Two days before official publication in the Federal Register of an Interim Final Rule with Comment Period that, inter alia, establishes new reporting and notification requirements applicable to nursing homes, the Centers for Medicare and Medicaid Services (“CMS”), Center for Clinical Standards and Quality/Safety & Oversight Group (“QSOG”) issued a Memorandum (“QSOG Memorandum”) that details deadlines for compliance, enforcement, and frequently asked questions (“FAQs”) regarding the scope of the requirements. The QSOG Memorandum, however, does not provide insight into CMS’ expectations regarding some of the more ambiguous language of the notification requirement for residents, resident representatives, and families.
Reporting and Notification Requirements
The Interim Final Rule, which become effective immediately upon publication in the Federal Register on Friday, May 8, establishes a new subsection (g) at 42 C.F.R. § 483.80 (infection control), which requires nursing homes to electronically report the following information no less frequently than every seven (7) days to the National Healthcare Safety Network (“NHSN”) maintained by the Centers for Disease Control and Prevention (“CDC”):
- Suspected and confirmed COVID-19 infections among residents and staff, including residents previously treated for COVID-19;
- Total deaths and COVID-19 deaths among residents and staff;
- Personal protective equipment (“PPE”) and hand hygiene supplies in the facility;
- Ventilator capacity and supplies in the facility;
- Resident beds and census;
- Access to COVID-19 testing while the resident is in the facility;
- Staffing shortages; and
- Other information specified by the Secretary.
In addition, the new Section 483.80(g) requires facilities to inform residents, their representatives, and families by 5 p.m. the next calendar day following the occurrence of either a single confirmed infection of COVID-19, or three (3) or more residents or staff with new-onset of respiratory symptoms occurring within 72 hours of each other. The facility must provide “cumulative updates” at least weekly or by 5 p.m. the next calendar day following the subsequent occurrence of either identification of a confirmed infection of COVID-19, or a cluster of three (3) or more residents or staff with new onset of respiratory symptoms occurring within 72 hours of each other.
Specifically, the Interim Final Rule states that the information provided to residents, resident representatives, and families must (i) not include personally identifiable information, and (ii) be accompanied by information on mitigating actions implemented to prevent or reduce the risk of transmission, including if normal operations of the facility will be altered.
While provider reaction to the NHSN reporting requirement has largely focused on enrollment problems with the NHSN reporting portal and on the redundancy of having to report COVID-19 data to NHSN as well as state and local agencies, the reaction to the resident, representative, and family notification requirement has centered on ambiguities in the language concerning what must be reported, when it must be reported and whether there can be clarifying language to provide context for the numbers. Unfortunately, the FAQs included in the QSOG Memorandum provide little insight into these issues.
Compliance and Enforcement
As noted above, the reporting and notification requirements become effective on Friday, May 8. Facilities must submit their first set of data to the CDC’s NHSN reporting system by 11:59 p.m. on Sunday, May 17, 2020. Despite the May 17 deadline, however, facilities will be afforded an initial two-week grace period to begin reporting data to the CDC’s NHSN system. As noted above, data must be submitted at least once every seven (7) days. As a result, facilities that fail to begin reporting by the end of the third week (11:59 p.m. on May 31) will receive a warning letter. Facilities that fail to report data by the close of the fourth week (11:59 p.m. on June 7), will be cited under new F884 at scope and severity level F (no actual harm with a potential for more than minimal harm that is not immediate jeopardy; widespread) and receive a per day civil monetary penalty (“CMP”) of $1,000 for one day. The CMP amount for citations under F884 is progressive and will increase by $500 for each subsequent week that the facility fails to report. Review of compliance with CDC reporting will be conducted by CMS Federal surveyors. Accordingly, state surveyors are being instructed not to cite F884.
CMS created F885 with respect to enforcement of the resident, representative and family notification requirement. The revised protocol for COVID-19 Focused Survey for Nursing Homes included in the QSOG Memorandum instructs surveyors to interview a resident and a resident representative or family member to determine whether they are receiving timely notifications from the facility. CMS notes there are a variety of ways that facilities can meet the notification requirement, including website postings, paper notification and/or recorded telephone messages. The QSOG Memorandum further states that review for compliance with F885 will occur onsite and may be conducted by either state or federal surveyors. Enforcement actions will follow the March 23, 2020 memorandum concerning prioritization of survey activities.
The QSOG Memorandum also includes 22 FAQs regarding the reporting and notification requirements. Of note:
- NHSN Reporting
- CMS will use NHSN-reported data to ensure nursing homes are following infection control requirements and to determine survey prioritization. The data will also be available to other agencies at the federal, state, and local level.
- Failure to submit complete and/or accurate data will subject the reporting facility to an enforcement action.
- The reporting and notification requirements will remain in effect until CMS announces otherwise.
- NHSN is capable of receiving retrospective reports as far back as January, 2020 but facilities will not face an enforcement action if they are unable to accurately report data that predate the effective date of the Interim Final Rule. Nevertheless, CMS encourages facilities to report older data in their initial NHSN submission only.
- Facilities must report resident deaths that occur in other locations, such as a hospital.
- Resident/Representative/Family Notification
- The facility is not required to identify new versus total cases in its cumulative update.
- Respiratory symptoms identified by CMS to be used to determine whether there is a cluster of three (3) or more resident and/or staff members experiencing symptoms in a 72-hour period include shortness of breath, difficulty breathing, new or change in cough, sore throat, or new loss of taste or smell. CMS, however, also identifies lesser symptoms, including new sputum production, rhinorrhea (runny nose), or hemoptysis (coughing up blood).
- New admissions of residents confirmed to have COVID-19 trigger the notification requirement.
- “Staff,” for purposes of the notification requirement, includes employees, consultants, contractors, volunteers, and caregivers who provide care and services to residents in the facility, including nurse aides that have not yet completed a nurse aide training, competency, and evaluation program but are providing services to residents.
- Facilities need not distinguish between residents and staff in their notifications.
- The new notification requirement does not relieve the facility of its responsibility to provide notification of change in condition under 42 C.F.R. 483.10(g)(14)(i)(B).
As noted above, CMS has left unanswered many questions about the scope of the resident, representative, and family notification requirement. Among them, how far back must the cumulative update extend? Can the count be lowered if it turns out that one or more symptomatic residents/staff in a cluster ultimately test negative for COVID-19 or are determined to have an unrelated condition? How will surveyors ensure that the resident, representative, or family member they interview to determine whether they are receiving timely notifications are accessing the means of notification on a timely basis themselves? May facilities provide additional information to give context to the numbers in their notifications? Only time will tell for sure how the agency will interpret these requirements.
In the meantime, however, providers may want to consider the following:
- Have you reviewed and become familiar with information available on the NHSN website regarding enrollment, as well as instructions and other resources for each of the reporting modules?
- If you are having problems with the enrollment or login process, are you documenting your attempts to enroll and access the NHSN system? Are you documenting all outreach efforts to NHSN for assistance as well as the results of those efforts?
- Are you gathering data for reporting at the same time on the same day(s) to ensure consistent reporting?
- Are you maintaining tracking logs of required information and reviewing the reporting data in daily stand-up meetings to ensure that the process of obtaining and validating data is accurate?
- Have you established procedures for the reporting process to require that verification by staff that reported data have been received by the NHSN system, and immediately take such actions as may be necessary in the event that the NHSN system indicates an error?
- Have you utilized the revised COVID-19 Focused Survey for Nursing Homes protocols included in the QSOG Memorandum to assess and evaluate the facility’s infection control practices?
- Have you established a system for tracking confirmed COVID-19 cases and identifying possible clusters of three (3) or more residents and/or staff experiencing new onset of respiratory symptoms within a 72-hour period to ensure timely notifications to residents, representatives, and families?
- What about instructing residents, representatives, and families regarding the method(s) the facility will use to provide notifications?
- Are you prepared to begin tracking confirmed cases of COVID-19 and identifying possible clusters of three (3) or more residents and/or staff experiencing new onset of respiratory symptoms within a 72-hour period as of the effective date of the Interim Final Rule on May 8, 2020?