We proposed a procedure for entities to follow if they want a new standard. We also proposed a procedure that we would follow if a standard needs to be revised.
Comments and Responses on the Procedures for New and Revised Standards
1. New Standards for Existing Transactions
Proposal Summary: To encourage innovation and promote development of new standards, we proposed to develop a process that would allow an organization to request a replacement of any adopted standard or standards.
An organization could request the replacement of an adopted standard by requesting a waiver from the Secretary of HHS to test a new standard. The organization, at a minimum, would have to demonstrate that the new standard clearly offers an improvement over the adopted standard. If the organization presented sufficient documentation that supported testing a new standard, we wanted to be able to grant the organization a temporary waiver to test the new standard while remaining in compliance with the law. We did not intend to establish a process that would allow organizations to request waivers as a mechanism to avoid using an adopted standard.
Comment: Most commenters supported the proposed process for testing proposed revisions to standards. Several commenters preferred the word “exemption” instead of the word “waiver,” since it makes it clearer that standards should generally not be waived. It was also suggested that the cost benefit analysis should apply to the report developed after the pilot study and not to the application phase of the temporary exemption. Another suggestion was to have organizations wishing to test a new standard submit written concurrences from trading partners who will participate in testing the new standard. Those organizations must also assure they will continue to support existing standards during the testing process.
Response: We agree that standards should generally not be “waived.” We agree with the substance of commenters concern and therefore, we have added language in § 162.940 to include the suggested changes and are using the term “exception” to indicate that the standard generally applies, but that a specific group of entities are not required to follow all or a portion of one standard to permit testing of proposed revisions. While industry practice uses 1 year for testing, we have decided to grant an exception for a period not to exceed 3 years. We decided to adopt a 3 year time frame because we believe this period gives us flexibility in determining the extent to which testing may be required. We emphasize that a new standard is a standard that is not one of the transactions defined in this rule, including code sets. A revised standard is specific to the version of the Secretary’s standard and the implementation specifications.
2. Revised Standards/Proposals for Additional Standards
Proposal Summary: We recognized the very significant contributions that the traditional data content committees (DCCs) (the NUCC, the NUBC, the ADA, and the National Council for Prescription Drug Programs (NCPDP)) have made to the content of health care transactions over the years and, in particular, the work they contributed to the content of the proposed standards in the proposed rule. We proposed that these organizations be designated to play an important role in the maintenance of data content for standard health care transactions. We proposed that these organizations, assigned responsibility for maintenance of data content for standard health care transactions, would work with X12N data maintenance committees to ensure that implementation documentation is updated in a consistent and timely fashion.
We intended that the private sector, with public sector involvement, would continue to have responsibility for defining the data content of the administrative transactions. Both Federal agencies and private organizations would continue to be responsible for maintaining medical data code sets.
a. Code Sets
Comment: Several health care systems, State agencies, and insurance companies submitted comments agreeing that all coding systems adopted as HIPAA standards should have an open updating process, e.g., the responsible panel or committee of experts should be representative of a broad cross-section of the relevant stake-holders; all panel or committee members should have voting privileges, any interested party should be eligible to submit proposals for additions and changes, and the meetings should be announced in advance and should be open to the public. They made specific criticisms of the current processes used for updating HCPCS (for example, no representation from the commercial companies that actually pay claims), CPT, and “The Code” (dental).
Commenters made several favorable comments about the current process for obtaining public input and making decisions regarding changes to ICD-9-CM.
Response: We agree that the current process for making decisions regarding updates to the ICD9-CM provides a useful model, and we consider it to be probably the most workable approach for code sets. This process encourages broad input but gives final decision-making authority to the organizations responsible for developing the code sets. A purely democratic approach, under which all changes are put to a vote by the members of a particular standards committee and any organization eligible to become a voting member, is likely to have significant drawbacks for routine code set maintenance, e.g., delays in updates, inability to make changes that are essential for a minority of players, and changes in the code set that undermine its logical structure. We received clarification from the developers of the “The Code” (dental) and the CPT-4 about their update processes that will be in place at the time these standards are implemented. We are confident that it will be a workable open updating process.
In response to the comments regarding the process for updating HCPCS, we have reviewed our current policies and procedures governing the submission of requests from the public for revisions/changes to the HCPCS. We have ensured that existing procedures are easy to use and are adequately communicated to the public. The current process for updating the HCPCS includes the following features:
- Identification of a central contact for information/assistance regarding the process for submitting requests to modify the coding system.
- Advance notice of meeting agendas.
- Identification of proposals submitted for coding consideration.
- Opportunity for public comment on the proposals.
- Subsequent posting of coding changes for public information.
b. Transaction Standards
Comment: While most commenters supported the proposal that the NUCC, NUBC, and the ADA be designated as the data content committees (DCCs), several commenters opposed this proposal. Commenters opposing designation of these bodies recommended that X12 be named as the sole content body, pointing out that X12 is sufficiently open to include views from the NUCC, NUBC, ADA and others. Some commenters believe that the NUBC and NUCC do not adequately support nor understand the health care providers they represent, and their expertise is grounded in paper rather than electronic transactions. Some commenters opposed selection of the ADA as it was perceived to include inadequate non-health care provider representation for data content issues. Others opposed the selection of the NUCC because it was perceived as non- representative of the full range of health care professionals.
Other commenters stated there should not be a separate DCC for each X12N transaction because a change in one transaction may impact another. Another commenter stated X12 should be allowed to have a permanent voting member on each DCC that is selected, and that X12 should retain responsibility for the maintenance of the data dictionary for the selected transactions. Some commenters recommended that the NUCC, NUBC, and ADA continue to interact with X12N, and did not see a need for government oversight of the process. They felt that the current process works well and should not be tampered with.
Several commenters recommended that these multiple content bodies should have consistent protocols and should implement them uniformly. They recommended that the committees have meetings open to the public with cross-industry representation, including input from the public sector. Commenters also suggested that the committees operate under an equitable consensus process, and that they sign a memo of understanding (MOU) with the Secretary to ensure due process, close cooperation with standard setting organizations, and balanced voting. They asked that the data maintenance and change process for the standards be clearly described in the final rule. A request was also made for the establishment of an oversight group responsible for arbitrating conflicting decisions reached by different data content committees; handling appeals on data content committee decisions; coordinating data requests involving more than one data content committee; and centrally coordinating with X12.
Some commenters recommended that while NUCC, NUBC and ADA have a DCC role, this role should focus primarily on claims information. These committees were not perceived as having experience with enrollment, eligibility, premium payment, remittance, claim status, and referral issues. It was recommended that X12N or another industry forum serve as the data content committee for these other standards.
A few commenters asked that, as an SSO, the NCPDP’s role in the DCC process be addressed in the final rule. A number of comments were also submitted concerning appointment of a DCC for the attachments transaction standard under HIPAA.
Response: Only the NUCC, NUBC, ADA, NCPDP and X12N expressed an interest in having a role as a DCC for the X12N standards selected for the HIPAA transactions in this rule. To address the issues raised by these comments, representatives of the Secretary have contacted many officers and members of the NUCC, NUBC, ADA, NCPDP, X12N, WEDI and other organizations. Discussions centered on the following issues: preferences; operational models; control and coordination issues; time frames for incorporation for a request for a data change in implementation specifications; membership composition; internal processing rules and voting requirements; willingness to serve; expectations; public participation; and other details.
In §162.910, we state that the Secretary may designate an organization(s) to maintain the standards, propose modifications to existing standards, and propose new standards to the National Committee on Vital Health Statistics (NCVHS). These organizations, which can include DCCs (for example, the NUCC) and SSOs (for example, X12N), also receive and process requests for the creation of a new standard, or the modification of an existing standard. In the proposed rule, we referred to these organizations strictly as DCCs and SSOs. In this final rule, we call the organizations that are designated under §162.910 Designated Standard Maintenance Organizations (DSMOs). The DSMOs are a subset of DCCs and SSOs, and we have published a notice announcing these organizations elsewhere in this Federal Register.
We recognize that not every medical specialty or health plan may consider itself to have sufficient voting representation or weight within the DSMOs. Therefore, the DSMOs will operate a process which allows open public access for requesting changes to the standards, consideration of the request by each organization, coordination and final agreement among the DSMOs on the request, an appeals process for a requester of a proposed modification if the final decision is not satisfactory. The DSMO’s process will also allow for an expedited process to address content needs of the industry, and address new Federal legislation within the implementation date requirements of the law. Recommendations will be presented by the DSMOs to the NCVHS, where appropriate. Change requests can be submitted via a designated web site that will be made available to the public.
The DSMOs will also improve coordination among themselves, publicize open meetings, and, in some cases, expand voting membership. The DSMOs understand that their appointments as DSMOs will be reconsidered if they fail to perform, coordinate, and respond to the public as described in §162.910.