HHS Adds New Teeth to Information Blocking Law for Health Care Providers

by Margaret Young Levi, Kathie McDonald-McClure, and Drayden Burton (Wyatt Summer Associate)

On July 1, 2024, the U.S. Department of Health and Human Services (HHS) published a final rule entitled “21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking,” 89 Fed. Reg. 54662 (Final Rule) establishing “disincentives” for health care providers who commit information blocking. Importantly, the 21st Century Cares Act explicitly delegated the authority to HHS to establish “appropriate disincentives” for information blocking through notice and comment rulemaking. 42 U.S. Code § 300jj–52(b)(2)(B). Previously, on October 23, 2023, HHS published its proposed rule seeking comments on the proposed appropriate disincentives (Proposed Rule).   

In general, “information blocking” means knowingly and unreasonably interfering with, preventing, or materially discouraging the access, exchange, or use of “electronic health information” (EHI) unless such blocking is required by law or permitted by regulatory exceptions. To learn more about information blocking and the permitted exceptions, see our article “Information Blocking Rule Effective April 5, 2021: Are Providers Ready?,” which provides an overview of the Rule’s key elements and requirements. The prohibition on information blocking went into effect on April 5, 2021, but until now did not contain any penalties for health care providers who engage in information blocking.  Previously, on June 27, 2023, the HHS Office of Inspector General (HHS-OIG) established civil monetary penalties of up to $1 million per information blocking violation by developers of certified health information technology and for health information networks (HINs) and health information exchanges (HIEs).  (88 Federal Register 42820).

This Final Rule adds some teeth, aiming to ensure that individuals and their health care providers always have access to the individual’s health information.  Some of the comments that HHS had received to its Proposed Rule supported disincentives that incentivize an exchange of EHI across care settings on the basis that this will lead to better patient outcomes. In issuing its Final Rule HHS stated, “When health information can be appropriately accessed and exchanged, care is more coordinated and efficient, allowing the health care system to better serve patients.”

The “Disincentives”

The Final Rule establishes certain “disincentives” for several categories of health care providers that HHS-OIG finds to have engaged in activities that interfere with or prevent access to EHI that constitute information blocking. These disincentives are as follows:

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Stages 1, 2, And Now 3, Meaningful Use Criteria

The Centers for Medicare & Medicaid Services (“CMS”) proposed Meaningful Use criteria to implement Stage 3 and allow eligible professionals, eligible hospitals and critical access hospitals (“CAHs”) to qualify for incentive payments (or avoid downward payment adjustments) under the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program implemented by the Health Information Technology for Economic and Clinical Health (“HITECH”) Act of 2009. stethoscope, keyboardThen CMS made changes to Stage 1 and Stage 2 Meaningful Use criteria to better align with the proposed Stage 3 criteria just two weeks later.

On March 30, 2015, CMS published a long-awaited proposed rule which, if finalized, would implement Stage 3, making changes to the objectives and measures of meaningful use for providers effective in Continue reading

Providers Talk, CMS Listens: CMS Announces Plan to Modify Meaningful Use Requirements

On January 29, 2015, Centers for Medicare & Medicaid Services (CMS) electronic health recordannounced its intent to make changes to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs beginning in 2015, which aim to “help to reduce the reporting burden on providers.”

Providers have expressed concerns about the EHR Incentive Programs’ requirements and their burden on providers. In response to those concerns, CMS is considering whether to:

  • Shorten the EHR reporting period in 2015 to 90 days to accommodate these changes.
  • Realign hospital EHR reporting periods to the calendar year to allow eligible hospitals more time to incorporate 2014 Edition software into their workflows and to better align with other CMS quality programs.
  • Modify other aspects of the program to match long-term goals, reduce complexity, and lessen providers’ reporting burdens.

CMS is expected to engage in rulemaking this spring to implement these changes to the EHR Incentive Programs. These changes will not be included in the proposed regulations regarding Stage 3 meaningful use requirements and criteria that CMS plans to issue by early March 2015 and which will apply in 2017 and subsequent years.

 

Can’t Complete the Stage 2 MU Summary of Care Measure 3 Test with a CMS Designated Test EHR? CMS Issues New FAQ on Alternative

HCP with stethoscope using phone while on laptopOn January 22, 2015, the Centers for Medicare and Medicaid Services (CMS) updated previously posted FAQ No. 11666 to help guide providers who are striving to meet Stage 2 Meaningful Use criteria under the Medicare and Medicaid EHR Incentive Programs implemented by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009. The updated FAQ addresses the problem providers are having in meeting Measure 3 under the Stage 2 Summary of Care objective. The question posed is:

“When reporting on the Summary of Care objective in the EHR Incentive Programs, how can eligible professionals, eligible hospitals, and critical access hospitals (CAHs) meet measure 3 if they are unable to complete a test with the CMS Designated Test EHR (NIST EHR-Randomizer Application)?”

The CMS answer is as follows: Continue reading

THE HIPAA SECURITY RISK ANALYSIS

businessman looking over his glasses with clipboard on hand - frUnder the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), eligible hospitals and critical access hospitals and eligible professionals must make a “meaningful use” of “certified electronic health technology” or face reductions in Medicare reimbursement. Conducting or reviewing a security risk analysis is a core objective in the meaningful use requirements of the Medicare and Medicaid electronic health record (“EHR”) incentive programs. These security risk analyses have been Continue reading