The patient event notification CoP requirement is limited to those hospitals, psychiatric hospitals, and critical access hospitals (CAH) that utilize electronic medical record systems or other electronic administrative systems that are conformant with the content exchange standard at 45 CFR 170.205(d)(2). However, conformance with this standard is only used to determine whether a facility will be evaluated under the CoP. Hospitals are not required to use a specific standard or technology to implement the electronic patient event notification required by the CoP. Hospitals subject to this rule may transmit patient event notifications using a range of approaches, including messages based on different versions of Health Level 7® (HL7) messaging standards, summary care records using the Consolidated Clinical Document Architecture (C-CDA) standard, or making notification information available via a Fast Healthcare Interoperability Resources®-based application programming interface (API) (see 85 FR 25596 through 25597). CMS does note that a fax is not considered an electronic method of data exchange in this context. Please see page 25584 of the final rule for full details of the CoP.

The applicability date for the patient event notifications requirement is April 30, 2021. Compliance with this requirement will be assessed through established survey and certification procedures.

CMS will not provide hardship extensions for compliance with the patient event notification requirements for hospitals or critical access hospitals (CAHs). We note that the final rule was published on May 1, 2020.

The intended goal of including the name of the treating practitioner in the minimum information that must be included in an electronic notification is the facilitation of care coordination. We believe that including the name of the treating practitioner in the notification enables seamless, coordinated patient care. Existing patient event notification systems have demonstrated that a minimal set of information can achieve the desired effect of improving care coordination while imposing minimal burden on providers.

In these instances (which we expect would only possibly occur upon initial registration in the emergency department [ED]), since the treating physician is not known at the time of issuance, hospitals would not need to include it in the notification.

No. The preamble language in the final rule notes the following: “The revisions we are finalizing here would require a hospital's system to send patient event notifications for patients who are registered in the ED, if applicable, and then also for patients admitted as inpatients, 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." (85 FR 25592-93). Note that the hospital must send patient event notifications for patients registered in the ED, patients discharged from the ED, patients who are admitted, and patients who are discharged or transferred from the hospital's inpatient services. Additionally, as noted in the preamble to the final rule, “However, while the requirements do not prohibit a hospital from electing to send a patient event notification when a patient is transferred to one inpatient services unit of the hospital to another, the requirements finalized in this rule are based on a change in the patient's status from outpatient to inpatient, and not necessarily on the physical location of the patient." (85 FR 25593). To clarify, since a patient in the ED and a patient in observation are both considered to be outpatients (as they have not been admitted to the hospital as inpatients), there is no change in the patient's status as an outpatient if the patient in the ED is then placed in observation. As per our discussion in the above example of an inpatient transferred from one inpatient services unit to another, the requirements here similarly do not prohibit a hospital from sending a patient event notification if a patient in the ED is subsequently placed in observation; however, such a notification is not required.

Under the requirements at 482.24(d)(5), 482.61(f)(5), and 485.638(d)(5), a hospital (or critical access hospital [CAH]) that is compliant with the content exchange standard under 45 C.F.R. 170.205(d)(2) must demonstrate that it has made a reasonable effort to ensure that its system sends the notifications to all applicable post-acute care services providers and suppliers, as well as to any of the following practitioners and entities, which need to receive notification of the patient's status for treatment, care coordination, or quality improvement purposes:

• The patient's established primary care practitioner; or
• The patient's established primary care practice group or entity; or
• Other practitioner, or other practice group or entity, identified by the patient as the practitioner, or practice group or entity, primarily responsible for his or her care.
• A hospital is not required to demonstrate that it has captured information about recipients for notifications in the EHR, but may capture information about recipients in whatever manner is convenient. If a hospital chooses to work with an intermediary to deliver notifications, the intermediary may capture information about recipients.

The Interoperability and Patient Access final rule requires at 42 CFR 482.24(d)(3) for hospitals, 482.61(f)(3) for psychiatric hospitals, and 485.638(d)(3) for critical access hospitals (CAHs), that if such hospital utilizes a compliant electronic medical records system or other electronic administrative system as discussed above, the system should send notifications directly, or through an intermediary that facilitates exchange of health information at the time of: (i) The patient's registration in the hospital's emergency department (if applicable) or (ii) The patient's admission to the hospital's inpatient services (if applicable). The final rule also requires at 42 CFR 482.24(d)(4), 482.61(f)(4), and 485.638(d)(4), that if a hospital (or CAH) utilizes an electronic medical records system or other electronic administrative system, the system should send notifications directly, or through an intermediary that facilitates exchange of health information, either immediately prior to, or at the time of: (i) The patient's discharge or transfer from the hospital's emergency department (if applicable) or (ii) The patient's discharge or transfer from the hospital's inpatient services (if applicable). We interpret “immediately" to be at the time of discharge or transfer and without any intentional delays. Further, at 482.24(d)(5), 482.61(f)(5), and 485.638(d)(5), the rule requires that the hospital (or CAH) make a reasonable effort to ensure that the system sends the notifications to post-acute care services providers and suppliers, as well as to other practitioners and entities, which need to receive notification of the patient's status for treatment, care coordination, or quality improvement purposes. The intent of this rule is to ensure that health information exchange is used to improve care coordination across settings, especially for patients at discharge, resulting in a reduction in readmissions, improved post-discharge transitions, and a reduction in the likelihood that a patient would face complications from inadequate follow-up care. As a result of this, and the cited regulatory provisions, hospitals are required to send the admission, discharge, and transfer notifications “at the time of" the patient's admission or registration and “immediately prior to, or at the time of" the patient's discharge or transfer. Intentional delays in sending these notifications is not consistent with the regulatory requirement.

However, these requirements would not preclude hospitals, working either directly with providers or through an intermediary, from tailoring the delivery of patient notifications in a manner consistent with individual provider preferences. Thus, in accordance with provider preferences, a hospital or intermediary would be permitted to group notifications for daily delivery if preferred.

The applicability date for the patient event notifications, as required under the Interoperability and Patient Access final rule, is April 30, 2021. The provisions of this final rule require that a hospital, psychiatric hospital, or a critical access hospital (CAH) demonstrate compliance with all of the patient event notification requirements contained at 42 CFR 482.24(d), 482.61(f), and 485.638(d), respectively, only if it utilizes an electronic medical records system or other electronic administrative system that is conformant with the content exchange standard at 45 CFR 170.205(d)(2). If the hospital is not utilizing an electronic medical record system that is not yet conformant with the requirements in the final rule, CMS would not expect the hospital to meet the patient event notification requirements.

As we noted in the preamble to the final rule, we limited the applicability of this requirement to only those hospitals (and CAHs) that utilize electronic medical records systems or other electronic administrative systems that are conformant with the content exchange standard at 45 CFR 170.205(d)(2), recognizing that not all Medicare- and Medicaid-participating hospitals and CAHs have been eligible for past programs promoting adoption of EHR systems. Consistent with that is also our recognition, as expressed in the provisional clause regarding conformance with the content exchange standard, since not every hospital or CAH is at the exact same stage in its individual adoption and efficient use of EHR systems, the patient event notification requirements might not be applicable to such a hospital or CAH at this time.

Nothing in this rule should be construed to supersede a hospital's compliance with the Health Insurance Portability and Accountability Act (HIPAA) or other state or federal laws and regulations related to the privacy of patient information. We note that hospitals are not required to obtain patient consent for sending a patient event notification for treatment, care coordination, or quality improvement purposes as described in the final rule. However, we also recognize that it is important for hospitals to be able to honor patient preferences to not share their information. While the Condition of Participation (CoP) would require hospitals to demonstrate that their systems can send patient event notifications, as we stated in the final rule, we do not intend to prevent a hospital from recording a patient's request to not share their information with another provider, and, where consistent with other laws, restrict the delivery of notifications as requested by the patient and consistent with the individual right to request restriction of uses and disclosures established in the HIPAA Privacy Rule. Similarly, if a hospital is working with an intermediary to deliver patient event notifications, the intermediary may record information about a patient's preferences for how they prefer their information is shared, and, where consistent with other laws, restrict the delivery of notifications accordingly. Regarding a patient's ability to request that his or her medical information (in the form of a patient event notification) not be shared with other providers and suppliers and/or practitioners, the requirements in the final rule explicitly state that a hospital (or critical access hospital [CAH]) must demonstrate that its notification system sends notifications, “to the extent permissible under applicable federal and state law and regulations and not inconsistent with the patient's expressed privacy preferences."

Nothing in these requirements should be construed as conflicting with a hospital's ability to comply with laws and regulations restricting the sharing of sensitive information. While hospitals subject to the CoPs will need to demonstrate that their systems send notifications to appropriate recipients, hospitals would not be expected to share patient information through a notification unless they have obtained any consents necessary to comply with existing laws and regulations.

Regarding improper disclosure of health information where a hospital cannot confirm the identity of a receiving provider, we note that under these requirements a hospital would not be under any obligation to send a patient event notification in such cases. Under our final rule, hospitals are required to make a “reasonable effort" to ensure their systems send notifications to the specified recipients. We believe this standard accounts for instances in which a hospital (or its intermediary) cannot identify an appropriate recipient for a patient event notification despite establishing processes for identifying recipients, and thus is unable to send a notification for a given patient.

The final rule permits and encourages use of an intermediary such as an HIE that manages care relationships and routes notifications to the appropriate provider. The final rule discusses a variety of methods through which hospitals can identify recipients for patient notifications, including through partnering with intermediaries such as health information exchanges (84 FR 7652). We believe this is an important approach that hospitals are currently using to identify and route notifications to appropriate recipients, and that using an intermediary to complete these tasks may reduce operational burden for hospitals. Thus, hospitals are permitted to delegate responsibility for identifying recipients to an intermediary where applicable.

Yes, as noted in the final rule (85 FR 25598), under the requirement, hospital systems must send patient notifications in accordance with the requirements. However, this would not preclude hospitals, working either directly with providers or through an intermediary, from tailoring the delivery of patient notifications in a manner consistent with individual provider preferences. For instance, if a specific provider prefers only to receive notifications upon discharge, nothing would prevent the hospital from limiting the notifications sent to that provider accordingly. Hospitals are encouraged to coordinate closely with receiving providers to ensure that the process is not burdensome and alerts are sent in a manner prioritizing the communication of clinically significant events and clinically significant data. Similarly, an intermediary may also support the hospital in developing a process that prioritizes communicating clinically significant events and data in a manner that does not disrupt the receiving providers' workflows.