58834 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 483 

[CMS–3198–F] 

RIN 0938–AN95 

Medicare and Medicaid Programs; 

Condition of Participation: 

Immunization Standard for Long Term 

Care Facilities 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: The goal of this final rule is 

to increase immunization rates in 

Medicare and Medicaid participating 

long term care (LTC) facilities by 

requiring LTC facilities to offer each 

resident immunization against influenza 

annually, as well as lifetime 

immunization against pneumococcal 

disease. LTC facilities will be required 

to ensure that before offering the 

immunization, each resident or the 

resident’s legal representative receives 

education regarding the benefits and 

potential side effects of immunization. 

The facilities will be required to offer 

immunization against influenza 

annually and immunization against 

pneumococcal disease once, unless 

medically contraindicated or the 

resident or the resident’s legal 

representative refuses immunization. 

Increasing the use of Medicare-funded 

preventive services is a goal of both 

CMS and the Centers for Disease Control 

and Prevention (CDC). This final rule is 

intended to increase the number of 

elderly receiving influenza and 

pneumococcal immunization and 

decrease the morbidity and mortality 

rate from influenza and pneumococcal 

diseases. 

DATES: Effective Date: These regulations 

are effective on October 7, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Anita Panicker, (410) 786–5646. Jeannie 

Miller, (410) 786–3164. Rachael 

Weinstein, (410) 786–6775. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. General 

The CDC’s Advisory Committee on 

Immunization Practices (ACIP) reported 

on May 28, 2004 (http://www.cdc.gov/ 

mmwr/preview/mmwrhtml/ 

rr5306a1.htm) that epidemics of 

influenza have been responsible for an 

average of approximately 36,000 deaths 

per year in the United States between 

1990 and 1999. There is an added 

danger when it comes to people age 65 

or older or with high risk conditions 

such as individuals residing in long 

term care facilities. In 2002, ACIP 

estimated the rates of influenza related 

hospitalization as 392 to 635 per 

100,000 among adults with one or more 

high risk conditions, compared to 13 to 

33 per 100,000 among those without 

high risk conditions. 

According to the CDC, influenza and 

invasive pneumococcal disease kill 

more people in the United States each 

year than all other vaccine-preventable 

diseases combined. Influenza and 

pneumonia combined represent the fifth 

leading cause of death in the elderly. 

Immunization is the primary method for 

preventing invasive pneumococcal 

disease as well as influenza and its more 

severe complications. In 2002, the ACIP 

reported that the primary target group 

for influenza vaccination includes 

persons who are at high risk for serious 

complications from influenza, including 

approximately 35 million persons who 

are more than 65 years of age and 

approximately 33 to 39 million persons 

less than 65 years of age who have 

chronic underlying medical conditions. 

ACIP recommends that all residents of 

long term care facilities should be 

assessed for their needs for 

pneumococcal polysaccharide vaccine 

(PPV) and that people 65 or older, as 

well as persons less than 65 who have 

chronic illness or who are living in long 

term care facilities, receive the 

immunization, if eligible. 

Despite the Federal Government’s 

unified efforts to increase the 

availability of safe and effective 

vaccines and despite substantial 

progress in reducing many vaccinepreventable diseases; many individuals 

are not receiving influenza and 

pneumococcal vaccines. 

Section 4107 of the Balanced Budget 

Act of 1997 extended the influenza and 

pneumococcal immunization campaign 

being conducted by CMS in conjunction 

with CDC and the National Coalition for 

Adult Immunization through fiscal year 

2002, authorizing $8 million for each 

fiscal year from 1998 to 2002. Although 

Medicare reimbursement for influenza 

and pneumococcal immunizations was 

increased under this legislation, rates of 

immunization did not improve as 

anticipated. 

On April 30, 1999, the CDC and CMS 

entered into an interagency agreement 

(IA 99–87) to establish a program of 

collaboration between the two agencies 

to enhance assessment of health status 

and delivery of preventive services to 

beneficiaries of the Medicare program. 

One of the initial areas highlighted for 

collaboration was improving influenza 

and pneumococcal immunization 

coverage through ‘‘standing orders’’ for 

those populations and settings 

designated as appropriate by the ACIP. 

A March 24, 2000 ACIP report, which 

includes implementation guidelines, 

recommended the use of standing orders 

programs in both outpatient and 

inpatient settings to increase the 

number of individuals who receive the 

influenza vaccine. See implementation 

guidelines at (http://www.cdc.gov/ 

mmwr/preview/mmwrhtml/ 

rr4901a1.htm). On October 2, 2002, (67 

FR 61808) CMS published a final rule 

with comment period that removed the 

physician order requirement for 

influenza and pneumococcal 

vaccinations from the Conditions of 

Participation (CoPs) for Medicare and 

Medicaid participating hospitals, (LTC) 

facilities, and home health agencies 

(HHAs). The final rule was effective as 

of its publication date. Although the 

CoPs for these provider types require a 

physician’s order for drugs and 

biologicals that must be signed by the 

practitioner responsible for the care of 

the patient or resident, the CoPs make 

an exception for influenza and PPV. 

These vaccines can now be 

administered per a physician-approved 

facility or agency policy, following 

assessment of the patient or resident for 

contraindications. The final rule was a 

major step towards increasing the 

immunization rates in the LTC 

population. To date, however, we do not 

have data on the specific immunization 

rates of nursing facility residents 

following the effective date of the final 

rule. 

The Medicare Current Beneficiary 

Survey (MCBS) data shows that the rate 

of influenza vaccination of individuals 

age 65 and older was 70.4 percent in the 

year 2000, 67.4 percent in 2001, 69 

percent in 2002 and 70.4 percent in 

2003. MCBS data for pneumococcal 

vaccination for individuals age 65 and 

older was 62.7 percent in 2000, 63.3 

percent in 2001, 64.6 percent in 2002 

and 66.4 percent in 2003. Nursing 

facility residents are included in these 

figures. These rates demonstrate the 

need to implement strategies to help 

achieve, the goal set by the Department 

of Health and Human Service’s (DHHS) 

Healthy People 2010 campaign. The 

Department’s goal in this campaign is to 

increase the rate of influenza and 

pneumococcal vaccination of adults 

aged 65 years and older to 90 percent. 

Further information on preventive 

services, like immunizations, are 

available at the healthy aging site at 

http://www.cms.hhs.gov/healthyaging/ 

Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 58835 

2a.asp and at http:// 

www.healthypeople.gov/. 

B. Influenza Incidence and Prevention 

Numerous studies referenced by the 

CDC on the Morbidity and Mortality 

Weekly Report (MMWR) Web site show 

that—(1) persons 65 years and older are 

at high risk of contracting influenza; (2) 

they are more likely than the general 

population to need hospitalization or to 

die from complications of influenza; 

and (3) immunizations are effective in 

preventing influenza and its 

complications in this population 

(http://www.cdc.gov/mmwr/preview/ 

mmwrhtml/rr5306a1.htm). 

In the May 2004 MMWR referenced 

above, the ACIP stated that while rates 

of influenza infection are high among 

children, rates of serious illness and 

death are highest among persons aged 

≥65 years and persons of any age who 

have medical conditions that place them 

at increased risk for complications from 

influenza. According to ACIP, the 

primary target groups recommended for 

annual vaccination are as follows: (1) 

Persons at increased risk for influenzarelated complications (for example, 

those aged ≥65 years and persons of any 

age with certain chronic medical 

conditions); (2) persons aged 50 to 64 

years (because this group has an 

elevated prevalence of certain chronic 

medical conditions); and (3) persons 

who live with or care for persons at high 

risk (for example, health-care workers 

and individuals within a household 

who have frequent contact with persons 

at high risk and who can transmit 

influenza to those persons at high risk). 

The ACIP report states that 

vaccination is associated with 

reductions in the following: influenzarelated respiratory illness and physician 

visits among all age groups, 

hospitalization and death among 

persons at high risk, otitis media among 

children, and work absenteeism among 

adults. Although influenza vaccination 

levels increased substantially during the 

1990s, further improvements in vaccine 

coverage levels are needed. Influenza 

vaccination remains the cornerstone for 

the control and treatment of influenza. 

(MMWR: Recommendations and 

Reports May 28, 2004/53 (RR06); 1–40 

http://www.cdc.gov/mmwr/preview/ 

mmwrhtml/rr5306a1.htm). 

Although influenza affects persons of 

all ages, the CDC has identified several 

groups who are at increased risk for 

complications. One such group is 

comprised of residents of nursing homes 

or other long-term care facilities. An 

article in American Family Physician, 

January 1, 2002 titled, ‘‘Influenza in the 

Nursing Home,’’ notes that during 

influenza epidemics, mortality rates 

among nursing home residents often 

exceed 5 percent of the nursing home 

population in the country. To lessen the 

impact of this infectious disease, the 

CDC recommends the influenza vaccine 

as the primary way of preventing the 

illness and its complications (http:// 

www.aafp.org/afp/20020101/75.html). 

On September 28, 2004, the Director 

of Health Care-Public Health Issues for 

the General Accountability Office (GAO) 

testified before the United States Senate 

Special Committee on Aging concerning 

a 2004 GAO study titled, ‘‘Infectious 

Disease Preparedness: Federal 

Challenges in Responding to Influenza 

Outbreaks’’ (http://www.gao.gov/ 

new.items/d041100t.pdf). The Director 

of GAO stated that the study was 

conducted to identify the challenges in 

preventing the spread of the influenza 

virus because influenza is associated 

with an average of 36,000 deaths and 

more than 200,000 hospitalizations each 

year in the United States. Furthermore, 

nine out of ten persons who die from 

influenza and one out of two who are 

hospitalized due to influenza are age 65 

or older. The GAO was asked to conduct 

the study to assess issues related to 

supply, demand, and distribution of 

vaccine during a typical flu season and 

to assess the Federal plan to respond to 

an influenza pandemic. The study was 

based on a survey of physician group 

practices, interviews with health 

department officials in all 50 states, as 

well as information about CDC activities 

in the 2003–04 flu season. The GAO 

found that the most effective way to 

prevent influenza is by immunizing 

individuals against influenza every fall 

season. 

The 2004 ACIP recommendations 

referenced earlier note that influenza 

vaccine effectiveness varies in the 

elderly; however, influenza vaccine is 

still effective at preventing severe 

illness, secondary complications, and 

death. In the elderly population residing 

in nursing homes, the vaccine can be 

50–60 percent effective in preventing 

hospitalization or pneumonia and 80 

percent effective in preventing death, 

even though the effectiveness in 

preventing influenza illness often ranges 

from 30 percent to 40 percent. 

According to the January 1, 2002 

article in American Family Physician 

referenced earlier, a number of studies 

have also shown that nursing homes 

with high rates of vaccinated residents 

have fewer outbreaks of influenza than 

nursing homes with lower vaccination 

rates. The article further states that 

many studies have shown that influenza 

vaccination of nursing home residents 

and staff can significantly decrease rates 

of hospitalization, pneumonia, and 

related mortality. Therefore, it is vital to 

the well-being of the residents of 

nursing homes that they are offered 

immunization if not medically 

contraindicated, and that facilities 

ensure residents receive the 

immunizations at the appropriate time 

to prevent the spread of the influenza 

virus if not refused by the resident or 

the resident’s representative. 

The February 14, 2005, article in the 

Archives of Internal Medicine titled 

‘‘Impact of Influenza Vaccination on 

Seasonal Mortality in the U.S. Elderly 

Population’’ reports the results of the 

study conducted by Lone Simonsen and 

colleagues on flu vaccination rates 

among the elderly population (http:// 

archinte.ama-assn.org/cgi/content/ 

abstract/165/3/265). This study reports 

that vaccination of the elderly 

population against influenza may be 

less effective in preventing death among 

the elderly than previously estimated. A 

joint CDC and National Institutes of 

Health (NIH) press release (February 15, 

2005), (http://www.cdc.gov/flu/pdf/ 

statementeldmortality.pdf), stated that 

the Simonsen, et al. study did not show 

that the flu vaccine is ineffective at 

protecting the elderly from influenza. 

Rather, the study indicated that 

different research approaches result in 

different estimates of influenza vaccine 

effectiveness at preventing death among 

the elderly. 

The Simonsen, et al., study does not 

imply that the elderly should not 

receive influenza vaccine. Furthermore, 

we note that this study addresses the 

elderly population as a whole, and does 

not analyze the more vulnerable group 

of nursing home residents addressed by 

this regulation and the studies of those 

residents summarized later in this 

preamble. The conclusions in the study 

are in contrast to most other peerreviewed studies that address the same 

issue (See for example, JAMA; Chicago; 

Oct 22–Oct 29 1997; 278; 16; Jane E 

Sisk; Alan J Moskowitz; William 

Whang; Jean D Lin. et al). The CDC and 

ACIP continually review their influenza 

vaccine recommendations as well as 

published research in order to develop 

the best recommendations for protecting 

all Americans from influenza. 

The study is a reminder that there is 

room for improvement in how we 

protect the elderly from influenza, and 

the CDC and NIH encourage research 

that strengthens our ability to do so. The 

study conducted by the CDC and 

published in the Journal of American 

Medical Association (JAMA), ‘‘Impact of 

Influenza Vaccination on Seasonal 

Mortality in the U.S. Elderly 

Population’’ by Simonsen et al., 

58836 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 

September 2005, looked at hospital data 

from 1961 to 2001 and found an overall 

increasing trend in the number of flurelated hospitalizations in the United 

States each year, despite the fact that the 

number of immunizations for influenza 

has increased. The CDC has provided 

the following information to explain 

this phenomenon: 

1. The range of illnesses analyzed in 

the new study is broader than in the 

previous study. The new study includes 

respiratory and heart diseases associated 

with influenza infections. The earlier 

CDC study published in 2000 analyzed 

only pneumonia and influenza 

hospitalizations. When analyses were 

restricted to pneumonia and influenza 

hospitalizations, however, there was 

still an increase in hospitalizations. 

2. Influenza A (H3N2) viruses 

predominated in several recent 

influenza seasons, and these viruses 

generally have been associated with 

higher numbers of serious illnesses than 

influenza A (H1N1) or influenza B 

viruses. The higher numbers of people 

hospitalized during H3N2 influenza 

seasons may have increased the average. 

3. The U.S. population is growing 

older and therefore, more vulnerable to 

developing severe complications from 

influenza. 

4. During the 1990s influenza viruses 

have either circulated or been detected 

for longer periods of time. (http:// 

www.cdc.gov/flu/about/qa/ 

hospital.htm). The CDC also provided 

additional information to help put the 

study in context. 

• The Simonsen et al. study does not 

show that the flu vaccine is ineffective 

at protecting the elderly from influenza. 

Rather, the study indicates that different 

research approaches result in different 

estimates of influenza vaccine 

effectiveness at preventing death among 

the elderly. 

• The Simonsen study has some 

significant limitations when it comes to 

assessing the effectiveness of influenza 

vaccination. 

• The study analyzes patterns of 

influenza vaccination and death among 

the elderly from 1961 to 2001 and 

suggests a relationship between the two. 

This type of analysis is called an 

‘‘ecologic study’’. 

• Ecologic studies look at overall 

trends and do not include information 

on specific individuals, such as 

vaccination status and health 

conditions. 

• Since there is no information on 

which of the individuals who died were 

vaccinated or their underlying 

conditions, the death and vaccination 

patterns identified in this study cannot 

be directly linked. Apparent 

associations can be inferred, but may be 

misleading or hard to interpret. 

• Many previously published 

‘‘observational studies’’ suggest a higher 

level of influenza vaccine effectiveness 

against death in the elderly than 

indicated in the Simonsen paper. 

• There are several types of 

epidemiologic studies, including 

ecologic studies, observational studies 

(for example, studies that compare 

vaccinated people to people who choose 

not to get vaccinated), and clinical trials 

(or experiments), where people are 

randomly assigned to a treatment or 

control group. Clinical trials provide the 

most reliable and valid data on vaccine 

effectiveness. However, conducting a 

true clinical trial of the effect of 

influenza vaccine in the elderly would 

be unethical, because investigators 

would randomly assign participants to 

get vaccinated or not, despite the fact 

that influenza vaccination has been 

recommended for many years for all 

those aged 65 and older. So, to study 

vaccine effectiveness researchers have 

observed what has happened among 

people who have chosen on their own 

to be vaccinated and those who have not 

(called ‘‘observational studies’’). 

• The main weakness of observational 

studies is that they are likely to be 

influenced by selection bias (for 

example, if very vulnerable elderly 

people are less likely to get vaccinated 

than the relatively healthy elderly, then 

this bias might lead to overestimates of 

vaccine effectiveness for preventing 

deaths). 

• The main strength of observational 

studies is that information on 

individuals is analyzed and factors that 

may bias the result can be taken into 

account during the analysis. For this 

reason, observational studies have been 

considered more appropriate than 

ecologic studies for evaluating vaccine 

effectiveness. For the entire CDC 

response to the Simonsen study see 

http://www.amda.com/clinical/ 

immunization/flustudy.htm. 

A meta-analysis of 40 years of studies 

performed by an international 

collaboration of scientists called the 

Cochrane Review Group was published 

in the British journal The Lancet in 

September 2005. The analysis found 

that the vaccine is only about 28 percent 

effective when given to people over 65. 

However, the researchers said that the 

vaccine is less effective for those elderly 

who live in the community and 

described the vaccine as ‘‘modestly 

effective’’ for elderly people in longterm care facilities. The study found 

that when used in nursing facilities, 

influenza vaccines prevented up to 42 

percent of deaths from influenza and 

pneumonia. They also found that for the 

elderly living in the community, 

influenza vaccination could prevent up 

to 30 percent of hospitalizations. 

Despite the results of this most recent 

study, influenza vaccination is still 

recommended by the CDC and the 

World Health Organization. In response 

to the study, a CDC spokesperson stated, 

‘‘There are a number of studies 

published that report on varying degrees 

of effectiveness. But there are also a lot 

of studies that point to the fact that the 

vaccines are effective in preventing the 

serious complications that lead to 

hospitalizations and death, and that’s an 

important note that we should never 

lose sight of. If I had a loved one who 

was in the high risk group, I would 

strongly recommend they get 

vaccinated.’’ Further, William 

Schaffner, who heads the preventive 

medicine department at Vanderbilt 

University’s medical school, pointed out 

in the September 22, 2005 Washington 

Post, ‘‘Vaccination is not perfect, but it 

still is enormously beneficial. Even 30 

percent effectiveness prevents a lot of 

suffering.’’ We agree. See http:// 

www.thelancet.com/. 

The CDC continues to recommend 

that people aged 65 and older get 

vaccinated against influenza each year 

as persons aged 65 and older are at high 

risk for complications, hospitalizations, 

and death from influenza. In the joint 

press release referenced above, the CDC 

and National Institutes of Health (NIH) 

continue to support the ACIP 

recommendation that people aged 65 

and older get vaccinated against 

influenza each year. 

C. Pneumococcal Disease Incidence and 

Prevention 

Like influenza, invasive 

pneumococcal disease is particularly 

prevalent and severe in those 65 years 

and older. This population is at high 

risk of contracting invasive 

pneumococcal disease, with a high risk 

of resultant complications, 

hospitalizations, and deaths. 

Pneumococcal immunizations are 

effective in preventing pneumococcal 

disease in this population. 

According to CDC’s Active Bacterial 

Core Surveillance for pneumococcal 

disease, approximately 5,700 deaths 

from invasive pneumococcal disease 

(bacteremia and meningitis) are 

estimated to have occurred in the 

United States in 2002 (http:// 

www.cdc.gov/ncidod/dbmd/abcs/ 

survreports/spneu02.pdf). An article in 

the American Journal of Preventive 

Medicine, August 2003, titled 

‘‘Standards for Adult Immunization 

Practices,’’ notes that overall, vaccine 

Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 58837 

effectiveness against invasive 

pneumococcal disease among 

immunocompetent people aged 65 years 

is 75 percent. Based on 1998 

projections, annually, 76 percent of 

invasive pneumococcal disease cases 

and 87 percent of resulting deaths 

occurred in people who were eligible for 

pneumococcal vaccine in the United 

States. (http://www.cdc.gov/nip/recs/ 

rev_stds_adult_AJPM.pdf). 

The ACIP and CDC recommend 

immunization for pneumococcal disease 

for those 65 years old or older, and for 

people with a serious long-term health 

problem, such as heart disease, diabetes, 

or immunosuppression due to disease, 

organ transplantation, or medical 

treatment such as chemotherapy. The 

American Lung Association warns that 

people considered at high risk for 

invasive pneumococcal disease include 

the elderly, the very young, and those 

with underlying health problems, such 

as chronic obstructive pulmonary 

disease (COPD). Patients with diseases 

that impair the immune system, such as 

AIDS, or patients with other chronic 

illnesses, such as asthma, or those 

undergoing cancer therapy or organ 

transplantation, are particularly 

vulnerable. 

According to CDC recommendations, 

usually one dose of the PPV is all that 

is needed to prevent pneumococcal 

disease or a person only needs to be 

immunized once in a lifetime. However, 

a second dose is recommended for 

people 65 and older who received their 

first dose prior to 65 years of age, if five 

or more years have passed since that 

dose. A second dose is also 

recommended for people with a 

damaged spleen or without a spleen, 

sickle-cell disease, HIV infection or 

AIDS, cancer, leukemia, lymphoma, 

multiplemyeloma, kidney failure or 

nephrotic syndrome, an organ or bone 

marrow transplant, or who are taking 

medication that lowers immunity (such 

as chemotherapy or long-term steroids). 

Accordingly, we believe it vital that 

facilities secure the consent of their 

residents or legal representative for 

vaccination and provide their residents 

with vaccinations. Educating residents 

about the advantages of being 

vaccinated allows residents to 

understand the benefits of 

pneumococcal vaccines. The 1997 ACIP 

recommendations state that, 

‘‘Pneumococcal polysaccharide vaccine 

generally is considered safe based on 

clinical experience since 1977, when 

the pneumococcal polysaccharide 

vaccine was licensed in the United 

States. Approximately half of the 

persons who receive pneumococcal 

vaccine develop mild, local side effects 

(for example, pain at the injection site, 

erythema, and swelling). These 

reactions usually persist for less than 48 

hours. Moderate systemic reactions (for 

example, fever and myalgias) and more 

severe local reactions (for example, local 

induration) are rare. Severe systemic 

adverse effects (for example, 

anaphylactic reactions) rarely have been 

reported after administration of 

pneumococcal vaccine. In a recent metaanalysis of nine randomized controlled 

trials of pneumococcal vaccine efficacy, 

local reactions were observed among 

approximately one third or fewer of 

7,531 patients receiving the vaccine, 

and there were no reports of severe 

febrile or anaphylactic reactions.’’ The 

1997 ACIP recommendations further 

stated that pneumococcal vaccination 

has not been causally associated with 

death among vaccine recipients. 

Additional information about 

precautions and contraindications can 

be obtained from the CDC. The vaccine 

manufacturer’s package insert may also 

be reviewed for more information. See: 

(http://www.cdc.gov/mmwr/preview/ 

mmwrhtml/ 

00047135.htm#00002349.htm). 

CDC’s March 24, 2000 MMWR states 

that in recent years, a rapid emergence 

of antimicrobial resistance among 

pneumococci, especially to penicillin, 

has occurred. Increasing pneumococcal 

vaccination rates could help prevent 

invasive pneumococcal disease caused 

by vaccine-type, multidrug-resistant 

pneumococci. Outbreaks of 

pneumococcal disease caused by a 

single drug resistant pneumococcal 

serotype have occurred in institutional 

settings, including nursing homes. The 

same MMWR report notes that in 1999, 

because of concerns about 

pneumococcal antimicrobial resistance 

and under use of pneumococcal 

vaccine, the American Medical 

Association and several partner 

organizations issued a Quality Care 

Alert that supports ACIP’s 

recommendations for pneumococcal 

vaccination. (Use of Standing Orders 

Programs to Increase Adult Vaccination 

Rates: MMWR 2000/49 RR01 15–26 

March 24). 

A CMS/CDC report, ‘‘Respiratory 

Disease Burden in Nursing Homes’’

(http://www.nationalpneumonia.org/ 

sop/RDBNH_INTERIMProjectRpt_1-31- 

03.pdf) notes that both influenza 

vaccine and PPV are protective to 

residents in nursing homes. Based on 

two years of analysis (multivariate/ 

multilevel), influenza vaccine may be 

associated with a 27 to 35 percent 

reduction in mortality, and a 44 to 52 

percent reduction in all-cause 

hospitalization. Similarly, 

pneumococcal vaccination may be 

associated with a 20 to 26 percent 

reduction in mortality, and a 12 to 28 

percent reduction in all-cause 

hospitalization in nursing home 

residents. The report also suggests that 

a facility-level influenza vaccination of 

80 percent of residents may be 

independently associated with reduced 

patient hospitalization and death. 

D. Why a Change in the Conditions of 

Participation Is Needed 

In January 2000, the Department of 

Health and Human Services launched 

Healthy People 2010, a comprehensive, 

nationwide health promotion and 

disease prevention campaign. 

‘‘Immunizations and Infectious 

Diseases’’ is one of the focus areas. 

Healthy People 2010 set the target rate 

for influenza and PPV vaccination of 

adults aged 65 years and older at 90 

percent. According to CMS’s Adult 

Immunization Project ‘‘despite the fact 

that influenza and pneumococcal 

vaccines are clinically effective, costeffective, and are Medicare Part B 

covered benefits, they remain 

underutilized.’’ (http://www.ofmq.com/

user_uploads/

National%20Immunization%20

Project.pdf). 

Based on the 1999 National Nursing 

Home Survey, only 66 percent of 

nursing home residents had received the 

influenza vaccine in the previous year 

and only 38 percent had ever had the 

pneumococcal vaccine. The October 

2004 article in the American Family 

Physician titled ‘‘Pneumonia in Older 

Residents of Long-Term Care Facilities’’

noted that,’’ when compared to persons 

in the overall community, residents in 

LTC facilities have more functional 

disabilities and underlying medical 

illnesses and are at increased risk of 

acquiring infectious diseases (http:// 

www.aafp.org/afp/20041015/ 

1495.html). Risk factors include unwitnessed aspiration, sedative 

medication, and co-morbid illnesses. 

Influenza-associated mortality is a major 

concern for persons with chronic 

diseases; this mortality increase is most 

marked in persons 65 years of age or 

older, with more than 90 percent of the 

deaths attributed to pneumonia and 

influenza occurring in persons of this 

age group. 

As noted in the October 15, 2004 

article, ‘‘Pneumonia in Older Residents 

of Long-Term Care Facilities’’ in the 

journal American Family Physician, 

‘‘The number of frail older adults living 

in LTC facility is expected to increase 

dramatically over the next 30 years.’’

(http://www.aafp.org/afp/20041015/ 

1495.html). The article further states 

58838 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 

that an estimated 40 percent of adults 

will spend some time in a LTC facility 

before dying. Unless control measures 

are more vigorously implemented, the 

number of deaths from influenza and 

pneumonia with respect to residents in 

LTC facilities and the number of 

consequent complications might 

increase significantly. 

In summary, immunizations save 

lives and can help avoid needless 

suffering and unnecessary costs of 

complications from various infectious 

diseases, and, as many family members 

and health care workers know, they can 

prevent the spread of infection to others. 

However, despite the availability of safe 

and effective vaccines, substantial 

portions of susceptible adults are not 

being immunized. To reduce morbidity 

and mortality rates, delivering 

appropriate vaccinations in a timely 

manner is vital. This rule is expected to 

facilitate the delivery of appropriate 

vaccinations to residents in LTC 

facilities in a timely manner and 

increase vaccination rates, thereby 

decreasing the morbidity and mortality 

rate of influenza and pneumococcal 

diseases in this population. This rule 

also has the potential to reduce overall 

healthcare costs by reducing the need 

for the treatment of influenza and 

pneumococcal diseases and their 

complications. 

E. Immunizations and LTC Facilities 

According to a June 2002 CDC 

summary of the National Nursing Home 

Survey, 46,000 nursing home residents 

(2.5 percent) had pneumonia in 1999. 

The average length of stay in a LTC 

facility for a resident with pneumonia as 

the primary diagnosis was 124 days in 

1999 (http://www.cdc.gov/nchs/data/

series/sr_13/sr13_152.pdf). 

A November 2000 article in the 

journal Infection Control and Hospital 

Epidemiology titled ‘‘Increasing 

Pneumococcal Vaccination Rates 

Among Residents of Long-Term Care 

Facilities,’’ noted that there were 

1,590,763 individuals over 65 years of 

age residing in LTC facilities in the 

United States in 1990, and the number 

is estimated to grow to 2.9 million by 

2020 (Infection Control and Hospital 

Epidemiology, Volume 21 (11) (705–

710) November 2000). A substantial 

increase in vaccination rates among 

such a large population will decrease 

the number of cases of influenza and 

pneumococcal bacteremia and related 

death. 

A 1999 RAND report stated that the 

proportion of the U.S. population over 

age 65 had increased from 5 percent in 

1900 to 13 percent in 1997. This change 

in demographics, combined with an 

increase in average life expectancy, has 

highlighted the importance of 

preventive care services for older 

individuals. The October 1997 Journal 

of the American Medical Association 

(JAMA) article ‘‘Cost-Effectiveness of 

Vaccination Against Pneumococcal 

Bacteremia Among Elderly People’’

indicated that vaccination of elderly 

people against pneumococcal 

bacteremia is one of the few 

interventions that have been found to 

both improve health and save medical 

costs. Vaccination both reduced medical 

expenses and improved health for the 

overall age group of 65 years and older 

(JAMA; Chicago; Oct 22–Oct 29 1997; 

278; 16; Jane E Sisk; Alan J Moskowitz; 

William Whang; Jean D Lin et al). The 

article further noted ‘‘Vaccination of the 

23 million elderly people unvaccinated 

in 1993 would have gained about 78,000 

years of healthy life and saved $194 

million.’’

Overall, the literature supports 

increasing pneumococcal 

immunizations. Pneumococcal 

vaccination saves health care dollars by 

preventing bacteremia alone and is 

greatly underused among the elderly 

population. These results support both 

recent recommendations of the ACIP as 

well as public and private efforts to 

increase vaccination rates. 

F. Vaccine Shortages 

In the Fall of 2004, there was a major 

shortage of inactivated influenza 

vaccine in the United States. One of the 

major manufacturers of the influenza 

vaccine informed the CDC in early 

October 2004 that none of its flu vaccine 

would be available for distribution in 

the United States. Because of the 

shortage, Federal health officials 

released new guidelines as to whom 

should receive a flu vaccine, describing 

those at high-risk of influenza-related 

health complications as priority groups. 

At that time, the interim 

recommendations from the CDC stated 

that people 65 and older, as well as all 

those between the ages of 2 to 64 with 

chronic medical conditions and 6–23 

month old children, were to be 

prioritized for receiving influenza 

vaccination. Another group deemed a 

priority was the population residing in 

nursing homes. 

We understand that providers of LTC 

services may be concerned about how 

they will meet the requirements of this 

regulation should an influenza vaccine 

shortage occur in the future. The 

September 2, 2005 MMWR, ‘‘Update: 

Influenza Vaccine Supply and 

Recommendations for Prioritization 

During the 2005–06 Influenza Season,’’

states that both influenza vaccine 

distribution delays and vaccine supply 

shortages have occurred in the United 

States in three of the last five influenza 

seasons. In response, prioritization has 

been implemented in previous years to 

ensure that enough influenza vaccine is 

available for those at the highest risk for 

complications. In the case of a true 

vaccine shortage as declared by HHS, 

CMS would exercise its enforcement 

discretion by instructing the State 

Survey Agencies (SSAs) not to take 

enforcement actions against facilities 

that are out-of-compliance with this 

requirement if they were unable to 

obtain vaccine for their residents. 

G. Requirements for Issuance of 

Regulations 

Section 902 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) 

amended section 1871(a) of the Act and 

requires the Secretary, in consultation 

with the Director of the Office of 

Management and Budget, to establish 

and publish timelines for the 

publication of Medicare final 

regulations based on the previous 

publication of a Medicare proposed or 

interim final regulation. Section 902 of 

the MMA also states that the timelines 

for these regulations may vary but shall 

not exceed 3 years after publication of 

the preceding proposed or interim final 

regulation except under exceptional 

circumstances. 

This final rule finalizes proposed 

provisions set forth in the August 15, 

2005 proposed rule (70 FR 47759), after 

considering public comments. In 

addition, this final rule has been 

published within the 3-year time limit 

imposed by section 902 of the MMA. 

Therefore, we believe that the final rule 

is in accordance with the Congress’

intent to ensure timely publication of 

final regulations. 

II. Provisions of the Proposed Rule 

On August 15, 2005, we published a 

proposed rule in the Federal Register 

(70 FR 47759) to respond to the ACIP 

recommendations on ‘‘Prevention and 

Control of Influenza’’ (http:// 

www.cdc.gov/mmwr/preview/ 

mmwrhtml/rr5306a1.htm), as well as to 

promote the DHHS Healthy People 2010 

goals for increasing immunization rates. 

Specifically, the ACIP outlined the 

requirements for a successful 

vaccination program including 

combined publicity and education for 

health-care workers and other potential 

vaccine recipients; a plan for identifying 

persons at high risk; and efforts to 

remove administrative and financial 

barriers that prevent persons from 

receiving the vaccines, including use of 

Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 58839 

standing orders programs. Based on the 

ACIP recommendation, we proposed the 

following requirements for LTC 

facilities at § 483.25(n): 

• Require LTC facilities to offer each 

resident immunization against influenza 

October 1 through March 31 annually, 

and facilities must also offer (without a 

specified timeframe) lifetime 

immunization against pneumococcal 

disease. A second immunization may be 

given under certain circumstances. 

• Require documentation in the 

resident’s medical record indicating the 

resident’s influenza and pneumococcal 

immunization status including whether 

influenza and pneumococcal 

immunizations were medically 

contraindicated and whether the 

influenza and pneumococcal 

immunization were refused. If refused, 

the record must indicate that the 

resident or his/her representative 

received appropriate education and 

consultation. 

III. Analysis of and Responses to Public 

Comments 

We received 61 comments from 

individuals, physicians, nurses, 

hospitals, long term care facilities, 

health care associations, pharmacy 

associations and state agencies. All 

comments were reviewed and analyzed. 

After associating like comments, we 

placed them in categories based on 

subject matter. Summaries of the public 

comments received and our response to 

those comments are set forth below. 

General 

Many commenters supported the 

proposed requirements. We also 

received comments suggesting changes 

in the rule (for example, to protect 

residents’ rights), and we received 

requests for clarification of various 

issues. In addition, some commenters 

said they did not believe the rule was 

necessary, and some commenters 

believed the rule could be harmful to 

LTC facility residents. The comments 

and our responses are listed below. 

Comment: Many commenters 

supported our proposed immunization 

rule, which would mandate offering 

influenza and pneumococcal vaccines to 

all residents of LTC facilities. The 

commenters cited the major impact that 

both influenza and pneumococcal 

diseases have on LTC residents. One 

commenter noted, ‘‘We consider this 

Proposed Rule to be of critical 

importance to the long-term care 

provider community and to the 

recipients of nursing facility services, all 

of whom are entitled to the ongoing 

provision of optimal care and services.’’

Another commenter supported the rule 

because ‘‘* * * the prevention of 

influenza and pneumococcal disease is 

both cost effective and good practice. 

Simply put, it is the right thing to do!’

Response: We appreciate commenters 

recognizing the positive impact of 

immunizations on the health of LTC 

residents. 

Comment: Some commenters stated 

that the influenza vaccine is 

contaminated with thimerosal (a 

vaccine preservative containing 

mercury), aluminum, or bacteria. One 

commenter stated that ‘‘until the flu 

shots are cleaned up (at least mercury 

and aluminum removed) it is madness 

to even administer them to long term 

care patients.’’ The commenter 

suggested instead investing in building 

immunity with raw and fermented food. 

Another commenter mentioned the 

influenza vaccine that was 

manufactured in England in 2004 and 

expressed concern about future bacterial 

contamination of influenza vaccine. 

Response: Some people believe that 

the mercury in thimerosal, a 

preservative used in some vaccines, has 

caused autism in children. Although 

researchers so far have found no 

evidence of a connection between the 

use of thimerosal in vaccines and 

autism, research is continuing. In 1999 

at the urging of the U.S. Public Health 

Service and the American Academy of 

Pediatrics, vaccine manufacturers 

agreed to reduce or eliminate thimerosal 

in pediatric vaccines. However, the FDA 

requires manufacturers to include a 

preservative in all vaccines distributed 

in multi-dose vials to prevent bacterial 

contamination of the vaccine. Since 

most injectable influenza vaccine is 

dispensed in multi-dose vials, most 

influenza vaccine contains thimerosal. 

Nevertheless, according to the CDC, 

there is no convincing evidence of harm 

caused by the low doses of thimerosal 

in vaccines, except for minor reactions 

like redness and swelling. 

Pneumococcal vaccine does not contain 

thimerosal. Influenza and 

pneumococcal vaccines do not contain 

aluminum. The CDC points out that, 

‘‘Vaccines are held to the highest safety 

standards.’’

We note that FDA found the influenza 

vaccine manufactured in England in 

2004 to be unsuitable for use, and the 

vaccine never reached the market. 

Comment: One commenter asks ‘‘Does 

anyone remember when President Ford 

got on TV to propagandize the masses 

into getting the Swine Flu vaccine?’’

The commenter said that lives were 

ruined due to Guillain-Barre ́ Syndrome 

caused by a vaccine that was supposed 

to protect them. 

Response: According to the CDC, ‘‘In 

1976, swine flu vaccine was associated 

with a severe temporary paralytic illness 

called Guillain-Barre ́ Syndrome (GBS) 

http://www.cdc.gov/nip/vacsafe/ 

concerns/gbs/default.htm. 

Influenza vaccines since then have 

not been clearly linked to GBS, although 

research suggests a small risk of the 

syndrome was associated with the 

influenza vaccines in 1992–1993 and 

1993–1994. However, if there is a risk of 

GBS from current influenza vaccines, it 

is estimated at 1 or 2 cases per million 

persons vaccinated * * * much less 

than the risk of severe influenza, which 

can be prevented by vaccination.’’

Comment: A few commenters charged 

that the influenza vaccine can cause the 

flu or other illnesses and may even 

cause death. Some provided anecdotal 

information about becoming ill after 

receiving a flu shot or said that an 

elderly parent had died after receiving 

a flu shot. One commenter said that 

some individuals have experienced 

severe reactions after receiving more 

than one pneumococcal immunization. 

One commenter raised the issue of the 

‘‘substantial injuries and medical costs 

that inevitably occur from mass 

vaccination.’’

Response: Both the influenza and 

pneumococcal vaccines are inactivated, 

that is, the virus in the vaccine has been 

killed; therefore these vaccines cannot 

cause influenza or pneumonia. We note 

that Flu Mist uses a live vaccine; 

however, it is not indicated for use in 

the elderly. The CDC has stated, ‘‘Most 

people who receive vaccines experience 

no, or only mild, reactions such as fever 

or soreness at the injection site. Very 

rarely, people experience more serious 

side effects, like allergic reactions * * * 

life-threatening allergic reactions are 

very rare,’’ particularly in relation to 

influenza vaccines. The 1997 ACIP 

recommendations state that 

pneumococcal vaccination has not been 

causally associated with death among 

vaccine recipients. As we stated in the 

preamble to the proposed rule ‘‘In a 

meta-analysis of nine randomized 

controlled trials of pneumococcal 

vaccine efficacy, very few local 

reactions were observed, and there were 

no reports of severe febrile or 

anaphylactic reactions.’’ The CDC 

article further states that, influenza and 

invasive pneumococcal disease kill 

more people in the United States each 

year than all other vaccine-preventable 

diseases combined. Therefore, the 

benefits of immunizations outweigh the 

small number of significant adverse 

effects observed after immunizations are 

administered. 

58840 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 

Comment: Many commenters stated 

that nursing home residents must be 

able to refuse immunizations. One 

commenter said, ‘‘Seniors should not be 

forced to be immunized since they are 

free sovereign individuals who are 

capable of making their own decisions 

on such matters.’’ Another commenter 

said that forced vaccination of American 

citizens is unconstitutional. One 

commenter expressed the fear that there 

would be reprisals against residents 

who refused or whose representatives 

refused immunization, including being 

refused treatment or being forced to 

leave the nursing home. 

Response: We agree with the 

commenters that residents of LTC 

facilities have the right to refuse 

immunizations. In fact, the existing 

Conditions of Participation (CoP) at 

§ 483.10(b)(4) state that residents of LTC 

facilities have the right to refuse 

treatment. On admission to an LTC 

facility, residents or their 

representatives are given written 

documentation about their right to 

refuse any medication or treatment. We 

have further emphasized this right in 

the text of the final rule, which states, 

‘‘The resident or the resident’s legal 

representative has the opportunity to 

refuse immunization.’’ Nevertheless, the 

final rule requires every facility to offer 

immunization because a goal of the rule 

is to prevent the spread of preventable 

illness. In addition, in accordance with 

§ 483.10(b)(4), residents have the right 

to refuse treatment. Therefore, facilities 

would not force any resident who 

refuses to be immunized to receive the 

vaccine. The benefits of immunization 

are evidenced in numerous studies 

referenced by the CDC in the Morbidity 

and Mortality Weekly Report (MMWR), 

which show that: (1) persons 65 years 

and older are at high risk of contracting 

influenza, (2) they are more likely than 

the general population to need 

hospitalization or to die from 

complications of influenza, and (3) 

immunizations are effective in 

preventing influenza and its 

complications in this population. 

(http://www.cdc.gov/mmwr/preview/ 

mmwrhtml/rr5306a1.htm). 

Comment: Some commenters stated 

that this rule is based on 

‘‘pharmaceutical company propaganda,’’

and it is for their benefit. One 

commenter stated that pharmaceutical 

companies have a strong influence over 

U.S. lawmakers and that drug 

companies spend millions in campaign 

contributions. Another commenter 

stated that ‘‘preying upon unsuspecting 

seniors whose care families have 

entrusted to long term care facilities to 

the financial benefit of pharmaceutical 

companies is criminal.’’ Another 

commenter stated that ‘‘vaccination is 

the quintessential form of medical 

quackery in our day and age and is 

causing untold damage to health, 

wellbeing and prosperity for all except 

those who profit from its use.’’

Response: The goal of this rule is to 

protect the health of LTC facility 

residents using a proven preventive 

measure to stop the spread of infection 

and reduce morbidity and mortality. 

The rule is not being published based 

on ‘‘propaganda from pharmaceutical 

companies,’’ but on data and evidence 

that the CDC and many other 

researchers have provided to the public 

and health care communities. The ACIP 

reported on May 28, 2004 that 

epidemics of influenza have been 

responsible for an average of 

approximately 36,000 deaths per year in 

the United States between 1990 and 

1999. It stated that there is an added 

danger when it comes to people age 65 

or older or with high risk conditions 

such as individuals residing in long 

term care facilities. According to the 

January 1, 2002 article in American 

Family Physician, a number of studies 

have also shown that nursing homes 

with high rates of vaccinated residents 

have fewer outbreaks of influenza than 

nursing homes with lower vaccination 

rates. The article further states that 

many studies have shown that influenza 

vaccination of nursing home residents 

and staff can significantly decrease rates 

of hospitalization, pneumonia, and 

related mortality. 

Consent for immunization 

Comment: Many commenters stated 

that before an immunization is given to 

a resident, informed consent must be 

obtained. Other commenters specified 

that a resident’s consent should be in 

writing. One commenter referenced an 

article, ‘‘The moral right to 

conscientious, personal belief or 

philosophical exemption to mandatory 

vaccination laws’’ by Barbara Loe 

Fisher, (http://www.nvic.org/Loe-Fisher/ 

blfstmt052097.htm) which states that 

‘‘The National Vaccine Information 

Center has not advocated the 

abolishment of vaccination laws as 

other groups have proposed. However, 

we have always endorsed the right to 

informed consent as an overarching 

ethical principle in the practice of 

medicine for which vaccination should 

be no exception.’’

Response: We agree it is vital that 

facilities secure the informed consent of 

their residents or legal representatives 

for vaccinations before they are 

administered. Therefore, we would 

require that the facilities document the 

resident’s immunization status and 

related information in the resident’s 

medical record. Moreover, we are 

requiring LTC facilities to ensure that 

before offering the immunizations, each 

resident or resident’s representative 

receives education regarding the 

benefits and potential side effects of 

influenza and pneumococcal 

immunizations. This final rule clearly 

states that the resident or the resident’s 

representative has the right to refuse the 

immunization. 

Comment: Under the proposed rule, 

we would have required facilities to 

educate residents or their 

representatives about immunization 

only if immunization were refused. 

Some commenters stated that educating 

residents or their representatives on the 

risks and benefits of immunization prior 

to giving the immunization is important, 

too. One commenter said that a more 

effective way to educate residents is to 

present the information upon 

admission. The commenter said, ‘‘This 

avoids the impression that the facility is 

trying to talk the resident into receiving 

a vaccination that the resident does not 

want.’’

Response: We agree that it is 

important to provide education prior to 

immunization. Therefore, this final rule 

requires LTC facilities to educate all 

residents or resident’s representation on 

the benefits and potential side effects of 

the influenza and pneumococcal 

vaccinations before offering 

immunization. At the discretion of the 

facility, this education can be provided 

at any time, including upon admission 

to the facility, as long as the education 

is provided before the immunizations 

are offered. 

Comment: One commenter asked for 

clarification of the intent of the 

proposed requirement for 

‘‘consultation’’ with residents who 

refused immunization. 

Response: We proposed a requirement 

for education and consultation in the 

proposed rule if immunization is 

refused. This final rule does not contain 

a specific requirement for consultation 

with residents or their representatives if 

immunization is refused. Instead, LTC 

facilities are required to provide 

education about immunization to all 

residents. We removed the word 

‘‘consultation’’ so as not to confuse 

facilities. 

Comment: Commenters had several 

suggestions to ensure residents receive 

adequate education about the 

immunizations. Some commenters said 

we should specify that residents must 

receive educational information in 

writing. 

Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 58841 

Response: We are providing flexibility 

to the facilities on how they provide 

educational information to the residents 

or their representatives. It is important 

to note, however, that all health care 

providers are required by the National 

Childhood Vaccine Injury Act to 

provide vaccine information sheets 

(VISs) prior to immunization. These 

sheets contain a wealth of information. 

For example, the influenza VIS explains 

how flu is spread, the symptoms, the 

potential complications, what types of 

flu vaccines are available (including 

vaccines with and without the 

preservative thimerosal), how the 

vaccines work, who should be 

vaccinated, contraindications to 

vaccination, and the risk of developing 

a reaction (including rare but lifethreatening allergic reactions and 

Guillain-Barre Syndrome). Single 

camera-ready copies of the vaccine 

information materials are available from 

State health departments. Copies are 

also available on the CDC Web site at 

http://www.cdc.gov/nip/publications/ 

VIS. Copies are available in English and 

in other languages. Instructions for 

using the vaccination information sheets 

can be found at http://www.cdc.gov/nip/ 

publications/VIS/vis-instructions.txt. 

Facilities may choose to use the VIS 

documents as a means of providing 

education. Note that the National 

Vaccine Injury Compensation program 

(NVICP) requires Vaccine Information 

Statements (VIS) be provided to patients 

or their legal representatives, once a 

vaccine is in the program and a final 

VIS has been developed. The NVICP 

provides compensation to adults as well 

as children for adverse events related to 

vaccines covered by the program. To 

date, pneumococcal vaccine is not in 

the program and although influenza 

vaccine is, the final VIS will not be 

available until approximately October. 

Comment: One commenter asked for 

clarification of the word ‘‘consent’’ and 

stated that the Vaccine Information 

Sheet (VIS) can be given to the resident 

or his or her representative and 

documented in the medical record to 

fulfill the requirement for informed 

consent. Special written consent is not 

required for vaccination, according to 

the commenter. 

Response: We agree that a special 

written consent is not necessary for 

vaccinations. As stated in the previous 

response, the National Childhood 

Vaccine Injury Act (‘‘the Act’’) requires 

health care providers to provide a 

current, relevant vaccination 

information sheet (VIS) produced by the 

CDC prior to giving immunizations to 

children or adults for diphtheria, 

tetanus, pertussis, measles, mumps, 

rubella, polio, hepatitis B, Haemophilus 

influenzae type b (Hib), varicella 

(chickenpox), or pneumococcal 

conjugate vaccinations (effective 12/15/ 

02). Additionally, the Act requires 

health care providers to make a notation 

in each patient’s permanent medical 

record at the time vaccine information 

materials are provided indicating: (1) 

The edition date of the materials 

distributed and (2) the date these 

materials were provided as per CDC’s 

requirements. 

Comment: One commenter stated that 

verbal discussion with the resident or 

the resident’s representative may be a 

problem if the resident is cognitively 

impaired and the representative lives 

out of state or is difficult to reach. 

Response: We understand that 

providing education prior to offering 

influenza and pneumococcal 

immunizations and obtaining consent 

may be difficult under some 

circumstances. However, as with other 

procedures that take place in LTC 

facilities, facilities should make a 

reasonable effort to obtain consent. 

Documentation 

Comment: One commenter stated that 

CMS should consider implementing a 

mechanism for residents or their 

representatives to indicate if they 

received immunizations within the 

recommended time frame. Another 

commenter stated CMS should create a 

system that ensures that accurate 

immunization information is captured. 

Response: We appreciate the 

comment. CMS is working on adding 

the immunization information in the 

MDS 3.0 version and that will be a 

source to capture accurate 

immunization information for each 

resident in the nursing facility. The 

other elements of resident’s medical 

record would also be a potential source 

for information. Another source of 

information would be individual State 

immunization registries. 

Comment: One commenter pointed 

out that it can be difficult or impossible 

to obtain a complete immunization 

history for some LTC facility residents. 

The commenter said that most residents 

have some degree of cognitive 

impairment and may not be able to 

provide a history. Family members or 

friends may be unavailable or unaware 

of a resident’s immunization history. 

Response: We agree that there may be 

difficulties in obtaining the history of 

immunizations especially in the case of 

cognitively impaired residents. 

However, we expect that facilities will 

make reasonable efforts to obtain 

immunization histories for their 

residents. 

Comment: One commenter pointed 

out that it can be difficult or impossible 

to obtain a complete immunization 

history for some LTC facility residents. 

The commenter said that most residents 

have some degree of cognitive 

impairment and may not be able to 

provide a history. Family members or 

friends may be unavailable or unaware 

of a resident’s immunization history. 

Response: We agree. This final rule 

does not contain language requiring LTC 

facilities to obtain and document 

complete immunization histories for all 

residents. However, we expect that 

facilities will make reasonable efforts to 

obtain immunization histories for their 

residents to avoid giving unnecessary 

immunizations. 

Comment: A few commenters pointed 

out that individual facilities, must have 

the flexibility to develop their own 

protocols for immunization and their 

own formats for documentation. One 

commenter said they we should specify 

that the medical records of residents 

who are immunized should be 

documented with the name and lot 

number of the vaccine, the quantity 

given, the route of administration, the 

date, and the signature of the person 

who administers the vaccine. 

Response: We agree that facilities 

must have some flexibility in 

implementing the requirements. The 

final rule dictates neither the protocols 

that need to be in place nor the format 

for documentation. However, facilities 

will need to be able to demonstrate to 

State agency surveyors that they have an 

immunization protocol and that they 

have documentation for each resident to 

show that they have educated residents 

or their representatives and offered 

influenza and pneumococcal 

immunizations. Additionally, we expect 

that facilities will follow standard 

practice and when an immunization is 

given, document the type of vaccine, the 

lot number, and other pertinent 

information per facility policy. 

Vaccine Availability 

Comment: Some commenters stated 

that the final rule should indicate that 

if a shortage or substantial delay in 

vaccine supply occurs, SNFs and 

nursing homes will be automatically 

exempt from compliance with this CoP 

during the shortage period. 

Response: We understand that 

providers of LTC services are concerned 

about meeting the requirements of this 

regulation if an influenza vaccine 

shortage occurs in the future. In the case 

of a vaccine shortage as declared by 

HHS or documented local or regional 

shortages, CMS could exercise its 

enforcement discretion by instructing 

58842 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 

State Survey Agencies (SSAs) not to 

take enforcement action against LTC 

facilities that are out of compliance with 

this requirement if the facilities were 

unable to obtain vaccine for their 

residents. We do not agree that the final 

rule should include an exemption for all 

LTC facilities, because situations and 

vaccine availability may vary across the 

country. We expect that the SSA would 

need to verify that a facility was unable 

to meet the requirement due to a 

shortage before determining that 

enforcement action was not warranted. 

Comment: One commenter said that 

CMS regards a vaccine shortage as the 

only relevant variable in exercising 

enforcement discretion to alter its 

mandated immunization of LTC 

residents. The commenter argued that a 

mandate to immunize a target 

population annually is not an essential 

feature of a responsible flu prevention 

and control strategy because a new 

influenza prevention and control 

strategy must be tailored to the 

distinctive characteristics of each year’s 

influenza strain; the types, effectiveness, 

and availability of potential preventive 

and other interventions; and other 

practical and ethical considerations. 

The commenter said that, in some years, 

there might be a better way to protect 

LTC residents from influenza than 

achieving a target vaccination rate. 

Further, there might be another 

subgroup for which access to the 

influenza vaccine is more scientifically 

and ethically justified. 

Response: We agree that each new flu 

season presents a challenge in terms of 

how best to prevent and control the 

spread of influenza throughout the U.S. 

population. We will carefully consider 

CDC’s annual guidance on an ongoing 

basis to determine whether to exercise 

our enforcement discretion for reasons 

other than a vaccine shortage. In 

addition, in contemplating future 

rulemaking, we will consider whether 

there are additional interventions that 

facilities should put into place to 

protect their residents from influenza. 

Staff Immunization 

Comment: A few commenters stated 

that staff in LTC facilities need to be 

immunized. One commenter pointed 

out that emerging data indicate that the 

best protection for the LTC population 

is to prevent exposure by immunizing 

health care providers and visitors to the 

facilities. 

Response: We agree that it is very 

important for health care workers to be 

immunized. In fact, CMS conditions of 

participation (CoPs) for nursing 

facilities (NFs) at 42 CFR 483.65 require 

nursing facilities (NF) to establish and 

maintain an infection control program 

designed to prevent the development 

and transmission of disease and 

infection. The CDC recommends that all 

health care workers be immunized 

annually. The Occupational Safety and 

Health Administration (OSHA) strongly 

supports the CDC guidelines for 

immunization of health care workers. 

OSHA’s mission is to assure the safety 

and health of America’s workers by 

setting and enforcing standards; 

providing training, outreach, and 

education; establishing partnerships; 

and encouraging continual 

improvement in workplace safety and 

health. OSHA has placed links to the 

CDC guidelines on immunization on the 

OSHA Web site at http://www.cdc.gov/ 

flu/professionals/vaccination/hcw.htm 

and http://www.cdc.gov/flu/index.htm. 

We are not requiring health care 

workers be immunized in this rule. We 

believe the current LTC requirements 

provide adequate incentives for LTC 

facilities to develop immunization 

protocols for their health care workers. 

Comment: One commenter stated that 

CMS should address the commenter’s 

concern that student nurses are not 

covered under the OSHA blood borne 

pathogens requirements for hospitals. 

Response: We agree that it is 

important for health care workers to be 

immunized in order to protect residents. 

OSHA seeks to assure the safety and 

health of America’s workers by setting 

and enforcing standards; providing 

training, outreach, and education; 

establishing partnerships; and 

encouraging continual improvement in 

workplace safety and health. As 

indicated above, we require nursing 

facilities to take steps to prevent staff 

transmission of disease. These 

requirements apply to all staff, whether 

or not they are students. 

Payment and Coverage 

Comment: One commenter stated that 

after publishing the final regulation and 

paying for the program for a year or two, 

Medicare might decide that the LTC 

facilities should be responsible for the 

immunizations and stop paying for 

them. 

Response: In accordance with section 

1861(s)(10) of the Social Security Act, 

Medicare covers both influenza and 

pneumococcal vaccines. Medicare began 

covering annual influenza 

immunizations in 1993 for Medicare 

beneficiaries. Medicare covers both the 

costs of the vaccine and its 

administration. There is no coinsurance 

or co-payment applied to this benefit, 

and a beneficiary does not have to meet 

his or her deductible to receive this 

benefit. Medicare began covering 

pneumococcal polysaccharide 

vaccinations in 1981. Medicare provides 

coverage for one pneumococcal 

polysaccharide vaccine per beneficiary. 

One vaccine at age 65 generally 

provides coverage for a lifetime, but for 

some high risk persons, a booster 

vaccine is needed. Medicare will cover 

a booster vaccine for high risk persons 

if 5 years have passed since the last 

vaccination. Medicare covers both the 

costs of the vaccine and its 

administration. There is no coinsurance 

or co-payment applied to this benefit, 

and a beneficiary does not have to meet 

his or her deductible to receive it. These 

programs are described in detail on the 

CMS Web site (http://www.cms.hhs.gov/ 

preventiveservices/2.asp). The Medicare 

reimbursement for influenza and 

pneumococcal immunizations has never 

been decreased or denied since it was 

started; in fact, payment amounts have 

increased. The 2005 influenza 

vaccination administration 

reimbursement rate is $18 (unweighted 

average of Medicare ‘‘National Flu Biller 

Administration Codes’’). The 2005 

Influenza vaccine reimbursement rate is 

$10.10 (Medicare rate; 95 percent of 

Average Wholesale Price (AWP)). 

Facilities that immunize their residents 

are not only reimbursed by Medicare 

but also experience cost savings because 

there is less illness among their 

residents. 

Comment: A few commenters argued 

that it is wrong to withhold Medicare 

payments to LTC facilities that do not 

provide flu and pneumococcal 

immunizations to nursing home 

residents. One commenter stated, ‘‘I am 

frustrated that you would consider 

linking nursing home payments to 

vaccinations.’’ However, another 

commenter praised the proposed rule as 

being ‘‘well thought out’’ and said that 

the rule, ‘‘importantly, does not 

penalize the facility if the resident or 

the resident’s legal representative 

refuses immunization or there are 

medical contraindications.’’

Response: Several commenters 

misunderstood the proposed rule. This 

rule does not penalize a facility 

financially if the resident or the 

resident’s representative refuses 

immunization. In this final rule, we are 

making it clear that residents must be 

immunized unless there is a medical 

contraindication or the resident or 

resident’s legal representative refuses. 

Therefore, if the LTC facility offers 

immunization, but the resident refuses, 

this would not be considered noncompliant. 

Comment: One commenter 

recommended that CMS authorize 

Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 58843 

Medicare payments to SNFs for the 

outlier cost of intravenous antibiotics. 

Response: The cost of intravenous 

antibiotics to SNFs is not within the 

purview of this regulation. SNFs are 

reimbursed as per the PPS payment 

rates, which cover all costs of furnishing 

covered SNF services (routine, ancillary, 

and capital-related costs). 

Comment: One commenter stated that 

the nursing facilities should have 

information on billing related to 

immunizations. 

Response: Information and guidance 

about billing for influenza and 

pneumococcal vaccinations, including 

electronic billing, is currently available 

to all providers at: http:// 

www.cms.hhs.gov/medlearn/flupdf.pdf. 

Alternately, LTC facilities may contact 

their Medicare Administrative 

Contractors. 

Comment: One commenter stated that 

CMS should direct Quality 

Improvement Organizations (QIOs) to 

increase immunization rates among 

nursing home residents and staff as a 

part of the core activities in the QIO 

Statement of Work with necessary 

additional funding apportioned for 

these efforts. 

Response: QIOs currently conduct 

projects focused on improving the 

health of all Medicare beneficiaries. 

These projects include, for example, 

efforts to improve diabetes care and the 

delivery of mammography and adult 

immunizations (influenza and 

pneumococcal). The goals of the adult 

immunization projects are to increase 

influenza and pneumococcal 

immunization rates for Medicare 

beneficiaries and improve treatment for 

pneumonia. Descriptions of these 

projects are available on the Medicare 

Quality Improvement Center (MedQIC) 

Web site at (http://www.medqic.org). 

Comment: One commenter stated that 

CMS should encourage superior 

performance on rates of resident and 

staff immunizations by posting 

performance information on Nursing 

Home Compare and including such 

measures as part of any LTC pay-forperformance. 

Response: We appreciate the 

comment. Incentives for high 

performance are beyond the purview of 

this rule. The MDS 3.0 is being modified 

to include immunizations, and is part of 

our effort to collect data that can be 

easily accessed for comparative study. 

Other efforts may follow including 

posting of performance information on 

the Nursing Home Compare Web site. 

Comment: One commenter stated that 

we do not have enough data on the 

number of LTC residents who have 

medical contraindications to 

immunization or who refuse 

immunization to determine whether we 

need to require facilities to offer 

immunization to all LTC residents. 

Another commenter protested the 

burden associated with the rule and 

recommended that immunization be a 

voluntary program. 

Response: We agree that additional 

data would be useful. By requiring 

documentation of these data in 

residents’ medical records, we expect to 

have the data available for reference in 

the future. However, as we stated in the 

preamble of the proposed rule, studies 

indicate that many LTC facility 

residents are not being immunized, 

despite the fact that these services are 

covered by Medicare. It is clear that 

voluntary immunization of residents is 

not adequate to ensure that all residents 

are being offered immunization. 

Comment: One commenter asks for 

clarification of the qualifications of the 

person who educates the resident or 

their representative on immunizations. 

Response: We believe it is important 

to give LTC facilities the flexibility to 

decide who will provide the education 

to the residents or their representatives, 

based on the resources available at the 

LTC facility. We are not requiring health 

care workers to be immunized in this 

rule. 

Comment: One commenter expressed 

concern that time constraints may result 

in implementation problems for 

facilities that must have policies and 

procedures in place by the effective date 

of the regulation. The commenter also 

noted that the 15-day comment period 

was not adequate for individuals and 

organizations to provide a thorough 

response, especially for organizations 

that would like their comments to 

reflect the opinions of their members. 

Response: The rule was expedited and 

published with a 15-day comment 

period so that it would be effective for 

the 2005–2006 flu season. We believe 

this rule will save lives, and a delay in 

implementation of the rule would 

greatly hinder increased immunization 

of residents in LTC facilities before the 

onset of this year’s influenza season. 

Therefore, a 60-day comment period 

was considered contrary to public 

interest. However, we understand that it 

may be difficult for LTC facilities to 

have their policies and procedures in 

place by the effective date of the rule. 

We expect facilities to begin 

implementation of the rule and move 

their implementation forward as quickly 

as possible. If surveyed by the State 

Survey Agency, they should be ready to 

discuss with the surveyors their process 

and plans. Since this rule is effective on 

publication, we expect surveyors will 

survey for these requirements with the 

understanding that facilities need a 

certain amount of time to fully 

implement the requirement. Surveyors 

will take the time factor into 

consideration as they review facilities 

for compliance with the CoPs. 

Comment: Two commenters asked for 

clarification regarding what facilities 

must do between October 1 and March 

31. One commenter asked whether 

influenza vaccination must be offered to 

a resident who is admitted on March 31, 

even if the vaccine will not be 

administered immediately because it is 

unavailable. 

Response: We expect facilities to use 

common sense in regard to residents 

admitted toward the end of March when 

supplies of the vaccine may be limited 

or unavailable. If the vaccine is 

unavailable, then the facility will not be 

able to vaccinate the new resident, and 

the facility can document this in the 

resident’s record. 

Comment: One commenter said, ‘‘Let 

the physicians make the medical 

decisions. If inappropriate medical 

decision making then results in a 

pandemic, only then would a Federal 

mandate be justified.’’

Response: The purpose of 

immunization is to avoid illness or 

death. The value of immunization is 

minimal once influenza is widespread. 

Comment: One commenter 

recommended that CDC and CMS work 

collaboratively to create an electronic 

health record that would include 

standard immunization verification 

information for Medicare beneficiaries. 

Response: CMS is in the process of 

including immunization status of all 

LTC facility residents in MDS 3.0. Also, 

on May 28, 2004, DHHS awarded a grant 

to promote the use of electronic health 

records to improve the quality of care 

provided to Americans by supporting a 

pilot project to provide comprehensive, 

standardized electronic health record 

(EHR) software to the health care 

community. In addition, DHHS has a 

recently-appointed National 

Coordinator of Health Information 

Technology, whose mission includes 

developing, maintaining, and directing 

the implementation of a strategic plan to 

guide the nationwide implementation of 

interoperable health information 

technology in both the public and 

private health care. More information 

can be found on the DHHS Web site at 

http://www.dhhs.gov. 

Comment: One commenter stated that 

assisted living residents should also be 

immunized because these high risk 

individuals fall under the CDC’s 

Advisory Committee on Immunization 

Practices (ACIP) priority grouping. 

58844 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 

Response: We agree; however, CMS 

does not have the statutory authority, 

through the Medicare program, to 

regulate the care provided in assisted 

living facilities. Generally, assisted 

living facilities are regulated and 

monitored by the states in which they 

are located. 

Comment: One commenter requested 

clarification in the final rule on whether 

it applies to skilled nursing services 

provided in hospital swing beds. 

Response: This rule is a Condition of 

Participation for nursing facilities and 

does not apply to skilled nursing 

services provided in hospital swing 

beds. However, there is nothing to 

prevent hospitals from immunizing this 

population. 

Comment: One commenter said that 

our statement in the preamble that, 

‘‘epidemics of influenza have been 

responsible for an average of 

approximately 36,000 deaths per year in 

the United States between 1990 and 

1999’’ is incorrect because fewer than 10 

percent of the 36,000 deaths were from 

the flu. The commenter’s conclusion 

was that since there are not very many 

deaths from influenza, immunization is 

not needed. 

Response: The commenter does not 

explain why the commenter thinks the 

statistic we provided in the preamble to 

the proposed rule overstates the number 

of deaths from influenza. 

According to ‘‘Prevention and Control 

of Influenza: Recommendations of the 

Advisory Committee on Immunization 

Practices (ACIP)’’ (MMWR 29 July 

2005;54[RR08]:1–40), ‘‘Influenza-related 

deaths can result from pneumonia and 

from exacerbations of cardiopulmonary 

conditions and other chronic diseases. 

Deaths of older adults account for > 90 

percent of deaths attributed to 

pneumonia and influenza. In one study 

of influenza epidemics, approximately 

19,000 influenza-associated pulmonary 

and circulatory deaths per influenza 

season occurred during 1976–1990, 

compared with approximately 36,000 

deaths during 1990–1999. Estimated 

rates of influenza-associated pulmonary 

and circulatory deaths/100,000 persons 

were 0.4–0.6 among persons aged 0–49 

years, 7.5 among persons aged 50–64 

years, and 98.3 among persons aged > 

65 years. In the United States, the 

number of influenza-associated deaths 

might be increasing in part because the 

number of older persons is increasing. 

In addition, influenza seasons in which 

influenza A (H3N2) viruses predominate 

are associated with higher mortality; 

influenza A (H3N2) viruses 

predominated in 90 percent of influenza 

seasons during 1990–1999, compared 

with 57 percent of seasons during 1976–

1990. 

Comment: One commenter stated that 

a recent study shows no decreased 

morbidity or mortality from the flu, 

despite rising rates of vaccination. One 

commenter specifically cited last year’s 

data as indicating that the flu vaccine is 

not effective. 

Response: As referenced earlier in this 

preamble, the Simonsen study 

published in September 2005 found an 

overall increasing trend in the number 

of flu-related hospitalizations in the 

United States each year, despite the fact 

that the number of immunizations for 

influenza has increased. In response, the 

CDC has pointed out that (1) The range 

of influenza-related illnesses analyzed 

in the study is broader than in the 

previous study; (2) certain influenza 

viruses that predominated in several 

recent influenza seasons are associated 

with higher numbers of serious illnesses 

than other strains; (3) the U.S. 

population is growing older and more 

vulnerable to developing severe 

complications; and (4) during the 1990s 

influenza viruses have either circulated 

or been detected for longer periods of 

time. 

It is true that influenza vaccine is not 

as effective in the elderly as it is in 

younger individuals. As discussed 

earlier in this preamble, although 

influenza vaccine effectiveness varies in 

the elderly, vaccination is still effective 

at preventing severe illness, secondary 

complications, and death. 

Recommendations made by ACIP in 

2004 state that in the elderly population 

residing in nursing homes, the vaccine 

can be 50–60 percent effective in 

preventing hospitalization or 

pneumonia and 80 percent effective in 

preventing death, even though the 

effectiveness in preventing influenza 

illness often ranges from 30 percent to 

40 percent. A study published in Lancet 

in September 2005 found that when 

used in nursing facilities, influenza 

vaccines prevented up to 42 percent of 

deaths from influenza and pneumonia. 

Comment: One commenter asked 

whether Medicare Part B or Part D will 

pay for the immunizations. 

Response: As we stated earlier, 

immunization is covered under Part B 

coverage, and Medicare will reimburse 

one flu vaccination per person per 

season. This may result in more than 

one bill per 12-month period across two 

flu seasons. Further information can be 

accessed online on the ‘‘immunizations 

toolkits’’ Web page at (http:// 

www.medqic.org). 

Comment: One commenter requested 

that CMS provide policy guidance with 

respect to immunizing residents who 

are receiving end-of-life care. The 

commenter expressed concern about 

potential side effects in residents who 

may have only weeks to live. 

Response: We would expect that 

when a resident is receiving end-of-life 

care, the resident’s attending 

practitioner would decide whether 

vaccination should be offered to the 

resident. 

Comment: One commenter stated that 

we greatly underestimated the burden 

associated with documentation because 

documenting immunization in residents 

records will take more than 5 minutes. 

Response: After further consideration 

of the time required for documentation, 

we agree with the comment and have 

increased the estimated amount of time 

in the burden estimate from 5 minutes 

to 10 minutes. 

Comment: One commenter stated that 

influenza vaccine does not work in the 

elderly because of their age. 

Response: CDC states that ‘‘persons 

with certain chronic diseases might 

develop lower post vaccination 

antibody titers than healthy young 

adults.’’ It further states that the vaccine 

can also be effective in preventing 

secondary complications and reducing 

the risk for influenza-related 

hospitalization and death among adults 

aged >65 years with and without highrisk medical conditions (for example, 

heart disease and diabetes). Among 

older persons who do reside in nursing 

homes, influenza vaccine is most 

effective in preventing severe illness, 

secondary complications, and deaths. 

See http://www.cdc.gov/mmwr/preview/ 

mmwrhtml/rr5408a1.htm. The CDC also 

provided the following information in 

its discussion of the Simonsen study. 

Observational studies, to date, have 

generally found that when the ‘‘match’’

between the vaccine and circulating 

influenza strains is close, the vaccine is 

30 percent-70 percent effective in 

preventing hospitalization for 

pneumonia and influenza among elderly 

persons living outside chronic-care 

facilities (such as nursing homes) and 

those persons with long-term (chronic) 

medical conditions. Observational 

studies have also found that among 

elderly nursing home residents, the flu 

shot can be 50 percent-60 percent 

effective in preventing hospitalization 

for pneumonia and up to 80 percent 

effective in preventing death from the 

flu. See http://www.amda.com/clinical/ 

immunization/flustudy.htm. 

Comment: One commenter was 

concerned that by including October 1 

in the regulation’s text, facilities were 

being required to begin immunizing 

residents on that date. The commenter 

further stated that if the influenza 

Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 58845 

immunization is given too early in the 

flu season, the resident’s resistance may 

wane over time. The commenter also 

stated that facilities are guided by CDC 

information on how many early flu 

cases are occurring and that often, the 

best date to begin immunizing for the 

flu is November 1. 

Response: In choosing the October 1 

through March 31 dates, we are 

following the guidelines that CDC has 

provided for the beginning and end of 

the flu season. Although flu season can 

begin as early as October, facilities 

should follow CDC guidelines for each 

flu season to determine the most 

efficacious time to begin immunizing 

their residents. The CDC states in 

‘‘When to Get Vaccinated’’ that October 

or November is the best time to get 

vaccinated, but getting vaccinated even 

later (before March 31) can still be 

beneficial. 

Comment: One commenter expressed 

concern regarding possible 

consequences that would result from a 

resident refusing immunization. 

Response: The rule clearly gives the 

right to the residents and their 

representatives to refuse immunization 

if they choose. Therefore, there would 

be no adverse effect or consequence 

because of the refusal. The existing CoP 

at 42 CFR 483.10 on resident rights, also 

provides freedom of choice to the 

resident. 

Comment: One commenter objected to 

the estimate of $5 million per statistical 

life saved and stated ‘‘While all life is 

sacred, placing $5 million per life saved 

on someone likely to die in a few weeks 

or months is exaggerated and 

unjustified. The commenter further 

stated that the savings are grossly 

inflated through use of this estimate.’’

Response: Five million dollars per 

statistical life saved is a figure 

commonly used by Federal agencies. 

Although the age of the affected 

population has been identified as an 

important factor in the theoretical 

literature on the value of a statistical life 

(VSL), the empirical evidence on age 

and VSL is mixed. In light of the 

continuing questions over the effect of 

age on VSL estimates, OMB Circular A–

4 recommends that agencies not use an 

age-adjustment factor in an analysis 

using VSL estimates. We could have 

used an alternative measure, such as 

statistical years of lives saved, but that 

would not have changed the overall 

conclusion that the benefits of the rule 

are substantial. In fact, the savings to 

Medicare alone are sufficient to make 

the rulemaking cost-beneficial, therefore 

the choice of how to value the lives 

saved due to this rulemaking is not 

decision critical. 

Comment: One commenter stated that 

CMS, at the very least, should describe 

within the rule a standardized format 

for obtaining required documentation. 

This will protect the facility from 

liability and provide a guide for 

surveyors. 

Response: The final rule provides 

flexibility to the facilities on how to 

document the information. This 

flexibility gives facilities the 

opportunity to choose the process and 

format that works best for them. 

Comment: One commenter expressed 

concern that by placing the 

requirements of the rule in § 483.25, 

rather than § 483.65, the facility could 

be subject to termination of the nurse 

aide training program if documentation 

deficiencies are widespread and the 

facility is found to be providing 

substandard care. 

Response: We believe this new 

requirement is appropriately placed 

under the ‘‘Quality of Care’’ CoP. It is 

more than just a documentation 

requirement. The extent of the deficient 

practices found in meeting this 

requirement during a survey will 

determine the type of enforcement 

warranted. 

Comment: One commenter wanted us 

to define a ‘‘legal’’ representative. 

Response: As they implement the 

requirements of the rule, we expect that 

facilities will be guided by the laws that 

pertain to the definition of ‘‘legal 

representative’’ of the states in which 

the facilities are located. Due to the 

variations in state law, we are not 

defining the term ‘‘legal representative.’’

Comment: One commenter asked for 

clarification of the ‘‘exception’’ under 

(2)(iv), specifically the requirements for 

the assessment. 

Response: We expect that the 

residents practitioner would decide on 

the degree of assessment necessary to 

determine if a second immunization is 

warranted in order to provide protection 

for the resident. 

IV. Provisions of the Final Regulations 

For the most part, this final rule 

incorporates the provisions of the 

proposed rule. The provisions of this 

final rule that differ from the proposed 

rule are as follows: 

1. Based on comments, LTC facilities 

must provide education to residents or 

the resident’s legal representative 

concerning influenza and pneumococcal 

immunization prior to immunization. 

Further we modified the regulation to 

include not just the benefits but also the 

potential side effects of influenza and 

pneumococcal immunization when 

education is provided to the resident or 

resident’s legal representative. 

2. We have listed some of the 

minimum documentation requirements 

and still provide the facilities the 

flexibility to document any additional 

information they believe is relevant. 

(See 483.25(n)(2)(iv).) 

V. Waiver of the 60-Day Delay in 

Effective Date 

We ordinarily provide a 30-day delay 

in the effective date of the provisions of 

a rule in accordance with the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(d)), which requires a 30-day 

delayed effective date. The 

Congressional Review Act (5 U.S.C. 

801(a)(3)), requires a 60-day delayed 

effective date for major rules. As stated 

in our regulatory impact analysis below, 

we believe this is a major rule. However, 

we can waive the delay in effective date 

if the Secretary finds, for good cause, 

that such delay is impracticable, 

unnecessary, or contrary to public 

interest, and incorporates a statement of 

the finding and the reasons in the rule 

issued. 5 U.S.C. 553(d)(3); 5 U.S.C. 

808(2). 

The Secretary finds that good cause 

exists to implement the requirements 

related to the LTC facilities offering 

each resident immunization against 

influenza annually, as well as lifetime 

immunization against pneumococcal 

disease immediately upon publication 

in the Federal Register. In accordance 

with section 1871(b)(2)(C) of the Act, we 

have waived the delay in the effective 

date for this final rule from 60-day delay 

to an immediate effective date to allow 

for implementation of the requirements 

in time for the 2005–2006 flu season. It 

is our view that a 60-day delay in 

effective date on this final rule will be 

extremely detrimental to the health of 

nursing home residents, as epidemics of 

influenza typically occur during the 

winter months and are responsible for 

an average of approximately 20,000 to 

40,000 deaths per year in the United 

States. Influenza viruses also can cause 

pandemics, during which rates of illness 

and death from influenza-related 

complications can increase 

dramatically. Rates of infection are 

highest among children, but rates of 

serious illness and death are highest 

among persons 65 and older and 

persons of any age who have medical 

conditions that place them at increased 

risk for complications from influenza 

and pneumonia. Vaccines are the most 

effective means to protect against many 

complications related to influenza and 

pneumonia. The ACIP 

recommendations for 2004 to 2005, to 

decrease the risk of influenza, state that 

the optimal time for influenza 

vaccinations is October through 

58846 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 

November. If expedited and published 

with an immediate effective date, a 

delay can be prevented and the rule can 

be effective in the 2005–2006 flu season, 

with the potential of saving many lives 

and preventing illness. 

One of our goals of publishing this 

rule is to increase immunization rates in 

nursing homes to 90 percent, which is 

the Healthy People 2010 goal. This will 

enable about half a million elderly 

individuals who are not currently 

immunized to be immunized. The CMS/ 

CDC standing orders project in 2003 

found that in nursing home residents, 

influenza vaccine is associated with a 

31–33 percent reduction in mortality, 

and a 38–45 percent reduction in allcause hospitalizations. Similarly, 

pneumococcal vaccination is associated 

with a 21–22 percent reduction in 

mortality, and a 27–28 percent 

reduction in all-cause hospitalization. 

We recognize that these associations are 

not necessarily causal because the data 

are cross-sectional with no correction 

for confounding variables. However, the 

findings are consistent with findings 

regarding immunization in the general 

population. Therefore, it is imperative 

that this final rule is published with an 

immediate effective date so that the 

requirements can be implemented in 

time for the 2005–2006 flu season. Even 

though pneumococcal vaccines can be 

administered throughout the year, the 

percentage of patients and residents 

immunized remains low. Therefore, this 

final rule would be a vehicle to improve 

immunization rates and would be 

consistent with the Healthy People 2010 

objective. 

We believe that a delay in 

implementation of this rule would 

greatly hinder increased immunization 

of residents in LTC facilities before the 

onset of this year’s influenza season. We 

conclude that, in this instance, a 60-day 

delay in effective date is unnecessary 

and contrary to public interest. We find 

on this basis, that there is good cause for 

waiving the 60-day delay in effective 

date under section 1871(b)(2)(C) of the 

Act. 

VI. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 30- 

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

We are soliciting public comment on 

the following information collection 

requirements contained in this 

document. 

This rule does require facilities to 

develop specific documentation. As a 

facility develops and implements 

immunization protocols or procedures, 

we expect that obtaining previous 

immunization history on each resident, 

when possible, would be a part of the 

process. Additionally, we expect the 

facility would document in the 

resident’s medical record information 

concerning immunization history, 

contraindications etc. as a part of the 

process of immunizing residents. 

The burden associated with these 

requirements in the first year, would be 

approximately 10 hours of a registered 

nurse’s time per facility that is 161,390 

hours for the first year (10 hours × 

16,139 facilities). In subsequent years, 

we estimate that the burden associated 

approximately 10 minutes of the 

registered nurse’s time, which would be 

16,139,000 minutes = 268,983 hours per 

year (10 minutes per resident × 100 

residents per facility × 16,139 facilities). 

Based on the latest data in an Online 

Survey Certification and Reporting 

System (OSCAR), there are 16,139 

facilities. 

If you comment on these information 

collection and recordkeeping 

requirements, please mail copies 

directly to the following: Centers for 

Medicare & Medicaid Services, Office of 

Strategic Operations and Regulatory 

Affairs, Regulations Development 

Group, Attn: Jim Wickliffe, CMS–3198–

F, Room C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850; 

and 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Room 10235, New Executive 

Office Building, Washington, DC 20503, 

Attn: Christopher Martin, CMS Desk 

Officer, CMS–3198–F, 

Christopher_Martin@omb.eop.gov. Fax 

(202) 395–6974. 

VII. Regulatory Impact 

A. Overall Impact 

We have examined the impacts of this 

rulemaking as required by Executive 

Order 12866 (September 1993, 

Regulatory Planning and Review), the 

Regulatory Flexibility Act (RFA) 

(September 19, 1980, Pub. L. 96–354), 

section 1102(b) of the Social Security 

Act, Executive Order 13132 (August 4, 

1999, Federalism), the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), and the Congressional Review 

Act (5 U.S.C. 804(2)). 

Executive Order 12866 directs 

agencies to issue regulations only after 

consideration of all costs and benefits of 

available regulatory alternatives and, if 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

rules with economically significant 

effects ($100 million or more in any 1 

year). This final rule is an economically 

‘‘significant regulatory action’’ as 

defined by section 3(f) of Executive 

Order 12866, and a ‘‘major rule’’ as 

defined in the Congressional Review 

Act. We have reached this conclusion 

because of the substantial life-saving 

effects of the rule and its anticipated 

reduction in the medical costs 

associated with influenza and 

pneumonia. We believe that there are no 

significant costs associated with this 

final rule. It will not impose any 

mandates on State, local, or tribal 

governments, or the private sector that 

will result in an expenditure of $100 

million in any given year. Since most 

program participants comply with the 

statutory and regulatory requirements 

making unnecessary the imposition of 

termination from Medicare, Medicaid 

and, where applicable, other Federal 

health care programs, and since 

Medicare generally pays the cost of the 

vaccines that are the subject of this rule 

we do not anticipate more than a 

minimal economic impact on nursing 

facilities as a result of this proposed 

rule. There is a cost to the Medicare 

program for the vaccines to the extent 

that they are provided to Medicare 

beneficiaries, as discussed below. 

This final rule will have a life-saving 

effect. We have developed estimates of 

these life-saving effects, along with 

estimated changes in medical care costs, 

and present these estimates and the 

assumptions on which they are based in 

the discussion and tables that follows. 

Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 58847 

Influenza 

Assumptions (Benefit): There are 

approximately 2 million residents in 

LTC facilities. Sixty-five percent had 

documentation stating they received 

influenza immunization per the 1999 

National Nursing Home Survey, 

National Center for Health Statistics, 

CDC. An October 2000 article in the 

Journal of American Geriatric Society 

‘‘Influenza outbreak detection and 

control measures in nursing homes in 

the United States (Zadeh MM, Buxton 

Bridges C, Thompson WW, Arden NH, 

Fukuda K.)’’ indicated that 83 percent of 

LTC residents in the study received 

immunizations. The midpoint between 

the two reports is 74 percent. The 

projected immunization rate after 

regulation implementation is 90 

percent. 

The 2005 influenza vaccination 

administration reimbursement rate is 

$18 (unweighted average of Medicare 

‘‘National Flu Biller Administration 

Codes’’). The 2005 Influenza vaccine 

reimbursement rate is $10.10 (Medicare 

rate; 95 percent of Average Wholesale 

Price (AWP). There is a wide variation 

in the influenza rate year to year, due to 

the prevalent strains of influenza virus 

each influenza season and the degree to 

which the vaccine matches prevalent 

strains as well as other factors. 

Effectiveness of influenza vaccine for 

preventing influenza illness is 30–40 

percent according to ACIP (Harper SA, 

Fukuda K, Uyeki TM, Cox NJ, Bridges 

CB; Prevention and control of influenza: 

recommendations of the ACIP. MMWR 

Recomm Rep. 2004 May 28; 53(RR–6):1–

40). 

As stated above, the rate of 

hospitalization for the LTC population 

among those ill with influenza is 25 

percent (Arden NH, et al.). The 

influenza vaccine is 50–60 percent 

effective in preventing hospitalization 

due to influenza in the LTC population 

(ACIP, May 2004). 

According to (Arden NH, et al.) the 

case-fatality for influenza disease in the 

LTC population is 10 percent of the 

number of residents who become ill 

with influenza. The influenza vaccine is 

80 percent effective in preventing death 

in LTC residents with influenza illness 

(ACIP, May 2004). The average 

Medicare cost per hospital discharge for 

influenza is $8,500 per the Office of the 

Actuary, CMS (including medical 

education, disproportionate share and 

other pass through). The data on the 

influenza related hospitalization of SNF 

residents is not available. SNF residents 

are short term stay therefore we do not 

think those numbers are sufficiently 

large to have a great impact on the 

overall Medicare costs. 

TABLE 1.—ESTIMATED FEDERAL BENEFITS DUE TO INCREASED RATE OF INFLUENZA IMMUNIZATIONS

LTC residents Current Projected Difference 

Percent who receive influenza immunization ............................................................ 74% 90% 16% 

Number who receive influenza immunization ............................................................ 1,480,000 1,800,000 320,000 

Number ill with influenza ........................................................................................... 133,380 123,300 (10,080) 

Number hospitalized due to influenza ....................................................................... 20,358 15,030 (5,328) 

Number who die from influenza complications ......................................................... 7,344 5,040 (2,304) 

Direct Medicare cost of inpatient hospital treatment ................................................. $173,043,000 $127,755,000 ($45,288,000) 

Assumptions (Cost): Influenza vaccine 

must be administered annually: 

however, virtually all influenza 

vaccinations administered in LTC 

facilities are covered under the 

Medicare Part B program. The cost to 

Medicare for provision of the influenza 

vaccinations is equal to the cost of the 

vaccines plus administration costs. In 

addition to these direct Medicare costs, 

an indirect Federal cost will be incurred 

from reduced savings in the Medicaid 

program. For every hospitalization of a 

LTC facility resident, Medicaid saves 

$1,000 for nursing home care not 

provided while the resident is in the 

hospital. The weighted average of the 

federal contribution to Medicaid is 57 

percent (Office of the Actuary, CMS), 

and Medicaid is a primary source of 

payment for 40 to 59 percent of LTC 

facility residents (1999 National Nursing 

Home Survey) and with a midpoint of 

50 percent. The total federal cost related 

to the increased influenza 

immunizations is the total of the direct 

Medicare costs combined with the lost 

savings to Medicaid. 

TABLE 2.—ESTIMATED FEDERAL IMPACT OF INCREASED INFLUENZA IMMUNIZATION ON MEDICARE & MEDICAID

Current ($) Projected ($) Difference 

Total Medicare reimbursement for cost of influenza vaccine and administration 

(320,000 × $28.10) ................................................................................................. 41,588,000 50,580,000 $8,992,000 

Federal share of Medicaid LTC facility savings due to resident hospital stays* ....... (5,802,030) (4,283,550) 1,518,480 

Total Federal Costs ............................................................................................ 35,785,970 46,296,450 10,510,480 

* (Number of residents hospitalized) × ($1000 cost for NH facility per hospitalization) × (57% Federal portion of Medicaid payments) × (50% 

portion of all NH patients paid by Medicaid). 

TABLE 3.—NET FEDERAL SAVINGS DUE TO INCREASED INFLUENZA IMMUNIZATION

Estimated Federal Savings (from Table 1) ................................................................................................................................... ($45,288,000) 

Estimated Federal Costs (from Table 2) ....................................................................................................................................... $10,510,480 

Total Net Federal Savings ............................................................................................................................................................. ($34,777,520) 

Lives saved per year ..................................................................................................................................................................... 2,304 

* Negative numbers reflect savings. 

58848 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 

We have used an average value of a 

statistical life of $5 million to monetize 

the decreased mortality benefits of the 

rule, as we have in other rulemakings. 

This value is in the middle of the range 

of $1–$10 million per statistical life 

saved recommended by OMB Circular 

A–4. The population affected by this 

rule has different demographic and 

other characteristics from the 

populations that were addressed in 

other CMS rulemakings. However, due 

to the lack of data on this specific 

population, we are assuming a value of 

$5 million for the average value of a 

statistical life for this rule. In addition, 

although the age of the affected 

population has been identified as an 

important factor in the theoretical 

literature, the empirical evidence on age 

and VSL is mixed. In light of the 

continuing questions over the effect of 

age on VSL estimates, OMB Circular A–

4 recommends that agencies not use an 

age-adjustment factor in an analysis 

using VSL estimates. 

Therefore, since we estimate 2,304 

lives will be saved by the influenza 

vaccination, we estimate the value 

saved from saving these lives as $11.5 

billion. 

As previously indicated in response 

to a comment, this estimate would be 

lower if we used an alternate measure 

such as statistical years lives saved. In 

addition, VSL is an inherently uncertain 

measure of value. By any reasonable 

measure of the value of these medical 

improvements, however, the benefits 

would, nonetheless, be very substantial. 

Invasive Pneumococcal Disease 

Assumptions (Benefit): There are 

approximately 2 million residents in 

LTC facilities. The projected 

immunization rate after regulation 

implementation is 90 percent. The LTC 

resident vaccination rate is estimated 

between 39 percent (1999 National 

Nursing Home Survey (NNHS)) and 56 

percent (community rate, 2003 National 

Health Interview Survey). Virtually all 

residents with invasive disease are 

hospitalized. The rate of pneumococcal 

invasive disease in unvaccinated 

persons aged greater than or equal to 65 

equals 52–85/100 000, (ACIP, 1997). 

The case fatality ratio of invasive 

pneumococcal disease in persons aged 

greater than or equal to 65 (despite 

appropriate medical treatment) is 30–40 

percent. The average cost per hospital 

discharge for invasive pneumococcal 

disease is $8500 (including medical 

education, disproportionate share and 

other pass through) (Office of the 

Actuary, CMS). According to CDC 

recommendations, usually one dose of 

the pneumococcal polysaccharide 

vaccine (PPV) is all that a person needs 

in a lifetime. However, in some 

situations a second dose is 

recommended for people 65 and older. 

Therefore, expense related to this rule is 

projected to cost more at the beginning 

period of implementation. 

The 45 percent documented 

immunization rate in the table below 

represents data obtained in the year 

1999, and since then the rate may have 

increased. Implementing the influenza 

immunization process is more 

challenging than implementing the 

similar PPV immunization process. 

Pneumococcal immunizations can be 

given all through the year without time 

constraints and the vaccine supplies 

have not been an issue. We anticipate 

that implementation of this rule would 

result in increase in immunization rate 

and documentation of the related data 

for future comparison. The table below 

is relating the years 1–5 to the current 

data. 

Invasive Pneumococcal Disease 

Assumptions (Benefit): 

TABLE 4.—ESTIMATED FEDERAL BENEFITS DUE TO INCREASED RATE OF PNEUMOCOCCAL IMMUNIZATIONS

LTC residents Current year 

Projected 

Year 1 Year 2 Year 3 Year 4 Year 5 

Percent who receive pneumococcal immunization ............................................ 45% 70% 75% 80% 85% 90% 

Number who receive pneumococcal immunization per year .............................. ........................ 500,000 100,000 100,000 100,000 100,000 

Cumulative number immunized (since inception of Medicare pneumococcal immunization benefits) ............................. 900,000 1,400,000 1,500,000 1,600,000 1,700,000 1,800,000 

Number who develop invasive pneumococcal disease ...................................... 970 742 697 651 606 560 

Deaths from invasive pneumococcal disease (or complications related to the disease) 

Benchmark—Number of deaths without 

increased immunizations ...................... 340 340 340 340 340 340 

Number of deaths following implementation of immunization regulation ............ ........................ 260 244 228 212 196 

Number of lives saved due to pneumococcal immunization ............................. ........................ 80 96 112 128 144 

Direct Federal costs for treatment of invasive pneumococcal disease 

Benchmark—costs without increased immunizations .......................................... $8,246,190 $8,246,190 $8,246,190 $8,246,190 $8,246,190 $8,246,190 

Costs following implementation of immunization regulation ................................ ........................ $6,310,740 $5,923,650 $5,536,650 $5,149,470 $4,762,380 

Savings following implementation of increased pneumococcal immunizations ........................ ($1,935,450) ($2,322,540) ($2,709,540) ($3,096,720) ($3,483,810) 

Assumptions (Cost): The 2005 

pneumococcal vaccination 

administration reimbursement rate is 

$18 (unweighted average of Medicare 

‘‘National Flu Biller Administration 

Codes’’) and the pneumococcal vaccine 

reimbursement rate is $23.28 (Medicare 

rate; 95 percent of AWP). The 

pneumococcal vaccine is generally 

Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 58849 

administered once per beneficiary 

lifetime. Therefore this is not a recurring 

cost, but would cost more up front to 

give lifetime immunity to residents (for 

the cost estimate, we assumed 500,000 

people would receive the vaccine in the 

first year and 100,000 people each 

would receive the vaccine in years two 

through five). The reason we assume the 

higher number the first year is because 

we expect all the eligible residents in 

the facilities in the first year would 

receive the pneumococcal vaccine. In 

the following years only the new 

residents who are eligible would need 

the immunization. Virtually all 

pneumococcal immunizations 

administered in LTC facilities are 

covered under the Medicare Part B 

program. For every hospitalization 

concerning Medicaid beneficiaries, 

Medicaid saves $1000 for nursing home 

care not provided while the resident is 

in the hospital. The weighted average of 

the Federal contribution to Medicaid is 

57 percent (Office of the Actuary, CMS). 

Medicaid is a primary source of 

payment for 40 to 59 percent in LTC 

(1999 National Nursing Home Survey) 

and the mid point is 50 percent. The 

total Federal cost related to the 

increased pneumococcal immunizations 

is the total of the direct Medicare 

reimbursement costs combined with the 

lost savings to Medicaid. 

TABLE 5.—FEDERAL IMPACT OF INCREASED PNEUMOCOCCAL IMMUNIZATION ON MEDICARE AND MEDICAID

Current year ($) 

Projected ($) 

Year 1 Year 2 Year 3 Year 4 Year 5 

Medicare reimbursement for cost of pneumococcal vaccine and administration 

Annual Medicare cost following increased pneumococcal immunization *............................ 20,640,000 4,128,000 4,128,000 4,128,000 4,128,000 

Cumulative Medicare cost (since inception of Medicare pneumococcal immunization benefits).37,152,000 ....... 57,792,000 61,920,000 66,048,000 70,176,000 74,304,000 

Federal share of Medicaid LTC facility savings due to resident hospital stays 

Federal savings per year without increased immunizations **.(276,490) .......... (276,490) (276,490) (276,490) (276,490) (276,490) 

Federal savings per year following increased pneumococcal immunization **............................ (211,595) (198,617) (185,638) (172,659) (159,680) 

Lost Federal savings due to increased 

pneumococcal immunization.

........................... 64,895 77,874 90,852 103,831 116,810 

Total Federal Costs (annual Medicare costs + lost Federal savings).Not Available .... 20,704,895 4,205,874 4,218,852 4,231,831 4,244,810 

* Year 1 (500,000 × $41.28); Years 2–5 (100,000 × $41.28). 

** (# of residents hospitalized) × ($1000 cost for NH facility per hospitalization) × (57% Federal portion of Medicaid payments) × (50% portion of 

all NH patients paid by Medicaid). 

TABLE 6.—NET FEDERAL COSTS DUE TO INCREASED PNEUMOCOCCAL IMMUNIZATION

Year 1: 

Estimated Federal Savings (from Table 4) ............................................................................................................................ ($1,935,450) 

Estimated Federal Costs (from Table 5) ................................................................................................................................ $20,704,895 

Total Net Federal Cost in Year 1 ........................................................................................................................................... $18,769,445 

Years 2–5: Estimated Federal savings (from table 4) + Estimated Federal costs (from table 5): 

Total Net Federal Cost in Year 2 ($2,322,540) + 4,205,874 ................................................................................................. $1,883,334 

Total Net Federal Cost in Year 3 ($2,709,540) + 4,218,852 ................................................................................................. $1,509,312 

Total Net Federal Cost in Year 4 ($3,096,720) + 4,231,831 ................................................................................................. $1,135,111 

Total Net Federal Cost in Year 5 ($3,483,810) + 4,244,810 ................................................................................................. $761,000 

Total Net Federal Cost Years 1–5 ......................................................................................................................................... $24,058,202 

Lives saved Years 1–5 ........................................................................................................................................................... 560 

Using the same $5 million per life 

value of a statistical life as before and 

since we estimate 560 lives will be 

saved by the pneumococcal vaccination, 

we estimate the value saved from saving 

these lives as $2.8 billion. 

For the purpose of this analysis we 

have considered the protective effects of 

influenza and pneumococcal 

immunization individually. However, 

the combined effect of both 

immunizations is additive in preventing 

hospitalization and deaths. The July 30, 

1999 article in the journal ‘‘Vaccine’’

titled ‘‘The additive benefits of 

pneumococcal vaccinations during 

influenza seasons among elderly 

persons with chronic lung disease’’

reports that both vaccinations together 

demonstrated additive benefit as there 

was a 65 percent reduction in 

hospitalization for pneumonia and 81 

percent reduction in death versus the 

situation when neither had been 

received. Also excluded in this analysis 

is the increased protection against 

influenza infection afforded by the 

‘‘herd’’ effect after 80 to 90 percent of 

residents are immunized against 

influenza. The 2003, CMS/CDC standing 

orders project report states that a 

facility-level influenza vaccination of 80 

percent and more of residents may be 

independently associated with reduced 

patient hospitalization and death. 

Further, the cost-saving effects of this 

58850 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 

rule, and the costs of the vaccine doses 

themselves, are respectively benefits 

and costs to the taxpayer. Since 

Medicare pays virtually all medical, 

hospital, and (starting in 2006) drug 

costs for this population, the expected 

savings from reduced hospitalizations 

would largely accrue to the Federal 

budget. 

In order to comply with this rule, 

facilities will develop the necessary 

policies and procedures which will be 

followed by staff as a standard practice. 

We estimate the time and cost related to 

this process in the following tables: 

POLICY AND PROCEDURE DEVELOPMENT RELATED TO THE IMMUNIZATION RULE

[This is only a one time expense for the facilities] 

Number of 

LTC 

facilities 

Hours spent per facility Total burden hours Total cost 

16,139 ...... 10 hours first year only ............................. 161,390 hours only first year .................... 161,390 hours × $23.70 * = $3,824,943. 

* $23.70 is the average salary of a registered nurse as per U.S. Department of Labor at (http://www.bls.gov/oes/current/oes291111.htm#nat). 

This rule proposes that the resident’s 

immunization status be documented in 

the resident’s medical record therefore, 

the following table presents the 

estimated time and cost related to the 

implementation of this process. 

DOCUMENTATION TIME OF IMMUNIZATION

[These expenses are annual] 

Number of 

LTC 

facilities 

Hours spent per resident per facility Total burden hours Total cost 

16,139 ...... 16,139 × 100 ** residents × 10 minutes = 16,139,000 

minutes k= 268,983 hours.

268,983 268,982 hours × $23.70 * = $6,374,897. 

* $23.70 is the average salary of a registered nurse as per U.S. Department of Labor (http://www.bls.gov/oes/current/oes291111.htm#nat). ** 100 is the average number of residents in each facility. 

The RFA (15 U.S.C. 603(a)), as 

modified by the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (SBREFA) (Pub. L. 104–121), 

requires agencies to determine whether 

proposed or final rules will have a 

significant economic impact on a 

substantial number of small entities 

and, if so, to identify in the notice of 

proposed rulemaking or final 

rulemaking any regulatory options that 

could mitigate the impact of the 

proposed regulation on small 

businesses. For purposes of the RFA, 

small entities include small businesses, 

nonprofit organizations, and small 

government jurisdictions. Most nursing 

facilities are small entities, either by 

nonprofit status or by having revenues 

of $11.5 million or less annually (the 

applicable size standard of the Small 

Business Administration). Individuals 

and States are not included in the 

definition of a small entity, and other 

medical care providers are not affected 

by this final rule except indirectly, 

through reduced utilization of care by 

individuals who do not, but would 

otherwise, require hospitalization. For 

the reasons explained in this analysis, 

we have concluded that this final rule 

will not have significant impact on a 

substantial number of small entities. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 604 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a Metropolitan Statistical Area and has 

fewer than 100 beds. We do not believe 

a regulatory impact analysis is required 

here because, for the reasons stated 

above, this final rule will not have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates may result in 

expenditure in any 1 year by State, 

local, or tribal governments, in the 

aggregate, or by the private sector, of 

$100 million in 1995 dollars. This final 

rule will impose no mandates on State, 

local, or tribal governments. As 

indicated elsewhere in this analysis, 

costs mandated on nursing facilities, are 

minimal, and do not remotely approach 

this threshold. 

Executive Order 13132 on federalism 

establishes certain requirements that an 

agency must meet when it publishes a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has federalism implications. 

We have determined that this final rule 

will not significantly affect the rights, 

roles, or responsibilities of the States. 

This final rule will not impose 

substantial direct requirement costs on 

State or local governments, preempt 

State law, or otherwise implicate 

federalism. 

B. Anticipated Effects 

1. Effects on LTC facilities. Based on 

the various studies and reports 

referenced earlier in the preamble, we 

expect that LTC facilities will benefit 

from the implementation of this final 

rule. The various studies discussed are 

evidence that prevention of influenza 

and pneumonia will lower the level of 

acuity, staff time and other expenses 

resulting in cost reductions. 

2. Effects on beneficiaries. The 

influenza vaccine is 50–60 percent 

effective in preventing hospitalization 

due to influenza in the LTC population 

and increased immunizations are 

expected to improve health overall for 

the age group of 65 years and older. As 

estimated above 2,304 lives may be 

saved annually when residents receive 

influenza immunizations. 

According to CDC’s Active Bacterial 

Core Surveillance for pneumococcal 

disease, approximately 5,700 deaths 

from invasive pneumococcal disease 

Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 58851 

(bacteremia and meningitis) are 

estimated to have occurred in the 

United States in 2002. The October 1997 

Journal of the American Medical 

Association (JAMA) article ‘‘CostEffectiveness of Vaccination Against 

Pneumococcal Bacteremia Among 

Elderly People’’ indicated that 

vaccination of elderly people against 

pneumococcal bacteremia is one of the 

few interventions that have been found 

to both improve health and save 

medical costs. 

3. Effects on the Medicare and 

Medicaid Programs. The report from the 

January 2000, CMS’s Adult 

Immunization Project, indicates that 

‘‘despite the fact that influenza and 

pneumococcal vaccines are clinically 

effective, cost-effective, and are 

Medicare Part B covered benefits, they 

remain underutilized.’’ Increased 

immunizations are expected to reduce 

the medical expenses and improve 

health overall for the age group of 65 

years and older as reported in the Oct, 

1997 JAMA article referenced earlier. As 

stated above, the rate of hospitalization 

for the LTC population among those ill 

with influenza is 25 percent (Arden NH, 

et. al.). The average cost per hospital 

discharge for influenza is $8,500 per the 

Office of the Actuary, CMS. The 

influenza vaccine is 80 percent effective 

in preventing death in the LTC 

population (ACIP, May 2004). As 

estimated above the net saving will be 

$34,777,520 and 2,304 lives saved when 

residents receive influenza 

immunizations. The net cost related to 

pneumococcal immunizations is 

estimated to be $18,821,360 the first 

year of implementation and $3,753,887 

in the following 2 to 5 years and 143 

lives saved. 

C. Alternatives Considered 

We considered other alternatives 

regarding immunizing residents. 

1. One alternative would be to keep 

the present rules, as they are written. 

The current regulations, however, have 

thus far not been effective at assisting us 

in increasing the rate of immunization 

of institutionalized residents to 90 

percent. Despite the Federal 

Government’s unified efforts to increase 

the availability of safe and effective 

vaccines and despite substantial 

progress in reducing many vaccinepreventable diseases, at-risk individuals 

are not receiving influenza and 

pneumococcal vaccines. Section 4107 of 

the Balanced Budget Act of 1997 

extended the influenza and 

pneumococcal immunization campaign 

being conducted by CMS in conjunction 

with CDC and the National Coalition for 

Adult Immunization through fiscal year 

2002, authorizing $8 million for each 

fiscal year from 1998 to 2002. Although 

Medicare reimbursement for influenza 

and pneumococcal immunizations was 

increased under this legislation, rates of 

immunization did not improve as 

anticipated. 

2. Another alternative would be to 

educate providers on the value of 

influenza and pneumococcal vaccines 

without rule making. However, as 

discussed in studies cited earlier in this 

rule, this has not been effective in 

improving immunization rates. 

D. Conclusion 

Increasing the utilization of costeffective preventive services is the goal 

of both CMS and CDC, and this final 

rule will facilitate the delivery of 

appropriate vaccinations in a timely 

manner, increase the levels of 

vaccination rate, and decrease the 

morbidity and mortality rate of 

influenza and pneumococcal diseases. 

As a result, the economic effects of the 

rule are substantial and overwhelmingly 

beneficial. In accordance with the 

provisions of Executive Order 12866, 

the Office of Management and Budget 

reviewed this final rule. 

List of Subjects in 42 CFR Part 483 

Grant programs—health, Health 

facilities, Health professions, Health 

records, Medicaid, Medicare, Nursing 

homes, Nutrition, Reporting and 

recordkeeping requirements, and Safety. 

■ For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR 

chapter IV as set forth below: 

PART 483—REQUIREMENTS FOR 

STATES AND LONG TERM CARE 

FACILITIES 

■ 1. The authority citation for part 483 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

Subpart B—Requirements for Long 

Term Care Facilities 

■ 2. Section 483.25 is amended by 

adding paragraph (n) to read as follows: 

§ 483.25 Quality of care. 

* * * * * 

(n) Influenza and pneumococcal 

immunizations—(1) Influenza. The 

facility must develop policies and 

procedures that ensure that—

(i) Before offering the influenza 

immunization, each resident or the 

resident’s legal representative receives 

education regarding the benefits and 

potential side effects of the 

immunization; 

(ii) Each resident is offered an 

influenza immunization October 1 

through March 31 annually, unless the 

immunization is medically 

contraindicated or the resident has 

already been immunized during this 

time period; 

(iii) The resident or the resident’s 

legal representative has the opportunity 

to refuse immunization; and 

(iv) The resident’s medical record 

includes documentation that indicates, 

at a minimum, the following: 

(A) That the resident or resident’s 

legal representative was provided 

education regarding the benefits and 

potential side effects of influenza 

immunization; and 

(B) That the resident either received 

the influenza immunization or did not 

receive the influenza immunization due 

to medical contraindications or refusal. 

(2) Pneumococcal disease. The facility 

must develop policies and procedures 

that ensure that—

(i) Before offering the pneumococcal 

immunization, each resident or the 

resident’s legal representative receives 

education regarding the benefits and 

potential side effects of the 

immunization; 

(ii) Each resident is offered an 

pneumococcal immunization, unless the 

immunization is medically 

contraindicated or the resident has 

already been immunized; 

(iii) The resident or the resident’s 

legal representative has the opportunity 

to refuse immunization; and 

(iv) The resident’s medical record 

includes documentation that indicates, 

at a minimum, the following: 

(A) That the resident or resident’s 

legal representative was provided 

education regarding the benefits and 

potential side effects of pneumococcal 

immunization; and 

(B) That the resident either received 

the pneumococcal immunization or did 

not receive the pneumococcal 

immunization due to medical 

contraindication or refusal. 

(v) Exception. As an alternative, based 

on an assessment and practitioner 

recommendation, a second 

pneumococcal immunization may be 

given after 5 years following the first 

pneumococcal immunization, unless 

medically contraindicated or the 

resident or the resident’s legal 

representative refuses the second 

immunization. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

58852 Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Rules and Regulations 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 23, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: September 27, 2005. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 05–19987 Filed 9–30–05; 3:51 pm] 

BILLING CODE 4120–01–P