On July 1, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released a final rule, linked below, to adopt penalties (referred to as “disincentives” in the rule) for health care providers that are found to have engaged in what is referred to as “information blocking," any practice that interferes with, prevents, or materially discourages access, exchange, or use of electronic health information, These rules arise from 21st Century Cures Act (Cures Act),  signed into law in 2016 and designed to help accelerate new innovations and advances in the delivery of patient care by promoting electronic health information exchange.

Last year, the U.S. Department of Health and Human Services (HHS) released a proposed rule that enumerated possible disincentives for healthcare providers found by the HHS Office of Inspector General (OIG) to have committed information blocking.

This month's final rule adopts several of the “disincentives” that were proposed last year for non-compliance with the information blocking rules, including: 

• Denial of eligibility to hospitals or critical access hospitals (CAHs) as meaningful electronic health record (EHR) users with the loss of 75 percent of the annual market basket increase to hospitals, and reductions in Medicare payments to CAHs to 100 percent of reasonable costs rather than the current 101 percent. 
• Loss of eligibility as meaningful users of certified EHR technology in a performance period resulting in a zero score under Medicare's Merit-based Incentive Payment System (MIPS) payments to physicians. 
• Making providers or suppliers that are Accountable Care Organization (ACO) participants ineligible to participate in the Medicare Shared Savings Program for a period of at least one year.

CMS and ONC reported that they had been asked by commenters on the proposed rule to delay imposition of there disincentives to those health care providers by the appropriate agency after the OIG found information blocking. In declining to do so, the agencies indicate in the final rule that OIG will not begin investigating possible information blocking committed by health care providers until after the effective date of the rule, and that OIG will exercise its enforcement discretion not to make any determinations regarding conduct that occurred prior to the effective date of this rule imposing information blocking penalties. The first two penalties above are effective on July 31, 2024. Penalties for ACO participants becomes effective on January 1, 2025.

Even without enforcement mechanisms in place, the information blocking rules have stimulated a growing number of imaging centers and radiology departments to terminate long-standing embargos on patient access to reports that were in place to allow time for treating physicians to receive, review, and discuss radiologists' findings with their patients. Now it is not uncommon for patients to have immediate access to their written radiology reports. This development has also generated increased patient engagement, including many radiology providers now providing access to more patient-friendly radiology reports that make use of interactive graphics and more easily understood “lay language" that promote understanding of those findings.

Of particular note, certain commenters on the proposed rule sought the ability to delay release of “sensitive and distressing health information and test results” and to allow for the patient's physician to first review the test results before making them available to the patient. Also requested was delay in penalties when the release of information was considered in the interest of patient safety. The agencies said they did not propose any further exceptions to information blocking in the Disincentives Proposed Rule since these issues are out of scope for this final rule. CMS and ONC have invited stakeholders to review current information blocking exceptions to better understand how various scenarios may be addressed by these exceptions. And they indicate that they may also consider this input for future rulemaking related to exceptions to information blocking.

Nevertheless, the publication of information blocking penalties should be a signal to hospital radiology departments and imaging centers that continue to universally embargo radiology reports to consider steps to ensure immediate patient access. Of course, those same imaging providers are permitted under the information blocking rules to make individualized determinations in good faith to hold back certain patient's report without it being considered interference. It will be interesting to follow the OIG's investigations, as well as the ongoing actions by imaging providers to expedite reporting of radiology test rests directly to patients.

Several of my Reed Smith colleagues have just published an excellent blog post on this final rule. I commend it to you.