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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations
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settings, can be high-risk places for COVID19 exposure and transmission.81
Vaccination is a critical part of the nations strategy to effectively counter the spread of COVID19 and ultimately help restore societal functioning.82 On December 11, 2020, FDA issued the first Emergency Use Authorization EUA for a COVID19 vaccine in the U.S.83
Subsequently, FDA issued EUAs for additional COVID19 vaccines.84
FDA determined that it was reasonable to conclude that the known and potential benefits of each vaccine, when used as authorized to prevent COVID19, outweighed its known and potential risks.85
As part of its national strategy to address COVID19, the Biden Administration stated that it would work with states and the private sector to execute an aggressive vaccination strategy and has outlined a goal of administering 200 million shots in 100
days.86 Although the goal of the U.S.
government is to ensure that every American who wants to receive a COVID19 vaccine can receive one, Federal agencies recommended that early vaccination efforts focus on those critical to the PHE response, including HCP providing direct care to patients with COVID19, and individuals at 81 Dooling, K, McClung, M, et al. The Advisory Committee on Immunization Practices Interim Recommendations for Allocating Initial Supplies of COVID19 VaccineUnited States, 2020. Morb Mortal Wkly Rep. 2020; 6949: 18571859.
82 Centers for Disease Control and Prevention.
2020. COVID19 Vaccination Program Interim Playbook for Jurisdiction Operations. Accessed on April 3, 2021 at: https www.cdc.gov/vaccines/imzmanagers/downloads/COVID-19-VaccinationProgram-Interim_Playbook.pdf.
83 U.S. Food and Drug Administration. 2020.
Pfizer-BioNTech COVID19 Vaccine EUA Letter of Authorization. Available at https www.fda.gov/
media/144412/download. as reissued on May 10, 2021.
84 U.S. Food and Drug Administration. 2020.
Moderna COVID19 Vaccine EUA Letter of Authorization. Available at https www.fda.gov/
media/144636/download as reissued on July 7, 2021; U.S. Food and Drug Administration. 2021.
Janssen COVID19 Vaccine EUA Letter of Authorization. Available at https www.fda.gov/
media/146303/download as reissued on June 10, 2021.
85 U.S. Food and Drug Administration. 2020.
Pfizer-BioNTech COVID19 Vaccine EUA Letter of Authorization. Available at https www.fda.gov/
media/144412/download as reissued on May 10, 2021 and U.S. Food and Drug Administration.
2020. Moderna COVID19 Vaccine EUA Letter of Authorization. Available at https www.fda.gov/
media/144636/download as reissued on July 7, 2021; U.S. Food and Drug Administration. 2021.
Janssen COVID19 Vaccine EUA Letter of Authorization. Available at https www.fda.gov/
media/146303/download as reissued on June 10, 2021.
86 https www.whitehouse.gov/briefing-room/
speeches-remarks/2021/03/29/remarks-bypresident-biden-on-the-covid-19-response-and-thestate-of-vaccinations/.

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highest risk for developing severe illness from COVID19.87 For example, the CDCs Advisory Committee on Immunization Practices ACIP
recommended that HCP should be among those individuals prioritized to receive the initial, limited supply of the COVID19 vaccination given the potential for transmission in health care settings and the need to preserve health care system capacity.88 Research suggests most states followed this recommendation,89 and HCP began receiving the vaccine in mid-December of 2020.90
There are approximately 18 million healthcare workers in the U.S.91 As of April 3, 2021 the CDC reported that over 162 million doses of COVID19 vaccine had been administered, and approximately 60 million people had received a complete vaccination course as described in IV.E.b.i of this final rule.92 By July 15, 2021 the CDC
reported that over 336,000,000 doses had been administered, and approximately 160,000,000 people had received a complete vaccination course.93 President Biden indicated on 87 Health and Human Services, Department of Defense. 2020 From the Factory to the Frontlines:
The Operation Warp Speed Strategy for Distributing a COVID19 Vaccine. Accessed December 18 at:
https www.hhs.gov/sites/default/files/strategy-fordistributing-covid-19-vaccine.pdf; Centers for Disease Control 2020. COVID19 Vaccination Program Interim Playbook for Jurisdiction Operations. Accessed December 18 at: https
www.cdc.gov/vaccines/imz-managers/downloads/
COVID-19-Vaccination-Program-Interim_
Playbook.pdf.
88 Dooling, K, McClung, M, et al. The Advisory Committee on Immunization Practices Interim Recommendations for Allocating Initial Supplies of COVID19 VaccineUnited States, 2020. Morb.
Mortal Wkly Rep. 2020; 6949: 18571859. ACIP
also recommended that long-term care residents be prioritized to receive the vaccine, given their age, high levels of underlying medical conditions, and congregate living situations make them high risk for severe illness from COVID19.
89 Kates, J, Michaud, J, Tolbert, J. How Are States Prioritizing Who Will Get the COVID19 Vaccine First? Kaiser Family Foundation. December 14, 2020. Accessed on December 16 at https
www.kff.org/policy-watch/how-are-statesprioritizing-who-will-get-the-covid-19-vaccine-first/.
90 Associated Press. Healing is Coming: US
Health Workers Start Getting Vaccine. December 15, 2020. Accessed on December 16 at: https
apnews.com/article/us-health-workers-coronavirusvaccine-56df745388a9fc12ae93c6f9a0d0e81f.
91 https www.cdc.gov/niosh/topics/healthcare/
default.html::text=
HEALTHCARE%20WORKERS,Related%20Pages&text=
Healthcare%20is%20the%20fastest%2Dgrowing, of%20the%20healthcare%20work%20force.
92 CDC. COVID Data Tracker. COVID19
Vaccinations in the United States. Accessed on 4/
4/21 at: https covid.cdc.gov/covid-data-tracker/
vaccinations.
93 CDC. COVID Data Tracker. COVID19
Vaccinations in the United States. Accessed on 7/
6/2021 at: https covid.cdc.gov/covid-data-tracker/
vaccinations.

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March 2, 2021 that the U.S. is on track to have sufficient vaccine supply for every adult by the end of May 2021.94
Subsequent to the publication of the IPF
PPS proposed rule, on June 3, 2021, the White House confirmed that there was sufficient vaccine supply for all Americans.95
We believe it is important to require that IPFs report HCP vaccination in their facilities in order to assess whether they are taking steps to protect health care workers and to help sustain the ability of IPFs to continue serving their communities throughout the PHE and beyond. Therefore, we proposed a new measure, COVID19 Vaccination Coverage Among HCP, beginning with the FY 2023 program year. For that program year, IPFs would be required to report data on the measure for the fourth quarter of 2021 October 1, 2021 through December 31, 2021. For more information about the reporting period, see section V.E.2.c of this final rule. The measure would assess the proportion of an IPFs health care workforce that has been vaccinated against COVID19.
Although at the time of the proposed rule, data to show the effectiveness of COVID19 vaccines to prevent asymptomatic infection or transmission of SARSCoV2 were limited, we stated our belief that IPFs should report the level of vaccination among their HCP as part of their efforts to assess and reduce the risk of transmission of COVID19
within their facilities. HCP vaccination can potentially reduce illness that leads to work absence and limit disruptions to care.96 Data from influenza vaccination demonstrates that provider uptake of the vaccine is associated with that provider recommending vaccination to patients,97 and we believe HCP COVID
19 vaccination in IPFs could similarly increase uptake among that patient population. We also believe that publishing the HCP vaccination rates would be helpful to many patients, including those who are at high-risk for 94 The White House. Remarks by President Biden on the Administrations COVID19 Vaccination Efforts. Accessed March 18, 2021 at: https
www.whitehouse.gov/briefing-room/speechesremarks/2021/03/02/remarks-by-president-bidenon-the-administrations-covid-19-vaccinationefforts/.
95 Press Briefing by White House COVID19
Response Team and Public Health Officials The White House.
96 Centers for Disease Control and Prevention.
Overview of Influenza Vaccination among Health Care Personnel. October 2020. 2020 Accessed March 16, 2021 at: https www.cdc.gov/flu/toolkit/
long-term-care/why.htm.
97 Measure Application Committee Coordinating Committee Meeting Presentation. March 15, 2021.
2021 Accessed March 16, 2021 at: http
www.qualityforum.org/Project_Pages/MAP_
Coordinating_Committee.aspx.

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