We are requesting reconsideration of RFI 1108 and DSMO CR1106 due to recent changes in law. Recent amendments to the 42 CFR Part 2 regulations make it clear that the basis on which the prior denial rested is incomplete. Under section 2.33 of the current Rule, payers may disclose data regulated by the Rule for certain payment/and or health care operations purposes, among other things (see e.g. Rule Sections 2.51-2.53).
This highlights the need for payers to understand what data is/not, covered under the rule. Without an indicator in claims and other transactions, lawful holders are forced to determine what data may be covered by other means - perhaps identifying data that might be covered based on diagnosis code. This can result in misidentification of information regulated by the Rule, leading to a negative impact on the quality of health care provided to patients. The regulations are already in force, and the industry needs immediate guidance for both 5010 and future versions of the transactions.
42 C.F.R. Part 2 requires Part 2 Program providers to include a Part 2 disclaimer with any disclosure, e.g. a claim submission. Such disclaimers are reportable on the 837 Professional in the Loop 2300 Claim Note NTE and on the 837 Institutional in Loop 2300 Billing Note NTE.
RFI 1108 was processed prior to the amendments to 42 CRF Part 2 in 2018. The DSMO CR is outside of X12’s ability to comment on.