[Federal Register Volume 70, Number 194 (Friday, October 7, 2005)]
[Rules and Regulations]
[Pages 58834-58852]
From the Federal Register Online via the Government Publishing 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 (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 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 
(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/

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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 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 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 
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. (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 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 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

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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. (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 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: (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, cost-effective, and are Medicare Part B covered 
benefits, they remain underutilized.'' (http://www.ofmq.com/user_uploads/National%20Immunization%20Project.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 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.'' (http://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 (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

[[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) 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.

[[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. (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.

[[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 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

[[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 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 
non-compliant.
    Comment: One commenter recommended that CMS authorize

[[Page 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-for-performance.
    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.

[[Page 58844]]

    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 high-risk 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

[[Page 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 Sec.  483.25, rather than Sec.  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

[[Page 58846]]

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 all-cause 
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 x 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 x 100 residents per facility x 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, 
[email protected]. 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.

[[Page 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              41,588,000         50,580,000         $8,992,000
 vaccine and administration (320,000 x $28.10).........
Federal share of Medicaid LTC facility savings due to          (5,802,030)        (4,283,550)          1,518,480
 resident hospital stays\*\............................
                                                        --------------------
    Total Federal Costs................................         35,785,970         46,296,450        10,510,480
----------------------------------------------------------------------------------------------------------------
\*\ (Number of residents hospitalized) x ($1000 cost for NH facility per hospitalization) x (57% Federal portion
  of Medicaid payments) x (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.


[[Page 58848]]

    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Projected
                      LTC residents                        Current year  -------------------------------------------------------------------------------
                                                                              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         900,000       1,400,000       1,500,000       1,600,000       1,700,000       1,800,000
 pneumococcal immunization benefits)....................
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                        340             340             340             340             340             340
 immunizations..........................................
Number of deaths following implementation of              ..............             260             244             228             212             196
 immunization regulation................................
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            ..............      $6,310,740      $5,923,650      $5,536,650      $5,149,470      $4,762,380
 regulation.............................................
Savings following implementation of increased             ..............    ($1,935,450)    ($2,322,540)    ($2,709,540)    ($3,096,720)    ($3,483,810)
 pneumococcal immunizations.............................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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

[[Page 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                           Projected ($)
                                                 Current year ($)        -------------------------------------------------------------------------------
                                                                              Year 1          Year 2          Year 3          Year 4          Year 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Medicare reimbursement for cost of pneumococcal vaccine and administration
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Medicare cost following           ...............................      20,640,000       4,128,000       4,128,000       4,128,000       4,128,000
 increased pneumococcal immunization *.
Cumulative Medicare cost (since          37,152,000.....................      57,792,000      61,920,000      66,048,000      70,176,000      74,304,000
 inception of Medicare pneumococcal
 immunization benefits).
----------------------------------------
                                      Federal share of Medicaid LTC facility savings due to resident hospital stays
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federal savings per year without         (276,490)......................       (276,490)       (276,490)       (276,490)       (276,490)       (276,490)
 increased immunizations **.
Federal savings per year following       ...............................       (211,595)       (198,617)       (185,638)       (172,659)       (159,680)
 increased pneumococcal immunization **.
Lost Federal savings due to increased    ...............................          64,895          77,874          90,852         103,831         116,810
 pneumococcal immunization.
                                        ----------------------------------
    Total Federal Costs (annual          Not Available..................      20,704,895       4,205,874       4,218,852       4,231,831      4,244,810
     Medicare costs + lost Federal
     savings).
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Year 1 (500,000 x $41.28); Years 2-5 (100,000 x $41.28).
** ( of residents hospitalized) x ($1000 cost for NH facility per hospitalization) x (57% Federal portion of Medicaid payments) x (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) +           $1,883,334
     4,205,874.......................................
    Total Net Federal Cost in Year 3 ($2,709,540) +           $1,509,312
     4,218,852.......................................
    Total Net Federal Cost in Year 4 ($3,096,720) +           $1,135,111
     4,231,831.......................................
    Total Net Federal Cost in Year 5 ($3,483,810) +             $761,000
     4,244,810.......................................
    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

[[Page 58850]]

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    Hours spent per      Total burden
   facilities         facility            hours            Total cost
------------------------------------------------------------------------
16,139.........  10 hours first     161,390 hours      161,390 hours x
                  year only.         only first year.   $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]
------------------------------------------------------------------------
                     Hours spent per       Total
  Number of LTC        resident per        burden         Total cost
    facilities           facility          hours
------------------------------------------------------------------------
16,139...........  16,139 x 100 **          268,983  268,982 hours x
                    residents x 10                    $23.70 * =
                    minutes =                         $6,374,897.
                    16,139,000 minutes
                    k= 268,983 hours.
------------------------------------------------------------------------
* $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

[[Page 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 ``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.
    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 
vaccine-preventable 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 cost-effective 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.

0
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

0
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

0
2. Section 483.25 is amended by adding paragraph (n) to read as 
follows:


Sec.  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

[[Page 58852]]

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