Presentation by Mary Emerson (HCFA) for February 1, 2000 Subcommittee on Standards and Security

Maintenance and Modification of Adopted Standards
Standards for Electronic Transactions Final Rule, dated August 17, 2000

Presented to the National Committee on Vital and Health Statistics

Subcommittee on Standards and Security

by Mary Emerson, Health Care Financing Administration

February 1, 2001

	Nature of Change	Final Rule References	Regulation Required?	Which Processes would be Used?
1.	Maintenance of adopted transaction implementation specifications, e.g., technical corrections, corrections of typographical errors or other non-substantive changes.	45 CFR162.103: Definition of maintenance.	No.	Standards Developing Organization (SDO)-defined process.
2.	Maintenance of adopted medical code sets, e.g., enhancement, expansion, addition or deletion of codes within a code set.	162.103: Definition of maintenance.	No.	Code set maintaining organization-defined process.
3.	Modification of transaction standard or implementation specification, where a standard had previously been adopted. Modifications would include substantive changes in implementation specification data content or format, such as addition or removal of data elements or segments, change in situational requirements for data elements, change in maximum length of data elements, change in allowable qualifiers for external code sources, or change in number of repeats of a segment or loop. These kinds of changes typically result in a new version of a transaction implementation specification.	160.103: Definition of modification; 160.104: Modifications; 162.910: Designated Standard Maintenance Organization (DSMO) process (applies to standards adopted under Subchapter C--Administrative Data Standards and Related Requirements).	Yes. Compliance date no earlier than 180 days after effective date. Secretary may consider time needed to comply in determining compliance date. Modification of a standard, except in the first year, may be done no more frequently than once every 12 months. Could be done on an annual cycle.	DSMO process, which includes SDO process and results in recommendations to NCVHS; followed by NCVHS recommendations to HHS; followed by HHS regulatory process, which results in a Final Rule.
4.	Modification of medical code set standard, where an initial standard had previously been adopted, e.g., adoption of HCPCS drug codes for non-retail pharmacy transactions, or adoption of ICD-10-CM code set for diagnoses. [Adoption of additional medical code sets for products and services, e.g., the Home Infusion EDI Coalition (HIEC) code set, the Alternative Link code set, or Universal Product Number (UPN) code set, would follow this path if we consider these kinds of adoptions to be additions where initial standard medical code sets (for products and services) had already been adopted. See also #6.]	Preamble p. 65 FR 50326: adoption of additional code sets; 160.103: Definition of modification; 160.104: Modifications; 162.910: DSMO process.	Yes. Compliance date no earlier than 180 days after effective date. Secretary may consider time needed to comply in determining compliance date. Modification of a standard, except in the first year, may be done no more frequently than once every 12 months. Could be done on an annual cycle.	DSMO process, which includes SDO process and results in recommendations to NCVHS; followed by NCVHS recommendations to HHS; followed by HHS regulatory process, which results in a Final Rule.
5.	Modification of adopted standard or implementation specification, as described in #3 or #4, within first year, where modification is necessary to permit compliance with the standard.	160.103: Definition of modification; 160.104 (b): Modifications within the first year; 162.910: DSMO process.	Yes. Compliance date no earlier than 180 days after effective date. Secretary may consider time needed to comply in determining compliance date.	DSMO process, which includes SDO process and results in recommendations to NCVHS; followed by NCVHS recommendations to HHS; followed by HHS regulatory process, which results in a Final Rule.
6.	Adoption of an initial standard for a transaction or medical code set, e.g., adoption of an implementation specification for first report of injury transaction. [Adoption of additional medical code sets for products and services would follow this path if we consider their adoption to be adoption of new initial standards. See also #4.]	Preamble p. 65 FR 50326: adoption of additional code sets; 162.910: DSMO process.	Yes. Compliance date not later than 24 months after effective date for all except small health plans; 36 months for small health plans.	DSMO process, which includes SDO process and results in recommendations to NCVHS; followed by NCVHS recommendations to HHS; followed by HHS regulatory process, which results in a Final Rule.
7.	Change of policy that does not involve change to adopted standard or implementation specification, e.g., change to a regulatory definition or to a requirement for covered entities.	Not addressed.	Yes.	HHS regulatory process, which results in a Final Rule.
8.	Exception to permit testing of a proposed modification.	162.940: Exceptions to test proposed modifications.	No.	Request to the Secretary. HHS process, which may include consultations with DSMOs. The Secretary may grant an initial exception period not to exceed 3 years. The Secretary, on request, may grant an extension to the initial exception period.
9.	Promotion of best practices, without change to adopted standards or implementation specifications.	Not addressed.	No.	Industry process. [The process undertaken by the Workgroup for Electronic Data Interchange/Strategic National Implementation Process is one model.]

Notes:

The type of HHS regulatory process required for modifications will depend upon the impact and significance of the change being adopted.
In order for a modification of a standard that was adopted on August 17, 2000 to supercede the adopted standard before the compliance date of October 16, 2002, the effective date of the modification must be no later than approximately April 16, 2002, in order to allow 180 days before the compliance date.
The Accredited Standards Committee X12N transaction workgroups have identified errata in the adopted X12N Version 4010 Implementation Guides that may require correction in order to permit compliance with the standards. The workgroups may wish to correct these errata by publishing an addendum to the X12N 4010 Implementation Guides or by republishing the X12N 4010 Implementation Guides. Adoption of such an addendum or republished Implementation Guides within the first year would follow path #5.
The Final Rule describes the DSMO process, which is to be used for modifications to the standards. Some people have questioned whether the full DSMO process may require too much time to allow adoption of a modification within the first year after the effective date of an initial standard.
The Final Rule states that the DSMO process is to be used for adoption of additional code sets. Since the primary expertise of the DSMOs lies in the transaction standards, some DSMO members have questioned whether they have the specialized code set expertise necessary to evaluate whether an additional code set should be recommended for adoption. For example, the DSMOs might need to be able to judge whether the additional code set overlaps with an adopted standard code set or whether the codes comprising the additional code set should be proposed for incorporation into an adopted standard code set.
If an additional code set is recommended for adoption, and the qualifier for this code set is not in the ASC X12 transaction standard, or is in the ASC X12 transaction standard but is designated "not used" in the adopted implementation guides, the X12 standard and/or the implementation guides will need to be changed. Then the new version of the implementation guides, as well as the additional code set, will need to be adopted as standards by the Secretary through the regulatory process. The coordination and timing of these changes will be very complex.

Maintenance and Modification of Adopted Standards Standards for Electronic Transactions Final Rule, dated August 17, 2000

Presented to the National Committee on Vital and Health Statistics

Subcommittee on Standards and Security

by Mary Emerson, Health Care Financing Administration

February 1, 2001

Maintenance and Modification of Adopted Standards
Standards for Electronic Transactions Final Rule, dated August 17, 2000