or use of EHI in order for the actor to have committed information blocking.9 For HCPs, the actor must have known that such practice is both unreasonable and likely to interfere with access, exchange or use of EHI.10 Additionally, the penalties and disincentives which may apply for information blocking conduct are different depending upon the category an actor falls into. What is the recent disincentives rule proposed by the Department of Health and Human Services under the 21st Century Cures Act? On November 1, 2023, CMS and ONC published their proposed rule for the establishment of disincentives for HCPs that have committed information blocking (the “Proposed Disincentives Rule”).11 This proposed rule seeks to address enforcement action and the application of disincentives against HCPs that commit information blocking. The newly proposed “appropriate disincentives” for HCPs who commit information blocking could now result in hefty financial ramifications for certain HCPs. What are the disincentives and/ or financial penalties applicable to actors engaging in information blocking? The Cures Act and the ONC CMP Enforcement Rule set forth specific civil monetary penalties for HIEs/HINs and Developers of Certified Health IT who commit information blocking. Where information blocking is conducted by an HIE/HIN or Developer of Certified Health IT, the Cures Act mandates the application of statutory civil monetary penalties up to $1,000,000 per 40 LAWYER MONTHLY DECEMBER 2023 the Medicare Promoting Interoperability Program or (iii) the Quality Payment Program. HCPs that do not participate in any of these federal incentive programs would not be subject to disincentives at this time if they committed information blocking. Each federal incentive program establishes different requirements tied to payment adjustments/shared savings which would be affected if an HCP were found to have committed information blocking. HCPs participating in a MSSP would be banned or rejected from participation for at least one year. For HCPs participating in the Medicare Promoting Interoperability Program, they would not be “meaningful users” of certified electronic health technology and would be ineligible for payment increases/subject to payment decreases under such program. HCPs participating in the Quality Payment Program would receive a score of zero for the Promoting Interoperability category requirements under such program, not receive positive payment adjustments and likely receive negative payment adjustments. If I do not participate in the Medicare Shared Savings Program, Promoting violation.12 The Cures Act states: “the provisions of section 1128A of the Social Security Act (other than subsections (a) and (b) of such section) shall apply to a civil money penalty applied under this paragraph in the same manner as such provisions apply to a civil money penalty or proceeding under such section 1128A(a).” Section 1128A sets forth specific procedures, including an appeal process, with regard to such determinations. However, the Cures Act and ONC CMP Enforcement Rule left to future rulemaking the establishment of “appropriate disincentives” for HCPs who commit information blocking, requiring the OIG to refer such individuals or entities to “the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law” as set forth through HHS rulemaking.13 Under the Proposed Disincentives Rule, disincentives and financial repercussions for HCPs who commit information blocking would be established based on whether the HCP participates in certain federal incentive programs. Therefore, the Proposed Disincentives Rule would only apply disincentives to HCPs participating in: (i) a Medicare Shared Savings Program (“MSSP”), (ii) Among other chief concerns, the Cures Act addressed the need for improved interoperability between disparate electronic health record technology, health care innovation and improved patient access to their health information.
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