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Federal Register / Vol. 86, No. 91 / Thursday, May 13, 2021 / Rules and Regulations
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TABLE 6ESTIMATE OF TOTAL COSTSContinued Costs in first year
Cost category
Costs in succeeding years
NHSN Reporting to CDC and CMS
Subtotal, NF Information Collection
ICFIID Information Collection
Subtotal Information Collection
Educating Residents & Staff
Providing Vaccine to Residents and Staff
Keeping Records of the Above Activities

27,175,000
79,825,000
11,426,000
91,251,000
35,220,000
23,460,000
9,125,000

27,175,000
49,826,000
5,351,000
55,177,000
26,415,000
17,595,000
5,518,000

Total Costs

159,056,000

104,705,000

These costs assume only unvaccinated are educated about vaccination.
These costs assume about 5 percent of total persons accept the vaccine offer over half already vaccinated.

While these estimates give the appearance of precision since they present costs to the nearest thousand dollars, this is simply the result of calculations based on numerical assumptions. There are major uncertainties in these estimates. One obvious example is whether vaccine efficacy will last more than the six months proven to date.84 Presumably, re-vaccination each year could maintain a high level of protection if vaccine protection wore off in a year. Revaccination or use of new and improved vaccines would likely maintain the effectiveness of vaccination for residents and staff. But the estimated costs of this rule would change in the table column for succeeding years to a level roughly equal to the first year estimate even if re-vaccinations were to be necessary.
For purposes of displaying the known second and succeeding year effects assuming no major changes in vaccine effectiveness, we have included in Table 5 and the tables covering information collection costs the predictable changes in second year cost estimates.
D. Anticipated Benefits of the Interim Final Rule There will be over 5 million residents, clients, and staff each year in the LTC
facilities and ICFsIID covered by this rule. In our analysis of first-year benefits of this rule we focus on prevention of death among residents of LTC facilities and ICFsIID, as well as on progress in reducing disease severity. We also focus only on benefits to the candidates for vaccination covered by this rule, not on possible benefits to family members, caregivers, or other persons who they might subsequently infect if not 84 For a discussion of this issue, see Sumathi Reddy, How Long To Covid19 Vaccines Protect You?, The Wall Street Journal, April 13, 2021, at https www.wsj.com/articles/how-long-do-covid19-vaccines-provide-immunity-11618258094.

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vaccinated.85 Reductions in resident, client, and staff mortality are benefits for which techniques exist though with some uncertainty to express estimates in dollar terms. One of the major benefits of vaccination is that it lowers the cost of treating the disease among those who would otherwise be infected and have serious morbidity consequences. The largest part of those costs is for hospitalization and they are very substantial. As discussed later in the analysis we do have data on the average costs of hospitalization of these patients it is, however, unclear as to how that cost is changing over time with better treatment options. A lesser but still very substantial amount of these morbidity costs is for care of gravely ill patients within the nursing home, but reducing those costs is another benefit we are unable to estimate at this time.
There is a potential offset to benefits that we have not estimated. As long as vaccine supplies do not meet all demands for vaccination, giving priority to some persons over others necessarily means that some persons will become infected who would not have been infected had the priorities been reversed. In this case, however, the priority for elderly persons virtually all of whom have risk factors who comprise the vast majority of LTC
facility residents, is prioritizing those at higher risk of mortality and severe disease over those whose risk of death is multiple orders of magnitude lower.86
As a result, there are some assumptions we make that could overstate benefits 85 We note that as of this writing there remains a major unanswered question as to whether and if so to what extent vaccinated persons transmit COVID19.
86 The risk of death from infection from an unvaccinated 75 to 84 year old person is 320 times more likely than the risk for an 18- to 29-years old person. CDC, Risk for COVID19 Infection, Hospitalization, and Death by Age Group, at https www.cdc.gov/coronavirus/2019-ncov/coviddata/investigations-discovery/hospitalizationdeath-by-age.html.

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should the assumptions be overtaken by adverse events.
The HHS Guidelines for Regulatory Impact Analysis explain in some detail the concept of Quality Adjusted Life Years QALYs.87 QALYs, when multiplied by a monetary estimate such as the Value of a Statistical Life Year VSLY, are estimates of the value that people are willing to pay for lifeprolonging and life-improving health care interventions of any kind see sections 3.2 and 3.3 of the HHS
Guidelines for a detailed explanation.
The QALY and VSLY amounts used in any estimate of overall benefits are not meant to be precise, but instead are rough statistical measures that allow an overall estimate of benefits expressed in dollars.
Under a common approach to benefit calculation, we can use a Value of a Statistical Life VSL to estimate the dollar value of the life-saving benefits of a policy intervention, such as this rule.
We adopt the VSL of approximately $10.6 million in 2020 as described in the HHS Guidelines, adjusted for changes in real income and inflated to 2019 dollars using the Consumer Price Index. Assuming that the average rate of death from COVID19 following SARS
CoV2 infection at nursing home resident ages and conditions is 5
percent, and the average rate of death after vaccination is essentially zero, the expected value of each resident receiving the full course of two vaccines who would otherwise be infected with SARSCoV2 is about $530,000
$10,600,000 .05.
Under a second approach to benefit calculation, we can estimate the monetized value of extending the life of nursing home residents, which is based on expectations of life expectancy and the value per life-year. As explained in the HHS Guidelines, the average 87 https aspe.hhs.gov/pdf-report/guidelinesregulatory-impact-analysis.

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