4 Analyses of this federal-register by attorneys

  1. More Roadblocks For Information Blocking: HHS Finalizes Rule Establishing Disincentives for Hospitals, Clinicians, and ACOs

    McCarter & English, LLPMegan NigroJuly 26, 2024

    ronic health record (EHR) user for a year; thus, an eligible hospital will not be able to earn three-quarters of the annual market basket increase, and a CAH payment will be reduced to 100 percent of reasonable costs from 101 percent.Under the Promoting Interoperability performance category of the Merit-based Incentive Payment System (MIPS), a MIPS-eligible clinician or group practice will not be a meaningful EHR user for a year; thus, they will receive a zero in that category, which is typically a quarter of a final score in a performance period/MIPS payment year.Under the Medicare Shared Savings Program (MSSP), a healthcare provider that is an Accountable Care Organization (ACO), or an ACO participant, provider, or supplier, will be ineligible to participate in the MSSP for at least one year. CMS will consider certain facts before applying this disincentive and deciding whether to apply it for more than one year.This rule was finalized on the heels of the OIG’s June 2023 final rule, 88 FR 42820, which allows the OIG to penalize certain health information technology individuals or entities committing information blocking.Additionally, the Office of the National Coordinator for Health Information Technology can post information on its website about healthcare providers who committed information blocking, including their name, their business address, the practice and the disincentives applied.Healthcare providers should expect more actions against information blocking in future rulemaking, as the final rule expressly acknowledges that the disincentives do not cover all the types of providers (e.g., laboratories and pharmacies) defined in 45 CFR 171.102.[View source.]

  2. HHS Publishes Proposed “Disincentives Rule” to Prevent Information Blocking by Health Care Providers

    Epstein Becker & GreenDecember 11, 2023

    practitioner, or clinician determined appropriate by theSecretary. See 45 C.F.R. §171.103. Information blocking is a practice by an "actor" that is likely to interfere with the access, exchange, or use of electronic health information, except as required by law or specified in an information blocking exception. HHS, 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program, 85 Fed. Reg. 25642, May 1, 2020, available athttps://www.govinfo.gov/content/pkg/FR-2020-05-01/pdf/2020-07419.pdf. The MIPS program as described in the Medicare Access and CHIP Reauthorization Actof 2015 (MACRA). CMS, 2022 Medicare Promoting Interoperability Program Requirements, available athttps://www.cms.gov/regulations-guidance/promoting-interoperability/2022-medicare-promoting-interoperability-program-requirements. See Medicare Shared Savings Program, 42 CFR Part 425, implementing Section 1899 of the Social Security Act. 88 Fed. Reg. 74947, 74951(Nov. 1, 2023). 88 Fed. Reg. 42820, 42823 (July 3, 2023). 88 Fed. Reg. 74947, 74952 (Nov. 1, 2023).Id., at 74952.See ONC’s Report on Health Information Blocking, Report to Congress, April 2015, available athttps://www.healthit.gov/sites/default/files/reports/info_blocking_040915.pdf. 42 CFR 425.112(b)(4)(i) and (b)(4)(ii)(C). “ACO,” “ACO participant,” and “ACO provider/supplier” are defined at 42 CFR 425.20. HHS has proposed to define “appropriate agency” (at 45 CFR §171.102) to mean a government agency that has established disincentives for health care providers that OIG determines have committed information blocking.[View source.]

  3. Information Blocking Enforcement Is Here – Are You Ready?

    Davis Wright Tremaine LLPJuly 28, 2023

    e Enforcement Rule. For example, review whether it offers certified health IT to others, or whether it controls access to a platform or service that enables exchange among others for treatment, payment or other health care operation purposes.Prior to Sept. 1, 2023, review data sharing practices to determine if a practice constitutes information blocking and take any necessary steps to modify those that pose the greatest enforcement risks.For those practices believed to fit within an information blocking exception, plan to retain related documentation for a timeframe beyond six (6) years. (In comparison, the Information Blocking Rule established a 10-year records and information retention requirement for health IT developers of certified health IT as part of the ONC Health IT Certification Program).After Sept. 1, 2023, if a practice is determined to constitute information blocking, consider steps to remediate the practice and consider whether to leverage OIG's self-disclosure protocol. 88 Fed. Reg. 42820 (July 3, 2023). 85 Fed. Reg. 25642 (May 1, 2020). A "practice" means an act or omission by an actor. 45 C.F.R. § 171.102. Under 45 C.F.R. § 171.103, Information blocking means a practice that -(1) Except as required by law or covered by an exception set forth in subpart B or subpart C of this part, is likely to interfere with access, exchange, or use of electronic health information; and(2) If conducted by a health IT developer of certified health IT, health information network or health information exchange, such developer, network or exchange knows, or should know, that such practice is likely to interfere with access, exchange, or use of electronic health information; or(3) If conducted by a health care provider, such provider knows that such practice is unreasonable and is likely to interfere with access, exchange, or use of electronic health information. Id. At 42823-42824.[View source.]

  4. Health IT Organizations Soon to Face Enforcement Under Final OIG Information Blocking Rule

    Manatt, Phelps & Phillips, LLPJonah FrohlichJuly 19, 2023

    ish whether specific individuals or entities, or categories of individuals or entities, will meet the definition of an HIE/HIN, nor does it exempt specific types of individuals or entities, including providers or payers, from the definition.ONC has separately proposed a rule that sets forth circumstances under which providers and others will not be considered “offerors” of certified health IT (offerors can be considered developers of health IT). Falling into the exceptions of the ONC rule, therefore, is an important protection for providers and other entities that want to avoid exposure to penalties up to $1 million.The agency indicated that, in making a fact-specific determination of whether “a health care provider or other entity is an HIN/HIE that could be subject to CMPs for information blocking, [it] anticipates engaging with the health care provider or other entity to better understand its functions and to offer the provider an opportunity to explain why it is not an HIN/HIE.”21 88 Fed. Reg. 42820 at 42833.2 88 Fed. Reg. 42818.