In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a much-anticipated framework to establish and manage “appropriate disincentives” for health care providers under the Information Blocking Rules. As described in more detail in the blog post, the proposed rule (Appropriate Disincentives Proposed Rule) includes proposed disincentives for (i) hospitals and critical access hospitals (CAHs) participating in the Medicare Promoting Interoperability Program; health care providers eligible for Merit-Based Incentive Payment System (MIPS) adjustments; and health care providers participating in the Medicare Shared Savings Program (MSSP).
Information blocking is defined as a practice that is likely to interfere with access, exchange, or use of electronic health information (EHI), unless the practice is covered by an exception or is otherwise required by law. The Information Blocking Rules include specific knowledge standards based on actor type. If conducted by a health care provider, the provider must know that the practice is unreasonable and is likely to interfere with, prevent, or materially discourage access, exchange, or use of EHI. Examples of information blocking by health care providers include practices such as implementing a patient portal that allows patients to directly transmit or request direct transmission of their EHI to a third party but not enabling such capability or taking several days to respond to a patient's request for EHI despite having the capability to provide same-day access to EHI.
Health care providers were omitted from the July 2023 civil monetary penalty (CMP) final rule that applied to only these actors: health IT developers of certified health IT, entities offering certified health IT, health information exchanges, and health information networks. Under the 21st Century Cures Act, health care providers determined by the HHS Office of Inspector General (OIG) to have violated the Information Blocking Rules would be separately referred by HHS “to the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law, as the Secretary sets forth through notice and comment rulemaking.”
Though the Information Blocking Rules remain broadly applicable to health care providers (as defined in 45 C.F.R. 171.102), HHS proposed that as “a first step” the appropriate disincentives would only apply to health care providers that are also eligible to participate in certain Federal health care programs: the Medicare Promoting Interoperability Program; MIPS; and the MSSP.
HHS is proposing to establish substantial financial and programmatic disincentives for certain health care providers through authorities under these existing CMS programs and applicable law. The Appropriate Disincentives Proposed Rule includes additional detail on the process in which OIG would investigate a claim of information blocking conduct by a health care provider and refer such claims to an applicable agency. The proposed rule also calls for HHS to publish certain information about all information blocking actors (not just health care providers) that have committed information blocking.
Medicare Promoting Interoperability Program
CMS proposed to use existing Medicare Promoting Interoperability Program authority concerning the meaningful use of certified electronic health record (EHR) technology to impose disincentives on eligible hospitals and CAHs. Eligible hospitals and CAHs must meet the definition of a meaningful EHR user “to the satisfaction of the Secretary”. If eligible hospitals or critical access hospitals (CAHs) participating in the Medicare Promoting Interoperability Program were found to have engaged in information blocking, the eligible hospital or CAH would lose its status as a meaningful EHR user during the EHR reporting period during the calendar year in which OIG referred the determination of information blocking. Revocation of an eligible hospital’s meaningful use designation would have significant ramifications for eligible hospitals and CAHs. Eligible hospitals would not be able to earn the three-quarters of the annual market basket increase associated with such designation. CMS would apply the downward adjustment to the eligible hospital’s payment adjustment year that occurs 2 years after the calendar year when the OIG referral occurs. If found to have committed information blocking, a CAH’s meaningful use payment would go from 101 percent of reasonable costs to 100 percent of reasonable costs; the downward adjustment would be applied to the payment adjustment year that is the same as the calendar year when the OIG referral occurs. CMS noted that that eligible hospitals and CAHs are already incentivized, in order to avoid downward payment adjustments, to promote interoperability and data sharing and comply with the Information Blocking Rules.
Medicare Merit-based Incentive Payment System (MIPS)
If an eligible clinician were determined to have committed information blocking, the clinician would lose their status as a meaningful EHR user during the calendar year of the reporting period. MIPS eligible clinicians are subject to a MIPS payment adjustment (positive, negative, or neutral) based on their performance in four performance categories (cost, quality, improvement activities, and promoting interoperability) compared to the established performance threshold for that performance period/MIPS payment year.
Using authority under the Social Security Act (SSA), CMS proposed that an information blocking determination would result in the reduction of a MIPS eligible clinician’s promoting interoperability performance category score to zero. The actual financial impact experienced by a health care provider as a result of the proposed disincentive, however, would be based on the MIPS eligible clinician’s performance across the four weighted MIPS performance categories (a “final score” as defined at 42 C.F.R. 414.1305). These are the weights for Calendar Year 2024: 30 percent for the quality performance category; 30 percent for the cost performance category; 15 percent for the improvement activities performance category; and 25 percent for the promoting interoperability performance category.
CMS added that it believes that the definitions of ‘MIPS eligible clinician’ under the SSA and ‘health care provider’ under the Information Blocking Rules are generally aligned, allowing the application of appropriate disincentives to MIPS eligible clinicians.
Medicare Shared Savings Program (MSSP)
Under the Appropriate Disincentives Proposed Rule, health care providers that are also accountable care organizations (ACOs), ACO participants, or ACO provider/suppliers, determined by OIG to have committed information blocking would be prospectively excluded from participating in the MSSP for at least 1 year. CMS proposed to apply the disincentive (i.e., exclusion from MSSP participation) no sooner than the first performance year after it received an information blocking referral from OIG and in which the health care provider is to participate in the MSSP.
If found to have engaged in information blocking, health care providers may be removed from or prevented from joining ACOs and, if a provider is an ACO, the ACO may not be able to participate in the MSSP. For example, as part of the annual application/change request for new and existing ACOs, CMS would prevent individual providers or physician practices from joining an ACO if the OIG has determined that the provider or physician practice has engaged in information blocking. CMS would also notify the ACO that an existing ACO participant has committed information blocking, which would require the ACO to remove the ACO participant or else face compliance action from CMS, including termination of its participation in MSSP.
In addition, as a condition of participation in the MSSP, an ACO would have to specifically agree (and must require its ACO participants, ACO providers/suppliers, and other individuals or entities performing functions or services related to the ACO's activities to agree) to not commit information blocking.
CMS asserted that sharing of EHI should already be a priority for ACOs in connection with their care coordination efforts, including the encouragement and promotion of enabling technologies and associated remedial processes and penalties.
Investigations and Priorities
When investigating health care providers, OIG stated in the preamble to the Appropriate Disincentives Proposed Rule that it expects to use four priorities from the July 2023 CMP final rule, focusing on practices that:
- resulted in, are causing, or have the potential to cause patient harm;
- significantly impacted a provider’s ability to care for patients;
- were of long duration; and
- caused financial loss to federal health care programs, or other government or private entities.
OIG also noted the aforementioned intent standard for health care providers under the Information Blocking Rules and added that it will draw from its experience and expertise from enforcing other laws that are intent-based (e.g. Anti-Kickback Statute and Civil Monetary Penalties Law) when investigating health care providers that OIG believes may have the requisite intent.
The appeals process for health care providers found to have engaged in information blocking is not as straightforward as appeals for health IT developers of certified health IT, and health information networks or health information exchanges under the July 2023 CMP final rule, which included specific appeals procedures. Under the Appropriate Disincentives Proposed Rule, once a disincentive has been applied, health care providers “may have the right to appeal administratively a disincentive if the authority used to establish the disincentive provides for such an appeal.” These appeals processes would be established through notice and rulemaking.
The Appropriate Disincentives Proposed Rule also calls for certain information to be publicly posted on ONC’s website about health care providers that have been determined by OIG to have committed information blocking and have received a disincentive or are subject to CMP liability, including: the health care provider’s name; business address (to ensure accurate provider identification); the practice found to have been information blocking; the disincentive(s) applied; and where to find additional information, where available, about the determination of information blocking that is publicly available via HHS or another part of the U.S. Government.
Similar to the intent of the Office for Civil Rights’ listing of breaches of unsecured protected health information affecting 500 or more individuals (also known colloquially as the “Wall of Shame”), HHS stated that publicly posting this information can help the public better understand enforcement of the information blocking regulations.
ONC and OIG already have a Report Information Blocking Portal in which they have received more than 800 claims of information blocking (including 685 claims against health care providers as of September 2023). They believe a natural progression would be to add to the portal the actual information blocking determinations by OIG, including any settlements of liability, civil money penalties, and disincentives.
The Appropriate Disincentives Proposed Rule will give health care providers who have been awaiting the release of appropriate disincentives a lot to consider. ONC’s recent blog post framed the Appropriate Disincentives Proposed Rule as “the first steps for holding health care providers accountable for information blocking under the 21st Century Cures Act.” In addition to assessing the significant financial effects of the proposed disincentives under the aforementioned CMS programs, health care providers will want to review and understand OIG’s enforcement priorities and the appeals process (or in some cases, the lack thereof). It is also important to note that HHS and CMS may propose additional disincentives in the future. The comment period opened on November 1, 2023 and will run until January 2, 2024. On November 15, 2023, ONC and CMS will host an information session on the proposal.