Information Blocking CMP Regulatory Authority & CMP Process. We proposed to add the CMP for information blocking to our existing CMP regulations at 42 CFR part 1003 and to apply the existing procedural and appeal rights at 42 CFR parts 1003 and 1005 to the CMP for information blocking. We solicited comment on the proposed application of the existing CMP procedures and appeal process in parts 1003 and 1005 to the CMP for information blocking. Commenters were generally in favor of incorporating the CMP for information blocking into these sections and applying the existing appeal processes set forth at 42 CFR part 1005. In this rule, we finalize the addition of the CMP for information blocking to 42 CFR part 1003 and the application of parts 1003 and 1005 to the CMP for information blocking as proposed without modification. We also proposed to add the authority for OIG’s imposition of CMPs for information blocking (section 3022 of the PHSA, 42 U.S.C. 300jj–52) to the list of statutory CMP provisions that appears in 42 CFR 1003.100. We received no comment on this proposed change and finalize the rule as proposed without modification. Comment: One commenter believed that the application of 42 CFR 1005.7 to the CMP for information blocking was unworkable in its current form. The commenter believed that the discovery process under 42 CFR 1005.7 as currently written was inconsistent with the Cures Act’s intent for ONC, OCR, and OIG to consult, refer, and coordinate in the investigation and enforcement of investigation blocking. The commenter further stated that, consistent with the prior OIG final rule, Amendments to the OIG Exclusion and CMP Authorities Resulting From Public Law 100-93, 57 FR 3325, January 29, 1992, OIG would only be required to produce documents in its possession and not documents in the possession of other branches or divisions of HHS. The commenter further believed 42 CFR 1005.7 as written would prohibit individuals and entities that appeal the imposition of CMPs for information blocking from obtaining relevant documentary evidence maintained in ONC’s possession. The commenter also believed that OIG could abuse the discovery process by refusing to take “possession” of documents in ONC’s care, custody, or control in an effort to avoid producing them. The commenter further believed that, as ONC would not be covered by the discovery rule at 42 CFR 1005.7, ONC would not be subject to any document preservation requirement that would increase the potential for the spoliation or destruction of evidence.
