Medicare and Medicaid Programs; Condition of Participation: Immunization Standard for Long Term Care Facilities, 58834-58852 [05-19987]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 194 (Friday, October 7, 2005)]
[Rules and Regulations]
[Pages 58834-58852]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19987]



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Part III





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Part 483



Medicare and Medicaid Programs; Condition of Participation: 
Immunization Standard for Long Term Care Facilities; Final Rule

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

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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.

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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 (https://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 vaccine-preventable 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 
(https://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 https://
www.cms.hhs.gov/healthyaging/

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2a.asp and at https://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 (https://
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 influenza-related 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: influenza-related 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 https://
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 (https://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'' (https://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 (https://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), (https://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 
peer-reviewed 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.,

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September 2005, looked at hospital data from 1961 to 2001 and 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. 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. (https://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 https://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 long-term 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 https://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 (https://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

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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. (https://
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 meta-analysis 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: (https://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'' 
(https://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, cost-effective, and are Medicare Part B covered 
benefits, they remain underutilized.'' (https://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 (https://www.aafp.org/afp/20041015/1495.html). Risk 
factors include un-witnessed 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.'' (https://
www.aafp.org/afp/20041015/1495.html). The article further states

[[Page 58838]]

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 (https://
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'' (https://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

[[Page 58839]]

standing orders programs. Based on the ACIP recommendation, we proposed 
the following requirements for LTC facilities at Sec.  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-
Barr[eacute] 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-
Barr[eacute] Syndrome (GBS) https://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.

[[Page 58840]]

    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 Sec.  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 Sec.  
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. (https://
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, (https://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.

[[Page 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 life-threatening 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 https://
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 https://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

[[Page 58842]]

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 immuniza