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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations
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Response: We recognize that there are many reasons, including religious objections or concerns regarding an individual providers specific health status, which may lead individual HCP
to decline vaccination. The CDCs NHSN tool allows facilities to report on the number of HCP who were offered a vaccination but declined for reasons including religious or philosophical objections.120 We agree that there is uncertainty about effectiveness among certain patient populations, including those with underlying conditions. The CDC has found that there is evidence of reduced antibody response to or reduced immunogenicity of COVID19
mRNA vaccine among some immunosuppressed people.121
However, we note that COVID19
vaccines may be administered to most people with underlying medical conditions.122 Therefore, we believe that individual HCP who may have underlying conditions that could affect vaccine efficacy should make the decision of whether to receive the COVID19 vaccination in discussion with their individual care provider. We believe that vaccination coverage rates are meaningful data for beneficiaries to use in choosing an IPF which can also be used for public health tracking.
Comment: One commenter expressed the concern that this may have an adverse impact on HCP as it is unclear whether in the future individual HCP
will be required to pay for the vaccination themselves.
Response: We understand the commenters concerns that individual HCP may potentially have to pay for the COVID19 vaccine in the future. In alignment with our pledge to put patients first in all our programs, we believe that it is important to empower patients to work with their doctors and make health care decisions that are best for them.123 This includes the belief that HCP should be empowered to work with their own healthcare providers to make the health care decisions that are best for them, based on the totality of their circumstances, including potential costs to receive the vaccine and their increased risks of contracting COVID19
based on occupational exposure.
Comment: Many commenters expressed concern that this measure 120 https www.cdc.gov/nhsn/forms/instr/57.220toi-508.pdf.
121 https www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinatedpeople.htmla.
122 https www.cdc.gov/coronavirus/2019-ncov/
vaccines/recommendations/underlyingconditions.html.
123 HomeCenters for Medicare & Medicaid Services CMS.

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should not be adopted until there is clarity around the impact of future boosters. These commenters also noted that booster availability could have an impact on vaccination coverage among HCP. One commenter specifically expressed concern regarding past supply chain disruptions and observed that similar issues may affect booster availability in the future.
Response: The COVID19 Vaccination Coverage among HCP measure is a measure of a completed vaccination course as defined in section IV.E.2.b.1
of the FY 2022 IPF PPS proposed rule 86 FR 19502 through 19503 and does not address booster shots. Currently, the need for COVID19 booster doses has not been established, and no additional doses are currently recommended for HCP. However, we believe that the numerator is sufficiently broad to include potential future boosters as part of a complete vaccination course and therefore the measure is sufficiently specified to address boosters. We acknowledge the potential for supply chain disruptions or other factors that affect vaccine availability, but we believe that the urgency of adopting the measure to address the current COVID
19 PHE outweighs these potential concerns.
Comment: Some commenters expressed that collecting the data to report this measure is challenging.
These commenters observed that because, unlike influenza vaccinations, HCP have received COVID vaccinations from settings outside their places of employment, employers may still be attaining vaccination records from employees. One commenter observed that the data for HCP is housed in separate systems from those typically used for quality reporting.
Response: We recognize that some IPFs may still be obtaining vaccination records from their employees and other personnel that work within their facilities. However, most healthcare settings, including IPFs, have been reporting COVID19 data to Federal or state agencies for some time and therefore have established the appropriate workflows or other means to obtain these records from employees or other personnel that work within the IPF. Therefore, we believe that IPFs must have the means to obtain the data, either directly from HCP or from other systems in which these data are housed, and that it is appropriate to require IPFs to report these data.
Comment: Another commenter expressed concern that the shortened performance period for the first year may lead to incomplete data. One commenter recommended allowing
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voluntary reporting without publicly reporting data for the first performance year to account for potential data gaps.
Response: Given that results would be calculated quarterly for this measure, facilities should show rapid progress as they obtain more complete data on vaccination coverage for their HCP.
While we understand the desire for a year of voluntary reporting to account for potential data gaps, we believe that the importance of providing patients and their caregivers with data on COVID19 Vaccination Coverage among HCP at individual IPFs in a timely manner outweighs this concern and should be accomplished as soon as practical.
Comment: A few commenters expressed concern that due to the delay between data collection which takes place during a quarter and public reporting which follows the reporting of the data collected during the quarter, the deadline for which is 4.5 months after the end of the quarter the data would not be useful by the time they are publicly reported either because they are too old or because the trajectory of the pandemic has changed. One commenter opposed public reporting until data has been reported for several years.
Response: We believe that it is important to make these data available as soon as possible. We agree with commenters that observe that there is a delay between data collection and public reporting for this measure, and note that such a delay exists for all measures in the IPFQR Program.
However, we believe that the data will provide meaningful information to consumers in making healthcare decisions because the data will be able to reflect differences between IPFs in COVID19 vaccination coverage among HCP even if the data do not reflect the current vaccination rates and we believe it will benefit consumers to have these data available as early as possible. We proposed the shortened reporting period for the first performance period to make the COVID19 Vaccination among HCP
measure data available as quickly as possible.
Comment: One commenter observed that the data would not provide consumers a complete picture of infection control procedures because vaccines are only one tactic to prevent and control infections. Another commenter observed that public reporting may lead to comparisons between facilities. An additional commenter recommended a validation process to ensure that consumers can rely on the data.

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