Reducing burdens with HIT
Interoperability and patient access
HHS expands penalties for information blocking
New rules impact physicians effective July 31, 2024
On June 24, 2024, HHS released a new Final Rule that imposes reimbursement penalties and other disincentives on physicians and non-physician clinicians (NPCs) who are found to have committed information blocking that impacts their participation in Medicare programs. Additionally, the ONC website will publicly identify physicians and NPCs who commit information blocking. “Information blocking” is defined as any action that hinders access to, exchange of, or use of electronic health information (EHI), unless an exception applies (PDF). These changes take effect July 31, 2024.
The 21st Century Cures Act mandated the HHS Office of the Inspector General (OIG) to investigate information blocking claims. The OIG can impose civil penalties of up to $1.25 million per violation on health IT developers, such as electronic health record (EHR) developers, health information networks (HIN), and health information exchanges (HIE). Developer compliance is crucial, because it impacts both patients and physicians. Contact your EHR developer, HIN, or HIE to discuss their compliance efforts.
Previously, only developers faced penalties, but under the new rule, physicians and NPCs also face disincentives. The Final Rule applies where information blocking impacts participation in the Medicare Promoting Interoperability Program, the Merit-based Incentive Payment System (MIPS), and the Medicare Shared Savings Program (MSSP). See below for more information.
Medicare Promoting Interoperability Program
Hospitals or critical access hospitals (CAHs) that engage in information blocking will not qualify as meaningful EHR users, resulting in a payment reduction of three-quarters of the annual market basket update. For CAHs, payments will be limited to 100% of reasonable costs instead of 101%.
Quality Payment Program
A physician found to be committing information blocking will not qualify as a meaningful user of certified EHR technology and will receive a zero score for the PI category. In group reporting, only the individual clinician committing the violation will face disincentives, not the entire group. However, if a group is found to have committed information blocking, disincentives will be applied at the group level. This disincentive affects the MIPS payment year, which comes two years later; for example, a determination in 2025 would impact the 2027 payment year.
Medicare Shared Savings Program
An Accountable Care Organization (ACO) or its participants may be deemed ineligible for at least one year if found guilty of information blocking. This can lead to providers being removed from or barred from joining an ACO, potentially impacting the ACO’s participation in the program and resulting in lost revenue. If an ACO reapplies, CMS will review the ACO for any further violations and corrective actions.
Additional resources on the 2024 Final Rule
What is information blocking and must I comply?
Dermatologists must comply with government rules on information blocking. Information blocking can be defined as preventing the proper flow of digital health information between providers and patients. HHS expects dermatologists to implement and use interoperable, patient-accessible technology.
However, the rule allows for certain exceptions. For example, if a physician decides to delay release of lab results to patients on a case-by-case basis in order to communicate the information directly, the intention of the delay is to prevent harm to the patient, not to block information. You can learn more about exceptions (PDF) or see a legal template below.
What patient information must be shared?
Beginning Oct. 6, 2022, HHS’s information blocking requirements shift to the entire electronic protected health information (EHI). After Oct. 6, physicians and other Actors will be responsible for the access, exchange, or use of the full EHI requirement and no longer limited to just the USCDI.
EHI includes information that would be included in a designated record set (DRS). The DRS is defined within the Health Insurance Portability and Accountability Act (HIPAA). A DRS is a group of records maintained by or for a HIPAA covered entity (e.g., physician or hospital) that is: 1) the medical records and billing records about individuals maintained by or for a covered health care provider; 2) the enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or 3) used, in whole or in part, by or for the covered entity to make decisions about individuals. Note, EHI specifically excludes psychotherapy notes as defined by HIPAA and information compiled in advance of a legal proceeding.
Previously, HHS required a smaller set of EHI called USCDI Version 1.
What do I need to do to comply?
Ensure your practice has implemented a process to evaluate and comply with the information blocking requirements.
Update your digital contact information in the National Plan and Provider Enumeration System (NPPES). CMS began publicly reporting providers who do not list or update their digital contact information in March 2021.
Dermatologists who use a certified EHR will automatically comply in many respects. Contact your EHR vendor to understand how they plan to assist you and your practice with compliance. For example, you may participate in the MIPS Promoting Interoperability (PI) category, which includes measures on patient access and health information exchange (HIE). All certified EHRs were required to provide their customers new technology that better enables access to EHI by Dec. 31, 2022.
What do I do if I’m concerned about unintended consequences?
Many physicians have expressed concern that patients who immediately access lab results may draw alarming conclusions. If you are a part of an institution where you would like to state your concern on the release date of lab results to patients, download this customizable template notice (Word) that you can share with your legal department or risk manager to advocate for more time, flexibility, and a more strategic process.
Learn more about the regulatory and legal background of the rule
Both the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released their respective final rules in March 2020. Both rules rely on the enforcement authority of the Office of the Inspector General (OIG) to investigate alleged data-blocking actors and their practices. The OIG will eventually fine and otherwise punish violators.
Together, both CMS & ONC final rules aim to enhance interoperability and increase patient access to their health information by imposing new standards, requirements, protocols, and deadlines to meet this policy goal. See below for more clarification:
The CMS rule governs new data-sharing standards to give patients access to their health data, impose interoperability requirements on payors, and push providers to adopt and implement information exchanges (HIEs). HIEs help providers share digital patient information.
The ONC rule governs electronic health information (EHI) blocking, interoperability, and the ONC Certification Program, which oversees certification of EHRs.
Both rules promote patient access and price transparency, and they advance the way data is exchanged between patients, health providers, payors, technology developers, and other health care stakeholders.
Both rules signal a push to remove barriers that impede patient access to data, expand access for payors and third-party companies, put patients in charge of their health records by giving patients more control in health care, and improve patient control while working toward a value-based healthcare system.
View the CMS Interoperability and Patient Access Final Rule.
Additional resources from HHS:
Additional AAD Resources
Read a DermWorld article that explains patient rights to access their medical records.
See a brief summary from the AMA on the information blocking rule (PDF).
Read the ONC’s fact sheet on the 21st Century Cares Act.
Access the HHS portal on information blocking to learn more on the regulations.
Read part 1 of a longer discussion from the AMA on information blocking (PDF).
Read the second part of the AMA's document on information blocking (PDF).
