On July 31, 2024, the final rule establishing disincentives for certain health care providers engaging in information blocking takes effect. Issued by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), this is one of several final rules implementing the 21st Century Cures Act provisions related to information blocking, which health care providers have been subjected to since April 5, 2021, but the first to create an enforcement mechanism against certain providers under the law. This article summarizes the newly expanded penalties for health care providers determined by the HHS Office of Inspector General (OIG) to have engaged in information blocking (which as a reminder, is defined as a practice likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (“EHI”), unless that interference is required by law or permitted by regulation). At a high-level, the final rule establishes information blocking disincentives only for Medicare-enrolled health care providers participating in the Medicare Promoting Interoperability Program, the Merit-based Incentive Payment System (MIPS) program, and the Medicare Shared Savings Program (MSSP). However, CMS and ONC suggest in the final rule that future rulemaking could usher in additional disincentives for other types of health care providers that are covered actors under the information blocking regulations. Specifically, the final rule applies penalties in the following instances to providers participating in certain CMS quality programs: CMS cannot independently penalize the above-mentioned providers; rather, the penalties only apply if an OIG investigation results in an affirmative finding that a provider committed information blocking and met the relevant knowledge standard by “knowing” that the targeted conduct constituted information blocking. While not binding, OIG provided a roadmap in the proposed rule issued last fall by ONC and CMS around the factors it plans to prioritize when conducting information blocking investigations, including conduct that: Investigations of certain providers for information blocking concerns may already be in progress, although the final rule states that OIG will exercise enforcement discretion not to make determinations about conduct occurring prior to July 31, 2024 (and CMS declined commenters’ request for a delay in the imposition of penalties). Going forward, when OIG makes a finding of information blocking (which requires a finding of intent to interfere with access, exchange, or use of EHI) it will also consider referrals to the appropriate agency to determine the appropriate disincentive(s) as described above. Alongside that referral, the names of the actors responsible for information blocking would be publicly posted on ONC’s website, along with details of the underlying conduct. Despite many requests from commenters that HHS adopt a uniform appeals process to alleviate concerns additional administrative burdens for certain providers, CMS and ONC declined, explaining that to do so “may conflict with, or duplicate, administrative review or appeals processes available under existing authorities.” Instead, providers subject to this final rule will have to go through the existing appeals process (if any) for their particular Medicare program to challenge the imposition of a disincentive. CMS and ONC also declined to provide warnings of non-compliance, education, corrective action, and technical assistance prior to imposing a disincentive on a provider. The agencies will, however, consider offering educational opportunities and materials to help providers going forward. For now, health care providers generally (and especially those subject to this final rule) should prepare themselves to mitigate risks relating to the disincentives by evaluating current policies and procedures to ensure compliance. To the extent currently existing practices need improvement, appropriate risk management strategies may include: [1] In the Proposed Rule, HHS simulated the impact of the MIPS disincentives on providers by using MIPS 2021 data. The analysis resulted in an estimated median disincentive of $686 per provider and estimating that 95% of penalties would fall between $38 and $7,184 per provider. For provider groups between 2 and 241 providers, HHS estimated a median group disincentive of $4,116, and that 95% of group penalties would fall between $1,372 and $165,326. See 88 Fed. Reg. 74947, 74960 (Nov. 1, 2023). For more information, please contact any member of Hooper, Lundy & Bookman, P.C.’s Digital Health Practice with questions, including Andrea Frey, Stephen Phillips, Claire Ernst or Andrew Hayes.HHS’s Information Blocking Disincentives for Health Care Providers Take Effect
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