special work group to look at providing guidance. He noted there were other regulations and laws that require institutional providers to comply with certain aspects of the Social Security Act. And other types of forms, like the A55 form that CMS required to indicate whether one was billing an intermediary, carrier, or the DME. He said, hopefully, some guidance could be provided in terms of how organizations were structured, their obligations, identifying certain components of service the organization provided, and around the documents. But he expressed concern that the WEDI-SNP survey gauged what industry did today, rather than help define terms and usages first, setting out clearly what industry was to do under different circumstances.

Discussion of Testimony by Subcommittee

Dr. Zubeldia summarized, beginning with ADA’s presentation on the process for the dental codes followed by contradictions and allegations. Noting the Subcommittee clearly requested a response, members drafted a brief letter confirming the request for a formal explanation of ADA’s position. After evaluating that response, members will decide if additional hearings are necessary.

Dr. Mc Donald said AMA’s statement that they didn't keep separate accounting and couldn’t tell where their licensing fees went was interesting, but he didn’t know that it was relevant. The Subcommittee’s job wasn’t to minimize profit. He suggested the test was: Is it a reasonable expense? Dr. Mc Donald said he wished he knew whether people were out of compliance with the medical records coding area. If every place touched was CPT code, it could be expensive--And he didn’t know how they’d enforce it. Maybe it could be done through vendors. Mr. Blair observed the issue of whether funds charged for license fees were diverted to other purposes within professional associations had been raised as a valid concern the industry had widespread concern about and should be dealt with consistently across the board. Dr. Mc Donald disagreed: it was the cost to the user that counted. The question was: Is it cheap--indefinitely cheap? Mr. Blair agreed ultimate cost to the user was a valid concern, but he noted the cost of a code set that was especially comprehensive or widely used with frequent updates might be high, but justified. A concern raised by many was whether the fee was being used for updating and maintaining the code set or for making a profit for the professional association. Mr. Blair said both were concerns.

Ms. Greenberg noted a number of issues were raised regarding ADA and they were formulating a response to the entire testimony. They were talking about a longstanding practice, whether it was WHO or a government agency, and she agreed they couldn’t get into those issues. When WHO sold ICD-10, gains didn't go back to the ICD process. She reminded them they’d agreed that it wasn’t the role of those who wanted more resources to say how it had to be done, because every organization had its own cost accounting process. The bottom line was: Is it reasonable in relationship in to what the user can pay and what it costs to produce? Dr. Mc Donald pointed out that they’d heard there wasn’t a schedule, there seemed to be capriciousness in a process that was raggedy, and people couldn't even come to meetings. Those complaints were solid. Dr. Yasnoff agreed. The Subcommittee didn’t want to get into costs and how profits were allocated. It wasn’t just the cost of maintenance; what about the investment in creating the code set? An organization should get return on investment. How much that should be, and for how long, were difficult issues. HIPAA said HHS was supposed to “establish efficient and low cost procedures for distribution, including electronic distribution of code sets and modifications made to such code sets.” Dr. Yasnoff said that was what they needed to work on. The primary issue was process. People were frustrated because they weren’t at the table in the way they wanted to be. And they’d made it clear that, if that was taken care of, other issues would go away. They didn't want to take on issues they didn't need to address. Ms. Humphreys agreed cost didn't sound like a major issue. But she point out there was concern about licensing issues not being required of everybody and efforts to outline intent or principles by which costs or licenses could be drafted.

Dr. Cohn suggested a first step was to do analyze the testimonies, pulling out issues that, if fixed, would help with implementation by October 2003. Once they had that list they could decide next steps. Dr. Zubeldia noted a big issue that surfaced again that day was version control. Except for the traditional CPT codes, everybody had version control issues that needed to be addressed. Ms. Humphreys noted two big and quite different issues--version control and the update schedule--were linked together. Dr. Yasnoff suggested that they might need to schedule time soon to deal with pharmacy transactions.

Ms. Humphreys noted a number of testifiers talked about including a specific guide for each code set as part of the implementation guidelines. Dr. Zubeldia said they’d seen clearly that there were subsets of the guides: home health, outpatient and inpatient subsets were spread throughout the 837 institutional guide. Requirements (e.g., for ambulance, DME, or anesthesia) were scattered also, making it difficult to implement. And there were no standard industry definitions of subsets. Noting they were working with CMS to define those subsets for Medicare, because Medicare already had well-defined instructions, Dr. Zubeldia suggested NUBC and NUCC, as data content organizations, could define subsets for all of industry still using those guides.

Dr. Yasnoff said they might want to bring the testimony about an agency responsible for code sets to the attention of the NHII work group because it was consistent with their final report’s recommendations for an office in HHS responsible for implementing NHII. Remarking they’d see over the next couple of sessions what fit into broader concepts, Dr. Cohn suggested they pull issues that applied to the next three hearings. Dr. Mc Donald agreed they shouldn't be deciding about some of the suggestions that “needed to be exposed to the world.” They’d heard testimony suggesting people were afraid of changing code sets; Dr. Mc Donald cautioned that they had to be careful going forward.

Members noted an issue was that the CPT guidance needed to be standardized as well as the code sets. Dr. Yasnoff said another issue they’d heard was that changing code sets created the burden of supporting both sets simultaneously, so claims for services filed before the change could be met. Ms. Humphreys noted there’d been a lot of discussion about that when they worked on the NPRM, but there hadn't been another way because otherwise people would grandfather themselves in forever. If one billed for a procedure in early December and the switch over was in January, Ms. Humphreys questioned what happened when it was adjudicated in February. The rule said to use what was there and implied the payer had to be able to process any valid transaction. A transaction created in December with a December code was valid. Dr. Zubeldia said the problem became acute when that transaction became a coordination of benefits transaction in January: the coordination of benefits transaction created in January had to have a December code that, intentionally, was no longer valid. Mr. Arges explained that according to the final rule, the date for inpatient purposes was the discharge, not the services date. But the clinical code assigned on an outpatient claim would be date of service. Rules were needed to guide people in applying the code sets. He suggested a one-year transition period backwards for maintaining the code sets would lessen the associated burden.

Ms. Gilbertson remarked that the only way to find out if those code sets were valid was to go to the X12 Web site. The code sets were listed, based on when they were reviewed. One might have to go look through a series of minutes to determine when a code was no longer active. She said that would be a problem when filing a claim or doing any of the transactions. Dr. Mc Donald speculated about a more rational way to transition code sets: one wouldn't transit to a new code set that couldn't be backward mapped, but some codes in the early sets wouldn’t always be valid.

Dr. Fitzmaurice said he’d heard that they were running out of God’s “infinite number of numbers.” ICD-9 had to go to 00 and, eventually, would have to transit to ICD-10-CM-PCS. Not immediately, but in time, Dr. Fitzmaurice said rules would be needed for the transition. Dr. Cohn commented on a tendency to solve every small problem; he advised that they had to get very smart about delegating and getting things resolved.

Ms. Pickett commented on a difference of opinion about what was actually included in ICD-9-CM Chapter 5 (which covered mental health and other behavioral disorders) and the DSM manual (which included code numbers, descriptors, and criteria for identifying conditions). Those latter components weren’t part of ICD-9-CM Chapter 5 and, according to APA, some descriptors in DSM technically weren’t the same as descriptors in ICD-9-CM. However, Ms. Pickett said the codes in DSM mirror-imaged or paralleled what was in ICD-9-CM. APA’s concern was that mental health providers had been assigning codes based on the DSM codes and their criteria; now ICD-9-CM was the official HIPAA standard and the DSM codes couldn’t be used. APA hoped the Committee would also adopt the DSM codes. Mr. Blair said they’d hear testimony on alternative billing codes in April. Noting there were a lot of different ways to address needs for those codes and that there would be testimony providing a number of solutions, Mr. Blair suggested they might want representatives of all four DSMOs present. Members noted that APA came that morning, prepared to testify, but decided, because they want to primarily address diagnosis gaps in the current HIPAA standards, to testify at the upcoming diagnosis hearing.

Review of PMRI Recommendations Letter

Mr. Blair explained the Subcommittee was reviewing the seventh version of the draft NCVHS recommendation letter on PMRI message format standards. About a year ago, members decided to cover message format standards during this first phase. They spoke to many SDOs, assembling criteria used to develop a meaningful questionnaire. Drawing upon SDOs feedback in the questionaire and from users and software vendors who critiqued their experiences with the different standards, members drafted and refined this letter to the Secretary. In January, a number of industry reviewers were asked to critique the letter and their feedback shaped this latest draft. Responses that raised issues for consideration during this review were e-mailed to members on January 24. Mr. Blair said he understood individuals in the room might have additional thoughts and he assured everyone there would be opportunities to comment.

Dr. Fitzmaurice led the Subcommittee through the seventh draft, pointing out changes that Dr. Cohn and he discussed earlier and covering comments from outside reviewers. The working draft began:

Dear Secretary Thompson: As part of its responsibilities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the National Committee on Vital and Health Statistics (NCVHS), was called upon to study the issues related to the adoption of uniform data standards for patient medical record information [PMRI], and the electronic exchange of such information. The NCVHS presented this report to the HHS Data Council on August the 9th, 2000, and it is attached. This report provided a framework to accelerate the development of PMRI standards and a set of guiding principles for the selection of specific PMRI standards. The report also recommended that the NCVHS use the guiding principles for selecting PMRI standards and send the first set of PMRI standards and recommendations to the Secretary of HHS by February 2002. This letter sets forth recommendations for the first set of PMRI standards. This first set of standards, are generally referred to as PMRI message format standards.

Mr. Blair noted concerns that it wasn't entirely clear that these recommendations on message format standards were only the first in a series of recommendations. Members also revised the opening paragraph to remove repetitions and clarify that the guiding principles were in the report:

Dear Secretary Thompson: As part of its responsibilities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the National Committee on Vital and Health Statistics (NCVHS), was called upon to “study the issues related to the adoption of uniform data standards for patient medical record information [PMRI] and the electronic exchange of such information. NCVHS presented this report to the HHS Data Council on August the 9th, 2000 (attached). This report provided a framework to accelerate the development of PMRI standards and a set of guiding principles for the selection of specific PMRI standards and a set of guiding principles for the selection of specific PMRI standards. This letter sets forth recommendations for the first set of PMRI standards which is limited to PMRI message format standards.

A redundancy was deleted from the second paragraph, revising it to read:

Standards for PMRI are important because they will facilitate significant improvements in the quality of patient care, promote patient safety, control rising healthcare costs, enhance the productivity of clinical research and strengthen the nation's ability to identify and respond to healthcare emergencies. They are critical to the creation of National Health Information Infrastructure.

Process to Select PMRI Message Format Standards

NCVHS used the following process for the selection of PMRI message format standards to obtain industry input from standards developing organizations, healthcare information system vendors, healthcare organizations and the professional societies and other users of these standards. First, the committee adapted the PMRI guiding principles to make them more appropriate for the selection of message format standards. Next, the committee incorporated the revised guiding principles into a questionnaire that was designed to help NCVHS evaluate the PMRI standards candidates in an objective manner. Finally, the committee compiled, analyzed and reviewed the SDOs responses to the PMRI questionnaire. Additional information and perspective about the candidate PMRI standards was obtained via direct testimony from health information system vendors and other users of these standards. This process continued from December 2000 through February 2002.

Guiding Principles Used as Criteria for Selection

NCVHS recommendations for PMRI message format standards are selected from the six SDOs that responded to the PMRI questionnaire: ASTM, DICOM, HL7, IEEE, NCPDP and Object Management Group’s Health Care Domain Task Force. The committee emphasized the following four criteria derived from the PMRI guiding principles; the degree of market acceptance of the standard, the extent to which the standard enables interoperability between information systems, the ability of the standard to facilitate the comparability of data and the aspects of the standard that support data quality, accountability and integrity. The criterion of market acceptance is helpful because it identifies those PMRI message format standards that are implementable, cost justified and flexible enough to meet the needs of most of the relevant marketplace.

Recognition of Current Standards and Incentives for Emerging Standards

NCVHS has recognized the important role played by the PMRI standards, currently used by the healthcare industry. Since it has taken years for several of today's standards to achieve broad market acceptance, they are based on older conceptual models. Those models do not uniformly provide the high degree of interoperability and data comparability that is necessary to support significant improvements in healthcare cost, quality and productivity. To promote more rapid realization of these benefits in accordance with the prior recommendations in the PMRI report, NCVHS is recommending that HHS recognize current standards as well as provide specific incentives to accelerate the development and early adoption of emerging PMRI standards.

Members edited this paragraph to read:

NCVHS has recognized the important role played by PMRI standards, currently used by the healthcare industry. Because it has taken years for several of today's standards to achieve broad market acceptance, they are based on older conceptual models. Those models do not uniformly provide the high degree of interoperability and data comparability that is necessary to support significant improvements in healthcare cost, quality and productivity. To promote more rapid realization of these benefits in accordance with prior recommendations in the PMRI report, NCVHS is recommending that HHS provide specific incentives to accelerate the development and early adoption of emerging PMRI standards as well as recognize current standards.

Recommendations Encourage HHS Guidance and Incentives Rather Than Mandates

The NCVHS recommendations for PMRI message format standards advise that HHS set forth guidance for industry use and migration to new versions, rather than the creation of NPRMs and federal regulations. NCVHS also recommends that the Secretary direct government healthcare institutions and other organizations to follow this guidance by becoming early adopters of emerging PMRI standards; thereby, serving as an example and as an incentive to the industry.

Members redrafted the paragraph to clarify that it addressed directing government agencies, not mandating to other organizations, and focused on PMRI message format standards:

NCVHS recommends that HHS set forth guidance for industry use of PMRI message format standards and migration to new versions, rather than create new federal regulations. NCVHS also recommends that the Secretary direct government agencies to follow this guidance by becoming early adopters of emerging PMRI standards, thereby serving as an example and as an incentive to the industry.

NCVHS recommendations for a specific PMRI message format standards

NCVHS recommends that HL7 be recognized as the core PMRI standard and that DICOM, NCPDP, Script and IEEE 1073 be recognized as standards for specific PMRI market segments. The recommendations for all of these PMRI standards are set forth in a framework identifying which version of the standard should be considered as: retired, current or emerging.

Retired Standards

The NCVHS recommends that HHS recognized the following PMRI message format standard as retired: HL7 version 2.1.

HHS guidance to Government and industry--No new products using this version of the HL7 standard should be purchased or developed. Vendors and users should plan to upgrade any system using HL7 version 2.1 to a current version of HL7.

The paragraph was revised to focus explicitly on the guidance the Subcommittee recommended HHS provide government agencies.

HHS Guidance to Government and Industry--Users should specify that no new products using this version of the HL7 standard should be purchased or developed. Vendors and users should plan to upgrade any system using HL7 version 2.1 to a current version of HL7.

Current Standards

The NCVHS recommends that HHS recognize the following HL7 versions and transaction sets as the current PMRI message format standard: HL7 versions 2.2, 2.3, 2.4 and later 2.x. This includes standards for the following transaction sets: order entry, scheduling, medical records/image management, patient administration, observation reporting, financial management, and patient care.

HHS Guidance to the Industry-HHS recognition of HL versions 2.2, 2.3, 2.4 and later 2.x, as current standards means that vendors and users of these versions will not be asked to migrate to newer versions until the more advanced version is fully implementable with the supporting implementation guides and conformance tests.

Members edited this (and subsequent) lead-ins to parallel the previous construction.

HHS Guidance to Government and Industry.

Emerging standards

The NCVHS recommends that HHS recognize the following PMRI message format standard as an emerging standard based on its potential to provide superior levels of interoperability and data comparability: HL7 version 3. This includes standards for the following (version 3) transaction sets: administrative management, health and clinical management, and infrastructure management.

Recommendation to HHS--NCVHS recommends that HHS provide incentives to accelerate the development and early adoption of the HL7 version 3 standards. These incentives include: the funding of publication of version 3 implementation guides and the development of conformance tests; and the early adoption of version 3 standards by departments and agencies within HHS.

Again, members paralleled another previous construction, revising the last sentence:

These incentives should include but not necessarily be limited to the funding of publication of version 3 implementation guides and the development of conformance tests, and the early adoption of version 3 standards by government agencies.

HHS Guidance to Government and Industry—After the implementation guides and conformance tests are available and early adoption of HL7 version 3 proves to be successful, additional HHS guidance to the industry will be forthcoming.

Ms. Narcisi asked why incentives weren’t provided to help users defray their costs. Mr. Blair said HHS had already responded favorably to the incentives recommended.

Market Segment PMRI Message Format Standards

Current Standards

The NCVHS recommends that HHS recognize the following as current PMRI market segment message format standards based on their market acceptance, ability to address specific market segment needs and of their cost effectiveness: (1) DICOM--Supports retrieval of information from imaging devices/equipment to diagnostic and review workstations, and to short-term and-long term storage systems, (2) NCPDP Script standard--This standard communicates prescription information between prescribers and pharmacies. These transactions include new prescriptions, prescription refill requests, prescription fill status notifications, and cancellation notifications.

HHS Guidance to Government and Industry--New users should adopt the latest versions of the DICOM and NCPDP Script PMRI market segment standards whenever possible.

Emerging standards

The NCVHS recommends that HHS recognize the following as an emerging PMRI market segment message format standard based on its potential for vendor acceptance and its anticipated ability to address specific market segment needs.

IEEE 1073 (1.1.1, 1.2.1, 1.3, 2.1.1, 3.2) A set of medical device communications standards also known as ISO 11073 standards. Communicates patient data from medical devices typically found in acute and chronic care environments (e.g., patient monitors, ventilators, infusion pumps, etc.).

HHS Guidance to Government and industry—Users should consider becoming early adopters of the IEEE 1073 medical development communications standard.

Noting members had expressed concern about how solid IEEE was, Mr. Blair said he’d added considering becoming early adopters to the HHS guidance. He said he didn’t put in anything about asking for HHS incentives because that didn't seem to be the will of the Subcommittee. Dr. Yasnoff suggested government agencies could pilot use of IEEE.

Dr. Cohn noted Todd Cooper had commented on the need for incentives and additional funding to create tools for supporting profile specification and conformance testing, as well as integration. Dr. Yasnoff recalled that members, concerned they didn't understand the issues related to market acceptance, were reluctant to recommend strong incentives at this point. This was mild—But he questioned paying for conformance testing for something that wasn’t there yet.

HHS Guidance to Government and industry—Users should consider becoming early adopters of the IEEE 1073 medical development communications standard. HHS should encourage government agencies to pilot the use of this standard where appropriate.

Harmonization among PMRI Message Format Standards

The NCVHS recommends that HHS encourage the PMRI SDOs to share their data elements and data definitions with the U.S. Health Information Knowledge Base (meta-data registry). Additionally, HHS should encourage the PMRI SDOs to continue their collaboration to reduce or eliminate duplicate or inconsistent data elements, especially those for patient information. Furthermore, HHS should encourage the PMRI SDOs to harmonize their data elements and data definitions for future versions so that they are consistent with the HL7 reference information model (RIM).

Ms. Gilbertson questioned how HL7 could be harmonized if HL7, NCPDP, X12 and other organizations harmonized within USHIK. Mr. Blair said they’d put both in because both were needed. The meta-data registry let SDOs and vendors compare data definitions when using different standards. The Subcommittee was trying to encourage all PMRI SDOs to focus on some single reference information model.

PMRI Standards for Future Consideration

NCVHS also recommends that HHS provide funding to support these PMRI SDO collaborative efforts toward harmonization.

PMRI Standards for Future Consideration

The NCVHS has limited these PMRI specific recommendations to message format standards. The committee plans to further investigate medical terminologies and code sets in 2002 and will be forwarding recommendations to you. The committee will also consider PMRI standards for clinical documents and the content and structure of patient records.

Dr. Cohn asked to delete the reference to 2002. They were investigating code sets; the date might lead to expectations that something would be sent out later this year. Ms. Gilfoy advised that defining the content of the patient medical record was a higher priority than terminologies and code sets. Dr. Cohn suggested amending the last paragraph to end:

The committee plans to further investigate medical terminologies, as well as PMRI standards for clinical documents and the content and structure of the patient records and then we will forward recommendations.

Members discussed Mary Kratz’s query about why some of the more contemporary methodologies weren’t being considered. They noted nothing was currently available; as candidates emerged they would be considered. Members also discussed Tom Hanks reservations about the standard not being mandated. After the hearings, they decided they couldn’t accept that position. Members voted to send the letter off to the full Committee, noting they would have a chance to review any comments from the full Committee.

Panel 4: Industry Activities to Develop a Model Compliance Extension Plan Required by P.L. 107-105

Mr. Tennant noted WEDI was named in the original HIPAA legislation and in the Administrative Simplification Compliance Act as a consultant to the government. As soon as the bill was introduced in the House, leaders from across WEDI's membership most impacted by this MCF created the Compliance Task Group CTG to develop recommendations about how this MCF might look. Some 25-30 members held numerous conference calls, drafted the model form, and held a face-to-face meeting sponsored by APEC and AHA along with participants from HHS and CMS. WEDI approved the recommendations and MCF in January.

WEDI believed that the MCF should be used to raise issues for NCVHS, not to challenge or test submitters. CTG was adamant that one size should fit all and that there shouldn't be multiple forms for different covered entities. The MCF should be viewed as a tool to assist covered entities in developing their compliance plans. CTG recommended that the MCF should be available in both electronic and paper forms. Although the law stipulates electronic, WEDI believed many small providers wouldn’t have access to the Internet version. In addition to the PDF-formatted MCF that could be downloaded from the Web site, WEDI recommended a fax-on-demand system and scanable documents to facilitate submissions.

The consensus was to keep the MCF’s content simple. A small dental--or complex multispecialty--clinic should be able to fill it out easily and fast. CTG also recommended combining the work plan implementation strategy and testing categories. For each phase, submitters would be asked whether they’d completed their compliance plan. Again, the consensus wasn’t to challenge submitters, but to make it a quick, easy form to fill out. CTG recommended a preamble that provided a brief explanations of HIPAA and the transaction code set, explained the legislation mandating the MCF, the purpose of the extension, and how to complete the MCF.

The Web site will include links to relevant information: the final rule for transactions and code sets, and ancillary documents enabling people to move forward quickly developing their compliance plans. The paper forms should also provide links to relevant Web sites. Both should have a glossary of terms and there should be a toll-free HHS help number. CTG recommended an auto-response feature to the Internet-based form, providing recipients with an e-mail confirming receipt of the compliance form. Receipt should be equivalent to being granted the one-year extension. However, form letters probably would be needed to acknowledge mailed submissions. People could also be encouraged to send return receipts or rely on FedEx and its receipt.

Numerous critical issues were unresolved. Mr. Tennant acknowledged that how HHS would handle the hundreds of thousands of submissions expected was a daunting task not easily solved. The industry was confused about how entities would be granted extensions and how covered entities would know it had been granted.

A critical issue for CTG was whether organizations could apply on behalf of multiple entities. Insurance plans wanted the flexibility to apply for extensions on behalf of their subsidiaries and appropriate business partners. Medical group practices wanted to be able to file on behalf of their individual physicians. Large multispecialty clinics didn’t want potentially thousands of their providers to be forced to submit compliance plans.

Another key issue was if the public had access to these compliance forms. How, under the Freedom of Information Act, would this be made available? Would people be able to get them in batches, or would they need to apply individually for specific covered entities?

A key concern was the legislative mandate for NCVHS to report on solutions. Analyzing a representative sample of the forms to identify key implementation barriers and develop solutions would be a Herculean task. Once solutions were developed, that information had to get out to the public. There was a short window of opportunity for NCVHS to accomplish these tasks. And for this information to be useful, it needed to get out as quickly as possible. Mr. Tennant noted WEDI had developed practical, consensus crafted white papers on implementation issues facing the industry; much of this work fell within the NCVHS mandate, and WEDI stood ready to help fulfill this legislative directive.

Panel 4: Industry Activities to Develop a Model Compliance Extension Plan Required by P.L. 107-105

Ms. Narcisi said AMA would prefer calling the MCF an extension form; physicians understood compliance to be a more complex and burdensome undertaking. The Administrative Simplification Compliance Act only required covered entities to submit a summary of how they planned to comply with the final rule, not a detailed compliance plan. And the statute only required submission of the form (not justification of compliance activities) to obtain the extension. AMA urged those drafting the form to follow the intent of administrative simplification and reduce the associated administrative burden and complexity, rather than add burdensome requirements.

Noting that small physician practices were already overwhelmed implementing HIPAA, Ms. Narcisi said AMA believed physicians should know what would be required under remaining HIPAA regulations and where requirements overlap, before making costly administrative and technology changes to their practices. AMA encouraged HHS to move expeditiously to promulgate the remaining rules, so physicians could implement the requirements cost effectively.

Given the penalties associated with not filing for the extension and/or not being compliant, Ms. Narcisi said AMA would advise members that, if there was any potential whatsoever that their practices wouldn’t be compliant by October 2002, they should file for the extension. Because modifications to the transactions rule hadn’t been finalized and there was uncertainty about when other covered entities with which physicians submitted covered transactions would be compliant, Ms. Narcisi anticipated most, if not all, physicians would submit extension forms. She cautioned HHS to be prepared to establish a simple, effective process to receive and acknowledge a very substantial number of forms.

Ms. Narcisi said the form developed by the WEDI Compliance Task Force was an acceptable approach based upon the deliberative work and consensus of numerous healthcare groups that represent covered entities under HIPAA. The WEDI model was simple, encouraged compliance, and a single format applied to all covered entities. It also required a minimum amount of information, conforming to the intent of the act while simplifying the limited analysis required by NCVHS under the statute. While understanding that CMS would have ultimate responsibility for drafting the extension form and the instructional companion guide, AMA believed the WEDI model should be considered and adopted to the maximum extent possible. AMA urged CMS to conduct focus groups with all types of covered entities, noting such feedback had been helpful in NUCC's work with HHS evaluating the HCFA 1500 claim form.

AMA recommended that the instruction form state clearly that the privacy officer or another individual responsible for HIPAA compliance for the physicians' group practice might submit the form on behalf of physicians in the group. AMA urged CMS to require the full name and unique provider or physician identification number, tax ID number, or other appropriate identifiers for each physician or covered entity. Ms. Narcisi said it might be necessary to allow an attachment or a field large enough to fit the names and identification numbers of all physicians in a very large group practice. And she emphasized that each physician or covered entity needed a receipt to verify that he or she had received the extension. Ms. Narcisi noted AMA’s concern that physicians might be subject to penalties or exclusions from Medicare based on a later legal interpretation that the physician did not in fact receive the extension.

Ms. Narcisi said simplicity of filing would be as important as simplicity of the form. The form should be available on the CMS or HHS Web site, and in hard copy. Covered entities should be able to submit electronically, by fax or mail. AMA urged CMS to publish only the name of the covered entity in any registry. Any additional detail that was required should be limited to minimal published information (e.g., address or zip code). AMA will urge members to communicate with vendors and payers long before testing begins to appraise the status of other covered entities. AMA urged CMS to ensure that the April 16, 2003 deadline was clear on the form and that it didn’t allow a covered entity to indicate a later date for testing.

Ms. Narcisi said the extension process was an excellent opportunity for CMS to educate covered entities on the requirements of the transactions rules and administrative simplification. She said AMA would educate members about the forms and how to develop an adequate compliance plan. Ms. Narcisi advised CMS that Frequently Asked Questions about the extension, the form, and HIPAA compliance should be widely disseminated. Medicare carrier personnel who interact with physicians should be prepared to respond appropriately to questions. AMA believed instructions were as important as the extension form and offered to help CMS develop them.

AMA also recommended that the instructions clarify which parts of the form were mandatory and which were optional. The form and instructions should clarify that submission automatically resulted in an extension. Noting many covered entities might miss a deadline or miscalculate resources needed, Ms. Narcisi said instructions should state covered entities were only expected to fill out the form as accurately as possible, based on available information. Initial budget estimates for technology-based projects often required adjustment and unanticipated events could lead to a different approach or timeframe than anticipated. Physicians striving toward timely fulfillment of compliance activities deemed necessary and appropriate needed to feel comfortable and free from fear of retribution.

Ms. Narcisi said AMA would alert members about the extension form and how to submit it, and urge them to become compliant as soon as possible. AMA urged CMS to utilize remittance notices, carrier bulletins, and in other ways help covered entities achieve compliance.

Panel 4: Industry Activities to Develop a Model Compliance Extension Plan Required by P.L. 107-105

Having served on the WEDI Compliance Task Force, Mr. Wilder thanked Mr. Tennant for leading such a diverse group to consensus and capturing it in the proposed MCF. He encouraged the Subcommittee to keep in mind several points in developing MCF. MCF needed to be simple, easy to understand and fill out. One size should fit all. The more complicated MCF was, the more likely it would be that covered entities would adopt their own compliance plan, inundating the Department with paper. HHS needed to set up a system to acknowledge receipt of compliance plans with mechanisms for e-mailed, faxed and mailed responses.

Mr. Wilder said HHS should allow one person to file compliance plans on behalf of multiple entities. Covered entities should be given the option to designate which transactions they choose to delay until October 2003. Once a compliance plan was filed, all transactions were extended. But covered entities might choose, as part of their work plan or implementation strategy, to implement some transaction standards in October 2002 and extend the compliance date for others.

Mr. Wilder emphasized that MCF wasn’t the important part of this legislation. What mattered was the additional period of time to get ready to implement the transactions and code sets rule. He said MCF reminded him of when he worked for a state insurance department and looked for unnecessary parts of the insurance regulations. The property and casualty division had a big file cabinet jammed full of annual reports that insurance companies were required by law to file each year; they’d been collected for ten years--and no one had ever read any of them. MCF was important because, sending it, a covered entity gained an extension. But people needed to spend their time getting ready to implement the rule, not filling out endless forms.

Mr. Wilder encouraged the Department to post MCF on its Web site and publish all the rules as soon as possible. AAHP’s member plans were concerned that they still didn’t have final rules on security, enforcement, claim attachments or plan, provider and employer identifiers.

Noting both the Department and the industry had to step up their educational efforts, Mr. Wilder encouraged the Committee to help entities educate their members.

Panel 4: Industry Activities to Develop a Model Compliance Extension Plan Required by P.L. 107-105

Ms. Doyle said that the more than 40 national organizations that comprised the industry-wide coalition that sought the October 2003 extension believed this additional time was necessary to analyze the new standards and code sets, make necessary system upgrades, business process changes, and (most importantly) adequately test systems with trading partners. BCBSA believed this additional time would not only improve compliance, but would afford organizations an opportunity to achieve through administrative simplification, rather than simple compliance with temporary band-aid solutions.

While a straightforward one-year extension would have been easier to administer, the legislation’s sponsors chose to ensure greater probability of compliance by October 2003, by requiring covered entities to analyze and consider the work to be done. The Congressional Record also showed it was important to the legislation’s sponsors that plans be "non-burdensome," involve a "minimal reporting requirement," and that granting extension be automatic, not discretionary. The compliance plan wasn’t intended to be a disclosure of all compliance activity, but a summary of select information on work to be completed.

Given that HHS's modification of the final rule had been further delayed, Ms. Doyle cautioned that there was little, if any, possibility that modifications would go into effect so covered entities could implement them together with the original standards by October 16, 2002. Consequently, covered entities that didn’t file for extensions would be required by law to implement covered transactions as they existed with known flaws, and to adopt a national drug code, rather than the more widely used HCPCS J-codes. And then they would have to install the revised transactions and code sets, once HHS's modifications were subsequently approved. Even if the final rule was promulgated this summer, Ms. Doyle said there would be little time for vendors to provide compliant software and for covered entities to make necessary system changes and complete trading partner testing prior to October 16, 2002.

According to HHS transactions and code set rule cost estimates, there were about 700,000 providers and non-employer health plans. AMA testified there were 850,000 physicians. Ms. Doyle said hundreds of thousands of compliance plans would be filed with HHS.

BCBSA offered comments and recommendations: (1) the goal should be simplicity, (2) the model form should be concise, and not exceed requirements of the law, (3) one universal model form could be used to file on behalf of multiple covered entities, (4) a place on the form indicated confidential information for the purposes of the Freedom of Information Act and NCVHS analysis, precluding disclosure of privileged and confidential trade secrets, commercial or financial information, and (5) a mechanism confirmed that plans had been received.

BCBSA believed MCF met both the intent of the law and the practical realities of the situation. Ms. Doyle suggested two changes identified since the WEDI board approval. She asked the Subcommittee to modify the box in Section 2, Reasons for Filing for This Extension that reads "compliant but trading partner(s) not ready," to "compliant but trading partner(s) or business associate(s) not ready,” minimizing the need for covered entities to use the "other" box for written text. And she urged that a section be added so covered entities could indicate information considered a trade secret, confidential and/or proprietary for purposes of the Freedom of Information Act as well as disclosure to NCVHS.

Ms. Doyle conveyed BCBSA’s belief that the extension would go a long way towards increasing compliance, but that (particularly with the transaction code set rules) it all began with education. Providers and state government had to understand the requirements so they could better assess their need and the regulations’ impact on day-to-day operations. Ms. Doyle noted that at the December hearings Jeff Fusile presented a report BCBSA commissioned from PricewaterhouseCoopers: HIPAA's Myths, Practical Realities and Opportunities: The Work Providers Need to Perform For Standard Transactions and Code Sets. She encouraged CMS to integrate aspects of the document into their provider education program.

Panel 4: Industry Activities to Develop a Model Compliance Extension Plan Required by P.L. 107-105

Mr. Arges noted AHA had recommended that HHS use its flexibility in enforcement to address providers' concerns about meeting the October 16, 2002 compliance deadline, rather than support legislative efforts to delay implementation of the transaction standards and code sets. He noted punitive measures included in the legislation only applied to healthcare providers and health plans, which could be barred from participating in the Medicare Program. These measures had little or no effect on clearinghouses that could wreck havoc on providers and plans if they weren’t ready.

While H.R. 3323 provided additional time for those who might need it, Mr. Arges said it also threatened to harm those ready to move forward with implementation. Organizations that believed they were ready, might find their application of the transaction standard failed with some trading partners. Consequently, they might face harsh sanctions, because their efforts towards compliance didn’t meet a yet undefined test criterion for successful application of the transaction standards. Mr. Arges said AHA was likely to recommend that all providers file for an extension, even though they believed they would be ready by October 2002.

Mr. Arges said AHA believed the WEDI MCF satisfied the requirements called for in H.R. 3323. AHA's HIPAA Web site will link to the form and provide additional instructional materials to aid hospitals in their completion of the MCF.

Mr. Arges said AHA had sent a letter to Secretary Thompson outlining concerns that delays in issuing the remaining regulations for electronic transaction standards created significant problems in meeting the compliance deadline. AHA urged HHS to expedite the Department's rules on the administrative simplification provisions that support the final electronic transaction and code set regulations. Mr. Arges noted many of these rules hadn’t been issued, even in proposed form. And there appeared to be little or no forward movement on other critical decisions, including expedited release of health plan identifiers, frequency of updates for clinical code sets, development of compliance and certification testing software, and steps to improve the coordination of benefits process. AHA urged HHS to address these unresolved implementation issues.

Mr. Arges noted there was also an opportunity for HHS to assist healthcare providers in realizing the full savings and efficiency potentials implicit in the enactment of HIPAA through rulemaking or guidance to facilitate prompt, accurate payment of claims.

Panel 4: Industry Activities to Develop a Model Compliance Extension Plan Required by P.L. 107-105

As a member of the Association for Electronic Health Care Transactions, Mr. McLaughlin said McKesson believed its concerns were representative of other “like vendors” in the healthcare industry. McKesson had a diverse array of information systems solutions, including a covered entity: a transaction-processing clearinghouse.

McKesson expected to roll out HIPAA solutions for the transactions and code sets early this year. Mr. McLaughlin expressed significant concern regarding the release of the pending NPRM for transactions and code sets, noting he wasn’t confident NPRM would be released in time to satisfy the 180-day modification requirement imposed by the legislation. Having made this caveat, Mr. McLaughlin said his comments were provided in anticipation and with the assumption that NPRM would be released on time and everyone’s concerns were for naught.

McKesson's clearinghouse would be ready to send and accept HIPAA compliant, currently supported transactions prior to the initial October 16, 2002 compliance date. But Mr. McLaughlin said the clearinghouse might have to file for an extension because of trading partners or payers who weren’t ready by the initial compliance date.

Mr. McLaughlin noted a critical piece of the Compliance Act was assignment of a timeframe for testing. As stated in the law, testing for the designated transactions and code sets must begin no later than April 16, 2003. WEDI-SNIP published two white papers, Business-to-Business Testing and Transaction Compliance and Certification, that detail levels of testing that must be provided in order to meet HIPAA requirements. Mr. McLaughlin urged the Subcommittee to clarify the testing level covered entities were expected to begin on or before April 16, 2003.

High-level definitions of testing include internal and external testing. Internal testing includes initial and repeated system debugging (unit and model testing), compliance testing to verify the information was sufficient to comply with the element requirements of the HIPAA standard, and beta testing once systems were installed at a customer site. Mr. McLaughlin said these tests were critical to the process and should be performed early in 2002. External testing included trading partner testing, necessary to insure proper connectivity between trading partners, data integrity testing to verify trading partners were transferring appropriate elements for the business need, and stress testing to validate that trading partners' systems were capable of handling the load of the new transactions.

Mr. McLaughlin described a scenario that illustrated the necessity for specifically depicting the level of testing that should begin on or before April 16. McKesson provided information solutions to thousands of providers including hospitals, physicians, home health agencies, and payers. Each provider and/or payer entity was or would need to install upgraded software McKesson provides for HIPAA data content requirements. Rollout and implementation by the provider/payer takes several months to complete. McKesson's clearinghouse had connectivity to thousands of payers. Testing with each was a critical component necessary prior to submitting “production” transactions to the payer. Each test cycle with a single payer could take weeks, sometimes months. Variance is due to many factors including: size of the payers's work queue for other trading partner tests, the number of resources committed, and internal test methods. Currently, McKesson’s clearinghouse had difficulty finding payers able to exchange HIPAA-compliant transactions. Those willing to begin testing wouldn’t allow McKesson to go into production for an undetermined amount of time, even after testing was completed. Mr. McLaughlin emphasized it was critical that external full trading partner testing begin no later than April 16, 2003.

McKesson believed further guidance from HHS was necessary to lead the industry toward early external testing and provide clarity and direction to covered entities that internal testing should take place as early as possible in 2002.

Discussion

Drs. Cohn and Zubeldia thanked the panelists for working so hard to develop a MCF and remarked that it was rewarding to find them in agreement about how to do this and that it basically followed recommendations in the Committee’s July 29 letter to HHS and the Secretary. Dr. Zubeldia agreed that multiple covered entities under the same corporate umbrella should be able to file on one form; but he was concerned by what he’d heard about a third party filing on behalf of a covered entity (e.g., a clearinghouse filing for providers or a member filing for clients). He asked how they could prevent that and still allow covered entities to file together with one application.

Mr. Arges expressed concern with the way punitive measures applied mostly to providers and health plans while clearinghouses weren't at risk. Many providers and health plans relied on clearinghouses to help them meet the standard's capacity. Given the uncertainties, they were signaling providers to file for an extension, just to protect themselves. Dr. Zubeldia suggested that the form could make members of a clearinghouse, vendor or trade association aware they were signing up to be compliant by a specific date. He agreed that a third party should only be able to file for entities for which it had corporate authority. Mr. Scanlon observed that this didn't raise any new issues; the Subcommittee already had to deal with the definition of covered entities, and the trade association wouldn’t be a compliant extension.

Mr. Blair supported Ms. Narcisi’s suggestion to name the MCF a HIPAA extension form. He said he’d seen his doctors recently and they were so preoccupied with the HIPAA privacy they didn't even know about the transaction rule. He asked if defining the MCF as the HIPAA transaction extension and code set form would distinguish it so everyone didn’t automatically assume this was related to privacy. Ms. Narcisi agreed that most providers were more concerned with the privacy regulations--It was an excellent idea.

Dr. Cohn said he’d heard a number of issues of particular concern to the Subcommittee. Clearly, their role was to ensure that the HIPAA implementation wasn’t unduly burdensome but successful. They had to ensure that the year was used in a productive way. And they were given responsibility under the compliance act to advise on MCF, figure out an analysis of the compliance form, and use it to assist in identifying problem areas and best practices. Units had to be able to easily file for an extension, yet HHS also needed to know who was filing. Kaiser Permanente medical groups had 3,500 physicians. Nobody wanted 3,500 forms, but everyone wanted to know they were all covered. There needed to be some way to accommodate those entities. Dr Cohn asked if it wouldn’t be helpful to know if people were having problems with a particular transaction. They’d noted the need to work together to encourage receipt of electronic transmissions and how to handle the paper format. They’d talked about educational programs. Noting the number of participants concerned about the likely possibility that the NPRM wouldn’t come out in time, Dr. Cohn wondered if the whole industry, by definition, would be required to file an extension, just because of the timeframes.

Mr. Tennant said the task group had discussed whether they should break out each transaction, but the form became longer and the consensus was that wasn't part of the mandate. He suggested a one-line question might be helpful. Ms. Narcisi noted that not all the transactions applied to the physicians and suggested including explanations in the companion document. Mr. Wilder agreed. They had to distinguish between what they needed to gather and what could be on the form. The law didn’t say anything about external or internal testing--only testing; the form wasn’t the place to encourage folks to do certain testing by a certain date. Ms. Doyle concurred. The law stated the compliance plan had to have a timeframe for testing that began no later than April. She interpreted that as a nod that (internal and external) testing was important and you had to make time for it in your compliance plan. But the forms had to be simple: people had the option of choosing their own. Ms. Doyle said they had to adhere to what was required by the law, eliminating anything that wasn’t. Mr. McLaughlin agreed that the legislation didn’t differentiate between external and internal testing. He said everyone asked for clarification because they were concerned that, if covered entities interpreted on their own, a lot of people wouldn’t be ready to begin trading partner testing and they’d be faced with another delay. Mr. Arges noted the task group had already gone through some of these issues. He said the form didn’t need to be explicit about internal/external, but there had to be guidance about what testing meant and that one had to test at all levels to be successful.

Mr. Scanlon asked if everyone could live with this model. Ms. Narcisi reiterated that AMA believed the MCF was acceptable, but, she emphasized that focus groups with all covered entities would determine if it was appropriate. Agreeing it made sense when sampling the MCFs to stratify in terms of the kinds of covered entities, Mr. Scanlon asked if a more refined categorization was needed than the three major covered entities listed on the MCF. Mr. Tennant reported an early draft broke out different types of providers. Again, the task group found it too complicated.

Ms. Greenberg remarked that the form indicated internal testing wasn’t how you scored when it asked whether you’d completed initial internal software testing. Noting it only asked whether there was a budget and sufficient resources, Ms. Greenberg asked if there was a strong comfort level that this was all Congress expected. Dr. Zubeldia shared her concern. The act stated the plan had to have a summary of the budget schedule, work plan, and implementation strategy. A summary of the budget would be the bottom line. But he noted asking for that was risky and he suggested that substantiating the existence of a budget might be a good compromise. Ms. Greenberg agreed that the way it was laid out nothing would be problematic or proprietary--And Congress had said it didn't want this to be burdensome.

Dr. Fitzmaurice suggested they could ask a sample of people detailed questions for additional, even proprietary, information. Everybody who filed wouldn’t be burdened. Ms. Doyle noted another check box could indicate information submitters considered proprietary and excluded under the Freedom of Information Act. Mr. Tennant said the task force had lengthy discussions about the issue of budgets. Several renditions had breakouts. The consensus in the face-to-face meeting was the important thing was finding out if people had trouble achieving their budget, because that might be an area of education NCVHS or CMS could meet.

Mr. Blair asked if the task force had considered asking if the budget had been approved or appropriated. Mr. Tennant explained that, while trying to keep the MCF as simple as possible, they attempted to ascertain the submitter’s level of difficulty (e.g., trouble getting executive support). Mr. Scanlon remarked that the point wasn’t the amount, but the process of considering the requirements and costing it out had begun. The amount wouldn’t be helpful and only made everything sensitive.

Dr. Fitzmaurice observed that a solo or small group practice that didn't have a computer could send their paper to a billing service that converted it to electronics. They could be covered, even if they didn't have a computer in their office. Ms. Narcisi said AMA found through their focus groups for the 1500 claim form that people did use billing services. They’d considered that in their WEDI discussions and believed there still would be paper. Ms. Narcisi noted that while less than 50 percent of physicians had access to the Internet at work, over 90 percent had access at home. Mr. Tennant suggested the key was to make the electronic form palatable and easy. One way was to advertise it through AMA, MGMA, AHA and other groups, so members knew about the electronic format, ancillary documents and help on the Web site. WEDI's workgroup suggested that any paper document should be scanable.

Noting some physicians wouldn't put information into a form over the Internet, Mr. Augustine asked about using SSL technology. Ms. Narcisi said they’d talked about that, too. She agreed they needed to consider security and make sure whoever designed the application was qualified.

Mr. Tennant cautioned that a lot of entities would submit electronically, but then be so worried about being excluded from Medicare that they’d courier over another form. Mr. Scanlon commented that the majority of folks sent earlier comments on the regulations in paper. It's psychological and legal and everyone wanted to see it and clear it. Ms. Greenberg acknowledged there was probably no way to avoid some paper forms and that scanable might be doable. She wondered if AHA and AMA could collaborate so providers could submit from the hospital. Mr. Arges said AHA would make every effort to inform members about what they needed in completing the form and make it available on their Web site. An advisory team would discuss options for other services and follow-up. He agreed with Ms. Narcisi about sending a reminder to providers about the extension option in remittance notices.

Dr. Kolodner said he heard two issues. One was whether an individual provider or small clinic had access; if the AMA numbers were true across all providers, then the number without access to Internet was relatively small. The other issue was who handled the burden of getting it into electronic form. Whether it was sent into NCVHS and became the government's burden, or the provider who didn't have access had somebody else enter the data for them. He noted that commercial systems not only gave an email receipt, but also a claim number on the screen that could be printed, giving immediate confirmation. He asked if it was reasonable to charge a burden cost for individuals who didn't trust the Internet. Mr. Blair asked if an immediate printable acknowledgement would be a compelling incentive for AMA and other professional associations’ members. Mr. Tennant agreed that getting something in your hand boosted confidence, though perhaps not the level you’d like. He added that he was leery about punitive measures for paper. And he pointed out that, although a physician could go to the library and fill out this form, if he or she didn't have Internet there probably wasn’t an e-mail account, either. Anything but paper confirmation might be difficult. He said the key was to make it easy and comfortable electronically, and then get the word out through trade associations that this was the way to do it.

Ms. Narcisi said they needed guidance from HHS on how providers or any covered entities would be acknowledged. Once they had that direction, they’d be happy to educate members. While agreeing that an electronic application was the simplest way to gather information, especially on the other end, she cautioned that she’d had problems they’d never envisioned in developing an electronic application at AMA. Most physicians were on AOL and there were problems with the browser they used when accessing the application. Dr. Yasnoff said this was a tremendous educational opportunity, not just to fill out the form, but also to provide a comprehensive Web site with extensive material including descriptions and information about the transactions, resources, and downloadable documents. Interactive seminars could be put on the Web site. People having trouble could fill out electronic forms and get feedback. Specific uses statistics on educational materials could provide input on areas people needed to hear more about. Dr. Yasnoff said one of the things they might recommend to HHS is that resources be allocated to put together a comprehensive educational resource, designed to provide feedback on usage and opportunities to collect information optionally that people wanted to provide. Mr. Tennant said the task group shared that vision. He noted they could link to the AMA, AHA and other private Web sites’ resources. Ms. Narcisi said AMA also envisioned a similar joint educational effort.

Dr. Zubeldia suggested an easy-to-justify incentive would be to give an acknowledgement of receipt to anyone filing electronically, while providers filing on paper didn't get anything until they received payment. He said another incentive might be to state that only electronic submissions would be sample--And that way, the paper form wouldn’t have to be scanable.

Noting under “Reason for filing the extension” the form listed ten reasons and "Other", Dr. Zubeldia predicted a lot of people would check one or more of the ten and then "Other". He cautioned that going through so much free text in sampling would be logistically impossible. He suggested asking submitters to indicate whether it was all right not to sample their forms. Mr. Scanlon said they could guarantee a form wouldn’t fall in the sample. Once submitted, plans were subject to FOIA requests and considered under individual merit. You could designate confidential, trade secret, and proprietary information--much like one did applying for FDA approval. Every attempt was made to redact; but one had to assume some would be available.

Mr. Tennant expressed concern about acting punitive toward providers submitting on paper by denying them a receipt. They should at least be explicit about sending it FedEx or with a postal receipt. Mr. Tennant said it should be made very clear that people shouldn’t expect anything back in the mail. But he cautioned that if NCVHS only sampled electronic submissions they ran the risk of biasing their sample and excluding a large segment that, perhaps, most needed assistance.

Noting they were discussing administrative simplification, not making this burdensome, and the Department’s limited resources for implementing HIPAA, Ms. Greenberg concurred with not scanning paper forms and sending out paper acknowledgements. She recommended discouraging both. Sampling electronic responses would get enough information. Anyone who wanted the Committee to be aware of something and couldn’t send in an electronic response, could always write a letter. Dr. Kolodner commented on the assumption that entities submitting the exemption cared whether NCVHS knew why they filed; what they cared about was the exception. Recalling Mr. Wilder’s analogy about the file drawer of forms people filed solely because of regulations, Mr. Arges asked whether NCVHS would do anything with the paper documents. If not, he suggested those who couldn’t file electronically online, could simply phone in a tax ID number and answer a couple questions by pressing buttons on their phone. They could be given a number indicating they’d complied.

Ms. Trudel asked if members wanted to consider whether a few more check boxes and a modest amount of additional information about why people filed and how they’d use vendor resources might be helpful in the analysis. Did the panelists feel a modest addition would be bothersome? Mr. Arges said he’d rather see a simple question: “Should NCVHS contact you with a follow-up questionnaire?” Ms. Greenberg noted it probably would require OMB clearance. Mr. Arges added that if it was on the form, it became part of the FOIA requirement, rather than a more focused study. Ms. Narcisi suggested optional questions might be added; however she noted both WEDI and AMA raised concerns about physicians being bombarded by marketing from vendors who had access to this list.

Mr. Blair said that, besides its utility to HHS for analysis, questions such as, “Why are you asking for an extension?” with its options (e.g., “Having difficulty migrating from local codes”) could be thought-provoking educational tools for the filer. Mr. Tennant said WEDI had set out to make the form something submitters learned from. Someone could read it and say, “These are the steps we've got to take to be compliant.” The task force was concerned that more specific questions could confuse folks. They suggested hyperlinks from words (e.g., legacy system, local code) to a glossary or dialogue.

Dr. Zubeldia said he worried that people would file their own paper if they didn’t have the option to send additional documentation electronically. Mr. Scanlon cautioned against confusing administrative efforts with research projects; their main purpose was compliance extension. Just as with public comments, covered entities needed leeway in how they filed.

Noting it wasn’t consistent with administrative simplification to have 5,000 tax IDs and names typed on a form when they could be automatically generated into a file, Dr. Yasnoff suggested CMS might define a format for an attachment that entities with multiple providers could use to submit tax IDs.

Ms. Trudel reflected that they were trying to do more than grant extensions and fulfill an assessment requirement. What was most important to Congress, who named this a compliance plan in the statute, was that people thought about this. They wanted this to be simple and easy, but they didn't want people dashing off a form without thinking through the steps they had to take and what this meant to them. If the Subcommittee didn't ask for some basic information that made people think about the transactions they had to implement, it would be difficult to go back to Congress and say they’d fulfilled their task. Ms. Trudel asked for panelists’ thoughts about the compliance extension plan requiring people to think through the steps and about not accepting any extension requests until June.

Model Compliance Extension Form and NCVHS Procedures

Ms. Trudel said she was concerned that people completing the form wouldn’t grasp Congress' main purpose in passing this version of the bill: making people think about what they had to do to become compliant--Then plan and work toward it. What Congress, and particularly Rep. Hobson didn’t want in October 2003 to still have people unaware and unable to comply, because of a lack of advanced planning. Ms. Trudel asked panelists how likely that was to happen. Would a threshold question (“Which transactions are you going to have to implement?”) and checklist give people food for thought and the Subcommittee more information to work with? Should they not accept compliance extension plans before a certain date, so people had the opportunity to think and plan? Mr. Arges concurred with utilizing this process as a way to make the healthcare community aware of the steps they need to take. The task force added the phases as a way of emphasizing those steps. But he questioned that postponing taking applications would raise awareness. He suggested it was incumbent on all healthcare organizations to ensure that their constituents and members knew these impeding changes (e.g., AHA developed a CEO binder on the transaction standards and code set that included checklists).

Mr. Tennant piggybacked on Mr. Arges’ comments. They couldn’t hold off on submissions; people had to get started as quickly as possible. They didn't want anyone thinking they could hold off until summer or fall. But he said Ms. Trudel’s point was salient: were they following the intent of the law? The Hobson staffer that wrote most this legislation had made exactly the same point: Jump start the provider community. Mr. Tennant said the form did that. The key wasn’t to have the form be the sole instrument of education; providing ancillary documents and assistance to the provider led to success. Ms. Doyle agreed. If people knew a form wasn’t due until June, they’d wait until May 15 to even look at it. BCBSA advised the earlier the better. This document was valuable in helping people understand all the work that needed to be done. Filing early gave trading partners an idea of where they were.

Dan Rode, speaking for the Coalition of Health Information Policy, said Ms. Trudel’s checklist of transactions would be helpful, because many providers didn’t follow most the transactions. It made them question what transactions they were going to be filing for and consider what they were. And it would give HHS and the Committee a sense of how much they were going to see. (The 837 claim might be predominant, while a number of other transactions might be highly situational.) Another factor they might add was whether submitters were going to use a clearinghouse instead of other types of vendors. Mr. Rode said those questions would be insightful for education, and give the Subcommittee a sense of how people were considering implemention. Ms. Narcisi agreed there were tremendous opportunities to educate the covered entities, but said any stalling in getting out the MCF was another delay in the whole HIPAA process.

Dr. Cohn said he heard that the panel’s general view was the form shouldn't be delayed, but asking which transactions people would work on was reasonable. Participants noted that it was at this point (where you got down to specific transactions) that the educational documents would be most helpful. Ms. Narcisi reiterated that all the transactions weren’t alike. A fundamental first step in the compliance plan was knowing which you were going to do. Mr. Wilder said the form attempted to educate people about the steps without getting complicated; a general question asking which transactions people were familiar with and providing a single link with explanations about the transactions might be helpful. Mr. Arges concurred. Noting that a number of physicians used billing services and didn't know what an 837 was or which transactions were mandatory, Ms. Narcisi questioned whether their answers would be valuable.

Dr. Cohn noted their strong concurrence about, not only having a form, but also an educational resource on the Internet. He asked about funding and support within CMS and HHS and if parts of this emerging plan were at risk. Ms. Trudel replied that the likelihood of a broad-scale provider/covered entity outreach program specific to the delay in the compliance form was at risk. Whether they could use resources to carry out very resource intensive processes like hand-keying paper documents depended upon return on investment. As Ms. Greenberg had noted, resources were limited. Ms. Trudel said the focus was on specifying in The Federal Register what the model compliance extension plan would look like and finding a straightforward way for people to provide this electronically. CMS would utilize other educational processes underway or other Web sites to the extent possible. The amount of educational materials available would expand to the extent funds increased. Dr. Fitzmaurice pointed out that the law allowing people to apply for extensions stated some $44 million was authorized to HCFA to implement HCFA processes. Would that money be essential and welcomed? Ms. Trudel said funding was always welcome; CMS knew exactly what they’d do with it. But she noted the funds were authorized, not appropriated. The appropriators would have to look at how this fit into other caps and pre-existing allocations. Things wouldn’t come to a crashing halt if they didn't get it--But it was the difference between doing a broad-scale outreach program, and one scaled back.

Mr. Blair reflected that many who worked on WEDI’s MCF were representatives of healthcare institutions that could afford their participation in this effort (a characteristics of many standard efforts). It was difficult for a solo practitioner or someone from a small group practice to carve out time for input. He asked if it would be useful to have two sets of instructions, one for institutions and another for small group practices. Ms. Trudel suggested that AMA and AHA, knowing their constituencies best, could develop an auxiliary set of instructions more explanatory and specific to their members. Ms. Narcisi said a companion document could be valuable. Mr. Arges said AHA had discussed this and planned to provide guidance to their constituents on their Web site. He said one form was sufficient, but anticipating questions that applied to a specific category of covered entities would be helpful. AHA would be happy to work with CMS. Mr. Tennant said many MGMA members were small group practices and the association would do something similar to what Mr. Arges mentioned. He suggested thinking of the one-page 1040-EZ tax form and its 50-page instruction booklet aimed for the average consumer as well as somebody with advanced degrees. Mr. Tennant said he hoped the CMS Web site had a section for the small office. He cautioned that many physician offices would be confused about what HIPAA was, let alone why they needed to apply for an extension. They needed a few paragraphs explaining what this was all about. Dr. Zubeldia suggested the WEDI-SNIP educational materials could help. Mr. Tennant said they had a series of one-page overviews of all the regulations, including an introduction to HIPAA that could be included. Ms. Doyle agreed there was value in having the payer associations help with instructional documents for payers. Dr. Cohn said stylized educational materials for various classes might address one of their first questions about whether that long list of transactions was necessary.

Ms. Trudel clarified that the form and instructions would be announced in a Federal Register notice that listed required data elements and values and told how to obtain the facsimile document and instructions. She recounted her understanding about further development of the MCF. They’d decided not to add a checklist of the transactions. But they would add some common compliance barriers. If they could get over the hurdle of proprietary information, they’d expand the section on vendor or contractor assistance. Members hadn’t a sense of consensus on using an attachment to list additional tax IDs or names of entities but Ms. Trudel said, with their recommendation that an entity could submit one single form covering other entities for which it had a legal obligation, she’d work the requirements out herself. Dr. Yasnoff noted that they’d agreed on SSO-enabled forms. They’d also said any electronic submission should result in immediate acknowledgement: a confirmation number that could be printed. Ms. Gilbertson asked if CMS knew what it might do with the information. There’d been some comment by the panel about posting it on the Web site. Would there be a way of checking who had filed compliance? Ms. Trudel said CMS wasn’t anticipating making a registry available. They didn’t want to interpose this process in ongoing communications providers and plans should be having with trading partners. This was a handshake between two parties, and the status would change over time. Members agreed to use the acknowledgment as a compelling incentive for electronic submissions. The Post Office offered registered and certified mail; HHS would not make a separate effort to acknowledge forms sent in by mail.

Review Annual Report to Congress on Administrative Simplification

Mr. Scanlon discussed a first draft of the 2001 annual report to the Congress. Among its many jobs assigned by Congress, NCVHS prepared an annual report to Congress on the implementation of HIPAA administrative simplification. This year's fifth annual report to Congress covered January 2001 through December 2001. Mr. Scanlon noted there was spillover because the compliance extension act came at the end of the year. Copies of the draft had been e-mailed to members of the Subcommittee and to the Chair of the Privacy Subcommittee, because the year’s activities integrated privacy standards with the suite of administrative standards.

Mr. Scanlon noted that, assuming agreement around the table, they would present a revised draft for the full Committee’s review at the February 26-27 meeting. They would take comments and, as usual with this report, seek approval with flexibility to incorporate further changes without waiting until the next full Committee meeting. Ms. Greenberg advised that the agenda books went out FedEx to the full Committee on February 18. Members had to turn around their comments quickly, in order to get revisions into a second version. Dr. Cohn asked the Subcommittee members to ensure the draft set the right tone, that major issues were there, and the information was factually correct. He said his traditional role, as Chair, was to work with Mr. Scanlon on wordsmithing issues.

Dr. Cohn noted a key issue was getting the rules out. Another issue brought out by the last testimony was that the delay in the rules (e.g., the modified NPRMs to final rules) made it inevitable that all parties would have to request a compliance extension, undermining potential success of the final implementation. Mr. Scanlon said the finalization of the privacy rule was a milestone, and there was also the issuance of guidelines. On the administrative simplification side, there were notable accomplishments in terms of the BSML process and the fast track changes. Congress had passed its delay, responding to industry concerns. No proposed or final rules relating to these standards had been issued. Work went on, but not much more was known about implementation of this suite of standards. Mr. Scanlon suggested the tone was that the delay seemed to be responsive to what industry wanted, but unless the final requirements were known, it was an empty delay and year. Mr. Blair said it might be useful to quote industry surveys indicating strong support for the administrative simplification provisions, despite all the frustration and inconveniences of the delays. Members noted that, although there were many voices in the industry in terms of work needed, as in today's testimony they’d heard in one voice that everyone wanted the standards expedited. Dr. Cohn suggested pulling from the Committees’ June 29th letter to the Secretary where they observed that, in all that testimony, there wasn’t anyone who was against administrative simplification. Mr. Blair was right: a key message was that there needed to be action. Ms. Greenberg pointed out they should reference the NHII report. Standards were a basic part of that report and it was a major milestone for the Committee and an opportunity to alert the Congress to that report. Members agreed they should comment on the $44 million authorization, reminding Congress that the appropriation would be welcomed and was needed. Mr. Scanlon noted implementation issues for the year included the need to have the remaining HIPAA standards, particularly the fast track changes, and the modifications to the privacy rules. HHS resources and funding for the FOIA identifiers were among other issues everyone was asked to look at. Members noted that the Subcommittee held hearings to determine what its final recommendations would be for PMRI. The draft stated that the first set of actual recommendations on standards for PMRI were anticipated in early 2002. Dr. Cohn said a separate letter released in advance of the report could convey that NCVHS was considering a strategy that didn’t require a final rule or mandate for PMRI standards, but looked instead for HHS industry guidance and incentives.

Mr. Scanlon said they might want to shorten the report to eight pages. The main point the Committee wanted to make and the bulk of the report could be in what had been the executive summary. The rest could be documentation. He hoped they could assume that much that had been in the previous years’ long summaries was understood, and they could focus on the issues.

Members agreed to submit their comments to Mr. Scanlon within a week. Dr. Cohn said they looked forward to Mr. Blair and Dr. Fitzmaurice’s comments about PMRI.

2002 Issues

Dr. Cohn noted the Administrative Simplification Compliance Act requirements were a new issue for 2002. The development of MCFs, which they’d already commented on, was basically a done interaction. Analysis of a sample of the compliance plans and publishing reports on effective solutions to compliance problems were issues for the remainder of the year. Dr. Cohn noted publishing reports on effective solutions didn't need to wait for responses to the MCF; if they found a few hours in the April meeting they could talk to WEDI and other organizations about publishable best practices. Solutions could be posted on the Web sites, with links to other documents. Ms. Greenberg noted that limited contractual funds could be available to a group currently working on documents or for developing their own. Dr. Cohn said their first step was to survey what's already out there and identify what was publishable. Noting prior discussions about the extent to which the Department or others could help WEDI function as a volunteer group, Ms. Greenberg suggested that was a possibility for underwriting particular topics.

Dr. Cohn said he already sensed that the code set issues from yesterday’s hearings would take up most of the April 9-10 meeting. Members would be e-mailed ranges of dates for three sets of two-day hearings July through December. Noting the Committees and the industry’s concern about the overall HIPAA process of getting the regulations, improvements, and updates out, Dr. Cohn proposed in summer or early fall holding a hearing focused on the overall federal process (how it worked, what was and wasn’t working), looking for recommendations to make to the Secretary or Congress about ways to make things work smoother. Mr. Blair said that might be useful and that he would mull over how they might do this in way that was constructive and actionable. Dr. Cohn said that was the point; this wouldn’t be a political discussion, but an opportunity to look at what had been learned over this five or six years. Ms. Greenberg remarked that everyone would agree that the process could work better, but aspects of due process, commenting and responding were time consuming, and there were changeovers in administration. Much in the political process slowed them down, which was one reason they didn't want regulations on PMRI. Mr. Blair suggested that Ms. Greenberg, Mr. Scanlon, Dr. Fitzmaurice, and Ms. Trudel consider who within HHS might provide suggestions or guidance for process changes that could help ameliorate these situations in the future. Ms. Greenberg envisioned a roundtable discussion. Dr. Cohn acknowledged that this was an election year and that they needed to do this in a way that wasn’t perceived as political. But he said it was an issue that needed to be heard and he’d brought it up to see if others felt it was a timely discussion for this year's agenda.

Ms. Greenberg asked if everybody was comfortable waiting until early April to discuss how the Subcommittee would discharge its responsibility to analyze the sample compliance plans. Dr. Cohn said he thought the bigger priority was publication of best practices, but he said he would look to what the others saw as the priority. Ms. Greenberg said the industry had taken a fair amount of freedom in interpreting what was required in the extension form. Nonetheless, it was required and had to be done in good faith. It was going to require some part of the Department (she assumed CMS) to do prior analysis, hopefully based on electronic submissions. It would take time for the analysis and some process from the Committee. She said they needed to be thinking about this by April. Mr. Blair reflected that the most critical piece of addressing an analysis of samples was design of the form, and the day's hearings had provided input into that. They’d already begun to structure it so they gathered useful information. Ms. Greenberg agreed, clarifying that she wanted to make sure they had a process. NCHS wasn’t in a position to tabulate those forms. Mr. Augustine said he would take the lead in developing a recommendation for how the analysis might be structured. Ms. Greenberg said NCVHS would work with him. Having the responsibility in this law was an exception; they had to figure out how they would do it.

Dr. Cohn noted the Subcommittee had a two-hour session during a breakout February 26 primarily involved with PMRI, that letter, and review. Ms. Trudel said the report on code sets was essentially done; WEDI was going through their full clearance process that day and hoped to get a slot in the February meeting. She said she would confirm. Dr. Cohn said WEDI might also be available to talk about the COSA report. Ms. Greenberg said the discussion of government e-health initiatives wouldn’t be ready until June. Dr. Cohn expressed appreciation to everyone and adjourned the meeting at 12:30 pm.


I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.

/s/ 12/28/2002

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Chair Date