The final rule also eliminates the use of local codes, requiring entities to request the establishment of a national code if necessary. Maintenance, Modification and Testing of New Standards Generally under the final rule, new standard versions or formats may not be required more than once every 12 months and implementation of a modification may not be required any earlier than 180 days following adoption of the modification. Maintenance is defined as the activities necessary to support the use of a standard, including technical corrections to an implementation specification and enhancements, additions, or deletions to a data code set. Public comment and notification is required for maintenance, but no regulatory action. Modification is defined as a change that is substantial enough to justify publication of a new version of an implementation specification.
Modification requires regulatory action.
The public has access and appeal rights with respect to DSMO decisions. Organizations seeking to test new standards may obtain exceptions from existing standards for up to three years to perform the testing process. Exceptions, however, may not be used to avoid using an adopted standard. Covered entities, however, must not use such agreements to attempt to circumvent the final rule, and are expressly prohibited from entering agreements that change or add to the elements of a standard or implementation specification. The final rule contains no enforcement provisions, but indicates that a future rule will address enforcement of all administrative simplification requirements.