The U.S. Department of Health and Human Services (HHS) recently finalized a rule that establishes “disincentives” for healthcare providers found to have engaged in information blocking.[i] Information blocking is defined broadly as “a practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI).”[ii]
In essence, these rule aims to enhance the accessibility, interoperability, exchange, and use of electronic health information (EHI), ensuring that patients and their care teams have seamless access to vital health data.[iii] In short, healthcare providers may now face penalties or “disincentives” for not sharing information, but must be mindful of the key privacy laws, indicating the importance of further investing in and maintaining robust controls for information management.
Scope and Applicability
The new rule targets healthcare providers, including both hospitals and individual clinicians, and participants in Accountable Care Organizations (ACOs), who knowingly engage in practices that interfere with the access, exchange, and use of EHI.[iv] The rule complements the existing penalties for health information technology developers and health information networks established by the Office of Inspector General (OIG) in June 2023.[v] These new rules will go into effect for hospitals and clinicians on July 31st, 2024, and for ACOs on or after January 1st, 2025.[vi]
Disincentives[vii]
- Medicare Promoting Interoperability Program: Eligible hospitals and critical access hospitals (CAHs) found to have committed information blocking will lose 75% of their annual market basket update. CAHs will see a reduction from 101% to 100% at reasonable costs.
- Merit Based Incentives Program (MIPS): Clinicians found to have committed information blocking will receive a score of zero in the MIPS Promoting Interoperability performance category, significantly impacting their overall MPS score.
- Medicare Shared Savings Program (MSSP): Providers in ACOs found guilty of information blocking may be ineligible to participate in the MSSP for at least one year, affecting their potential revenue from the program.
Exceptions to Information Blocking
The rule also highlights nine exceptions where practices do not constitute information blocking. These exceptions provide for exceptions that involve not fulfilling requests for information, and exceptions that allow for procedures for providing information.[viii] The exceptions include:
- Privacy Exception: This exception permits practices that are necessary to protect an individual’s privacy, including practices required by law to protect privacy and practices consistent with a patient’s privacy preferences.[ix]
- Infeasibility Exception: This exception applies when it is not feasible to provide information, including situations where the request is infeasible due to the unavailability of the technology, or the request cannot be fulfilled due to legal or practical constraints.[x]
- Content and Manner Exception: This exception allows for the provision of EHI in a particular manner and format that is feasible for the providers. Some examples included in this exception are providing EHI in the manner requested by the patient or another entity, if feasible, or providing EHI in an alternative manner if the requested manner is not feasible.[xi]
Where implementing these measures may prove costly for healthcare providers, it is important to emphasize that there is an exception, permitting the charging of fees for accessing, exchanging, or using EHI, if the fees are based on the cost of providing the service, and not a barrier to the access, exchange, or use of EHI.[xii] Moreover, as a result of the American Health Care Association National Center for Assisted Living comments, the HHS recognized a “one-size-fits-all approach” may not be suitable for all healthcare providers, particularly those facing technological limitations.[xiii] In response to these comments, the HHS provided flexibility in the policies enforcement that will “consider the unique circumstances of the healthcare provider when applying this disincentive.”
Implications for Healthcare Providers
Healthcare providers must be diligent in ensuring their information management practices align with the new regulations to avoid these new severe penalties. The new rules emphasize the importance of interoperability and data sharing, while safeguarding patient privacy, security, and safety. There are several permissible exceptions to providers engaging in information blocking, but providers should consult their attorneys to ensure they are compliant. Ultimately, providers should review their current practices, identify potential areas of non-compliance, and implement necessary changes to adhere to the new standards.
Conclusion
HHS Secretary Xavier Becerra touts the new rule as a critical step toward the health care system providing more efficient and coordinated care and superior outcomes, while also emphasizing that healthcare providers will also need to ensure patient privacy and preferences are preserved.[i] In contrast, both the American Hospital Association and the Medical Group Management Association acknowledged the usefulness of the disincentives for providers but criticized the rule’s stiff administrative financial penalties within Medicare quality programs.[ii] In sum, healthcare providers must stay informed and proactive in complying with the new regulations to avoid severe penalties, and to ultimately contribute to a more interconnected healthcare environment.
For more detailed information, visit the HHS website or consult with legal experts here at Wolfe Pincavage LLP.
[i] U.S. Dep’t of Health & Human Servs., 21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking (June 2024), https://www.healthit.gov/sites/default/files/2024-06/Disincentives_Final_Rule.pdf; U.S. Dep’t of Health & Human Servs., HHS Finalizes Rule Establishing Disincentives for Health Care Providers That Have Committed Information Blocking (June 24, 2024), https://www.hhs.gov/about/news/2024/06/24/hhs-finalizes-rule-establishing-disincentives-health-care-providers-that-have-committed-information-blocking.html.
[ii] 45 C.F.R. § 171.103 (2024).
[iii] U.S. Dep’t of Health & Human Servs., HHS Finalizes Rule Establishing Disincentives for Health Care Providers That Have Committed Information Blocking (June 24, 2024), https://www.hhs.gov/about/news/2024/06/24/hhs-finalizes-rule-establishing-disincentives-health-care-providers-that-have-committed-information-blocking.html.
[iv] U.S. Dep’t of Health & Human Servs., 21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking (June 2024), https://www.healthit.gov/sites/default/files/2024-06/Disincentives_Final_Rule.pdf; U.S. Dep’t of Health & Human Servs., HHS Finalizes Rule Establishing Disincentives for Health Care Providers That Have Committed Information Blocking (June 24, 2024), https://www.hhs.gov/about/news/2024/06/24/hhs-finalizes-rule-establishing-disincentives-health-care-providers-that-have-committed-information-blocking.html.
[v] U.S. Dep’t of Health & Human Servs., HHS Finalizes Rule Establishing Disincentives for Health Care Providers That Have Committed Information Blocking (June 24, 2024), https://www.hhs.gov/about/news/2024/06/24/hhs-finalizes-rule-establishing-disincentives-health-care-providers-that-have-committed-information-blocking.html.
[vi] Id.
[vii] U.S. Dep’t of Health & Human Servs., 21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking (June 2024), https://www.healthit.gov/sites/default/files/2024-06/Disincentives_Final_Rule.pdf; U.S. Dep’t of Health & Human Servs., HHS Finalizes Rule Establishing Disincentives for Health Care Providers That Have Committed Information Blocking (June 24, 2024), https://www.hhs.gov/about/news/2024/06/24/hhs-finalizes-rule-establishing-disincentives-health-care-providers-that-have-committed-information-blocking.html.
[viii] Cures Act Final Rule: Information Blocking Exceptions, Office of the Nat’l Coordinator for Health Info. Tech., U.S. Dep’t of Health & Hum. Servs. (Apr. 2024), https://www.healthit.gov/sites/default/files/2024-04/IB_Exceptions_Fact_Sheet_508_0.pdf; Information Blocking, Off. of the Nat’l Coordinator for Health Info. Tech., U.S. Dep’t of Health & Hum. Servs., https://www.healthit.gov/topic/information-blocking (last visited July 23, 2024).
[ix] 45 C.F.R. § 171.202 (2024).
[x] 45 C.F.R. § 171.204 (2024).
[xi] 45 C.F.R. § 171.301 (2024).
[xii] 45 C.F.R. § 171.302 (2024).
[xiii] Dan Ciolek, HHS Rule Establishes Disincentives for Health Care Providers Committing Information Blocking, Am. Health Care Ass’n/Nat’l Ctr. for Assisted Living (June 25, 2024), https://www.ahcancal.org/News-and-Communications/Blog/Pages/HHS-Rule-Establishes-Disincentives-for-Health-Care-Providers-Committing-Information-Blocking-.aspx.
[1] U.S. Dep’t of Health & Human Servs., HHS Finalizes Rule Establishing Disincentives for Health Care Providers That Have Committed Information Blocking (June 24, 2024), https://www.hhs.gov/about/news/2024/06/24/hhs-finalizes-rule-establishing-disincentives-health-care-providers-that-have-committed-information-blocking.html.
[1] HHS Finalizes Rule on Provider Disincentives for Health Care Providers That Have Committed Information Blocking, Am. Health L. Ass’n (July 1, 2024), https://www.americanhealthlaw.org/content-library/health-law-weekly/article/647b0bd9-b9e3-437a-9ed9-9f4f71604bec/hhs-finalizes-rule-on-provider-disincentives-for-h.
