Washington, D.C.
The Computer-based Patient Record Workgroup within the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics met on June 1 and 2, 2000 at the Hubert H. Humphrey Building in Washington, D.C.
An hour was scheduled on the second day of the full Committee meeting for the Subcommittee and Workgroup to deal with comments and changes stemming from the full Committee's input.
A conference call was scheduled for Wednesday, June 7, 1:00 p.m. EST, to review draft 7.2 and any remaining editorial issues. Copies of draft 7.2 will be distributed in advance.
Dr. Cohn asked for leads on speakers for upcoming panels and hearings.
The next hearings are scheduled for July 13-14 in Washington, D.C..
The next set of formal two-day hearings is scheduled on October 26 and 27.
Ms. Fyffe requested that updates focus on when the NPRMs or final rules would be published in the Federal Register.
The Computer-based Patient Record Workgroup reviewed and amended the sixth and final draft of the report to the Secretary of HHS on uniform data standards for PMRI. Comments and critiques solicited from outside reviewers were incorporated into the extensive review and revisions. The Workgroup produced a substantially crafted draft and a clear sense of the editorial work that Ms. Amataykul would polish and the members would finalize in a conference call on June 7.
The Subcommittee for Standards and Security approved, with changes to be made, the forwarding of the document to the National Committee for consideration at the June meeting. Dr. Cohn summarized the Subcommittee's business. An hour was scheduled on the second day of the Full Committee Meeting, for the Subcommittee and Workgroup to deal with comments and changes stemming from the full Committee's input. The July hearings would focus on tracking implementation. The next set of formal, two-day hearings in October would examine issues around the mandate to look at changes to the standards being implemented and also the digital signature. Dr. Mayes provided an update on NPRMs and the rule-making process. Ms. Fyffe requested that updates focus on when the NPRMs or final rules would be published in the Federal Register. Dr. Cohn summed up: the Workgroup had a major deliverable for June and other actions set up for the rest of the year.
June 1 - 2, 2000
Mr. Blair convened this meeting of the Computer-based Patient Record Workgroup, within the Subcommittee on Standards and Security, part of the National Committee on Vital and Health Statistics to review the sixth and final draft of the report to the Secretary of HHS on uniform data standards for PMRI.
In April, the Workgroup solicited comments and critiques from outside reviewers. During May, these comments were melded by Ms. Amataykul and mapped into a matrix: an Excel spreadsheet tracking comments from each reviewer, in relationship to both draft 5.4 and key topics. Ms. Amataykul crafted draft 6.1, incorporating and identifying suggested changes. Controversial changes were highlighted. Mr. Blair and Ms. Amataykul wordsmithed the draft; Susan Burke-Bebee and Clauda Tessier assisted in proofreading and editing. Prior to the hearing, draft 6.1 was distributed electronically to Workgroup members and staff.
Mr. Blair expressed appreciation for the spreadsheet and draft, which would help expedite the review, and called for the Workgroup to consider and verify whether they accepted the changes.
Mr. Blair noted the large contribution of thoughtful, insightful comments. Dr. Paul Tang, in particular, had presented a crisp, clear revised outline of the recommendations. Many of those sub-points had been folded into draft 6.1, improving clarity and flow. Paragraphs needed in draft 5.4 to describe the selection process were no longer necessary and had been deleted.
Ms. Amataykul led the Workgroup through the fairly significant changes in the recommendations section, paragraph by paragraph, with everyone focusing on wordsmithing and conceptual issues. Ms. Amataykul and Mr. Blair explained annotations as necessary.
The introduction remained basically unchanged.
The National Committee on Vital and Health Statistics, (NCVHS) has identified several major impediments to improving healthcare quality and cost and achieving administrative simplification, including:
The second paragraph, drafted in response to queries about why consumer health records and content had not been addressed more, presented a declaration and explanation of focus.
The NCVHS also recognizes the continuing evolution that defines and redefines the content and structure of patient medical record information (PMRI). The most recent example of this evolution is the emergence of web-based personal health records. NCVHS believes that it is important to accelerate the interoperability and comparability of PMRI in a manner that will leave the content and structure of health records flexible to adapt to new medical knowledge, procedures, technologies and public policies.
Participants stated that some of the above was commentary and belonged elsewhere. Noting this revision was a response to critiques and suggestions and that many readers begin with the introduction, Mr. Blair suggested some of the thinking behind the report needed to be reflected here. Others thought references to Web-based personal health records belonged in the section on emerging technologies and observed that the report had not addressed emerging personal health records. Dr. McDonald reflected that the prime message to convey here was the importance of linking records to each other, so data could flow: emphasis was on adaptability and finding the place (personal health records) to put data. Areas for wordsmithing were noted. Ms. Amataykul confirmed that the revised paragraph then read:
The NCVHS also recognizes the continuing evolution that defines and redefines the content and structure of patient medical record information (PMRI). NCVHS believes that it is important to accelerate the interoperability and comparability of PMRI in a manner that will lead the content and structure of health records flexible to adapt to new medical knowledge, procedures, technologies such as web-based personal health records for new technologies, and public policies.
Ms. Amataykul explained that queries about how the report and its recommendations related to HIPAA and the claims attachment standards led to the following revisions in the third paragraph intended to clarify intent.
This report reflects the belief that significant quality and cost benefits can be achieved in healthcare, if clinically specific data are captured once at the point of care and derivatives of this data are made available for all legitimate purposes. In addition, the standards for PMRI that will result from the recommendations in this report should be consistent and compatible with the administrative and financial transaction standards, including the claims attachment standards. Furthermore, these recommendations address standards to exchange comparable PMRI seamlessly within a healthcare enterprise, as well as to share data in a secure manner with those outside the enterprise who have legitimate need for such information.
It was agreed to use the word will rather than should in referring to the recommendation. The last paragraph in this section then read:
Therefore in accordance with the directives in Section 263 of the Administrative Simplification Provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and in consideration of industry testimony, the NCVHS makes the following recommendation.
The guiding principles, Ms. Amataykul explained, would appear in a box on the left page, the first of the recommendations on the right. It was pointed out that the first recommendation includes the guiding principles. The recommendation section began:
Recommendation 1. As a result of hearing the testimony, and considering the potential impact of standards required in the Administrative Simplification Provisions of HIPAA, the NCVHS recommends that the Secretary of HHS, adopt the guiding principles for selecting PMRI standards (see box) as a criterion to select uniform data standards for patient medical record information:
The NCVHS will recommend an initial set of specific standards within 18 months, following the Secretary's acceptance of this report.
The Guiding Principles for Selecting PMRI Standards. The principles proposed below are derived from the guiding principles that were developed to guide choices for the standards to be adopted by the Secretary of HHS, that were published in the Notice of Proposed Rulemaking for administrative and financial transaction standards. In developing these recommendations and legislative proposals, NCVHS will aim to promote PMRI standards that:
The Workgroup discussed conceptual and terminology issues related to bringing consistency and uniformity to other HIPAA standards. While PMRI standards would not cover administrative data, it was noted that they provided uniform vocabulary, terminology and a reference point. Dr. Fitzmaurice suggested it was even more important to bring consistency and uniformity to the use of other HIPAA standards. Dr. Fitzmaurice observed that when one found that a standard he was consistent with was deficient, he needed to be able to propose an alternative--even conflicting--standard. Mr. Blair suggested they were dealing with two concepts. One was addressed by the change, "consistent with." The other might be an additional guiding principle articulating Dr. Fitzmaurice's concept.
While a recommendation identified the need to be consistent with the meta data registry, it was noted that putting something in the registry resulted in only low-level coordination--a meta data registry identified gaps but did not provide enforcement. Dr. Fitzmaurice pointed out that PMRI standards provided a uniform vocabulary and terminology to reference. Dr. Cohn concurred. Many data sets in the administrative and financial transactions were not part of the clinical or medical vocabularies; PMRI standards would not cover administrative data, but could provide a significant reference point.
Dr. Cohn encouraged the group to consider a recommendation to be consistent and uniform with other HIPAA standards and to declare this in the introduction. Uncertain how to refine this concept or whether to include it in the guiding principles or a section addressing decisions about standards that needed to be developed or adopted, it was "parked" while work continued on other recommendations.
The next guiding principle remained unchanged:
45. Have low additional standards development and implementation costs relative to the benefits of using PMRI standards
The fifth guiding principle, originally worded as in the transaction standards, had been revised in draft 6.1 to address concerns expressed in the hearings about private organizations acting as standards development organizations.
5. Will be supported by an accredited standards developing organization. Where an accredited standards developing organization does not address a domain, another private or public organization may be selected. All organizations selected to support standards must operate in an open consensus manner and assure continuity and efficient update of the standards over time.
The value of open process and preserving code standards from becoming property of a monopoly was acknowledged by the Workgroup, but it was noted that the revision did not address the legal distinction between transaction standards and code standards. HIPAA law does not cover code standards in a similar way. It was also pointed out that sometimes consensus and efficiency could seem to be a contradiction. Whether efficient, workable updates of code standards could come purely from consensus was questioned. The group also noted that the ANTI accredited aspect would be difficult for WHO ICD-9 and other organizations. Retaining some of draft 5.4's wording and closing the paragraph with the reference to open manner was an effort to help resolve these issues.
5. Will be supported by an accredited standards development organization or other private or public organization that will assure continuity and efficient update of the standard over time. All organizations selected to support standards must operate in an open manner.
6. Have timely developmental testing, implementation and updating procedures to achieve benefits faster.
7. Are vendor neutral and technologically independent of the computer platforms and transmission protocols used in the electronic exchange of PMRI.
8. Are precise and unambiguous, but as simple as possible.
9. Keep additional data collection and paperwork burdens on users as low as is feasible.
10. Incorporate flexibility to more easily adapted changes in the healthcare infrastructure, such as new services, organizations and provider types and changes in information technologies (such as new forms of data capture, knowledge representation and information presentation).
11. Are consistent with the characteristics and attributes for clinically specific PMRI terminology. These characteristics and attributes as described in section three have been recognized within several scholarly works in the industry, culminating in an ASTME 2097 standards specification of quality indicators for controlled health vocabularies.
Noting very similar wording was accepted in the HL-7 vocabulary TC, Mr. Blair suggested that ASDM attributes and characteristics would become guidelines for the registration of vocabularies that fit into HL-7. The group considered including the standard as an appendix, but decided the material was easier to understand the way Ms. Amataykul had laid it out: attributes and characteristics were immediately accessible. Readers would be referred to the overview, which cited the ASTM standard. The paragraph was cut to read:
12. Are consistent with the features and characteristics of data quality as described by the American Health Information Management Association's data quality management model, as described in section 3….
The group discussed including the ASTM standard as an appendix, noted it had a copyright, and agreed that the attributes and characteristics were clear the way Ms. Amataykul had formatted them. It was decided to list the 10 characteristics of data quality (which could be used as a check-off list) as bullets. Mr. Blair described how participants, as they went through the standards selection process looking for examples of message format standards for PMRI and reviewing characteristics and attributes in the HEMA for data quality, could ask SDOs to enhance the message format standards to include attributes for data quality, data integrity, and accountability.
The group questioned whether, years from now, the guiding principles might become outdated because of some of these changes. Mr. Blair commented that attributes and characteristics had been selected that were divorced from technology and new medical procedures.
Noting that the draft did not refer to market acceptance, Dr. Fitzmaurice observed that the Committee held hearings and actively sought the market's opinion and guidance. He predicted that market acceptance for PMRI standards was not likely in the first year or two, and suggested it would be a matter of both leadership and leading the market. Mr. Blair recommended that PMRI standards that already had some degree of market acceptance (e.g., transaction standards) be included among the guiding principles.
13. Are based on a publicly available set of semantic models of the clinical domain.
Ms. Amataykul explained that this last principle was the suggestion of one reviewer, but comments had come from multiple viewpoints. Some spoke to a need to reflect ontological principles for developing clinically specific vocabularies. Others asserted the report should recognize the strength of a standard based on a model that promoted consistency, compatibility, and updatability.
Dr. Bealer stated his belief that any organization proposing standards should have a published semantic model that was used to ensure the standard's internal consistency and continuity. Acknowledging that some current guiding principles (4, 8, 10 and 11) argued for support of an information model, he urged the group to add an additional principle calling for standards to be based on a stable, publicly available set of semantic models of the clinical domain. Dr. Fitzmaurice agreed, but noted this was still a work in progress. He suggested a statement that NCVHS should investigate and adopt a model was more a recommendation than a principle.
Ms. Humphreys observed that being based an ontologies already was referenced among the desirable characteristics for clinical terminology. The Workgroup eliminated principle 13, but noted to include the discussion in the overview section, retaining this perspective. Noting that honing remained to be done on market acceptance and wordsmithing on sections 3, 5, and the bullet, the group moved on.
Recommendation 2. To direct NCVHS to select uniform data standards for PMRI, according to the criteria in the guiding principles for selecting PMRI standards. Where standards do not exist or are still under development, the NCVHS would identify mechanisms to accelerate the development of those standards. The NCVHS will recommend specific standards for adoption and appropriate mechanisms to accelerate standards within 18 months following the Secretary's acceptance of this report.
Some 12 expert reviewers had commented that the original time line was quite aggressive. The Workgroup discussed whether or not to drop the time frame. They noted that this was an ongoing effort and amended the paragraph (and recommendation 4) to read, "recommend the first set of specific standards." While acknowledging that 18 months was ambitious, the group committed itself to meeting these deadlines.
The Workgroup amended the first two sentences of the next recommendation as follows:
Recommendation 3. Provide immediate funding to accelerate the development of uniform data standards for PMRI. This should take the form of support for maintenance, enhancement, distribution and application of clinical vocabularies useful in PMRI.
a) government participation in standards development
(1.) as members of healthcare informatics standards development organizations
(2.) as a departmental member of the American National Standards Institute Healthcare Informatics Standards Board.
b) broader participation of expert representation in standards development
(1.) through outreach and demonstration projects to those groups typically under represented in the standards process (for example, clinicians from small provider organizations, physicians from subspecialty groups and nursing and allied health professionals)
(2.) to encourage standards developing organizations to make greater use of the Internet to solicit comments and conduct balloting
(3.) through making existing government teleconferencing facilities available to standards development organizations.
The group discussed that demonstration projects for entities not involved in the standards process could demonstrate how their business and interest were being impacted and that "they had better get into the room." The point was to demonstrate that the standards worked in their environment. Groups could be funded to do test implementations. Dr. Fitzmaurice commented that if the government was to support standards, facilities should not be restricted to teleconferencing. Each SDO might discover as it evaluated its participation that there were under-represented groups that needed to be mentioned. The Workgroup deleted the parenthetical.
c) enhancement and maintenance of the unified medical language system used in the medi thesaurus, through support for the National Library of Medicine, the Agency for Health Care Research and Quality, two, through encouragement of vocabulary developers to embody enhanced mapping capabilities among and between medical vocabularies and between the medical vocabularies and the more general statistical classifications and reimbursement code sets, designated in the HIPAA standards for financial administrative transactions.
The group noted that the focus on enhancement and maintenance of UMLS was too narrow-- only a subcategory. What the government needed to do now, was to promote clinical vocabularies. The consensus was that this report should encourage proceeding with government-wide licensing and up-front support mechanisms for clinical terminologies. Moving this up earlier, the group meant to convey that there would be no waiting for recommendations, but immediate support. Providing funding would be mentioned at the beginning, along with a list of things requiring funds.
Emphasis here was on clinical vocabularies with strong potential as PMRI standards: distributing, applying, testing and evaluating them to see if they had potential for standards. Another intent was to make standards available at little or no cost
Deployment and evaluation through:
(1.) government-wide licensure or comparable arrangements, so these vocabularies are available for use at little or no cost.
(2.) continued development of the National Library of Medicine's unified medical library system, MLS, to embody enhanced capabilities among and between medical vocabularies and between medical vocabularies and the more general statistical classification and reimbursement code sets, designated in the HIPAA standards for financial and administrative transactions.
e) development of a uniform implementation guide for each standard.
Dr. Cohn noted that a research and evaluation piece belonged here. Research and demonstration projects that demonstrated the benefits and costs of using uniform data standards for PMRI had to be funded immediately. Mr. Blair explained that concerns about business case issues and costs, and the fact that this was a different type of research had motivated forming this independent recommendation. Ms. Amataykul noted comments urging the determination of the cost of implementing these standards. She mentioned concern in drafting 6.1 that putting this before the final rules would constrain the time frame by forcing everything to wait until these studies were done.
Recommendation 4. For each standard recommended by NCVHS, commit funding for each subsequent development of implementation guide, development of conformance testing procedures and selection of performance testing organization.
a. development of a uniform implementation guide,
b. development of conformance testing procedures and selection of conformance testing organization or organizations, and
c. coordination of data elements among all standards selected for adoption under HIPAA through funding,
(1.) the development and maintenance of an open data registry and
(2.) working conferences to harmonize message format and vocabulary standards.
d. coordination of data elements among all standards selected for adoption or HIPAA through funding, one, the development and maintenance of an open meta data registry and two, working conferences to harmonize message format and vocabulary standards.
e. development and ongoing maintenance of the drug reference terminology
The group discussed resequencing the above so that each step followed logically. Dr. Kolodner reiterated the importance of immediate funding and encouraged a commitment for follow-up funding. Dr. Cohn clarified that the recommendations stated NCVHS would recommend the first set of specific standards based on industry readiness for adoption, and appropriate mechanisms to accelerate standards within 18 months.
Direct NCVHS to select uniform data standards for PMRI according to the criterion, the guiding principles for selecting PMRI standards. Where standards do not exist or are still under development, the NCVHS will identify mechanisms to accelerate the development of those standards. The NCVHS will recommend the first set of specific standards based on industry readiness for adoption within 18 months following delivery of this report.
The Workgroup discussed whether waiting upon acceptance was necessary or advisable. Bill Yasnoff had felt the group's authority wasn't as definitive as it had been to set the financial and administrative transactions and had suggested that this might reinforce the authority to move forward. The group observed that they had already been charged to do this by law; they were concerned that considerable time and momentum might be lost. The choices were either to leave the recommendation as it was, acknowledging they would wait, or to introduce this effort as a first set of recommendations, stating another set would be forthcoming. The group noted to consult with Mr. Scanlon and Dr. Braithwaite and seek further counsel at the full Committee meeting.
Dr. McDonald commented that it would take more than just funding the development of meta data to get anything out of it: a mechanism needed to be developed to maximize commonality. Dr. Cohn observed that the time and way the group could influence development centered around the selection of the public airing process. He said that if there was an issue regarding a standard, then NCVHS could acknowledge the candidate's promise, while explaining that it could not be accepted as it stood because the data elements "were off the map"--but that the group would welcome seeing the next version. Dr. Cohn said they could argue whether this would be effective or not, but he suggested it was a good idea. Dr. McDonald cautioned that no one really knew what an open meta data registry was, and that there were no incentives to do "deep, heavy work." He expressed concern that people would think they understood it, while really doing nothing.
Dr. Kolodner noted the need to add government wide or multi-agency projects (e.g., GCPR) to the mechanisms listed (3C) for doing enhancement, distribution, testing, and application. Government wide licensure and UMLS were already listed, but Dr. Kolodner cited the importance of a multi-agency collaborative approach in conjunction with data standards. An insert, "through applicable portions of multi-agency projects such as a GCPR framework project in conjunction with standards development organizations," was added to the recommendation.
Dr. Greberman reported that FDA had suggested expanding 3E ("developing and ongoing maintenance of a drug reference terminology that promotes the ability to share clinically specific drug information, that is, dose, route, frequency, strength, chemical composition, etc.") to include the broader area of medical products. He proposed adding "development and ongoing maintenance of a medical products reference terminology that promotes the ability to share clinically relevant information related to medical products, including drugs, biologics (vaccines, blood, blood products, genetic material) and devices." Mr. Blair acknowledged this addition might be helpful, but expressed concern that this was done as separate items, so the need for clinically specific drug vocabularies was not mixed with another valid need for vocabularies that covered supplies. Dr. McDonald raised "a deeper" question. He said this sounded like standardization by or through MEDRA; the words Dr. Greberman proposed could imply "standardize everything in healthcare."
Ms. Humphreys validated the international effort to base a new terminology on the work done at ECRI with the universal device nomenclature system. He said he could support that, but had reservations about anything else. Dr. Hansel pointed out two elements: ECRI provides groupings of devices, but does not "get down to" specific devices; and the universal product number, which he termed the equivalent of the universal drug code. He predicted that UPN for medical devices, currently utilized primarily in conjunction with expendables, would eventually be utilized by industry on all devices. Ms. Humphreys commented on another polarity. People on the drug side had NDC codes, but could not connect back to anything more clinically meaningful describing purpose or function or dose. On the device side, ECRI UMNDS provided categorization, but could not go down to the individual number. He pointed out that solving these two problems required different kinds of work, and suggested it was best to divide them out.
Ms. Fyffe observed that medical product reference terminology was a level of detail that wasn't appropriate for the report. Dr. Greberman stressed that the gray area between medical devices and drugs and biologics only became grayer as technology evolved. Ms. Humphreys queried whether going down to the UPN was a good idea that needed support and, potentially, funding--and so should therefore be recognized in the report. Dr. Hansel said the VA was looking at the need to follow DoD and require UPNs in their procurement and inventory process. FDA considered going down to the "model level listing," equivalent to universal product codes with drugs. Dr. Hansel noted the number of individual devices was so large, compared to drugs, that cost was a concern.
Dr. McDonald commented that a universal product identifier (which he noted was an ongoing activity in the industry) was not necessarily within the scope of the report. A strong switch in government sentiment about five years ago, he said, had made the private sector the center of gravity for standards activities. The Workgroup would describe a universal product code to be used across industry in healthcare, but it would not be FDA or drugs specific. The group discussed including a reference to identifier codes for medical devices in the recommendations.
Mr. Blair observed that what almost everyone on the committee had expressed discomfort with was the idea that universal product codes addressed the need for clinically specific drug vocabularies to help in the patient care process. Dr. McDonald said the universal product code was an ongoing activity in the industry and "a no-brainer." New conceptualizations, data structures and fields would be built, independent of how the industry collected that data in hospitals and clinics. "That," he remarked, "was what he worried about."
Mr. Blair noted that the entire thrust of the report was focused on how to collect data that was part of the normal patient care process (non-disruptive, not an independent information- gathering activity) and, then, utilize derivatives of that information to support all the other uses. Mr. Blair said that was the report's underlying principle. Dr. Greberman replied that they were talking about collecting and using clinically relevant data to determine when problems occur. Dr. Cohn said he supported a drug reference terminology and that he had looked "very hard" at extensive testimony in order to understand the issue. He noted the group had crafted a recommendation. He suggested the Workgroup might want to hold more hearings. They had not yet held extensive hearings on the UPNs--and only briefly on UCRI. There would be discussions on codes later this year and next. It might be time to recognize this as an independent issue to revisit. Dr. Fitzmaurice suggested that addressing this issue could strengthen the report. He said he had not heard that these things did not need to be enumerated and coded. What he did hear was that an agency did not always operate in an open process. Addressing this in the report would tie them with the guiding principles for developing PMRI standards. Anyone who developed the standards would be obliged to look at the guiding principles.
Mr. Blair suggested a recommendation that funding be available to study uniform product identifiers, such as medical devices and biomedics, so that they could work cooperatively and harmoniously with other PMRI standards. Dr. McDonald noted they could easily insert discussion about adverse drug reporting. And the product experience reporting section could describe in explicit detail clinical studies illustrating the benefits of the standards. The web was seamless: everyone used the same terminology in X-ray, laboratory, allergy, and blood pressure measurements reporting. There was no contradiction or disagreement, but he questioned singling out one agency to have this particular piece in the recommendation. The drugs and biologics could be in one category, medical devices in another. Mr. Blair concurred that the thoughts suggested by the representatives of the FDA could be invoked and included in a separate line item. Ms. Amataykul said she sensed that drugs and biologics went together; devices probably needed to be separate. Dr. Ferrans recommended adding drug reference terminology to the glossary of terms.
Dr. Cohn addressed the issue of medical devices. Queries included the need for funding and the possibility of revisiting the issue of UPN at a hearing later this year. Both deliberations were taken under advisement. Noting the Workgroup planned on going into code sets later in the year, Dr. Cohn said it was an appropriate time to revisit the issue. Dr. Fitzmaurice observed that the important thing was to communicate this, so that it was known to fall under the domain of what NCVHS was considering. He noted the group had already recommended that a hearing be held next year.
Art Chankowsky from the Center for Devices commented that medical devices were becoming competitive with drugs; e.g., for the treatment of anti-tachycardia. Certain types of pacemakers and defibrillators were proving to be better than equivalent therapy.
Dr. Cohn said that a notation of the need to evaluate this further could be inserted in the body of the text. He noted that this also was an issue for the hearings on codes, adding he did not think it fit in the recommendation that NCVHS would study UPNs later this year. Ms. Amataykul recalled suggestions to update the NCVHS work plan, which was in one of the appendices; she noted the possibility of adding some of this to next year's work plan.
Recommendation 5. Issue a notice of proposed rulemaking to gather comments and publish the first of a series of final rules for PMRI standards within 18 months after acceptance of the NCVHS recommendation for the selection of PMRI standards.
Ms. Amataykul explained that recommendation 5 (previously 4) had been split. The notice of proposed rulemaking within 18 months was now separate from the implementation requirement in which NCVHS would recommend time frames. Dr. Fitzmaurice observed that time frames would be given when NCVHS made its recommendations.
The group edited the recommendation to include "The NCVHS will recommend the initial set of specific standards," indicating the sequence to be followed."
The group discussed the revision's ambiguity regarding the two different 18-month phases, the need at this point in the draft to reinsert "acceptance of recommendations" in order to avoid setting up a second potential time-gap, and the clarity to be gained from incorporating some of the wording used in recommendation 2.
Recommendation 6. Promote early adoption of PMRI standards within government programs to provide broadened feedback to the standards development community. These early adoption activities should begin as soon as possible in order to provide information to assist with both the selection of PMRI standards and their official designation as HHS regulations. To achieve this, HHS should support use of PMRI standards according to the following priority:
- Within government projects, such as the GCPR framework project.
- Within government agency programs that deliver health care services.
- Within federally funded clinical research, where applicable.
Ms. Amataykul explained that "where applicable" had been added because people had said it would be difficult for everything to be required. Dr. Greberman commented that HCFA and FDA ought to be among the entities grouped in the second bullet; since neither directly delivered healthcare services, he suggested rephrasing the end of the line to "programs that deliver or have an impact on healthcare services." Mr. Blair summarized that the concept that was trying to be conveyed was that before end-user agencies could obtain clinically specific data, providers had to capture it. The previous set of recommendations had been criticized for listing agencies that used the data, and so the group had prioritized the revision in terms of agencies that captured the data. Dr. Fitzmaurice noted that some agencies do not deliver healthcare, but do have an impact. Asked to clarify what they meant by government agency programs that deliver healthcare services, Dr. Greberman replied VA Health Service and DoD Health Affairs--both captured patient data. Dr. Fitzmaurice suggested simply stating within government agency programs; the programs themselves could decide where to begin implementing this. Some early implementation should start within government agency programs, not just those that deliver healthcare services.
The group sharpened focus on clinical vocabularies that had the potential to be PMRI standards and the dual components of promoting early adoption of PMRI standards and taking the lead on evaluating candidates for PMRI standards.
Dr. Cohn remarked that the following still needed wordsmithing, but that he did not want to take more of the Subcommittee's time for that.
Recommendation 6 (Revised) Promote early adoption of PMRI standards and gain experience with and early evaluation of candidates for PMRI standards within government programs to provide broadened feedback to the standards development community. These early adoption activities should begin as soon as possible in order to provide information to assist with both the selection of PMRI standards and their official designation as HHS regulations. To achieve this, HHS should support use of PMRI standards according to the following priority:
- Within government projects, such as the GCPR framework project.
- Within government agency programs that deliver health care services.
- Within federally funded clinical research, where applicable.
Government agencies that may be candidates for this support include the National Cancer Institute, Centers for Disease Control and Prevention, Agency for Health Care Research and Quality, Indian Health Service as an HHS participant in the GCPR framework project, Health Care Financing Administration and the Food and Drug Administration.
The Workgroup identified a number of basic issues that cut across many of the standards that needed to be addressed. The intent here was to describe early adoption activities and feedback. Included were basic questions brought up by testifiers, basic research, things that impeded the adoption of standards, and the user interface for data capture issues. While noting that they could not gauge priorities in each agency, they favored recommending as a Committee that informatics research was a high priority, required funding, and needed to be done. The group noted the importance of supporting research, demonstration and evaluation studies.
a. Study and promote data capture systems that can make it faster and more economical to collect clinically specific information at the point of care. The intent of these studies is to find ways to improve the ability to capture clinically specific information, once at the point of care, and enable derivatives of that data to be used for payment, public health research and other purpose.
b. Basic health care informatics research on health data representation, data mining methods, work flow efficiency, change management and human-computer interfaces.
Recommendation 7. Provide leadership and funding to accelerate the development, implementation and education of a National Health Information Infrastructure. HHS should work in collaboration with other federal departments and the private sector on demonstration projects, test beds and/or networks such as the GCPR framework project.
Dr. Fitzmaurice commented on the importance of evaluating the projects and "seeing what we are getting for our money." Dr. Ferrans noted that unless there were specific directions, the federal government sometimes had trouble working with state governments. Dr. Fitzmaurice pointed out that federal departments, state governments and the private sector all needed to interact. Dr. Cohn observed a clearer understanding of what was meant by NHII was needed; the definition in the glossary seemed to include all the previous recommendations. He asked the group what exactly was being discussing here that had not been addressed already. Dr. Fitzmaurice replied that this was about interoperability and comparability of data. He envisioned that providing this leadership and funding would illustrate both the interoperability of health systems and the comparability of data at different levels: i.e., between federal departments and state governments, and between both and the private sector. Dr. Fitzmaurice summed up: "We are promoting interoperability and comparability of data." Mr. Blair expressed concern that people would believe an evaluation had to be completed before standards were implemented. Dr. Fitzmaurice said the revision indicated working with everyone on projects and test beds all in one phrase--everything was not held up until projects were evaluated. Ms. Amataykul read the revisions:
Recommendation 7 (Revised) Accelerate the development and implementation of a national health information infrastructure. HHS should work in collaboration with other federal components, state governments and the private sector on demonstration and evaluation projects, test beds and/or networks such as the GCPR framework project.
The next recommendation required only minimal wordsmithing.
Recommendation 8. Demonstrate the benefits and measure the costs of using uniform data standards for PMRI. Research and demonstration projects should be funded to measure the added value for use of PMRI standards. Areas where value may be demonstrated include clinical performance measurement, use of practice guidelines, reduction in medical adverse events and public health surveillance and intervention.
Recommendation 10. Promote enabling legislation for use and exchange of electronic data, including the following:
a. comprehensive federal privacy and confidentiality legislation. This should insure that all health information in any medium used for any purpose and disclosed to any entity receives equal protection under law, and that individuals have private right of action under such law
b. establishment of a center for health care privacy and security. This should help the health care industry identify and correct vulnerabilities and respond appropriately to privacy and security incidents. This center would develop privacy and security training, produce model contract provisions, research causes of privacy and confidentiality violations, continually monitor violations, privacy legislation and regulation, and issue periodic reports.
c. HHS should promote legislative initiatives that enable electronic retention of PMRI, and acceptance of electronic signatures to authenticate PMRI in all 50 states. This is intended to promote the electronic exchange of PMRI that will contribute to administrative simplification.
The group clarified that the Secretary was not being asked to propose new legislation, but to strongly support enabling legislation that would protect the privacy and confidentiality of health records. It was suggested that the next two sections not be too detailed. As Dr. McDonald pointed out, the Congress wrote legislation; the Workgroup's intent was to produce a recommendation that would work within the framework of any future legislation. The essential thing, Mr. Blair observed, was that the Secretary support legislation that would strengthen privacy and confidentiality of healthcare information.
The group discussed the establishment of a center for healthcare privacy and security: a federal center or institute in the private sector, perhaps federal funded. Reservations were expressed about creating a regulatory agency. Ms. Amataykul described a private organization, like CERT at Carnegie Mellon (a private security and privacy emergency response team that alerts about computer viruses) or the center being created in response to the IOM patient safety. She saw it as a place where people could report privacy issues and receive training. Mentioning Georgetown University, Dr. Fitzmaurice remarked that such a place might already exist.
Dr. McDonald commented that "continuing monitoring violations," connoted a regulatory role. He offered, instead, a description of a private organization that would actually make it easier for people to properly implement privacy. Dr. Fitzmaurice reflected that one might measure the costs and benefits and find $20,000 was spent to protect 20 cents worth of data--or one could overlook independent advice or something that needed to be protected.
If the group wanted to make an argument about a public center that required federally funding, Dr. Cohn noted it should be within this recommendation. If not, he suggested that this idea, which had not come from testimony, should be dropped. The group retained a "placeholder" for the idea by pruning the second sentence to, "establishment of public-private mechanisms to help the healthcare industry identify…."
Mr. Blair noted that this recommendation addressed the issue highlighted in the report of how inconsistent state laws impeded the transfer of PMRI. Ms. Amataykul observed that already some states, doubting a federal law would come soon enough, were creating electronic signature laws. Dr. Fitzmaurice proposed adding the concept of uniformity across all 50 states in acceptance of electronic retention and acceptance of electronic authentication.
Recommendation 10 (Revised) Strongly supporting enabling legislation for use and exchange of electronic data:
a. comprehensive federal privacy and confidentiality legislation. This should insure that all health information in any medium used for any purpose and disclosed to any entity receives equal protection under law, and that individuals have private right of action under such law.
b. establishment of a center for healthcare privacy and security. This should help the health care industry identify and correct vulnerabilities and respond appropriately to privacy and security incidents. This center would develop privacy and security training, produce model contract provisions, research causes of privacy and confidentiality violations, continually monitor violations, privacy legislation and regulation, and issue periodic reports.
c. uniform recognition by all states of electronic health record keeping and electronic authentication signatures.
Noting that Bill Yasnoff had reported widespread concern and objection within CDC that they might have to pay for data, the Workgroup turned again to discussing incentives to promote the equitable distribution of the costs for using PMRI standards among all major beneficiaries (Recommendation 3, C (1)). Dr. Cohn said that an earlier version stated that HHS should encourage the private sector to adopt incentives that included having payors and researchers fairly compensate providers for the use of clinically specific data. Dr. Fitzmaurice considered that providers who supplied the data that made the system more efficient or delivered a higher quality of care should be paid for supplying the means--i.e., the better PMRI. Mr. Blair said he had fought to retain the notion of incentives to be fair to testifiers, but that he could not ignore Bill Yasnoff's observation that providers benefited directly from improving the quality of care--they were chosen by health plans, competed better and reduced their costs. Mr. Blair cautioned it would be difficult to gain support for charging payors and researchers for data. Dr. McDonald remarked that the person who had to get into the electronic side of the clinical data had all the work and did not get any gain. The federal government gained a "cheaper" quality review, the payors gained by receiving more electronically, the public health departments gained by getting the data for communicable diseases. The costs were on the wrong end of the stick; no one had yet crafted a way to make this more equitable. The group noted that the concept in this recommendation was about vocabularies with the potential to be PMRI standards that were selected for adoption. Dr. Ferrans proposed committing funding for insuring that the selection was available to all at little or no cost. He noted that laid out the benefit to those who had their standards selected. He also suggested adding government licensure available in both the public and the private sectors.
A participant expressed concern over the CPT codes and the copyright granted to the AMA, stating that a non-government organization profiting off a required or recommended action was a sore point for many providers.
Dr. Fitzmaurice suggested taking out "protection of," which could be seen as a protectionism mechanism, and saying "facilitate United States interests." The others concurred that the government was promoting international harmonization, and trying to insure coordination with the international standards community of its activities.
Uncertain that HIPAA was clear about whether the NCVHS had authority to select PMRI standards, the subcommittee's draft asked the Secretary to direct them to move forward on the recommendation. Nearly all the recommendations had been framed from the standpoint that the Subcommittee sought her authority to go forward. However, this would force the Subcommittee to wait for a formal go-ahead that might or might not happen for a variety of reasons. Mr. Scanlon said the idea of the NCVHS identifying consensus in existing standards was consistent with the rest of HIPAA. The whole approach in the earlier part of HIPAA was the idea of industry identifying consensus and then the NCVHS acting as the forum to hear, balance and make recommendations. He did not see any problem with offering the NCVHS as the forum in which the process took place, identifying and assessing potential additional standards, and then making recommendations to HHS.
Both Mr. Scanlon and Dr. Cohn noted a fair amount of authority already existed: included in the residual class of HIPAA standards were other financial and administrative transactions deemed appropriate by the Secretary. Mr. Scanlon said his only worry was that NCVHS might be looking like it was putting itself into a position that did not fit with the model in the rest of HIPAA. He suggested a recommendation that indicated NCVHS would identify candidate standards and make recommendations. The draft was revised ("The NCVHS will identify, evaluate and recommend PMRI standards") so that the Secretary was asked to consider the recommendation for the selection of standards that will be sent to her in 18 months. The Committee could proceed with the evaluation process.
Dr. Cohn questioned that it was appropriate to tell the Secretary that she needed to respond in 18 months. Dr. Fitzmaurice suggested that could be accomplished in a letter of transmission. Mr. Blair explained that was put in for a broader audience: those who were not distinguishing between the recommendations from the NCVHS and the final rule. He said many folks would be fearful that this was about to be enacted without an opportunity for them to express concerns. People needed to know there would be an opportunity to comment.
The group discussed at length the draft's structure, which starts discussing standards, standards concepts, and definitions of terms. The draft then tangentially mentioned standards organizations and mentions accountability, without examples or details. The overview of data standards issues and discussion about interoperability and comparability that came next were viewed by some as theoretical, difficult and tiresome: it lacked specificity and needed to be cut. Only after all this, did the draft describe in any detail what the organizations had done, the current status of data standards, and which data standards addressed various issues. On the other hand, many reviewers were positive: some said they used the draft as a primer and learning process. The reference to standards organizations had been moved up because people had not understood what issues the standards addressed. They also had not been clear about interoperability and comparability; now a definition was given first, followed by an example. Dr. Cohn noted that the draft had to be voted on in the morning to go to the Workgroup. He reminded the group that the full committee was expecting evolutionary, not revolutionary changes. He suggested that if organization was a problem but the information within was fine, they probably ought to defer revisions.
Dr. McDonald objected to the report stating the healthcare delivery systems appeared to have placed a higher priority on standards necessary to facilitate reimbursement than those addressing quality of care. He doubted such accusatory statements could be supported with facts, persuade anyone, or make the industry want to embrace the recommendations. And he noted that the Healthy People 2010 Report showed a remarkable improvement in life span over the last 10 years. Mr. Blair pointed out that testifiers had urged that the report recommend the creation of incentives for quality. He noted it had often been observed in testimony that incentives were in place for data for the reimbursement process: the claims and reimbursement codes were the first put in place, mature, and could be moved forward while "we struggle over standards of patient care." Dr. Fitzmaurice commented on the range of financial and billing systems and limited number of clinical information systems. Over the decade, he observed, a lot of literature suggested clinical data systems could improve quality. Dr. Ferrans recalled taking foreign dignitaries to tour information systems at a major academic hospital. They came away saying, "It looks like 90 percent of your computers are all about billing." The issue was a major concern, Mr. Blair noted. Physicians, active in patient care, testified they struggled with the fact that, in order to get paid, they had to have this data--but there were few incentives for them to demonstrate the quality of the care they give. Some physicians want to create different incentives. Dr. McDonald cautioned that some in the healthcare industry were not happy with the standards; accusatory statements hurt any chance to have the recommendations embraced or get political support.
Mr. Blair suggested inserting that many clinicians complained that the healthcare delivery system did this. Dr. Cohn said he was not sure the reference was needed. He said, as one who practiced clinical medicine, he felt attacked--as though he was not delivering good care, and so the government had to come out with stronger incentives and regulations. Some days, he acknowledged, he felt that was the case, but he did not think they necessarily wanted to recommend that. What they were really talking about, he suggested, was PMRI standards to help support care. By toning things down, they might come up with a reasonable statement.
Dr Cohn observed that under data quality, data accountability and data integrity the draft made "a full court press" on the need for the unique identifier (the UPI). He suggested the issue was not lack of a unique identifier for patients, but the inability to uniquely identify patients. A unique patient identifier was an ideal choice, but much could also be done to enhance data quality by improving master patient indexes. Although less efficient, master person indices still afforded benefits. Dr. Ferrans added that the draft presented a fairly marginal argument that might not be convincing; a brief explanation was needed of how the UPI could contribute.
Mr. Blair thanked the participants and especially Ms. Amataykul for enabling the group to proceed in an orderly manner. The meeting adjourned at 5:15 p.m. to be reconvened the following morning
Mr. Blair reconvened the meeting of the Computer-based Patient Record Workgroup at 8:30 a.m. on Friday, June 2, 2000, continuing its review of the sixth and final draft of the report to the Secretary on uniform data standards for patient medical record information. The second day's session began with the members taking a few minutes to individually review the evolving version of the recommendations revised overnight. Then, led by Ms. Amataykul, the group moved through working draft 6.1 on a point-by-point basis, discussing and resolving issues.
The group amended the second paragraph of the introduction to read: "NCVHS believes that it is important to improve the interoperability and comparability of PMRI in a manner that will allow sufficient flexibility in the content and structure of health records to adapt to new medical knowledge."
Recommendation 1, which is both the recommendation around the guiding principles and the guiding principles themselves, read as amended: "adopt the guiding principles for selecting PMRI standards, see box, as a criteria to select uniform data standards for patient medical record information." An earlier guiding principle 5 ("will be supported by an ANSI-accredited standards developmental organization or other private or local organization that will assure continuity and efficient update of the standard over time") had been reinserted. Ms. Amataykul noted that this wording was consistent with the notice of proposed rule-making related to administrative and financial transactions. Noting that guiding principle 13 was about the market acceptance of candidate PMRI standards rather than PMRI standards, the principle was amended to read: "consider the degree to which the market has accepted each candidate PMRI standard."
Dr. Zubeldia, responding to the overnight delivery of draft 6.1 and a fax of the revised recommendations, suggested that guiding principle 3 ("bring consistency and uniformity") might be split into two. The "will be consistent" could be retained; another recommendation could address "promote consistency and uniformity with the other HIPAA standards." Mr. Blair noted that the group had a complicated discussion yesterday and determined that the concept of consistency was being carried by several other guiding principles, especially the principle that referenced the characteristics and attributes of terminologies, which references the section in the overview of standards where those characteristics and attributes were indicated and included the word consistency. Dr. Zubeldia expressed concern that the guiding principles would be quoted in other contexts, including an NPRM and other situations without access to a whole document, and principles would be quoted without that reference. Options discussed included referencing the standard, picking up verbiage from page 21 that briefly described characteristics and attributes, and referencing the other location within the document.
Dr. Zubeldia suggested listing the attributes: generality, structure, maintenance and evaluation and referring to the self-contained standard. Dr. Cohn noted yesterday's discussion about describing an external document. He commented on the decision not to put the ASTM standard as an appendix, since it was a copyrighted, separate document from ASTM. He proposed saying, "As described in Section three, page 20 and 21, and in the ASTM standard," so people did not have to do a literature search to find the standard. Mr. Blair suggested referring to the overview of standards and putting it into context as well.
"Consider acceptance of the forthcoming NCVHS recommendations for PMRI standards. These recommendations will be delivered to the Secretary 18 months following submission of this report. The recommendations will identify an initial set of PMRI standards using the criteria, guiding principles as described, include implementation time frames, which consider industry readiness, identify mechanisms to accelerate the development of these standards that are not ready for implementation. Following the Secretary's acceptance of the NCVHS recommendations, the NCVHS is prepared to assist the HHS with the prompt initiation of the rule making process, provisional comment periods and publication to adopt a final rule to adopt the standards."
Dr. Cohn remarked that what the Workgroup was really recommending to the Secretary was that HHS approach the issue of PMRI standards in the same way that they had approached financial and administrative transaction standards. Ms. Bebee recounted that the whole idea discussed yesterday was that the group recognized that this was not going to happen all at one once, but realized they had to start somewhere. That was where the idea of an initial set was born: they had considered specific, first, and, finally, initial set.
Ms. Amataykul pointed out that, in saying the recommendations would be delivered to the Secretary beginning 18 months and then that they would identify an initial set, nothing had been said about when any subsequent standards recommendations would be made. That was the whole point, Ms. Bebee said. Mr. Blair agreed; it left the door open for the group to determine.
Dr. Cohn commented that what the group had drafted yesterday talked about urging the Secretary to promptly initiate the rule-making process. Dr. Fitzmaurice said draft 6.1 had been more directive than advisory. Mr. Blair explained that they were trying to cast a more supportive and encouraging role. Dr. Cohn responded that the revision indicated that NCVHS was assisting HHS with the prompt initiation of the rule-making process, and that was not how he understood their role--Their role was to recommend the standards. It was the role of HHS to develop the NPRM, deal with the comment period, and publish the final rules.
Mr. Blair explained that the revision was meant to reassure people in SDOs concerned about how this would affect their organization or terminology developer. It let them know they would have an opportunity for an NPRM end comment. Ms. Fyffe said she, too, looked at this document as a communication vehicle, and reminded the group that "you had to think of the audience." She observed that many knowledgeable people do not understand the steps in legislation, regulation, and implementing law. Dr. Fitzmaurice observed that it was always wise to get comments from knowledgeable people and from those affected by what you did. He noted that ultimately it would be up to the Secretary to decide how to do this, and suggested recommending that the specific standard be published in the Federal Register for public comment.
Ms. Amataykul pointed out that the section in question substituted for the recommendation that said, "Issue a notice of proposed rule making, gather comments, publish the first set of a series of final rules for PMRI standards within 18 months after acceptance of the NCVHS recommendations, require implementation of PMRI standards within the time frames recommended by NCVHS." She reminded the group that everyone had seemed comfortable with that, except for its placement within the sequence of recommendations. Dr. Cohn said the group thought it was a bit presumptuous to start giving the Secretary timelines. Ms. Amataykul asked if the group had backed off the suggestion that this be done in a rule-making process. Dr. Fitzmaurice noted that, normally, the official way to do this was to put a notice in the Federal Register; that way the Secretary had met the legal obligation to give public notice.
Mr. Blair suggested that, once the NCVHS submitted its recommendations, they might encourage the Secretary to have an open process to give the industry an opportunity to comment before the final rule was made. An open process would involve holding hearings, like NCVHS did for financial administrative transactions, followed by the NPRM. Dr. Fitzmaurice summarized: the Workgroup was forming a recommendation to go to the Secretary. The Secretary formed the process whereby it was adopted and implemented. NCVHS encouraged the Secretary to broaden the process to include open consultation with the industry and the public.
Dr. Cohn said they would not take more of the workgroup's time dealing with wordsmithing, but would defer to Ms. Amataykul. Recommendation 2 still did not feel quite right, but together they had made significant changes. The next recommendation began:
Recommendation 3. Provide immediate funding to accelerate the development of uniform data standards for PMRI. This should take the form of support for:
a. government participation in standards development as members of standards development organizations and as a Departmental member of the American National Standards Institute Healthcare Informatics Standards Board.
b. broader participation of expert representation in standards development, rural outreach projects, encouraging SDOs to make greater use of the Internet, and making existing government facilities available for teleconferencing and other uses.
c. enhancement, distribution and maintenance of clinical vocabularies which have the potential to be PMRI standard through:
(1.) government-wide licensure or comparable arrangements, so that vocabularies are available for use at little or no cost
(2.) Continued development and testing of the National Library of Medicine's UMLS with embodied enhanced mapping capabilities among and between medical vocabularies and the more general statistical classifications and reimbursement code sets designated in the HIPAA standards for financial and administrative transactions and other uses.
(3.) development and testing of applicable portions of multi-agency projects such as the GCPR framework project in conjunction with SDOs.
Dr. Fitzmaurice emphasized the need for immediate funding, given pressures on patient safety, the fact that quality measures (NCQA and others) were used--the faster there was linkage with terminologies, the faster patient medical records standards could bring uniformity to this exchange of information. The cost of getting this information would also be reduced.
The group substituted "terminologies" for "vocabularies" in C and C-1, thereby including the code sets and classifications as well as vocabularies.
Dr. Fitzmaurice proposed inserting "Developing and testing of quality measures such as are found in AHRQ's National Quality Measures Clearinghouse, clinical practice guidelines such as are found in AHRQ's National Guidelines Clearinghouse, and patient safety measures, for their compatibility with existing and developing clinical terminologies".
After considerable discussion the recommendation was amended:
Recommendation 3. Provide immediate funding to accelerate the development of uniform data standards for PMRI. This should take the form of support for:
a. government participation in standards development as:
(1.) members of health care informatics standards development organizations.
(2.) a Departmental member of the American National Standards Institute Healthcare Informatics Standards Board.
b. broader participation of expert representation in standards development through:
(1.) outreach projects to those groups who may be under represented in the standards process.
(2.) encouraging standards development organizations to make greater use of the Internet to solicit comments and conduct balloting.
(3.) making existing government facilities, including teleconferencing available to standards development organizations
c. maintenance, enhancement, distribution, testing and application of clinical terminologies with potential for PMRI standard through:
(1.) government-wide licensure or comparable arrangements, so these terminologies are available for use at little or no cost
(2.) continued development of the National Library of Medicine's UMLF to embody enhanced mapping capabilities among and between medical vocabularies and between medical vocabularies, and the more general statistical classifications and reimbursement code sets designated in the HIPAA standards for financial and administrative transactions.
(3.) development of a uniform implementation guide for each standard.
d. coordination of data elements among all standards selected for adoption under HIPAA through funding,
(1.) development and maintenance of an open medical data registry.
(2.) working conferences to harmonize message format and vocabulary standards.
(3.) ease development and maintenance of reference terminology for drugs and biologics that promote the ability to share clinically significant information.
(4.) form needs for each standard recommended by NCVHS, commit funding for:
(a) development of the uniform implementation guide.
(b) development of conformance testing procedures and selection of performance testing organizations, ongoing government licensure of those terminologies selected for adoption as PMRI standards so that these code sets, classifications and vocabularies are available for use in the public and private sector at little or no cost.
The Workgroup made no changes in the balance of recommendation 3 or in recommendation 4. Recommendation 5 was amended as follows:
Recommendation 5. Promote early adoption of PMRI standards and evaluation of candidates for PMRI through PMRI standards within government programs to provide broadened feedback to the standards development community. These early adoption activities should begin as soon as possible in order to provide information to assist with both the selection of PMRI standards and their official designation as HHS regulations. To achieve this, HHS should support use of PMRI standards according to the following priority:
- Within government projects, such as the GCPR framework project.
- Within government agency programs that deliver health care services.
- Within federally funded clinical research, where applicable.
Government agencies that may be candidates for early adoption activities include but are not limited to the National Cancer Institute, Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality, the Indian Health Service (as the HHS participant in the GCPR framework project), Health Care Financing Administration, and the Food and Drug Administration.
In recommendation 6, reservations that the phrasing of the reference to the data derivatives cast an overtone of "surveillance," led to a focus on the concept of data captured once and used for multiple purposes:
Recommendation 6. Support increases in funding for research, demonstration and evaluation studies to:
a. Promote data capture systems that can make it faster and more economical to collect clinically specific information once at the point of care, and enable derivatives of that data to be used for payment, quality improvement, public health, research and other purposes.
b. to undertake basic informatics research on health data representation, data mining methods, work flow efficiency, change management and human-computer interfaces.
The Workgroup, weighing the need to simplify and consolidate the recommendations with Mr. Scanlon's comments during the first day on privacy and NHII, chose to retain the following as a separate bullet.
Accelerate the development and implementation of a national health information infrastructure. HHS should work in collaboration with other federal components, state government and the private sector on demonstration and evaluation projects, test beds and/or networks such as the GCPR framework project.
The group noted that a number of individuals and special-interest groups had focused on cost benefits and yesterday the next bullet had been separated out for visibility. Discussion clarified that a study of costs and assistance was needed so that, when an impact analysis was presented (e.g., in the NPRM), there would be input to work with. The following was moved to 4. c.; the current c. became d.
Demonstrate the benefits and measure the costs of using uniform data standards for PMRI. Areas where value may be demonstrated include clinical performance measures, use of practice guidelines, reduction in adverse events, and public health surveillance and intervention.
The next change was in:
Recommendation 9. Promote United States' interest in international health data standards development:
a. through HHS participation in international healthcare informatics standards development organizations.
b. In cooperation with the Secretary of the Department of Commerce, through monitoring the activity of U.S. healthcare information system vendors abroad and taking appropriate steps to correct anti-competitive activities that may be based on standards.
While acknowledging that American vendors and healthcare delivery systems were extending worldwide, some members of the group found "anti-competitive activities that may be based on standards" awkward and disconcerting. This was amended to read, "in cooperation with the Secretary and the Department of Commerce to monitor the activity of U.S. healthcare informatic system vendors abroad."
Recommendation 10 began:
Recommendation 10. Encourage enabling legislation for use and exchange of electronic data, including the following:
a. comprehensive federal privacy and confidentiality legislation issued to ensure that all health information in any medium used for any purpose and disclosed to any entity receives equal protection under the law.
b. Establishment of public/private mechanisms to help the healthcare industry identify and correct vulnerabilities and respond appropriately to privacy and security incidents.
c. electronic retention of PMRI and acceptance of electronic authentication, visual signature, in a compatible manner across all 50 states.
Mr. Blair commented that there were three points: state legal recognition of healthcare data in electronic form, uniformity in retention of PMRI in electronic form, and authentication. They still needed to address the first two. The revision had "pulled back" from describing a center that the group had not been able to clarify as either public or private. Dr. Cohn suggested that this idea was an example of the need, in the move toward storage of PMRI, to support privacy and confidentiality. Dr. Zubeldia suggested going back to the original wording and establishing a privacy emergency response team, like CERT. Ms. Amataykul pointed out that privacy law was stuck in Congress and that the notice of proposed rule practically begged for legislation. Dr. Zubeldia suggested that if they wanted something like CERT, this should be included in recommendation 4, "commit funding for an emergency response center that addresses issues concerning security and privacy of PMRI." Mr. Blair pointed out that there was no agency, central body or recourse to help correct problems; people were worried about having something erroneous in their electronic medical record. Ms. Fyffe observed that there was an office of civil rights, a body of law that would be applicable, and the proposed rules for the privacy provisions of HIPAA had provisions for inspection and correction of medical record information. Mr. Blair pointed out that this was only within the provider and health plan sector. Ms. Amataykul remarked that the proposed Privacy Rule created a federal complaint center where privacy issues could be brought to the Federal Government. She suggested that the group was looking at more of a response center in the private sector to help the industry, as opposed to an entity that might ultimately cause a provider to have an inspection. Dr. Cohn noted that he had not heard anything from proponents either clarifying this or making it compelling, and suggested deleting it; anyone could bring it up again at the June meeting. The revision read:
c. establishment of public/private mechanisms to help the healthcare industry identify and correct vulnerabilities and respond appropriately to privacy and security incidents.
d. electronic retention of PMRI in electronic format and acceptance of electronic authentication, visual signature, in a compatible manner across all 50 states.
e. uniform recognition by all states of electronic health record keeping and electronic authentication signatures.
Having completed the review of the recommendations, the Workgroup returned to page one and began again to move through the document handling conceptual issues that felt uncomfortable. The group focused on areas Ms. Amataykul had marked for discussion and on a seven-page list of comments (both wordsmithing changes and substantive issues) from Dr. McDonald. In the interest of time, wordsmithing additions, and changes were held for Ms. Amataykul to handle in preparing the final draft.
Ms. Amataykul explained that a revision of "other provisions of administrative simplification administrative and financial transactions and the code sets within them identify our security and privacy" on page seven of the introduction, Section A, Purpose and Scope, was a response to comments asking for clarification of the relationship between PMRI standards and the transaction standards.
Mr. Blair commented that a sentence explaining that the Executive Summary was intended to "provide a brief overview of the entire report" was added to the body of the report in response to people who said they wanted to use it as an educational tool and had asked for this explanation.
Both Dr. Lumpkin and Dr. Starfield doubted the validity of the first sentence after question number 1 ("How does this report help to address national healthcare issues?") Dr. Starfield recommended changing it to, "Technologically, the healthcare delivery system in the United States is considered to be among the best in the world." In the next paragraph, she suggested addressing the issue with, "However, the U.S. healthcare delivery system has some complex and serious problems." Ms. Fyffe noted that one had to go through three paragraphs before finally getting to the answer to the lead question in the fourth paragraph. That paragraph stating "This report recommends standards or actually an approach to standards that contributes not only to the administrative…" was placed first; the other three paragraphs remaining in sequence. This same structure--with answers immediately following each question--was utilized throughout the series. Ms. Amataykul explained that the fourth question ("Why has healthcare been slower than other industries to implement information infrastructure to improve quality and control costs?") and answer had been rewritten to introduce several issues: complexity, lack of commitment, and behavior modification.
Dr. Cohn remarked that Dr. McDonald's comments brought to mind the fact that some of the benefits that drove other industries might be less effective because healthcare was labor intensive and resistant to replacement of people by automation. Ms. Amataykul said the revision would include that as another reason things had moved slowly.
One reviewer challenged the group to justify the statement, "The lack of interoperability and comparability of healthcare data makes it difficult to measure quality and therefore impacts the ability to improve clinical processes." (6: What are the consequences of not having complete and comprehensive standards for PMRI?) Dr. Fitzmaurice proposed responding that it becomes difficult to aggregate quality measures and therefore impacts the ability to improve clinical process. How could one compare best practices when one could not add things together to determine them? Dr. Cohn noted it also became more difficult to implement the systems to improve the quality of care; he suggested stating that this was about improving as well as measuring quality.
Dr. McDonald had concerns about the third paragraph under question 7: "Why is it taking so long to develop and implement complete and comprehensive standards for PMRI?" Ms. Amataykul proposed: "Many observers have noted that the healthcare delivery system appears to place a higher priority on acquiring information systems for reimbursement than systems that support quality of care. There are several reasons for this. First, the standardization of information required for the claims process was easier to automate than standardizing information for the clinical process. Second, standards for supporting clinical processes have not been universally developed or applied." The draft then segued to the recognition that lack of investment in healthcare information systems was further impacted by the fact that many who benefited from these systems did not share in the cost of implementing and using them.
A discussion about privacy and security led to the following revisions. "Another issue is the lack of uniform privacy protections for PMRI and the lack of widely-implemented security mechanisms." Dr. Zubeldia noted that the administrative provisions of HIPAA in these two areas were good, although incomplete, steps toward correcting this deficiency. The group discussed rewriting the question. Dr. Cohn noted two issues: one was NIAA; the other involved privacy and confidentiality. He suggested privacy might be important enough to be a number.
One reviewer had suggested that in number 9 ("What benefits can we expect when standards for PMRI facilitate a health information infrastructure?") the statement, "These and many other examples in peer-reviewed medical literature lead us to the conclusion that information systems have the potential to both improve the quality and lower the cost of healthcare," and the examples could lead one to believe that standards were not needed. Another sentence was added: "These examples, however, are isolated in large part because of a lack of standards."
The group discussed an example in the Overview, Section A, "PMRI Standards Concepts, PMRI, Electronic Exchange, Uniform Data, and Health Information Infrastructure, Section 4, Health Information Infrastructure." A reviewer had commented on the sentence, "A radiologist may conduct a teleradiology consult with another radiologist in another country," saying that was illegal. The consensus was that the example was fine; while consultations involving discussions between different states might be illegal, this example involving another country was not.
Dr. McDonald had recommended some changes to the history that Dr. Cohn suggested should be accepted as appropriate.
Ms. Amataykul noted that, yesterday, Dr. McDonald suggested some content from section D (page 28) be moved under number 2, Standards Development Organizations. The group discussed how that could cause problems. She said a few sentences would be added to this paragraph to explain more about the specific SDOs.
In Overview of Data Standards Issues, a reviewer suggested bringing the definition of interoperability and comparability up front in each section.
Dr. McDonald proposed a number of comments, with examples, which emphasized that optionality was linked to variability in workflow. Comments also considered why optionality existed. Most the comments and examples were incorporated into the draft. Mr. Blair questioned the usefulness of going into reasons that would not be addressed by PMRI standards, but by standardization of clinical processes-- unless they were needed for balance, they would only be tangential and distracting. Dr. McDonald had noted that optionality could require costly custom programming, but that the larger problems were deviant implementation of the standard to violate the letter or the intent of the standard and enormous variability of vocabulary. Dr. Cohn acknowledged the complexity of this area, that there were still problems, and the need for a conference call to resolve some of these issues.
Dr. Cohn noted that the clearest articulation of the business case the group had been searching for was on page 18. He suggested that much of the paragraph could go up into the Executive Summary.
The group discussed and decided against including a reference to the data content committees. Although they used information from the patient medical record to do the billing and prepare the claims, they focused on administrative transactions and did not have expertise on PMRI.
The definition of comparability was moved up in that section.
Under terminology concepts, Ms. Amataykul explained that the definition of terminology was partially repeated to clarify that the term was being used in a particular way in this report. Feedback indicated that this had been confusing to some people.
The summary of the ASTM standard was condensed in the vocabulary characteristics and attributes section.
Dr. Fitzmaurice pointed out the need for refining the parallel structure of the vocabulary model. Dr. Cohn noted the importance of making the model more understandable, since it was being referenced as part of the guiding principles. The group, which had chosen not to include the ASTM document, felt a responsibility to explain, in a relatively brief format, what was needed in terms of: general characteristics, structural characteristics, maintenance, and evaluation. Dr. Cohn noted that the revision would be reviewed during a conference call. Dr. McDonald rebuffed the example about vital signs on page 22. Ms. Amataykul pointed out that it was one the joint commission represented and used in testimony. The group could not concur with Dr. Zubeldia's suggestion that the clinical pathology profile was simpler, and decided to retain the example as a default, in case they did not produce a better one.
Another issue discussed and added to the draft was the lack of a standard terminology or standard reference vocabulary. The parsing methodologies, which were dependent upon a reference vocabulary, were in early development and limited because there was not yet an existing standard reference terminology.
Under the first paragraph of recommendation 3 (data quality, data accountability and data integrity) Dr. Fitzmaurice struck out "usually in aggregate form." He noted that, in many cases, aggregated data was needed to look at things like best practices. Individual observations did not need to be identified, but there was a need to look at individual observations that were not aggregated:
Lack of ability to uniquely identify patients because each provider creates its own patient medical record identifier system and maintains its own master patient index. Patients have different identifiers at each location where they have received care. This makes it very difficult to seize the exchange data when authorized among providers.
Additionally, different master patient indexes and for the sign identifiers often collect different information making it difficult to map identifiers. For instance, one system may capture patient name, address, telephone number and date of birth. Another system may substitute Social Security number for date of birth, not capture telephone number but capture mother's maiden name.
Sometimes, patients get assigned several different numbers by one provider such as when a patient has a name change or uses a nickname on a subsequent visit. This can result in loss of data for patient care purposes. It constrains the ability to exchange data across providers for continuity of care.
As providers merge and consolidate, there is a huge cost of merging master patient indexes into an enterprise-wise master person index due to the lack of a unique patient identifier. While there are benefits to a unique patient identifier, the availability of standards for master person indexes, while less efficient, may also contribute to data quality.
The Workgroup reshaped the draft so that it noted the issue, rather than gave a solution. Readers could make their own conclusions.
Mr. Blair noted a number of people called for some mention of a master person index as a balance to a reference. Dr. Zubeldia clarified that the appropriate terminology was provider-created patient index. A master patient index, for identifiers from multiple sources, aggregated multiple identifiers.
Ms. Fyffe remarked that Congress declaring there could be no more funding for a unique patient identifier was a big problem and proposed that a delineation of this dilemma should be highlighted in the Executive Summary.
Responding to the sentence, "Evidence of accountability does not persist through the life of the data making auto-mobility of data content difficult or impossible," Dr. Fitzmaurice remarked it did not seem to be hard to audit data content. "Either it was there or it wasn't." Ms. Amataykul observed that because the audit trail often is not retained for long, it was difficult to determine who wrote, reviewed or approved the data content. The need for editing was noted.
Under "Other issues, privacy, confidentiality and security," another insert improved the balance. "There is widespread public concern that PMRI in electronic form may compromise an individual's privacy by reducing his confidentiality. Many healthcare professionals share this concern. On the other hand, many believe that the existence of electronic security tools will protect the confidentiality of PMRI even better than in their current paper form"
The statement about European directives supported the need for privacy, but the consensus was that it still did not "fit in" the draft. Ample reasons for privacy and confidentiality had already been addressed in the report; a case did not need to be made for privacy and confidentiality legislation.
A question was raised in the section on business partners about: "A significant privacy concern is potential for unauthorized disclosure of data by business partners that provide services to the healthcare organizations." While acknowledging that this was part of the privacy NPRM, Ms. Amataykul pointed out that the revision spoke to the need for privacy legislation. Business partners were not covered, except through a business partner agreement. With a privacy law, hopefully, they would be covered.
Dr. McDonald expressed concern about the reference to supporting travel by U.S. subject matter experts. It was deleted.
After discussion, it was decided to retain "vendor" in: Many testifiers identified the level of participation in the standards development process by both professionals and vendors is insufficient to accelerate the development of PMRI standards. Concern had been heard from small ambulatory focused physicians and caregivers.
Reviewers' concern that clearer understanding was needed of how PMRI related to the transactions standards (and, especially, the claims attachments) led to an insert at the end of the section on data elements to produce PMRI content. Refocusing on broadly defined data elements, the group's revision read: "Data elements within this mid-level content area have begun to be defined in the financial and administrative transactions standards and will continue to be defined as claims attachment standards are developed. Definitions of data elements for clinical data and their sources are being defined within message format and medical terminology development activities. The standards for PMRI that will result from the recommendations in this report will be consistent and compatible with the administrative and financial transaction standards and will accelerate the claims attachment standards."
Concerned by a "Big Brother" aspect, Dr. Zubeldia added "anonymized" on page 27, line 35 to 43: "Public health needs PMRI to monitor the health status of the population, create public health programs to improve health status and to manage health studies of our communities. PMRI, in its new virtual form, would provide a longitudinal view of anonymized data to identify factors that affect population health at all life-cycle stages." The last sentence was changed to read: "Data in electronic form may be easily de-identified or made anonymous."
Dr. Zubeldia noted that it was easier to de-identify or render anonymous electronic data than paper data; this was one advantage of the PMRI. Dr. Fitzmaurice clarified that it was not the services that were to be held confidential, but the identity of recipients of community health services.
Ms. Amataykul pointed out that NCPDP had been added on the right-hand side of the diagram to the connection between billing and payers. X-12-N had been removed between the pharmacy benefits managers and the community pharmacies. NCPDP had responded that they billed auxiliary pharmacy and PME equipment, getting the 835s with X-12. The flow went from the community pharmacies to the payers, normally to a PDM. X-12 was reinstated.
Under medical terminologies, a change on page 30 addressed the FDA's concern that the NDC did not support specific requirements for patient care: "However, it should be noted that there is a need for multiple domain coverage but that all terminologies need to converge. What may not be apparent from the diagram is the variation in specificity or gaps that need to be addressed. Also, there are some areas of content coverage where the need for greater specificity and harmonization are more acute than others. For example, the need for harmonization of terminologies in a drugs area is very acute."
Reference to the J-codes was deleted.
Dr. Hansel suggested changes in figure two along with related word changes. He suggested adding the UPN. Use of the appendix was also discussed.
Asked about redundancy with earlier comments about data quality, data accountability and data integrity, Ms. Amataykul explained that one section dealt with the status of data quality while the other described the issues. Dr. Fitzmaurice noted the paragraphs needed to be restructured in that order: data quality, accountability and integrity.
Participants discussed the issue of five-digit ICD codes. Most opted for ICD and CPT codes and questioned the need for more detail.
Dr. Cohn cited the need to reorganize data quality, data accountability and data integrity. He questioned whether the issue of a five-digit ICD was pertinent to this discussion, and suggested referencing the issue of something more specific that a physician could use to go to the right level of specificity. Dr. Cohn remarked that this was an example of the value of clinical terminology.
Dr. McDonald noted that the Quick Group had responded to the report's comments about the IOM studies. The website was noted along with the possibility of referencing.
Commenters representing major professional organizations had questioned the Secretary's authority to regulate standards for internal exchange of PMRI, and whether the report should address only PMRI that could be exchanged in transaction standards. One group, noting that there was no federal law requiring implementation of medical records standards, questioned if the HIPAA model for transaction standards extended to intra-enterprise. Another group asked the Workgroup to clarify whether these recommendations were intended to address transfer of information from one party to another, only trading partners, or also applied to internal PMRI uses. Ms. Fyffe observed that, considering combinations, permutations, and hybrid organizations, this was "quite an issue." Ms. Amataykul proposed clarifying the issue on the Executive Summary's opening page. Mr. Blair expressed his understanding that the administrative simplification provisions indicated that NCVHS was to make these recommendations. He suggested that the issue raised went beyond the report, and proposed that the group not address it.
Noting that, if the recommendations did not make sense, the whole 60-page report lost clarity, the group allotted up to 4 pages, but opted to keep the Executive Summary as concise as possible.
Dr. Cohn summed up: the Workgroup had produced a substantially drafted form, but a fair amount of editorial work remained to be done. The recommendations needed to stand on their own. A decision remained to be made about how to handle the first recommendation. The business case and the important issues had to be in a section. Other highlighted areas remained besides wordsmithing. A guiding principles example was still needed. And the principles might have to be replicated as a final page of the Executive Summary. Areas that needed to be in the Executive Summary had been identified and the summary had to be revised to parallel recommendations in the body of the report that had been modified.
The meeting adjourned to reconvene as the Subcommittee for Standards and Security.
Dr. Cohn reconvened the workgroup as the Subcommittee for Standards and Security. The members approved, with changes to be made, the forwarding of the document to the National Committee for consideration at the June meeting. A conference call was scheduled on Wednesday, June 7, 1:00 p.m. EST, to review draft 7.2, the polished version of the work just done, along with any editorial issues that required additional input. Copies would be distributed in advance.
Dr. Cohn summarized the Subcommittee business. An hour was scheduled on the second day of the Full Committee Meeting, for the Subcommittee and Workgroup to deal with comments and changes stemming from the full Committee's input.
The next hearings (July 13-14 in Washington) would focus on tracking implementation. Hopefully testifiers from WEDI and elsewhere would discuss early implementation issues and what some have done to implement HIPAA standards. Discussions would include code set issues related to the implementation and the elimination of local code sets.
The next set of formal, two-day hearings (October 26 and 27) would examine issues around the mandate to look at changes to the standards being implemented and also the digital signature. The Workgroup would hold hearings on this deferred standard, considering if it was appropriate. Based on yesterday's conversations, issues around device code sets would also be examined: discussions would include devices, code sets for devices, and a consideration of how far things have come since the initial NPRM identified this as an area that needed watching but (as of a few years ago) was not ready to be a standard. The code set panel would be in November.
Dr. Mayes provided an update on NPRMs and the rule-making process. The transaction code set regulation was still targeted for June 30, though an issue (whether OMB must clear the standards) remained about the Paperwork Reduction Act. The NCVHS's recommendations supported the Department's position that OMB clearance should not be required.
Dr. Mayes reported the General Counsel raised issues about whom could be required to have an identifier; the intent was still to get the final rule on the National Provider Identifier published in 2000. The Employer ID was being revised; it was expected to be ready in a few weeks for Department and agency clearance. Issues remaining to be worked out in aligning the Privacy and Security Rules were likely to be resolved as the Privacy Rule moved toward its final form. Dr. Mayes said the hope was that both would be out this year, but he noted that there were some 150,000 comments on the privacy rule alone.
Hopefully, the plan ID would be in formal clearance by mid-summer. The attachment standards were on hold until the financial administrative transactions and code sets were promulgated. Once that rule was published, the claims attachment NPRM would be revised in alignment with final decisions on the transactions standards. The claims attachment to NPRM was "in good shape" the last time it went through clearance; its progress depended on changes required based on the final transaction rule.
The naming of a digital signature standard had been removed from the security rule. NISB still monitored development of this technology and was waiting for industry consensus before naming a standard. Hopefully, there would be a presentation at the June National Committee Meeting.
Ms. Fyffe requested that updates focus on when the NPRMs or final rules would be published in the Federal Register. She noted that was when the public could see them, and referring to internal clearances and OMB was confusing. It was pointed out that these publishing milestones provided a sense of progress within the department--e.g., anything that had not obtained departmental clearance, probably would still be several months. Noting nothing was official until it appeared in the Federal Register, Ms. Fyffe urged that both this observation and the projected date of publication in the Federal Register be included in updates.
Ms. Fyffe said her interpretation was that they were still on track for NPRMs and final regulations to be published in 2000 in the Federal Register. Dr. Cohn commented that it would be awkward to have hearings on early implementation and implementation issues, if there was not a final regulation on the transactions before July 15.
Dr. Cohn summed up. The conference call was set up. The Workgroup had a major deliverable for June and other things set up for the rest of the year. He asked for leads on effective presenters for upcoming panels and hearings.
Responding to a query, Dr. Cohn said it was his understanding that HCFA was taking responsibility for development and maintenance of the registry for the National Provider ID Rules, but that it might not happen. Dr. Mayes reported some clarification that, if funds were available, HCFA could support it; HCFA would decide shortly whether development and operation would be done in-house or contracted. Dr. Cohn suggested there might be more information at the June full session formal briefing.
Dr. Cohn thanked everyone for a very hard day-and-a-half, reminded the group of the upcoming conference call, and adjourned the meeting.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
Jeffrey S. Blair 4-10-2001
/s/
Chair Date
Workgroup on Computer-based Patient Records
Simon P. Cohn 4-17-2001
/s/
Chair Date
Subcommittee on Standards and Security