On Nov. 1, 2023, the Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator (ONC) issued a proposed rule, the "21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking."
The proposed rule applies to Medicare-enrolled healthcare providers (including entities and individuals) and is aimed at disincentivizing healthcare providers from committing information blocking. If finalized, the proposed rule would complement the HHS and the Office of Inspector General's (OIG) Sept. 3, 2023, final rule, which established information blocking penalties for health information technology (IT) developers of certified health IT, entities offering certified health IT, health information exchanges and health information networks (the "health IT final rule").
Read on for an overview of how the Proposed Rule would disincentivize health care providers from committing information blocking.
As defined under 45 CFR 171.103, "information blocking" means acts (i) that are likely to interfere with access, exchange or use of electronic health information; and (ii) that a healthcare provider knows are unreasonable and likely to interfere with access, exchange or use of electronic health information.
As HHS Secretary Xavier Becerra expressed, the proposed rule, much like the Health IT final rule, aims to "discourage information blocking to help people and the health providers they allow to have access to their electronic health information." As an expression of how seriously governmental authorities are committed to ensuring access to electronic health information, violations of the health IT final rule may be subject to a penalty of up to $1 million per violation. While the proposed rule does not include hefty civil monetary penalties, healthcare providers that OIG determines have committed information blocking may be subject to various disincentives as described below.
Disincentives for Healthcare Providers
Medicare-enrolled healthcare providers that OIG determines have committed information blocking would be subject to various disincentives, some of which are specific to provider type:
- Under the Medicare Promoting Interoperability Program, a hospital or critical access hospital (CAH) would no longer be a meaningful electronic health record (EHR) user in an applicable EHR reporting period. This would mean that any such hospital or CAH would not be able to earn 75% of the annual market basket increase associated with qualifying as a meaningful EHR user.
- Under the Promoting Interoperability performance category of the Merit-based Incentive Payment System (MIPS), an eligible clinician or group would no longer be a meaningful EHR user during a performance period. A MIPS-eligible clinic would also receive a "zero" score in the Promoting Interoperability performance category of MIPS. This score typically represents 25% of a clinician or group's total MIPS score in a year.
- Under the Medicare Shared Savings Program, an accountable care organization (ACO), ACO participant or ACO provider or supplier would be barred from participating in the Shared Savings Program for a minimum of one year.
In addition to the above, information regarding healthcare providers subject to disincentives would be posted and publicly available on ONC's website to "promote transparency" for the public. The published information would include the healthcare provider's name, business address, the violative information blocking practice, the disincentive(s) applied and where to find additional information, if relevant.
How OIG Will Investigate Information Blocking
OIG will use four criteria to guide its investigations of healthcare providers alleged to have committed information blocking. These criteria shed light on the kinds of allegations OIG is more likely to investigate and its priorities in enforcing the proposed rule if finalized as proposed.
OIG will assess whether the information blocking conduct:
- Will result in, cause, or have the potential to cause patient harm;
- Significantly impacted a provider's ability to care for patients;
- Occurred for an extended period of time; and
- Caused financial loss to Federal health care programs, or other government or private entities.
OIG welcomes comments regarding the four criteria used to evaluate information blocking conduct, including whether there are issues specific to information blocking that warrant either revising these criteria or incorporating additional criteria. OIG also invites comments regarding what additional information, if any, should be posted to ONC's website following a determination that a healthcare provider has committed information blocking. The comment period will close Jan. 2, 2024.
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