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ACP is reviewing the proposed rule to determine the impact on members

Nov. 17, 2023 (ACP) -- The �������ý is carefully reviewing a proposed federal regulation that aims to improve patient access to medical records.

At issue is the sharing of electronic health information (EHI) that is mandated by the 21st Century Cures Act of 2016 with some exceptions for certain “reasonable and necessary activities.”

“Access by clinicians and patients to health information, particularly in a timely manner, is at stake,” said Nadia Daneshvar, ACP associate for health IT policy. “We are still working on reviewing the proposals in the proposed rule and determining how much of an impact they will have for ACP members and what we think the proposed rule gets right and where we have concerns.”

One important aspect of the law is the outlawing of “information blocking” by certain “actors” such as health care entities and practitioners, developers of certified health information technology and health information networks/exchanges. Clinicians and physicians can be considered to have engaged in information blocking if they must have known that such a practice “is unreasonable and is likely to interfere with access, exchange or use of EHI,” according to a fact sheet from the U.S. Department of Health and Human Services.

Certain practices do not constitute information blocking, however, if they are required by law or meet one of eight exceptions defined under the Office of the National Coordinator for Health Information Technology (ONC) 2020 Cures Act Final Rule, Daneshvar explained.

The Cures Act required that the HHS secretary establish certain disincentives to deter information blocking practices. In the “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking” proposed rule, HHS suggests a series of disincentives across Centers for Medicare & Medicaid Services programs.

“If finalized, the disincentives would apply to certain Medicare-enrolled clinicians and physicians that have been found to have committed information blocking by the HHS Office of Inspector General (OIG) and for which OIG refers its determination to CMS,” Daneshvar said.

One proposed disincentive would affect the Quality Payment Program. As stated in an HHS fact sheet on the proposed rule: “Under the Promoting Interoperability performance category of the Merit-based Incentive Payment System (MIPS), an eligible clinician or group would not be a meaningful user of certified EHR [electronic health record] technology in a performance period and would therefore receive a zero score in the Promoting Interoperability performance category of MIPS, if required to report on that category. The Promoting Interoperability performance category score typically can be a quarter of a clinician or group's total MIPS score in a year.”

Another proposed disincentive would affect the Medicare Shared Savings Program. As stated in the fact sheet: “A health care provider that is an Accountable Care Organization (ACO), ACO participant, or ACO provider or supplier would be deemed ineligible to participate in the program for a period of at least one year.”

The fact sheet goes on to explain that being deemed ineligible may result in being removed from an ACO or prevented from joining an ACO. Being restricted from participating in the Shared Savings Program for at least one year would result in potentially not receiving revenue that a participant might otherwise have earned if they had participated in the Shared Savings Program.

Clinicians and physicians who are subject to information blocking regulations but do not render services under the programs covered in the rule are not affected by the proposals in this rule. However, “HHS considers this proposed rule to be a ‘first step’ in deterring information blocking by clinicians and physicians,” Daneshvar said. “The proposed rule includes a request for information regarding additional disincentives that would apply to clinicians and physicians not impacted by the proposed disincentives in the current proposed rule for the purposes of future rulemaking.”

The proposed rule also explains proposed OIG processes for investigating claims of information blocking by clinicians and physicians, determining whether a physician has committed information blocking and referring the physician to be subject to disincentives.

According to Daneshvar, OIG has indicated that it will prioritize clinician and physician information blocking practices that “(i) resulted in, are causing, or have the potential to cause patient harm; (ii) significantly impacted a provider's ability to care for patients; (iii) were of long duration; and (iv) caused financial loss to federal health care programs, or other government or private entities.”

The proposed rule also includes proposals to publicize information about actors on the ONC website, including clinicians and physicians, that commit information blocking.

For clinicians and physicians subject to a disincentive, HHS proposes to publicly release their name and business address, the practice determined to be information blocking, the disincentive(s) imposed and where to find additional publicly available information about the determination (including links to court actions).

“ACP will be submitting comments in response to this proposed rule, which are due to HHS by Jan. 2, 2024,” Daneshvar said. “For clinicians and physicians, OIG enforcement would begin upon finalization of the proposed rule. We do not know when a final rule will be released.”

Back to the November 17, 2023 issue of ACP Advocate