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

July 3, 2024October 17, 2024 Kathie McDonald-McClure Cures Act and Program Interoperability, Electronic Health Records, Health Information Technology, HITECH Law, Meaningful Use Accountable Care Organizations, ACOs, civil penalties, Critical Access Hospitals, eligible hospitals, health information blocking, Health Information Technology, meaningful use of certified EHR, Medicare, Merit-based Incentive Payment System, MIPS, MSSP, ONC, Promoting Interoperability Program, Shared Savings Program

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 21^st 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:

INFORMATION BLOCKING RULE EFFECTIVE APRIL 5, 2021: ARE PROVIDERS READY?

April 6, 2021July 15, 2021 WyattLLP Cures Act and Program Interoperability, Health Information Technology 21st Century Cures Act, electronic health information, health information blocking, ONC, patient right of access

By Kathie McDonald-McClure and Margaret Young Levi

The Information Blocking Final Rule, a provision of the 21st Century Cures Act geared towards ensuring access, exchange and use of electronic health information (EHI), was published on May 1, 2020, and became effective on June 20, 2020. However, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health IT (ONC) extended the compliance effective dates for the Final Rule several times over the last year—and most providers were hopeful that it would be extended once again—but there are no more delays. Information Blocking compliance is now effective, as of April 5, 2021. Health care providers should take immediate steps to ensure compliance.

Continue reading →

CMS Issues COVID-19 Related Extension of the Deadline for Hospitals to Implement Electronic Patient Event Notifications

April 28, 2020July 24, 2021 Kathie McDonald-McClure Cures Act and Program Interoperability, Health Information Technology 21st Century Cures Act, COVID-19, EHR Program Interoperability, Hospital ADT Event Notifications, Hospital Conditions of Participation (CoPs), Medicare Programs

by Margaret Young Levi and Kathie McDonald-McClure

Post-Note: On April 30, 2021, the requirements for hospitals with certain EHR capabilities to send admission, discharge and transfer notifications to other providers went into effect. See CMS webpage, “Policies and Technology for Interoperability and Burden Reduction“.

Last year, we wrote about the CMS Proposed Rule on Hospital EHR “Electronic Patient Event Notifications” in which CMS proposed new Medicare Conditions of Participation (CoPs) for hospitals that will require the hospital to send electronic event notifications to primary care or post-acute care providers identified by the patient when a patient has been admitted, discharged, or transferred (ADT Notifications). ADT Notifications are an outgrowth of the 21st Century CURES Act passed by a bi-partisan majority of Congress and signed into law on December 13, 2016 (CURES Act). The CURES Act contains aggressive goals to promote the interoperability of electronic health records and patient access to their health information.

The objective of ADT Notifications is to improve care coordination and patient outcomes. These ADT Notifications are to be integrated into either the hospital’s interoperable certified electronic health record technology (CEHRT) or other electronic administrative system such as a registration system. An ADT Notification will be required when the patient is:

registered in the Emergency Department (ED) or as an observational stay;
admitted to the hospital (regardless if the patient was admitted from the ED, from an observation stay, or as a direct admission from home, from their practitioner’s office, or as a transfer from some other facility);
transferred from the ED or inpatient care; or
discharged from the ED, observational stay or inpatient services unit.

Continue reading →

CMS Proposed Rule on Hospital EHR “Electronic Patient Event Notifications”

April 9, 2019May 14, 2019 Kathie McDonald-McClure Cures Act and Program Interoperability, Data Privacy & Security, EHR Certification Standards, Electronic Health Records, Health Information Technology, HIPAA, HITECH Law Care coordination, CMS EHR Program Interoperability, Electronic Health Records, HHS CMS Proposed Rule, Hospital Conditions of Participation (CoPs), PAC providers

By Kathie McDonald-McClure and Margaret Young Levi

Summary: CMS proposes new Medicare Conditions of Participation (CoPs) for hospitals that will require the hospital EHR to send electronic event notifications to post-acute care providers when a patient has been admitted, discharged, or transferred. What must hospitals do, and how much time is needed, to operationalize the new CoPs, considering a process will need to be developed that identifies providers who should and can receive these event notices? What will be required, and how much time is needed, to reconfigure EHRs to send the notifications and demonstrate compliance with the multiple facets of the CoP? Will PAC providers be obligated to operationalize the receipt and use of these notifications under the IMPACT Act? CMS is seeking stakeholder input on its proposal, including a reasonable time frame for implementation. Comments are due June 3, 2019.* Continue reading →