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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations
expressed concern that because it can take up to 28 days for an individual to be fully vaccinated, requiring reporting for HCP who have worked only one day of the reporting period is burdensome or that this disparately affects facilities without access to the one-dose vaccine.
Response: We believe that it is appropriate to require data on HCP who have received complete COVID19
vaccination courses, because an IPF has more long-term and regular contact with the HCP who work there than an ambulatory care provider, such as those being evaluated under the MIPS
Program, has with their patient population. This gives the IPF more ability to track and encourage HCP to receive their complete vaccination course.
We recognize that since a complete vaccination course could take up to 28
days, some IPFs may initially appear to have lower performance than others based on having access to two dose vaccinations as opposed to one dose vaccination. However, we believe that with the reporting frequency these providers should show rapid improvement as their staff become fully vaccinated. We note that given the highly infectious nature of the COVID
19 virus, we believe it is important to encourage all personnel within the IPF, regardless of patient contact, role, or employment type, to receive the COVID19 vaccination to prevent outbreaks within the IPF which may affect resource availability and have a negative impact on patient access to care.
Comment: Some commenters recommended deferring measurement of vaccine coverage among HCP until there is at least one vaccine that has received full FDA approval as opposed to an EUA. A few commenters expressed concern that the long-term effects of the vaccines are unknown and that some HCP concerned about the risk of serious adverse events; one commenter further expressed concerns regarding the rapid development and EUA timelines. A few commenters expressed concerns regarding HCP being unwilling to receive a vaccine which has not received full FDA approval.
Response: We support widespread vaccination coverage, and note that in issuing the EUAs for these vaccines FDA has established that the known and potential benefits of these vaccines outweigh the known and potential risks.117 Furthermore, as July 15, 2021, more than 336,000,000 doses have been 117 https www.fda.gov/vaccines-blood-biologics/
vaccines/emergency-use-authorization-vaccinesexplained.

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administered in the United States.118
Although COVID19 vaccines are authorized for emergency use prevent COVID19 and serious health outcomes associated with COVID19, including hospitalization and death,119 we understand that some HCP may be concerned about receiving the COVID
19 vaccine prior to the vaccine receiving full FDA approval. We also understand that some HCP may be concerned about long-term effects. We note that the COVID19 Vaccination Coverage Among HCP measure does not require HCP to receive the vaccination, nor does this measure reward or penalize IPFs for the rate of HCP who have received a COVID19 vaccine. The COVID19
Vaccination Coverage Among HCP
measure requires IPFs to collect and report COVID19 vaccination data that would support public health tracking and provide beneficiaries and their caregivers information to support informed decision making. Therefore, we believe that it is appropriate to collect and report these data as soon as possible.
Comment: One commenter observed that there are interventions through which an IPF can promote vaccination coverage, such as by removing barriers to access through means such as extended vaccine clinic hours. This commenter recommended encouraging these interventions as opposed to promoting vaccination coverage among HCP by adopting the COVID19
Vaccination Coverage Among HCP
measure.
Response: We agree with the commenter that there are interventions through which an IPF can increase vaccination coverage by reducing barriers to access. However, we believe that it is appropriate to propose this measure for the IPFQR Program to encourage such interventions by collecting data on vaccination coverage among HCP. We believe that vaccination is an important health intervention that can protect the health of vulnerable patients and the availability of the healthcare system that is, limiting the number of HCP absent from work due to illness to ensure that patients have access to care.
Comment: Some commenters expressed the belief that it is 118 CDC

COVID Data Tracker.

119 https www.fda.gov/emergency-preparedness-

and-response/coronavirus-disease-2019-covid-19/
pfizer-biontech-covid-19-vaccine, https
www.fda.gov/emergency-preparedness-andresponse/coronavirus-disease-2019-covid-19/
moderna-covid-19-vaccine, https www.fda.gov/
emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19/janssen-covid19-vaccine.

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inappropriate to use IPF payment policies to drive vaccination coverage among HCP. Some commenters expressed concern that this measure could lead facilities to mandate vaccines for staff, with potential unintended consequences specifically, staff quitting or legal risk for facilities for staff experiencing adverse events. One commenter expressed the belief that the tie to public reporting and potentially IPF payment is an indirect vaccine mandate.
Several commenters recommended CMS not consider this measure for payfor-reporting because state laws regarding mandates vary and therefore could lead to inconsistent performance through no fault of facilities. One commenter expressed the belief that this measure was developed for public health tracking and is not appropriate for quality assessment.
Response: We note that this measure does not require vaccination coverage among HCP at IPFs; it requires IPFs to report of COVID19 vaccination rates.
Therefore, we believe it is incorrect to characterize this measure as a vaccine mandate. Furthermore, we note that the historical national average of providers who had received the influenza vaccination, as reported on the then Hospital Compare website was 85 percent, 80 percent, and 82 percent respectively for the FY 2017, FY 2018, and FY 2019 payment determinations prior to removal of the Influenza Vaccination Coverage among Healthcare Personnel measure from the IPFQR
Program. We do not believe that this represents performance that would be consistent with a widespread vaccine mandate and therefore we do not believe that a vaccination coverage among HCP measure, including the COVID19 Vaccination Coverage among HCP measure, inherently leads to vaccine mandates. However, we believe that data regarding COVID19
vaccination coverage among HCP are important to empower patients to make health care decisions that are best for them.
Comment: Some commenters expressed concern that the measure does not fully account for potential reasons that HCP may not receive COVID19 vaccinations. One commenter recommended expanding the exclusions to the measures calculation, specifically citing religious objections as an exclusion category.
Another commenter observed that there is uncertainty about how effective vaccines are for certain populations, such as those with underlying conditions.

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