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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations
Furthermore, section 1871e1Aii of the Act permits a substantive change in regulations, manual instructions, interpretive rules, statements of policy, or guidelines of general applicability under Title XVIII of the Act to be applied retroactively to items and services furnished before the effective date of the change if the failure to apply the change retroactively would be contrary to the public interest. Finally, the Congressional Review Act CRA
Pub. L. 104121, Title II requires a 60day delay in the effective date for major rules unless an agency finds good cause that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, in which case the rule shall take effect at such time as the agency determines. 5 U.S.C. 801a3, 8082.

chain challenges that exist with two of the three currently available vaccines that make obtaining and providing the vaccine more challenging for small facilities that do not have the necessary storage equipment. Ensuring the health and safety of all Americans, including Medicare and Medicaid beneficiaries, and health care workers is of primary importance. This IFC directly supports that goal by requiring education about and offer of COVID19 vaccination for LTC facility and ICFIID residents, clients, and staff. This IFC also requires reporting of COVID19 vaccination status and use of COVID19
therapeutics of LTC facility residents and staff, which will provide vital data that CMS, CDC, and other public health entities can use to target our outreach and resources in support of vaccination.

A. COVID19 and Populations at Higher Risk On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization WHO declared the outbreak a Public Health Emergency of international concern. On January 31, 2020, pursuant to section 319 of the PHSA, the Secretary determined that a PHE exists for the United States to aid the nations health care community in responding to COVID19. On March 11, 2020, the WHO publicly declared COVID19 a pandemic. On March 13, 2020, the President declared the COVID19 pandemic a national emergency.
Over 569,000 individuals have lost their lives to COVID19 in the United States as of April 27, 2021,60 including more than 131,000 LTC facility residents, or close to one tenth of the average national LTC facility resident census of 1.4 million.61 In recognition of the susceptibility of their residents, clients, and staff, LTC facilities and other congregate settings, including ICFsIID, have been prioritized for vaccination. The data show that COVID19 cases are declining in LTC
facilities concurrently with increasing vaccination among residents and staff, but as noted below, we are concerned that the rate of vaccination in LTC
facilities may slow in the absence of regulation and the conclusion of the Pharmacy Partnership program, especially in light of consistent, frequent resident and staff turnover in these facilities and the cold storage
B. Supporting Vaccine Distribution and Uptake In response to the COVID19
pandemic, pharmaceutical developers around the world began development of vaccine that would prevent severe illness and death and they have produced several vaccines authorized for use in the United States. Because the first cohort of authorized vaccines require specialized handling, and LTC
facility residents have been at higher risk of severe illness from COVID19, CDC established the Pharmacy Partnership for Long-Term Care LTC
Program, which has facilitated on-site vaccination of residents and staff at more than 63,000 enrolled nursing homes and assisted living facilities while reducing the burden on facility administrators, clinical leadership, and health departments. At no cost to facilities, the program has provided endto-end management of the COVID19
vaccination process, including cold chain management, on-site vaccinations, and fulfillment of reporting requirements.
While the Pharmacy Partnerships have had much success in ensuring timely vaccine access to many LTC
facility residents and staff, we note that not all such individuals were able to receive vaccine under the program.
Internal CDC data show that approximately 2,500 or about 16 percent of CMS-certified SNFs a subset of LTC
facilities enrolled as Medicare providers that are enrolled in NHSN
did not participate in the Pharmacy Partnership program. LTC facility residents are unable to live independently, and generally are unable to access the vaccine without significant assistance from the facility in which they reside or from family members or caregivers. As we currently do not
60 https covid.cdc.gov/covid-data-tracker/
datatracker-home.
61 LTC Facility deaths are from COVID19
Nursing Home Data, CMS, Week Ending 3/28/2021, at https data.cms.gov/stories/s/COVID-19Nursing-Home-Data/bkwz-xpvg/.

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require LTC facilities to report vaccination status within their facility, we have no comprehensive way of knowing whether residents or staff of those facilities have acquired the vaccine through avenues outside the Partnerships. Ensuring that individuals residing in LTC facilities that did not participate in the Pharmacy Partnerships have access to vaccination against COVID19 is critical so as to expeditiously ensure that residents are protected.
Most LTC facilities participated in the Pharmacy Partnerships but the Partnerships concluded in March 2021.
The Pharmacy Partnership program was designed as time-limited effort designed to quickly vaccinate thousands of facility residents per week.
Ending the program without appropriate requirements to ensure facilities continue to seek vaccination opportunities for their residents and staff puts future incoming LTC facility residents and staff at risk. Turnover of both LTC facility residents admissions and discharges and staff can be significant. It is difficult to estimate the number of admissions and discharges in LTC facilities as 20 to 25 percent of beds are often reserved for shorter term weeks to months rehabilitation stays, while other individuals reside in the facility for years. That said, resident turnover within a year may be significant, possibly up to 40 percent based on internal CMS estimates. Staff turnover is more easily considered, with some estimates as high as 100 percent for certain facilities within a year,62 and if a facility finds itself with a large portion of its community being unvaccinated, all residents and staff may again face a higher risk of infection, similar to the risk levels during the early months of the pandemic. For example, if final Partnership vaccination rates reach even 90 percent an illustrative example as we do not have final or complete data of the residents present in the first 3 months of 2021, turnover during the rest of the year may be such that by year-end as few as two-thirds of LTC residents present at some point during the year would have been vaccinated absent a continuing and effective effort.
Turnover rates demonstrate there will be an ongoing need for new resident or staff vaccinations. For example, when the Pharmacy Partnership completes its time commitment, it is likely that it will have seen only about half of the persons who will reside or work in these facilities in 2021. Even if two-thirds of 62 https www.healthaffairs.org/doi/full/10.1377/
hlthaff.2020.00957.

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