It is not arguable that having this information is important. However, this measure will be burdensome to small and rural hospitals and hospitals in medically-underserved areas. Many of the providers and staff are rotating in and out under contracts, and many hospitals do not have the technical tools to collect and store this information. The sole person who would be responsible for collecting this information at small or rural hospitals will likely wear many hats and have multiple responsibilities (employee health, risk, infection prevention, quality), and data collection would be manual (trying to track down the people individually to request their vaccine status). This will take away from their other work and responsibilities caring for patients and other staff issues. It would be more ideal for the sites and locations actually administering the vaccines to collect information on the workforce sector for which individuals may be employed. Alternatively, with the end of the public health emergency, please consider less frequent data collections for this measure. Thank you for the opportunity to comment.
We recommend the COVID-19 Vaccination Coverage among HCP measure be retired to reflect the end of the Public Health Emergency and the changes announced by the Biden Administration. We note that on May 1st, 2023, the White House announced the end to several vaccination requirements at the end of the PHE on May 11th and highlighted that CMS would be releasing additional guidance for the end of the COVID-19 vaccination mandate for healthcare workers. (The Biden-Harris Administration Will End COVID-19 Vaccination Requirements (accessible at: https://www.whitehouse.gov/briefing-room/statements-releases/2023/05/01/the-biden-administration-will-end-covid-19-vaccination-requirements-for-federal-employees-contractors-international-travelers-head-start-educators-and-cms-certified-facilities/).) Additionally, the CDC updated guidance on May 2nd to indicate those who “may” get an updated vaccine are those over 65 and immunocompromised. (See, Stay Up to Date with COVID-19 Vaccines (accessible at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html).) Given these two recent announcements, this measure likely will not provide useful information to consumers or represent quality of care, as HCP vaccination status will likely represent community levels of vaccination status and cannot justify the burden of data collection.
The measure also does not align with the Revised Guidance for Staff Vaccination Requirements in the Hospital Conditions of Participation A-0792 §482.42, which considers staff fully vaccinated if it “has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine.” (Memoranda QSO-23-02-ALL, published October 1, 2022 by Center for Clinical Standards and Quality/Quality, Safety, Oversight Group.) As noted above, CMS recently issued guidance that the COVID-19 vaccination requirements for CMS-certified facilities will end “soon.” At the very least, HCP COVID vaccination measure should align with the requirements of the Hospital Conditions of Participation and allow not only medical exemptions but religious exemptions in accordance with Title VII.
As the definition of “up to date” changes, the measure and vaccination rates also change significantly. According to the CDC, 69.4% of the US population has completed their primary COVID vaccination series (the current measure definition), while only 16.7% of the population has completed their first booster; for the population ≥ 65, 94.3% have completed the primary series, while only 42.6% have received a booster dose9. The updated CDC guidance will likely decrease the “up to date” rate further, as fewer Americans are receiving subsequent boosters. This limits the ability to trend or compare the measure over time, since different definitions of "vaccination" have significantly different vaccination rates.
In addition to our concerns on how varying definitions of “up to date” impacts reporting, we have concerns on how the data are collected for the measure. If the measure is not retired, we recommend revising the measure specifications to have data submitted in monthly or quarterly periods – a weekly rate to represent a month’s worth of data should not be used. Currently, each “quarter” of data only includes 3 weekly data reporting points representing these 13 weeks of time. Reporting HCP COVID-19 vaccination data on a weekly basis can result in vaccination rate fluctuations, based on which healthcare workers work in a given week. The impact of this dynamic on the data could cause confusion for anyone examining the data, because its representative nature could be biased or skewed due to hospitals submitting their highest vaccination weekly rate in any given month. Instead, the period being measured and reported should be extended to a month or quarter and not based on a single week of data to represent a month’s worth of data.
Since there is no longer a NJ State requirement for Covid vaccination and there has not been a change in the "Fully Vaccinated" definition for quite some time; I do not think at this time it should be necessary to collect this data. Hospitals are still recovering from the pandemic and staffing has not yet returned to Pre Covid numbers, I believe anything to decrease Hospital burden should be done.
Reporting of COVID vaccination coverage is difficult as many states have eliminated the vaccine be mandated for employment. We can request copies of vaccination cards, but my system has no way of putting out an accurate report so I have to do the majority of this calculation manually. There is no quarterly reporting of influenza vaccination. I think there should be an annual report, just like for influenza. The burden of reporting this is high.
While AMRPA has supported COVID-19 vaccination efforts for IRF personnel and patients during the PHE, we do not support the modification and continued endorsement of this measure. Also, with the PHE now officially over, we request that CMS remove this measure from the IRF QRP. In consideration of this measure, AMRPA members expressed the following concerns:
- Reporting requirements may lead to inaccurate reporting of performance and a need to continually re-ask HCP based upon the evolving nature of the “up to date” definition.
The requirement to report one week every month and now having to continuously reconsider the most recent definition of “up to date” places an inordinate amount of administrative burden on IRFs and their clinicians, especially as IRFs are dealing with unprecedented workforce issues. Having to continually track and update vaccination status for a workforce that constantly changes based upon the availability of temporary/contract personnel is already challenging, and the proposed modification will complicate matters further. This will result in reporting issues as well as the inaccurate display of performance on the publicly reported outcome for this measure.
- Requirements are not consistent with federal/state mandates which required only a primary vaccination series, and with the PHE ending, many (if not all) of these mandates are being lifted.
Vaccination mandates from CMS and various states largely required that healthcare personnel complete their primary series of COVID-19 vaccinations. These mandates did not extend the HCP vaccination requirement to include the bivalent booster or any other booster. Additionally, CMS recently announced that with the end of the COVID-19 PHE, the mandate for vaccination of healthcare personnel will be lifted, under the updated Omnibus COVID-19 Health Care Staff Vaccination final rule (CMS-3415). When the mandate is lifted, we believe that the need for HCP to be “up to date” with vaccinations will be diminished, and the resulting benefit of this measure may be compromised.
- Inconsistent application of the measure or concerns over exclusions for medical contraindications and religious beliefs.
While the measure does exclude HCP with medical contraindications, the measure does not exclude those HCP with deeply held religious beliefs that were granted exemption from vaccinations. Additionally, while HCP with medical contraindications are excluded from the measure, we believe that this exclusion may be inconsistently applied among IRFs and other health care settings.
- Continued issues with the CDC National Healthcare Safety Network (NHSN) data submission portal and CMS quality measure systems have negative consequences for IRFs.
In recent years, IRFs have inappropriately received 2% payment penalties because of a failure to reconcile data between the CDC NHSN system and the CMS quality measure system. Technical issues between CDC and CMS have required IRFs to spend additional (and significant) administrative effort to prove that they submitted the appropriate information and have CMS reconsider the 2% payment penalties that are instituted for failure to provide information for the IRF QRP (for example, numerous members report having to invest in forensic technology to demonstrate their compliance). Given these issues, we do not believe that this measure should be modified or endorsed.
AMRPA recognizes the importance of vaccinations and the benefits that vaccinations offer to patients and providers. We note, however, that the end of COVID-19 PHE declaration and the Administration’s decision to lift various vaccination mandates will significantly impact the value of this measure. We, therefore, recommend that this measure not be modified or continue to be endorsed. AMRPA also requests that CMS consider removing this measure from the IRF QRP.
The Association for Professionals in Infection Control and Epidemiology (APIC) supports vaccination as the most effective infection prevention tool against COVID-19. APIC has been a strong supporter of vaccination, and especially healthcare-personnel (HCP) vaccination not just against SARS-CoV-2, but all vaccine preventable diseases (https://www.apic.org/Resource_/TinyMceFileManager/Advocacy-PDFs/APIC_Influenza_Immunization_of_HCP_12711.pdf ). As the SARS-CoV-2 virus has mutated, vaccine manufacturers, as well as the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have kept pace by modifying the vaccines and updating vaccination approvals and recommendations as needed to keep populations safe. As SARS-CoV-2 vaccination recommendations continue to evolve with updated vaccines, this creates challenges in reporting as facilities need to update their definitions of what is considered “up-to date.” Without clear data that quarterly reporting has benefit, we would recommend annual reporting to insure alignment with definitions and reduced burden.
APIC recommends that COVID-19 vaccination among healthcare personnel be reported annually rather than quarterly, similar to HCP influenza vaccination. It is not clear that there is a benefit to quarterly reporting over annual reporting for HCP COVID-19 vaccination, and without evidence of benefit, the additional burden of quarterly reporting is not justified. Therefore, we believe vaccination data collection should be on an annual basis, when it can be coordinated with other annual employee check-ins such as influenza vaccination and/or respirator fit-testing.
We agree that the denominator definition for COVID-19 HCP reporting should align with the denominator definition for influenza HCP vaccine reporting. By aligning COVID-19 HCP Vaccine reporting with influenza HCP vaccine reporting the denominator data cannot only be collected at the same time, but also submitted, preferably in the same reporting module, during the same sign in period. Alignment of the two metrics allows for batching the work, consolidating the resources to source the data, and will afford for aligned denominator data, as well as more accurate and reliable data.
These continue to be unprecedented times where concerns about personal liberties have impacted the ability to collect robust employee vaccination data. We feel it is important for PQM to be aware that healthcare facilities can collect and report data; however, this does not guarantee that the data is reliable and accurate as data will be impacted by the ability to collect the information.
APIC is a nonprofit, multidisciplinary organization representing 15,000 infection preventionists whose mission is to create a safer world through prevention of infection. We are committed to improving the quality of patient/resident care across the healthcare continuum. We have seen the positive impact required reporting has in the prevention of healthcare-associated infections (HAIs) in acute care facilities and in order to provide safe care for all we support continued expansion of these best practices across the continuum.