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October 7, 2005

Part III

Department of
Health and Human
Centers for Medicare & Medicaid Services

42 CFR Part 483

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

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

DEPARTMENT OF HEALTH AND per year in the United States between One of the initial areas highlighted for
HUMAN SERVICES 1990 and 1999. There is an added collaboration was improving influenza
danger when it comes to people age 65 and pneumococcal immunization
Centers for Medicare & Medicaid or older or with high risk conditions coverage through ‘‘standing orders’’ for
Services such as individuals residing in long those populations and settings
term care facilities. In 2002, ACIP designated as appropriate by the ACIP.
42 CFR Part 483 estimated the rates of influenza related A March 24, 2000 ACIP report, which
hospitalization as 392 to 635 per includes implementation guidelines,
100,000 among adults with one or more recommended the use of standing orders
RIN 0938–AN95 high risk conditions, compared to 13 to programs in both outpatient and
33 per 100,000 among those without inpatient settings to increase the
Medicare and Medicaid Programs; high risk conditions. number of individuals who receive the
Condition of Participation: According to the CDC, influenza and influenza vaccine. See implementation
Immunization Standard for Long Term invasive pneumococcal disease kill guidelines at (
Care Facilities more people in the United States each mmwr/preview/mmwrhtml/
AGENCY: Centers for Medicare & year than all other vaccine-preventable rr4901a1.htm). On October 2, 2002, (67
Medicaid Services (CMS), HHS. diseases combined. Influenza and FR 61808) CMS published a final rule
pneumonia combined represent the fifth with comment period that removed the
ACTION: Final rule.
leading cause of death in the elderly. physician order requirement for
SUMMARY: The goal of this final rule is Immunization is the primary method for influenza and pneumococcal
to increase immunization rates in preventing invasive pneumococcal vaccinations from the Conditions of
Medicare and Medicaid participating disease as well as influenza and its more Participation (CoPs) for Medicare and
long term care (LTC) facilities by severe complications. In 2002, the ACIP Medicaid participating hospitals, (LTC)
requiring LTC facilities to offer each reported that the primary target group facilities, and home health agencies
resident immunization against influenza for influenza vaccination includes (HHAs). The final rule was effective as
annually, as well as lifetime persons who are at high risk for serious of its publication date. Although the
immunization against pneumococcal complications from influenza, including CoPs for these provider types require a
disease. LTC facilities will be required approximately 35 million persons who physician’s order for drugs and
to ensure that before offering the are more than 65 years of age and biologicals that must be signed by the
immunization, each resident or the approximately 33 to 39 million persons practitioner responsible for the care of
resident’s legal representative receives less than 65 years of age who have the patient or resident, the CoPs make
education regarding the benefits and chronic underlying medical conditions. an exception for influenza and PPV.
potential side effects of immunization. ACIP recommends that all residents of These vaccines can now be
The facilities will be required to offer long term care facilities should be administered per a physician-approved
assessed for their needs for facility or agency policy, following
immunization against influenza
pneumococcal polysaccharide vaccine assessment of the patient or resident for
annually and immunization against
(PPV) and that people 65 or older, as contraindications. The final rule was a
pneumococcal disease once, unless
well as persons less than 65 who have major step towards increasing the
medically contraindicated or the
chronic illness or who are living in long immunization rates in the LTC
resident or the resident’s legal
term care facilities, receive the population. To date, however, we do not
representative refuses immunization.
immunization, if eligible. have data on the specific immunization
Increasing the use of Medicare-funded Despite the Federal Government’s rates of nursing facility residents
preventive services is a goal of both unified efforts to increase the following the effective date of the final
CMS and the Centers for Disease Control availability of safe and effective rule.
and Prevention (CDC). This final rule is vaccines and despite substantial The Medicare Current Beneficiary
intended to increase the number of progress in reducing many vaccine- Survey (MCBS) data shows that the rate
elderly receiving influenza and preventable diseases; many individuals of influenza vaccination of individuals
pneumococcal immunization and are not receiving influenza and age 65 and older was 70.4 percent in the
decrease the morbidity and mortality pneumococcal vaccines. year 2000, 67.4 percent in 2001, 69
rate from influenza and pneumococcal Section 4107 of the Balanced Budget percent in 2002 and 70.4 percent in
diseases. Act of 1997 extended the influenza and 2003. MCBS data for pneumococcal
DATES: Effective Date: These regulations pneumococcal immunization campaign vaccination for individuals age 65 and
are effective on October 7, 2005. being conducted by CMS in conjunction older was 62.7 percent in 2000, 63.3
FOR FURTHER INFORMATION CONTACT: with CDC and the National Coalition for percent in 2001, 64.6 percent in 2002
Anita Panicker, (410) 786–5646. Jeannie Adult Immunization through fiscal year and 66.4 percent in 2003. Nursing
Miller, (410) 786–3164. Rachael 2002, authorizing $8 million for each facility residents are included in these
Weinstein, (410) 786–6775. fiscal year from 1998 to 2002. Although figures. These rates demonstrate the
Medicare reimbursement for influenza need to implement strategies to help
and pneumococcal immunizations was achieve, the goal set by the Department
I. Background increased under this legislation, rates of of Health and Human Service’s (DHHS)
immunization did not improve as Healthy People 2010 campaign. The
A. General Department’s goal in this campaign is to
The CDC’s Advisory Committee on On April 30, 1999, the CDC and CMS increase the rate of influenza and
Immunization Practices (ACIP) reported entered into an interagency agreement pneumococcal vaccination of adults
on May 28, 2004 ( (IA 99–87) to establish a program of aged 65 years and older to 90 percent.
mmwr/preview/mmwrhtml/ collaboration between the two agencies Further information on preventive
rr5306a1.htm) that epidemics of to enhance assessment of health status services, like immunizations, are
influenza have been responsible for an and delivery of preventive services to available at the healthy aging site at
average of approximately 36,000 deaths beneficiaries of the Medicare program.

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

2a.asp and at http:// influenza epidemics, mortality rates of hospitalization, pneumonia, and among nursing home residents often related mortality. Therefore, it is vital to
exceed 5 percent of the nursing home the well-being of the residents of
B. Influenza Incidence and Prevention
population in the country. To lessen the nursing homes that they are offered
Numerous studies referenced by the impact of this infectious disease, the immunization if not medically
CDC on the Morbidity and Mortality CDC recommends the influenza vaccine contraindicated, and that facilities
Weekly Report (MMWR) Web site show as the primary way of preventing the ensure residents receive the
that—(1) persons 65 years and older are illness and its complications (http:// immunizations at the appropriate time
at high risk of contracting influenza; (2) to prevent the spread of the influenza
they are more likely than the general On September 28, 2004, the Director virus if not refused by the resident or
population to need hospitalization or to of Health Care-Public Health Issues for the resident’s representative.
die from complications of influenza; the General Accountability Office (GAO) The February 14, 2005, article in the
and (3) immunizations are effective in testified before the United States Senate Archives of Internal Medicine titled
preventing influenza and its Special Committee on Aging concerning ‘‘Impact of Influenza Vaccination on
complications in this population a 2004 GAO study titled, ‘‘Infectious Seasonal Mortality in the U.S. Elderly
( Disease Preparedness: Federal Population’’ reports the results of the
mmwrhtml/rr5306a1.htm). Challenges in Responding to Influenza study conducted by Lone Simonsen and
In the May 2004 MMWR referenced Outbreaks’’ ( colleagues on flu vaccination rates
above, the ACIP stated that while rates new.items/d041100t.pdf). The Director among the elderly population (http://
of influenza infection are high among of GAO stated that the study was
children, rates of serious illness and conducted to identify the challenges in abstract/165/3/265). This study reports
death are highest among persons aged preventing the spread of the influenza that vaccination of the elderly
≥65 years and persons of any age who virus because influenza is associated population against influenza may be
have medical conditions that place them with an average of 36,000 deaths and less effective in preventing death among
at increased risk for complications from more than 200,000 hospitalizations each the elderly than previously estimated. A
influenza. According to ACIP, the year in the United States. Furthermore, joint CDC and National Institutes of
primary target groups recommended for nine out of ten persons who die from Health (NIH) press release (February 15,
annual vaccination are as follows: (1) influenza and one out of two who are 2005), (
Persons at increased risk for influenza- hospitalized due to influenza are age 65 statementeldmortality.pdf), stated that
related complications (for example, or older. The GAO was asked to conduct the Simonsen, et al. study did not show
those aged ≥65 years and persons of any the study to assess issues related to that the flu vaccine is ineffective at
age with certain chronic medical supply, demand, and distribution of protecting the elderly from influenza.
conditions); (2) persons aged 50 to 64 vaccine during a typical flu season and Rather, the study indicated that
years (because this group has an to assess the Federal plan to respond to different research approaches result in
elevated prevalence of certain chronic an influenza pandemic. The study was different estimates of influenza vaccine
medical conditions); and (3) persons based on a survey of physician group effectiveness at preventing death among
who live with or care for persons at high practices, interviews with health the elderly.
risk (for example, health-care workers department officials in all 50 states, as The Simonsen, et al., study does not
and individuals within a household well as information about CDC activities imply that the elderly should not
who have frequent contact with persons in the 2003–04 flu season. The GAO receive influenza vaccine. Furthermore,
at high risk and who can transmit found that the most effective way to we note that this study addresses the
influenza to those persons at high risk). prevent influenza is by immunizing elderly population as a whole, and does
The ACIP report states that individuals against influenza every fall not analyze the more vulnerable group
vaccination is associated with season. of nursing home residents addressed by
reductions in the following: influenza- The 2004 ACIP recommendations this regulation and the studies of those
related respiratory illness and physician referenced earlier note that influenza residents summarized later in this
visits among all age groups, vaccine effectiveness varies in the preamble. The conclusions in the study
hospitalization and death among elderly; however, influenza vaccine is are in contrast to most other peer-
persons at high risk, otitis media among still effective at preventing severe reviewed studies that address the same
children, and work absenteeism among illness, secondary complications, and issue (See for example, JAMA; Chicago;
adults. Although influenza vaccination death. In the elderly population residing Oct 22–Oct 29 1997; 278; 16; Jane E
levels increased substantially during the in nursing homes, the vaccine can be Sisk; Alan J Moskowitz; William
1990s, further improvements in vaccine 50–60 percent effective in preventing Whang; Jean D Lin. et al). The CDC and
coverage levels are needed. Influenza hospitalization or pneumonia and 80 ACIP continually review their influenza
vaccination remains the cornerstone for percent effective in preventing death, vaccine recommendations as well as
the control and treatment of influenza. even though the effectiveness in published research in order to develop
(MMWR: Recommendations and preventing influenza illness often ranges the best recommendations for protecting
Reports May 28, 2004/53 (RR06); 1–40 from 30 percent to 40 percent. all Americans from influenza. According to the January 1, 2002 The study is a reminder that there is
mmwrhtml/rr5306a1.htm). article in American Family Physician room for improvement in how we
Although influenza affects persons of referenced earlier, a number of studies protect the elderly from influenza, and
all ages, the CDC has identified several have also shown that nursing homes the CDC and NIH encourage research
groups who are at increased risk for with high rates of vaccinated residents that strengthens our ability to do so. The
complications. One such group is have fewer outbreaks of influenza than study conducted by the CDC and
comprised of residents of nursing homes nursing homes with lower vaccination published in the Journal of American
or other long-term care facilities. An rates. The article further states that Medical Association (JAMA), ‘‘Impact of
article in American Family Physician, many studies have shown that influenza Influenza Vaccination on Seasonal
January 1, 2002 titled, ‘‘Influenza in the vaccination of nursing home residents Mortality in the U.S. Elderly
Nursing Home,’’ notes that during and staff can significantly decrease rates Population’’ by Simonsen et al.,

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

September 2005, looked at hospital data associations can be inferred, but may be pneumonia. They also found that for the
from 1961 to 2001 and found an overall misleading or hard to interpret. elderly living in the community,
increasing trend in the number of flu- • Many previously published influenza vaccination could prevent up
related hospitalizations in the United ‘‘observational studies’’ suggest a higher to 30 percent of hospitalizations.
States each year, despite the fact that the level of influenza vaccine effectiveness Despite the results of this most recent
number of immunizations for influenza against death in the elderly than study, influenza vaccination is still
has increased. The CDC has provided indicated in the Simonsen paper. recommended by the CDC and the
the following information to explain • There are several types of World Health Organization. In response
this phenomenon: epidemiologic studies, including to the study, a CDC spokesperson stated,
1. The range of illnesses analyzed in ecologic studies, observational studies ‘‘There are a number of studies
the new study is broader than in the (for example, studies that compare published that report on varying degrees
previous study. The new study includes vaccinated people to people who choose of effectiveness. But there are also a lot
respiratory and heart diseases associated not to get vaccinated), and clinical trials of studies that point to the fact that the
with influenza infections. The earlier (or experiments), where people are vaccines are effective in preventing the
CDC study published in 2000 analyzed randomly assigned to a treatment or serious complications that lead to
only pneumonia and influenza control group. Clinical trials provide the hospitalizations and death, and that’s an
hospitalizations. When analyses were most reliable and valid data on vaccine important note that we should never
restricted to pneumonia and influenza effectiveness. However, conducting a lose sight of. If I had a loved one who
hospitalizations, however, there was true clinical trial of the effect of was in the high risk group, I would
still an increase in hospitalizations. influenza vaccine in the elderly would strongly recommend they get
2. Influenza A (H3N2) viruses be unethical, because investigators vaccinated.’’ Further, William
predominated in several recent would randomly assign participants to Schaffner, who heads the preventive
influenza seasons, and these viruses get vaccinated or not, despite the fact medicine department at Vanderbilt
generally have been associated with that influenza vaccination has been University’s medical school, pointed out
higher numbers of serious illnesses than recommended for many years for all in the September 22, 2005 Washington
influenza A (H1N1) or influenza B those aged 65 and older. So, to study Post, ‘‘Vaccination is not perfect, but it
viruses. The higher numbers of people vaccine effectiveness researchers have still is enormously beneficial. Even 30
hospitalized during H3N2 influenza observed what has happened among percent effectiveness prevents a lot of
seasons may have increased the average. people who have chosen on their own suffering.’’ We agree. See http://
3. The U.S. population is growing to be vaccinated and those who have not
older and therefore, more vulnerable to (called ‘‘observational studies’’). The CDC continues to recommend
developing severe complications from • The main weakness of observational that people aged 65 and older get
influenza. studies is that they are likely to be vaccinated against influenza each year
4. During the 1990s influenza viruses influenced by selection bias (for as persons aged 65 and older are at high
have either circulated or been detected example, if very vulnerable elderly risk for complications, hospitalizations,
for longer periods of time. (http:// people are less likely to get vaccinated and death from influenza. In the joint than the relatively healthy elderly, then press release referenced above, the CDC
hospital.htm). The CDC also provided this bias might lead to overestimates of and National Institutes of Health (NIH)
additional information to help put the vaccine effectiveness for preventing continue to support the ACIP
study in context. deaths). recommendation that people aged 65
• The Simonsen et al. study does not • The main strength of observational and older get vaccinated against
show that the flu vaccine is ineffective studies is that information on influenza each year.
at protecting the elderly from influenza. individuals is analyzed and factors that
may bias the result can be taken into C. Pneumococcal Disease Incidence and
Rather, the study indicates that different
account during the analysis. For this Prevention
research approaches result in different
estimates of influenza vaccine reason, observational studies have been Like influenza, invasive
effectiveness at preventing death among considered more appropriate than pneumococcal disease is particularly
the elderly. ecologic studies for evaluating vaccine prevalent and severe in those 65 years
• The Simonsen study has some effectiveness. For the entire CDC and older. This population is at high
significant limitations when it comes to response to the Simonsen study see risk of contracting invasive
assessing the effectiveness of influenza pneumococcal disease, with a high risk
vaccination. immunization/flustudy.htm. of resultant complications,
• The study analyzes patterns of A meta-analysis of 40 years of studies hospitalizations, and deaths.
influenza vaccination and death among performed by an international Pneumococcal immunizations are
the elderly from 1961 to 2001 and collaboration of scientists called the effective in preventing pneumococcal
suggests a relationship between the two. Cochrane Review Group was published disease in this population.
This type of analysis is called an in the British journal The Lancet in According to CDC’s Active Bacterial
‘‘ecologic study’’. September 2005. The analysis found Core Surveillance for pneumococcal
• Ecologic studies look at overall that the vaccine is only about 28 percent disease, approximately 5,700 deaths
trends and do not include information effective when given to people over 65. from invasive pneumococcal disease
on specific individuals, such as However, the researchers said that the (bacteremia and meningitis) are
vaccination status and health vaccine is less effective for those elderly estimated to have occurred in the
conditions. who live in the community and United States in 2002 (http://
• Since there is no information on described the vaccine as ‘‘modestly
which of the individuals who died were effective’’ for elderly people in long- survreports/spneu02.pdf). An article in
vaccinated or their underlying term care facilities. The study found the American Journal of Preventive
conditions, the death and vaccination that when used in nursing facilities, Medicine, August 2003, titled
patterns identified in this study cannot influenza vaccines prevented up to 42 ‘‘Standards for Adult Immunization
be directly linked. Apparent percent of deaths from influenza and Practices,’’ notes that overall, vaccine

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effectiveness against invasive (for example, pain at the injection site, pneumococcal vaccination may be
pneumococcal disease among erythema, and swelling). These associated with a 20 to 26 percent
immunocompetent people aged 65 years reactions usually persist for less than 48 reduction in mortality, and a 12 to 28
is 75 percent. Based on 1998 hours. Moderate systemic reactions (for percent reduction in all-cause
projections, annually, 76 percent of example, fever and myalgias) and more hospitalization in nursing home
invasive pneumococcal disease cases severe local reactions (for example, local residents. The report also suggests that
and 87 percent of resulting deaths induration) are rare. Severe systemic a facility-level influenza vaccination of
occurred in people who were eligible for adverse effects (for example, 80 percent of residents may be
pneumococcal vaccine in the United anaphylactic reactions) rarely have been independently associated with reduced
States. ( reported after administration of patient hospitalization and death.
rev_stds_adult_AJPM.pdf). pneumococcal vaccine. In a recent meta-
The ACIP and CDC recommend D. Why a Change in the Conditions of
analysis of nine randomized controlled
immunization for pneumococcal disease Participation Is Needed
trials of pneumococcal vaccine efficacy,
for those 65 years old or older, and for local reactions were observed among In January 2000, the Department of
people with a serious long-term health approximately one third or fewer of Health and Human Services launched
problem, such as heart disease, diabetes, 7,531 patients receiving the vaccine, Healthy People 2010, a comprehensive,
or immunosuppression due to disease, and there were no reports of severe nationwide health promotion and
organ transplantation, or medical febrile or anaphylactic reactions.’’ The disease prevention campaign.
treatment such as chemotherapy. The 1997 ACIP recommendations further ‘‘Immunizations and Infectious
American Lung Association warns that stated that pneumococcal vaccination Diseases’’ is one of the focus areas.
people considered at high risk for has not been causally associated with Healthy People 2010 set the target rate
invasive pneumococcal disease include death among vaccine recipients. for influenza and PPV vaccination of
the elderly, the very young, and those Additional information about adults aged 65 years and older at 90
with underlying health problems, such precautions and contraindications can percent. According to CMS’s Adult
as chronic obstructive pulmonary be obtained from the CDC. The vaccine Immunization Project ‘‘despite the fact
disease (COPD). Patients with diseases manufacturer’s package insert may also that influenza and pneumococcal
that impair the immune system, such as be reviewed for more information. See: vaccines are clinically effective, cost-
AIDS, or patients with other chronic ( effective, and are Medicare Part B
illnesses, such as asthma, or those mmwrhtml/ covered benefits, they remain
undergoing cancer therapy or organ 00047135.htm#00002349.htm). underutilized.’’ (
transplantation, are particularly CDC’s March 24, 2000 MMWR states user_uploads/
vulnerable. that in recent years, a rapid emergence National%20Immunization%20
According to CDC recommendations, of antimicrobial resistance among Project.pdf).
usually one dose of the PPV is all that pneumococci, especially to penicillin, Based on the 1999 National Nursing
is needed to prevent pneumococcal has occurred. Increasing pneumococcal Home Survey, only 66 percent of
disease or a person only needs to be vaccination rates could help prevent nursing home residents had received the
immunized once in a lifetime. However, invasive pneumococcal disease caused influenza vaccine in the previous year
a second dose is recommended for by vaccine-type, multidrug-resistant and only 38 percent had ever had the
people 65 and older who received their pneumococci. Outbreaks of pneumococcal vaccine. The October
first dose prior to 65 years of age, if five pneumococcal disease caused by a 2004 article in the American Family
or more years have passed since that single drug resistant pneumococcal Physician titled ‘‘Pneumonia in Older
dose. A second dose is also serotype have occurred in institutional Residents of Long-Term Care Facilities’’
recommended for people with a settings, including nursing homes. The noted that,’’ when compared to persons
damaged spleen or without a spleen, same MMWR report notes that in 1999, in the overall community, residents in
sickle-cell disease, HIV infection or because of concerns about LTC facilities have more functional
AIDS, cancer, leukemia, lymphoma, pneumococcal antimicrobial resistance disabilities and underlying medical
multiplemyeloma, kidney failure or and under use of pneumococcal illnesses and are at increased risk of
nephrotic syndrome, an organ or bone vaccine, the American Medical acquiring infectious diseases (http://
marrow transplant, or who are taking Association and several partner
medication that lowers immunity (such organizations issued a Quality Care 1495.html). Risk factors include un-
as chemotherapy or long-term steroids). Alert that supports ACIP’s witnessed aspiration, sedative
Accordingly, we believe it vital that recommendations for pneumococcal medication, and co-morbid illnesses.
facilities secure the consent of their vaccination. (Use of Standing Orders Influenza-associated mortality is a major
residents or legal representative for Programs to Increase Adult Vaccination concern for persons with chronic
vaccination and provide their residents Rates: MMWR 2000/49 RR01 15–26 diseases; this mortality increase is most
with vaccinations. Educating residents March 24). marked in persons 65 years of age or
about the advantages of being A CMS/CDC report, ‘‘Respiratory older, with more than 90 percent of the
vaccinated allows residents to Disease Burden in Nursing Homes’’ deaths attributed to pneumonia and
understand the benefits of ( influenza occurring in persons of this
pneumococcal vaccines. The 1997 ACIP sop/RDBNH_INTERIMProjectRpt_1-31- age group.
recommendations state that, 03.pdf) notes that both influenza As noted in the October 15, 2004
‘‘Pneumococcal polysaccharide vaccine vaccine and PPV are protective to article, ‘‘Pneumonia in Older Residents
generally is considered safe based on residents in nursing homes. Based on of Long-Term Care Facilities’’ in the
clinical experience since 1977, when two years of analysis (multivariate/ journal American Family Physician,
the pneumococcal polysaccharide multilevel), influenza vaccine may be ‘‘The number of frail older adults living
vaccine was licensed in the United associated with a 27 to 35 percent in LTC facility is expected to increase
States. Approximately half of the reduction in mortality, and a 44 to 52 dramatically over the next 30 years.’’
persons who receive pneumococcal percent reduction in all-cause (
vaccine develop mild, local side effects hospitalization. Similarly, 1495.html). The article further states

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

that an estimated 40 percent of adults increase in average life expectancy, has distribution delays and vaccine supply
will spend some time in a LTC facility highlighted the importance of shortages have occurred in the United
before dying. Unless control measures preventive care services for older States in three of the last five influenza
are more vigorously implemented, the individuals. The October 1997 Journal seasons. In response, prioritization has
number of deaths from influenza and of the American Medical Association been implemented in previous years to
pneumonia with respect to residents in (JAMA) article ‘‘Cost-Effectiveness of ensure that enough influenza vaccine is
LTC facilities and the number of Vaccination Against Pneumococcal available for those at the highest risk for
consequent complications might Bacteremia Among Elderly People’’ complications. In the case of a true
increase significantly. indicated that vaccination of elderly vaccine shortage as declared by HHS,
In summary, immunizations save people against pneumococcal CMS would exercise its enforcement
lives and can help avoid needless bacteremia is one of the few discretion by instructing the State
suffering and unnecessary costs of interventions that have been found to Survey Agencies (SSAs) not to take
complications from various infectious both improve health and save medical enforcement actions against facilities
diseases, and, as many family members costs. Vaccination both reduced medical that are out-of-compliance with this
and health care workers know, they can expenses and improved health for the requirement if they were unable to
prevent the spread of infection to others. overall age group of 65 years and older obtain vaccine for their residents.
However, despite the availability of safe (JAMA; Chicago; Oct 22–Oct 29 1997;
and effective vaccines, substantial G. Requirements for Issuance of
278; 16; Jane E Sisk; Alan J Moskowitz;
portions of susceptible adults are not Regulations
William Whang; Jean D Lin et al). The
being immunized. To reduce morbidity article further noted ‘‘Vaccination of the Section 902 of the Medicare
and mortality rates, delivering 23 million elderly people unvaccinated Prescription Drug, Improvement, and
appropriate vaccinations in a timely in 1993 would have gained about 78,000 Modernization Act of 2003 (MMA)
manner is vital. This rule is expected to years of healthy life and saved $194 amended section 1871(a) of the Act and
facilitate the delivery of appropriate million.’’ requires the Secretary, in consultation
vaccinations to residents in LTC Overall, the literature supports with the Director of the Office of
facilities in a timely manner and increasing pneumococcal Management and Budget, to establish
increase vaccination rates, thereby immunizations. Pneumococcal and publish timelines for the
decreasing the morbidity and mortality vaccination saves health care dollars by publication of Medicare final
rate of influenza and pneumococcal preventing bacteremia alone and is regulations based on the previous
diseases in this population. This rule greatly underused among the elderly publication of a Medicare proposed or
also has the potential to reduce overall population. These results support both interim final regulation. Section 902 of
healthcare costs by reducing the need recent recommendations of the ACIP as the MMA also states that the timelines
for the treatment of influenza and well as public and private efforts to for these regulations may vary but shall
pneumococcal diseases and their increase vaccination rates. not exceed 3 years after publication of
complications. the preceding proposed or interim final
F. Vaccine Shortages regulation except under exceptional
E. Immunizations and LTC Facilities In the Fall of 2004, there was a major circumstances.
According to a June 2002 CDC shortage of inactivated influenza This final rule finalizes proposed
summary of the National Nursing Home vaccine in the United States. One of the provisions set forth in the August 15,
Survey, 46,000 nursing home residents major manufacturers of the influenza 2005 proposed rule (70 FR 47759), after
(2.5 percent) had pneumonia in 1999. vaccine informed the CDC in early considering public comments. In
The average length of stay in a LTC October 2004 that none of its flu vaccine addition, this final rule has been
facility for a resident with pneumonia as would be available for distribution in published within the 3-year time limit
the primary diagnosis was 124 days in the United States. Because of the imposed by section 902 of the MMA.
1999 ( shortage, Federal health officials Therefore, we believe that the final rule
series/sr_13/sr13_152.pdf). released new guidelines as to whom is in accordance with the Congress’
A November 2000 article in the should receive a flu vaccine, describing intent to ensure timely publication of
journal Infection Control and Hospital those at high-risk of influenza-related final regulations.
Epidemiology titled ‘‘Increasing health complications as priority groups.
Pneumococcal Vaccination Rates At that time, the interim II. Provisions of the Proposed Rule
Among Residents of Long-Term Care recommendations from the CDC stated On August 15, 2005, we published a
Facilities,’’ noted that there were that people 65 and older, as well as all proposed rule in the Federal Register
1,590,763 individuals over 65 years of those between the ages of 2 to 64 with (70 FR 47759) to respond to the ACIP
age residing in LTC facilities in the chronic medical conditions and 6–23 recommendations on ‘‘Prevention and
United States in 1990, and the number month old children, were to be Control of Influenza’’ (http://
is estimated to grow to 2.9 million by prioritized for receiving influenza
2020 (Infection Control and Hospital vaccination. Another group deemed a mmwrhtml/rr5306a1.htm), as well as to
Epidemiology, Volume 21 (11) (705– priority was the population residing in promote the DHHS Healthy People 2010
710) November 2000). A substantial nursing homes. goals for increasing immunization rates.
increase in vaccination rates among We understand that providers of LTC Specifically, the ACIP outlined the
such a large population will decrease services may be concerned about how requirements for a successful
the number of cases of influenza and they will meet the requirements of this vaccination program including
pneumococcal bacteremia and related regulation should an influenza vaccine combined publicity and education for
death. shortage occur in the future. The health-care workers and other potential
A 1999 RAND report stated that the September 2, 2005 MMWR, ‘‘Update: vaccine recipients; a plan for identifying
proportion of the U.S. population over Influenza Vaccine Supply and persons at high risk; and efforts to
age 65 had increased from 5 percent in Recommendations for Prioritization remove administrative and financial
1900 to 13 percent in 1997. This change During the 2005–06 Influenza Season,’’ barriers that prevent persons from
in demographics, combined with an states that both influenza vaccine receiving the vaccines, including use of

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standing orders programs. Based on the because ‘‘* * * the prevention of Response: According to the CDC, ‘‘In
ACIP recommendation, we proposed the influenza and pneumococcal disease is 1976, swine flu vaccine was associated
following requirements for LTC both cost effective and good practice. with a severe temporary paralytic illness
facilities at § 483.25(n): Simply put, it is the right thing to do!’ called Guillain-Barré Syndrome (GBS)
• Require LTC facilities to offer each Response: We appreciate commenters
resident immunization against influenza recognizing the positive impact of concerns/gbs/default.htm.
October 1 through March 31 annually, immunizations on the health of LTC Influenza vaccines since then have
and facilities must also offer (without a residents. not been clearly linked to GBS, although
specified timeframe) lifetime Comment: Some commenters stated research suggests a small risk of the
immunization against pneumococcal that the influenza vaccine is syndrome was associated with the
disease. A second immunization may be contaminated with thimerosal (a influenza vaccines in 1992–1993 and
given under certain circumstances. vaccine preservative containing 1993–1994. However, if there is a risk of
• Require documentation in the mercury), aluminum, or bacteria. One GBS from current influenza vaccines, it
resident’s medical record indicating the commenter stated that ‘‘until the flu is estimated at 1 or 2 cases per million
resident’s influenza and pneumococcal shots are cleaned up (at least mercury persons vaccinated * * * much less
immunization status including whether and aluminum removed) it is madness than the risk of severe influenza, which
influenza and pneumococcal to even administer them to long term can be prevented by vaccination.’’
immunizations were medically care patients.’’ The commenter Comment: A few commenters charged
contraindicated and whether the suggested instead investing in building that the influenza vaccine can cause the
influenza and pneumococcal immunity with raw and fermented food. flu or other illnesses and may even
immunization were refused. If refused, Another commenter mentioned the cause death. Some provided anecdotal
the record must indicate that the influenza vaccine that was information about becoming ill after
resident or his/her representative manufactured in England in 2004 and receiving a flu shot or said that an
received appropriate education and expressed concern about future bacterial elderly parent had died after receiving
consultation. contamination of influenza vaccine. a flu shot. One commenter said that
III. Analysis of and Responses to Public Response: Some people believe that some individuals have experienced
Comments the mercury in thimerosal, a severe reactions after receiving more
We received 61 comments from preservative used in some vaccines, has than one pneumococcal immunization.
individuals, physicians, nurses, caused autism in children. Although One commenter raised the issue of the
hospitals, long term care facilities, researchers so far have found no ‘‘substantial injuries and medical costs
health care associations, pharmacy evidence of a connection between the that inevitably occur from mass
associations and state agencies. All use of thimerosal in vaccines and vaccination.’’
comments were reviewed and analyzed. autism, research is continuing. In 1999 Response: Both the influenza and
After associating like comments, we at the urging of the U.S. Public Health pneumococcal vaccines are inactivated,
placed them in categories based on Service and the American Academy of that is, the virus in the vaccine has been
subject matter. Summaries of the public Pediatrics, vaccine manufacturers killed; therefore these vaccines cannot
comments received and our response to agreed to reduce or eliminate thimerosal cause influenza or pneumonia. We note
those comments are set forth below. in pediatric vaccines. However, the FDA that Flu Mist uses a live vaccine;
requires manufacturers to include a however, it is not indicated for use in
General preservative in all vaccines distributed the elderly. The CDC has stated, ‘‘Most
Many commenters supported the in multi-dose vials to prevent bacterial people who receive vaccines experience
proposed requirements. We also contamination of the vaccine. Since no, or only mild, reactions such as fever
received comments suggesting changes most injectable influenza vaccine is or soreness at the injection site. Very
in the rule (for example, to protect dispensed in multi-dose vials, most rarely, people experience more serious
residents’ rights), and we received influenza vaccine contains thimerosal. side effects, like allergic reactions * * *
requests for clarification of various Nevertheless, according to the CDC, life-threatening allergic reactions are
issues. In addition, some commenters there is no convincing evidence of harm very rare,’’ particularly in relation to
said they did not believe the rule was caused by the low doses of thimerosal influenza vaccines. The 1997 ACIP
necessary, and some commenters in vaccines, except for minor reactions recommendations state that
believed the rule could be harmful to like redness and swelling. pneumococcal vaccination has not been
LTC facility residents. The comments Pneumococcal vaccine does not contain causally associated with death among
and our responses are listed below. thimerosal. Influenza and vaccine recipients. As we stated in the
Comment: Many commenters pneumococcal vaccines do not contain preamble to the proposed rule ‘‘In a
supported our proposed immunization aluminum. The CDC points out that, meta-analysis of nine randomized
rule, which would mandate offering ‘‘Vaccines are held to the highest safety controlled trials of pneumococcal
influenza and pneumococcal vaccines to standards.’’ vaccine efficacy, very few local
all residents of LTC facilities. The We note that FDA found the influenza reactions were observed, and there were
commenters cited the major impact that vaccine manufactured in England in no reports of severe febrile or
both influenza and pneumococcal 2004 to be unsuitable for use, and the anaphylactic reactions.’’ The CDC
diseases have on LTC residents. One vaccine never reached the market. article further states that, influenza and
commenter noted, ‘‘We consider this Comment: One commenter asks ‘‘Does invasive pneumococcal disease kill
Proposed Rule to be of critical anyone remember when President Ford more people in the United States each
importance to the long-term care got on TV to propagandize the masses year than all other vaccine-preventable
provider community and to the into getting the Swine Flu vaccine?’’ diseases combined. Therefore, the
recipients of nursing facility services, all The commenter said that lives were benefits of immunizations outweigh the
of whom are entitled to the ongoing ruined due to Guillain-Barré Syndrome small number of significant adverse
provision of optimal care and services.’’ caused by a vaccine that was supposed effects observed after immunizations are
Another commenter supported the rule to protect them. administered.

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Comment: Many commenters stated companies is criminal.’’ Another resident’s immunization status and
that nursing home residents must be commenter stated that ‘‘vaccination is related information in the resident’s
able to refuse immunizations. One the quintessential form of medical medical record. Moreover, we are
commenter said, ‘‘Seniors should not be quackery in our day and age and is requiring LTC facilities to ensure that
forced to be immunized since they are causing untold damage to health, before offering the immunizations, each
free sovereign individuals who are wellbeing and prosperity for all except resident or resident’s representative
capable of making their own decisions those who profit from its use.’’ receives education regarding the
on such matters.’’ Another commenter Response: The goal of this rule is to benefits and potential side effects of
said that forced vaccination of American protect the health of LTC facility influenza and pneumococcal
citizens is unconstitutional. One residents using a proven preventive immunizations. This final rule clearly
commenter expressed the fear that there measure to stop the spread of infection states that the resident or the resident’s
would be reprisals against residents and reduce morbidity and mortality. representative has the right to refuse the
who refused or whose representatives The rule is not being published based immunization.
refused immunization, including being on ‘‘propaganda from pharmaceutical Comment: Under the proposed rule,
refused treatment or being forced to companies,’’ but on data and evidence we would have required facilities to
leave the nursing home. that the CDC and many other educate residents or their
Response: We agree with the researchers have provided to the public representatives about immunization
commenters that residents of LTC and health care communities. The ACIP only if immunization were refused.
facilities have the right to refuse reported on May 28, 2004 that Some commenters stated that educating
immunizations. In fact, the existing epidemics of influenza have been residents or their representatives on the
Conditions of Participation (CoP) at responsible for an average of risks and benefits of immunization prior
§ 483.10(b)(4) state that residents of LTC approximately 36,000 deaths per year in to giving the immunization is important,
facilities have the right to refuse the United States between 1990 and too. One commenter said that a more
treatment. On admission to an LTC 1999. It stated that there is an added effective way to educate residents is to
facility, residents or their danger when it comes to people age 65 present the information upon
representatives are given written or older or with high risk conditions admission. The commenter said, ‘‘This
documentation about their right to such as individuals residing in long avoids the impression that the facility is
refuse any medication or treatment. We term care facilities. According to the trying to talk the resident into receiving
have further emphasized this right in January 1, 2002 article in American a vaccination that the resident does not
the text of the final rule, which states, Family Physician, a number of studies want.’’
‘‘The resident or the resident’s legal have also shown that nursing homes Response: We agree that it is
representative has the opportunity to with high rates of vaccinated residents
important to provide education prior to
refuse immunization.’’ Nevertheless, the have fewer outbreaks of influenza than
immunization. Therefore, this final rule
final rule requires every facility to offer nursing homes with lower vaccination
requires LTC facilities to educate all
immunization because a goal of the rule rates. The article further states that
residents or resident’s representation on
is to prevent the spread of preventable many studies have shown that influenza
the benefits and potential side effects of
illness. In addition, in accordance with vaccination of nursing home residents
the influenza and pneumococcal
§ 483.10(b)(4), residents have the right and staff can significantly decrease rates
vaccinations before offering
to refuse treatment. Therefore, facilities of hospitalization, pneumonia, and
immunization. At the discretion of the
would not force any resident who related mortality.
facility, this education can be provided
refuses to be immunized to receive the
Consent for immunization at any time, including upon admission
vaccine. The benefits of immunization
are evidenced in numerous studies Comment: Many commenters stated to the facility, as long as the education
referenced by the CDC in the Morbidity that before an immunization is given to is provided before the immunizations
and Mortality Weekly Report (MMWR), a resident, informed consent must be are offered.
which show that: (1) persons 65 years obtained. Other commenters specified Comment: One commenter asked for
and older are at high risk of contracting that a resident’s consent should be in clarification of the intent of the
influenza, (2) they are more likely than writing. One commenter referenced an proposed requirement for
the general population to need article, ‘‘The moral right to ‘‘consultation’’ with residents who
hospitalization or to die from conscientious, personal belief or refused immunization.
complications of influenza, and (3) philosophical exemption to mandatory Response: We proposed a requirement
immunizations are effective in vaccination laws’’ by Barbara Loe for education and consultation in the
preventing influenza and its Fisher, ( proposed rule if immunization is
complications in this population. blfstmt052097.htm) which states that refused. This final rule does not contain
( ‘‘The National Vaccine Information a specific requirement for consultation
mmwrhtml/rr5306a1.htm). Center has not advocated the with residents or their representatives if
Comment: Some commenters stated abolishment of vaccination laws as immunization is refused. Instead, LTC
that this rule is based on other groups have proposed. However, facilities are required to provide
‘‘pharmaceutical company propaganda,’’ we have always endorsed the right to education about immunization to all
and it is for their benefit. One informed consent as an overarching residents. We removed the word
commenter stated that pharmaceutical ethical principle in the practice of ‘‘consultation’’ so as not to confuse
companies have a strong influence over medicine for which vaccination should facilities.
U.S. lawmakers and that drug be no exception.’’ Comment: Commenters had several
companies spend millions in campaign Response: We agree it is vital that suggestions to ensure residents receive
contributions. Another commenter facilities secure the informed consent of adequate education about the
stated that ‘‘preying upon unsuspecting their residents or legal representatives immunizations. Some commenters said
seniors whose care families have for vaccinations before they are we should specify that residents must
entrusted to long term care facilities to administered. Therefore, we would receive educational information in
the financial benefit of pharmaceutical require that the facilities document the writing.

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Response: We are providing flexibility rubella, polio, hepatitis B, Haemophilus Comment: One commenter pointed
to the facilities on how they provide influenzae type b (Hib), varicella out that it can be difficult or impossible
educational information to the residents (chickenpox), or pneumococcal to obtain a complete immunization
or their representatives. It is important conjugate vaccinations (effective 12/15/ history for some LTC facility residents.
to note, however, that all health care 02). Additionally, the Act requires The commenter said that most residents
providers are required by the National health care providers to make a notation have some degree of cognitive
Childhood Vaccine Injury Act to in each patient’s permanent medical impairment and may not be able to
provide vaccine information sheets record at the time vaccine information provide a history. Family members or
(VISs) prior to immunization. These materials are provided indicating: (1) friends may be unavailable or unaware
sheets contain a wealth of information. The edition date of the materials of a resident’s immunization history.
For example, the influenza VIS explains distributed and (2) the date these Response: We agree. This final rule
how flu is spread, the symptoms, the materials were provided as per CDC’s does not contain language requiring LTC
potential complications, what types of requirements. facilities to obtain and document
flu vaccines are available (including Comment: One commenter stated that complete immunization histories for all
vaccines with and without the verbal discussion with the resident or residents. However, we expect that
preservative thimerosal), how the the resident’s representative may be a facilities will make reasonable efforts to
vaccines work, who should be problem if the resident is cognitively obtain immunization histories for their
vaccinated, contraindications to impaired and the representative lives residents to avoid giving unnecessary
vaccination, and the risk of developing out of state or is difficult to reach. immunizations.
a reaction (including rare but life- Response: We understand that Comment: A few commenters pointed
threatening allergic reactions and providing education prior to offering out that individual facilities, must have
Guillain-Barre Syndrome). Single influenza and pneumococcal the flexibility to develop their own
camera-ready copies of the vaccine immunizations and obtaining consent protocols for immunization and their
information materials are available from may be difficult under some own formats for documentation. One
State health departments. Copies are circumstances. However, as with other commenter said they we should specify
also available on the CDC Web site at procedures that take place in LTC that the medical records of residents facilities, facilities should make a who are immunized should be
VIS. Copies are available in English and reasonable effort to obtain consent. documented with the name and lot
in other languages. Instructions for number of the vaccine, the quantity
Documentation given, the route of administration, the
using the vaccination information sheets
can be found at Comment: One commenter stated that date, and the signature of the person
publications/VIS/vis-instructions.txt. CMS should consider implementing a who administers the vaccine.
Facilities may choose to use the VIS mechanism for residents or their Response: We agree that facilities
documents as a means of providing representatives to indicate if they must have some flexibility in
education. Note that the National received immunizations within the implementing the requirements. The
Vaccine Injury Compensation program recommended time frame. Another final rule dictates neither the protocols
(NVICP) requires Vaccine Information commenter stated CMS should create a that need to be in place nor the format
Statements (VIS) be provided to patients system that ensures that accurate for documentation. However, facilities
or their legal representatives, once a immunization information is captured. will need to be able to demonstrate to
vaccine is in the program and a final Response: We appreciate the State agency surveyors that they have an
VIS has been developed. The NVICP comment. CMS is working on adding immunization protocol and that they
provides compensation to adults as well the immunization information in the have documentation for each resident to
as children for adverse events related to MDS 3.0 version and that will be a show that they have educated residents
vaccines covered by the program. To source to capture accurate or their representatives and offered
date, pneumococcal vaccine is not in immunization information for each influenza and pneumococcal
the program and although influenza resident in the nursing facility. The immunizations. Additionally, we expect
vaccine is, the final VIS will not be other elements of resident’s medical that facilities will follow standard
available until approximately October. record would also be a potential source practice and when an immunization is
Comment: One commenter asked for for information. Another source of given, document the type of vaccine, the
clarification of the word ‘‘consent’’ and information would be individual State lot number, and other pertinent
stated that the Vaccine Information immunization registries. information per facility policy.
Sheet (VIS) can be given to the resident Comment: One commenter pointed
out that it can be difficult or impossible Vaccine Availability
or his or her representative and
documented in the medical record to to obtain a complete immunization Comment: Some commenters stated
fulfill the requirement for informed history for some LTC facility residents. that the final rule should indicate that
consent. Special written consent is not The commenter said that most residents if a shortage or substantial delay in
required for vaccination, according to have some degree of cognitive vaccine supply occurs, SNFs and
the commenter. impairment and may not be able to nursing homes will be automatically
Response: We agree that a special provide a history. Family members or exempt from compliance with this CoP
written consent is not necessary for friends may be unavailable or unaware during the shortage period.
vaccinations. As stated in the previous of a resident’s immunization history. Response: We understand that
response, the National Childhood Response: We agree that there may be providers of LTC services are concerned
Vaccine Injury Act (‘‘the Act’’) requires difficulties in obtaining the history of about meeting the requirements of this
health care providers to provide a immunizations especially in the case of regulation if an influenza vaccine
current, relevant vaccination cognitively impaired residents. shortage occurs in the future. In the case
information sheet (VIS) produced by the However, we expect that facilities will of a vaccine shortage as declared by
CDC prior to giving immunizations to make reasonable efforts to obtain HHS or documented local or regional
children or adults for diphtheria, immunization histories for their shortages, CMS could exercise its
tetanus, pertussis, measles, mumps, residents. enforcement discretion by instructing

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State Survey Agencies (SSAs) not to maintain an infection control program pneumococcal polysaccharide
take enforcement action against LTC designed to prevent the development vaccinations in 1981. Medicare provides
facilities that are out of compliance with and transmission of disease and coverage for one pneumococcal
this requirement if the facilities were infection. The CDC recommends that all polysaccharide vaccine per beneficiary.
unable to obtain vaccine for their health care workers be immunized One vaccine at age 65 generally
residents. We do not agree that the final annually. The Occupational Safety and provides coverage for a lifetime, but for
rule should include an exemption for all Health Administration (OSHA) strongly some high risk persons, a booster
LTC facilities, because situations and supports the CDC guidelines for vaccine is needed. Medicare will cover
vaccine availability may vary across the immunization of health care workers. a booster vaccine for high risk persons
country. We expect that the SSA would OSHA’s mission is to assure the safety if 5 years have passed since the last
need to verify that a facility was unable and health of America’s workers by vaccination. Medicare covers both the
to meet the requirement due to a setting and enforcing standards; costs of the vaccine and its
shortage before determining that providing training, outreach, and administration. There is no coinsurance
enforcement action was not warranted. education; establishing partnerships; or co-payment applied to this benefit,
Comment: One commenter said that and encouraging continual and a beneficiary does not have to meet
CMS regards a vaccine shortage as the improvement in workplace safety and his or her deductible to receive it. These
only relevant variable in exercising health. OSHA has placed links to the programs are described in detail on the
enforcement discretion to alter its CDC guidelines on immunization on the CMS Web site (
mandated immunization of LTC OSHA Web site at preventiveservices/2.asp). The Medicare
residents. The commenter argued that a flu/professionals/vaccination/hcw.htm reimbursement for influenza and
mandate to immunize a target and pneumococcal immunizations has never
population annually is not an essential We are not requiring health care been decreased or denied since it was
feature of a responsible flu prevention workers be immunized in this rule. We started; in fact, payment amounts have
and control strategy because a new believe the current LTC requirements increased. The 2005 influenza
influenza prevention and control provide adequate incentives for LTC vaccination administration
strategy must be tailored to the facilities to develop immunization reimbursement rate is $18 (unweighted
distinctive characteristics of each year’s protocols for their health care workers. average of Medicare ‘‘National Flu Biller
influenza strain; the types, effectiveness, Comment: One commenter stated that Administration Codes’’). The 2005
and availability of potential preventive CMS should address the commenter’s Influenza vaccine reimbursement rate is
and other interventions; and other concern that student nurses are not $10.10 (Medicare rate; 95 percent of
practical and ethical considerations. covered under the OSHA blood borne Average Wholesale Price (AWP)).
The commenter said that, in some years, pathogens requirements for hospitals. Facilities that immunize their residents
there might be a better way to protect Response: We agree that it is
are not only reimbursed by Medicare
LTC residents from influenza than important for health care workers to be
but also experience cost savings because
achieving a target vaccination rate. immunized in order to protect residents.
there is less illness among their
Further, there might be another OSHA seeks to assure the safety and
subgroup for which access to the health of America’s workers by setting
and enforcing standards; providing Comment: A few commenters argued
influenza vaccine is more scientifically
training, outreach, and education; that it is wrong to withhold Medicare
and ethically justified.
Response: We agree that each new flu establishing partnerships; and payments to LTC facilities that do not
season presents a challenge in terms of encouraging continual improvement in provide flu and pneumococcal
how best to prevent and control the workplace safety and health. As immunizations to nursing home
spread of influenza throughout the U.S. indicated above, we require nursing residents. One commenter stated, ‘‘I am
population. We will carefully consider facilities to take steps to prevent staff frustrated that you would consider
CDC’s annual guidance on an ongoing transmission of disease. These linking nursing home payments to
basis to determine whether to exercise requirements apply to all staff, whether vaccinations.’’ However, another
our enforcement discretion for reasons or not they are students. commenter praised the proposed rule as
other than a vaccine shortage. In being ‘‘well thought out’’ and said that
Payment and Coverage the rule, ‘‘importantly, does not
addition, in contemplating future
rulemaking, we will consider whether Comment: One commenter stated that penalize the facility if the resident or
there are additional interventions that after publishing the final regulation and the resident’s legal representative
facilities should put into place to paying for the program for a year or two, refuses immunization or there are
protect their residents from influenza. Medicare might decide that the LTC medical contraindications.’’
facilities should be responsible for the Response: Several commenters
Staff Immunization immunizations and stop paying for misunderstood the proposed rule. This
Comment: A few commenters stated them. rule does not penalize a facility
that staff in LTC facilities need to be Response: In accordance with section financially if the resident or the
immunized. One commenter pointed 1861(s)(10) of the Social Security Act, resident’s representative refuses
out that emerging data indicate that the Medicare covers both influenza and immunization. In this final rule, we are
best protection for the LTC population pneumococcal vaccines. Medicare began making it clear that residents must be
is to prevent exposure by immunizing covering annual influenza immunized unless there is a medical
health care providers and visitors to the immunizations in 1993 for Medicare contraindication or the resident or
facilities. beneficiaries. Medicare covers both the resident’s legal representative refuses.
Response: We agree that it is very costs of the vaccine and its Therefore, if the LTC facility offers
important for health care workers to be administration. There is no coinsurance immunization, but the resident refuses,
immunized. In fact, CMS conditions of or co-payment applied to this benefit, this would not be considered non-
participation (CoPs) for nursing and a beneficiary does not have to meet compliant.
facilities (NFs) at 42 CFR 483.65 require his or her deductible to receive this Comment: One commenter
nursing facilities (NF) to establish and benefit. Medicare began covering recommended that CMS authorize

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Medicare payments to SNFs for the immunization or who refuse survey for these requirements with the
outlier cost of intravenous antibiotics. immunization to determine whether we understanding that facilities need a
Response: The cost of intravenous need to require facilities to offer certain amount of time to fully
antibiotics to SNFs is not within the immunization to all LTC residents. implement the requirement. Surveyors
purview of this regulation. SNFs are Another commenter protested the will take the time factor into
reimbursed as per the PPS payment burden associated with the rule and consideration as they review facilities
rates, which cover all costs of furnishing recommended that immunization be a for compliance with the CoPs.
covered SNF services (routine, ancillary, voluntary program. Comment: Two commenters asked for
and capital-related costs). Response: We agree that additional clarification regarding what facilities
Comment: One commenter stated that data would be useful. By requiring must do between October 1 and March
the nursing facilities should have documentation of these data in 31. One commenter asked whether
information on billing related to residents’ medical records, we expect to influenza vaccination must be offered to
immunizations. have the data available for reference in a resident who is admitted on March 31,
Response: Information and guidance the future. However, as we stated in the even if the vaccine will not be
about billing for influenza and preamble of the proposed rule, studies administered immediately because it is
pneumococcal vaccinations, including indicate that many LTC facility unavailable.
electronic billing, is currently available residents are not being immunized, Response: We expect facilities to use
to all providers at: http:// despite the fact that these services are common sense in regard to residents covered by Medicare. It is clear that admitted toward the end of March when
Alternately, LTC facilities may contact voluntary immunization of residents is supplies of the vaccine may be limited
their Medicare Administrative not adequate to ensure that all residents or unavailable. If the vaccine is
Contractors. are being offered immunization. unavailable, then the facility will not be
Comment: One commenter stated that Comment: One commenter asks for able to vaccinate the new resident, and
CMS should direct Quality clarification of the qualifications of the the facility can document this in the
Improvement Organizations (QIOs) to person who educates the resident or resident’s record.
increase immunization rates among their representative on immunizations. Comment: One commenter said, ‘‘Let
nursing home residents and staff as a Response: We believe it is important the physicians make the medical
part of the core activities in the QIO to give LTC facilities the flexibility to decisions. If inappropriate medical
Statement of Work with necessary decide who will provide the education decision making then results in a
additional funding apportioned for to the residents or their representatives, pandemic, only then would a Federal
these efforts. based on the resources available at the mandate be justified.’’
Response: QIOs currently conduct LTC facility. We are not requiring health Response: The purpose of
projects focused on improving the care workers to be immunized in this immunization is to avoid illness or
health of all Medicare beneficiaries. rule. death. The value of immunization is
These projects include, for example, Comment: One commenter expressed minimal once influenza is widespread.
efforts to improve diabetes care and the concern that time constraints may result Comment: One commenter
delivery of mammography and adult in implementation problems for recommended that CDC and CMS work
immunizations (influenza and facilities that must have policies and collaboratively to create an electronic
pneumococcal). The goals of the adult procedures in place by the effective date health record that would include
immunization projects are to increase of the regulation. The commenter also standard immunization verification
influenza and pneumococcal noted that the 15-day comment period information for Medicare beneficiaries.
immunization rates for Medicare was not adequate for individuals and Response: CMS is in the process of
beneficiaries and improve treatment for organizations to provide a thorough including immunization status of all
pneumonia. Descriptions of these response, especially for organizations LTC facility residents in MDS 3.0. Also,
projects are available on the Medicare that would like their comments to on May 28, 2004, DHHS awarded a grant
Quality Improvement Center (MedQIC) reflect the opinions of their members. to promote the use of electronic health
Web site at ( Response: The rule was expedited and records to improve the quality of care
Comment: One commenter stated that published with a 15-day comment provided to Americans by supporting a
CMS should encourage superior period so that it would be effective for pilot project to provide comprehensive,
performance on rates of resident and the 2005–2006 flu season. We believe standardized electronic health record
staff immunizations by posting this rule will save lives, and a delay in (EHR) software to the health care
performance information on Nursing implementation of the rule would community. In addition, DHHS has a
Home Compare and including such greatly hinder increased immunization recently-appointed National
measures as part of any LTC pay-for- of residents in LTC facilities before the Coordinator of Health Information
performance. onset of this year’s influenza season. Technology, whose mission includes
Response: We appreciate the Therefore, a 60-day comment period developing, maintaining, and directing
comment. Incentives for high was considered contrary to public the implementation of a strategic plan to
performance are beyond the purview of interest. However, we understand that it guide the nationwide implementation of
this rule. The MDS 3.0 is being modified may be difficult for LTC facilities to interoperable health information
to include immunizations, and is part of have their policies and procedures in technology in both the public and
our effort to collect data that can be place by the effective date of the rule. private health care. More information
easily accessed for comparative study. We expect facilities to begin can be found on the DHHS Web site at
Other efforts may follow including implementation of the rule and move
posting of performance information on their implementation forward as quickly Comment: One commenter stated that
the Nursing Home Compare Web site. as possible. If surveyed by the State assisted living residents should also be
Comment: One commenter stated that Survey Agency, they should be ready to immunized because these high risk
we do not have enough data on the discuss with the surveyors their process individuals fall under the CDC’s
number of LTC residents who have and plans. Since this rule is effective on Advisory Committee on Immunization
medical contraindications to publication, we expect surveyors will Practices (ACIP) priority grouping.

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Response: We agree; however, CMS with 57 percent of seasons during 1976– are receiving end-of-life care. The
does not have the statutory authority, 1990. commenter expressed concern about
through the Medicare program, to Comment: One commenter stated that potential side effects in residents who
regulate the care provided in assisted a recent study shows no decreased may have only weeks to live.
living facilities. Generally, assisted morbidity or mortality from the flu, Response: We would expect that
living facilities are regulated and despite rising rates of vaccination. One when a resident is receiving end-of-life
monitored by the states in which they commenter specifically cited last year’s care, the resident’s attending
are located. data as indicating that the flu vaccine is practitioner would decide whether
Comment: One commenter requested not effective. vaccination should be offered to the
clarification in the final rule on whether Response: As referenced earlier in this resident.
it applies to skilled nursing services preamble, the Simonsen study Comment: One commenter stated that
provided in hospital swing beds. published in September 2005 found an we greatly underestimated the burden
Response: This rule is a Condition of overall increasing trend in the number associated with documentation because
Participation for nursing facilities and of flu-related hospitalizations in the documenting immunization in residents
does not apply to skilled nursing United States each year, despite the fact records will take more than 5 minutes.
services provided in hospital swing that the number of immunizations for Response: After further consideration
influenza has increased. In response, the of the time required for documentation,
beds. However, there is nothing to
CDC has pointed out that (1) The range we agree with the comment and have
prevent hospitals from immunizing this
of influenza-related illnesses analyzed increased the estimated amount of time
in the study is broader than in the in the burden estimate from 5 minutes
Comment: One commenter said that
previous study; (2) certain influenza to 10 minutes.
our statement in the preamble that, Comment: One commenter stated that
viruses that predominated in several
‘‘epidemics of influenza have been influenza vaccine does not work in the
recent influenza seasons are associated
responsible for an average of elderly because of their age.
with higher numbers of serious illnesses
approximately 36,000 deaths per year in Response: CDC states that ‘‘persons
than other strains; (3) the U.S.
the United States between 1990 and with certain chronic diseases might
population is growing older and more
1999’’ is incorrect because fewer than 10 develop lower post vaccination
vulnerable to developing severe
percent of the 36,000 deaths were from antibody titers than healthy young
complications; and (4) during the 1990s
the flu. The commenter’s conclusion adults.’’ It further states that the vaccine
influenza viruses have either circulated
was that since there are not very many or been detected for longer periods of can also be effective in preventing
deaths from influenza, immunization is time. secondary complications and reducing
not needed. It is true that influenza vaccine is not the risk for influenza-related
Response: The commenter does not as effective in the elderly as it is in hospitalization and death among adults
explain why the commenter thinks the younger individuals. As discussed aged >65 years with and without high-
statistic we provided in the preamble to earlier in this preamble, although risk medical conditions (for example,
the proposed rule overstates the number influenza vaccine effectiveness varies in heart disease and diabetes). Among
of deaths from influenza. the elderly, vaccination is still effective older persons who do reside in nursing
According to ‘‘Prevention and Control at preventing severe illness, secondary homes, influenza vaccine is most
of Influenza: Recommendations of the complications, and death. effective in preventing severe illness,
Advisory Committee on Immunization Recommendations made by ACIP in secondary complications, and deaths.
Practices (ACIP)’’ (MMWR 29 July 2004 state that in the elderly population See
2005;54[RR08]:1–40), ‘‘Influenza-related residing in nursing homes, the vaccine mmwrhtml/rr5408a1.htm. The CDC also
deaths can result from pneumonia and can be 50–60 percent effective in provided the following information in
from exacerbations of cardiopulmonary preventing hospitalization or its discussion of the Simonsen study.
conditions and other chronic diseases. pneumonia and 80 percent effective in Observational studies, to date, have
Deaths of older adults account for > 90 preventing death, even though the generally found that when the ‘‘match’’
percent of deaths attributed to effectiveness in preventing influenza between the vaccine and circulating
pneumonia and influenza. In one study illness often ranges from 30 percent to influenza strains is close, the vaccine is
of influenza epidemics, approximately 40 percent. A study published in Lancet 30 percent-70 percent effective in
19,000 influenza-associated pulmonary in September 2005 found that when preventing hospitalization for
and circulatory deaths per influenza used in nursing facilities, influenza pneumonia and influenza among elderly
season occurred during 1976–1990, vaccines prevented up to 42 percent of persons living outside chronic-care
compared with approximately 36,000 deaths from influenza and pneumonia. facilities (such as nursing homes) and
deaths during 1990–1999. Estimated Comment: One commenter asked those persons with long-term (chronic)
rates of influenza-associated pulmonary whether Medicare Part B or Part D will medical conditions. Observational
and circulatory deaths/100,000 persons pay for the immunizations. studies have also found that among
were 0.4–0.6 among persons aged 0–49 Response: As we stated earlier, elderly nursing home residents, the flu
years, 7.5 among persons aged 50–64 immunization is covered under Part B shot can be 50 percent-60 percent
years, and 98.3 among persons aged > coverage, and Medicare will reimburse effective in preventing hospitalization
65 years. In the United States, the one flu vaccination per person per for pneumonia and up to 80 percent
number of influenza-associated deaths season. This may result in more than effective in preventing death from the
might be increasing in part because the one bill per 12-month period across two flu. See
number of older persons is increasing. flu seasons. Further information can be immunization/flustudy.htm.
In addition, influenza seasons in which accessed online on the ‘‘immunizations Comment: One commenter was
influenza A (H3N2) viruses predominate toolkits’’ Web page at (http:// concerned that by including October 1
are associated with higher mortality; in the regulation’s text, facilities were
influenza A (H3N2) viruses Comment: One commenter requested being required to begin immunizing
predominated in 90 percent of influenza that CMS provide policy guidance with residents on that date. The commenter
seasons during 1990–1999, compared respect to immunizing residents who further stated that if the influenza

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immunization is given too early in the Comment: One commenter stated that 2. We have listed some of the
flu season, the resident’s resistance may CMS, at the very least, should describe minimum documentation requirements
wane over time. The commenter also within the rule a standardized format and still provide the facilities the
stated that facilities are guided by CDC for obtaining required documentation. flexibility to document any additional
information on how many early flu This will protect the facility from information they believe is relevant.
cases are occurring and that often, the liability and provide a guide for (See 483.25(n)(2)(iv).)
best date to begin immunizing for the surveyors. V. Waiver of the 60-Day Delay in
flu is November 1. Response: The final rule provides
Response: In choosing the October 1 Effective Date
flexibility to the facilities on how to
through March 31 dates, we are document the information. This We ordinarily provide a 30-day delay
following the guidelines that CDC has flexibility gives facilities the in the effective date of the provisions of
provided for the beginning and end of opportunity to choose the process and a rule in accordance with the
the flu season. Although flu season can format that works best for them. Administrative Procedure Act (APA) (5
begin as early as October, facilities Comment: One commenter expressed U.S.C. 553(d)), which requires a 30-day
should follow CDC guidelines for each concern that by placing the delayed effective date. The
flu season to determine the most requirements of the rule in § 483.25, Congressional Review Act (5 U.S.C.
efficacious time to begin immunizing rather than § 483.65, the facility could 801(a)(3)), requires a 60-day delayed
their residents. The CDC states in be subject to termination of the nurse effective date for major rules. As stated
‘‘When to Get Vaccinated’’ that October aide training program if documentation in our regulatory impact analysis below,
or November is the best time to get deficiencies are widespread and the we believe this is a major rule. However,
vaccinated, but getting vaccinated even facility is found to be providing we can waive the delay in effective date
later (before March 31) can still be substandard care. if the Secretary finds, for good cause,
beneficial. Response: We believe this new that such delay is impracticable,
Comment: One commenter expressed requirement is appropriately placed unnecessary, or contrary to public
concern regarding possible under the ‘‘Quality of Care’’ CoP. It is interest, and incorporates a statement of
consequences that would result from a more than just a documentation the finding and the reasons in the rule
resident refusing immunization. requirement. The extent of the deficient issued. 5 U.S.C. 553(d)(3); 5 U.S.C.
Response: The rule clearly gives the practices found in meeting this 808(2).
right to the residents and their requirement during a survey will The Secretary finds that good cause
representatives to refuse immunization determine the type of enforcement exists to implement the requirements
if they choose. Therefore, there would warranted. related to the LTC facilities offering
be no adverse effect or consequence Comment: One commenter wanted us each resident immunization against
because of the refusal. The existing CoP to define a ‘‘legal’’ representative. influenza annually, as well as lifetime
at 42 CFR 483.10 on resident rights, also Response: As they implement the immunization against pneumococcal
provides freedom of choice to the requirements of the rule, we expect that disease immediately upon publication
resident. facilities will be guided by the laws that in the Federal Register. In accordance
Comment: One commenter objected to pertain to the definition of ‘‘legal with section 1871(b)(2)(C) of the Act, we
the estimate of $5 million per statistical representative’’ of the states in which have waived the delay in the effective
life saved and stated ‘‘While all life is the facilities are located. Due to the date for this final rule from 60-day delay
sacred, placing $5 million per life saved variations in state law, we are not to an immediate effective date to allow
on someone likely to die in a few weeks defining the term ‘‘legal representative.’’ for implementation of the requirements
or months is exaggerated and Comment: One commenter asked for in time for the 2005–2006 flu season. It
unjustified. The commenter further clarification of the ‘‘exception’’ under is our view that a 60-day delay in
stated that the savings are grossly (2)(iv), specifically the requirements for effective date on this final rule will be
inflated through use of this estimate.’’ the assessment. extremely detrimental to the health of
Response: Five million dollars per Response: We expect that the nursing home residents, as epidemics of
statistical life saved is a figure residents practitioner would decide on influenza typically occur during the
commonly used by Federal agencies. the degree of assessment necessary to winter months and are responsible for
Although the age of the affected determine if a second immunization is an average of approximately 20,000 to
population has been identified as an warranted in order to provide protection 40,000 deaths per year in the United
important factor in the theoretical for the resident. States. Influenza viruses also can cause
literature on the value of a statistical life pandemics, during which rates of illness
(VSL), the empirical evidence on age IV. Provisions of the Final Regulations and death from influenza-related
and VSL is mixed. In light of the For the most part, this final rule complications can increase
continuing questions over the effect of incorporates the provisions of the dramatically. Rates of infection are
age on VSL estimates, OMB Circular A– proposed rule. The provisions of this highest among children, but rates of
4 recommends that agencies not use an final rule that differ from the proposed serious illness and death are highest
age-adjustment factor in an analysis rule are as follows: among persons 65 and older and
using VSL estimates. We could have 1. Based on comments, LTC facilities persons of any age who have medical
used an alternative measure, such as must provide education to residents or conditions that place them at increased
statistical years of lives saved, but that the resident’s legal representative risk for complications from influenza
would not have changed the overall concerning influenza and pneumococcal and pneumonia. Vaccines are the most
conclusion that the benefits of the rule immunization prior to immunization. effective means to protect against many
are substantial. In fact, the savings to Further we modified the regulation to complications related to influenza and
Medicare alone are sufficient to make include not just the benefits but also the pneumonia. The ACIP
the rulemaking cost-beneficial, therefore potential side effects of influenza and recommendations for 2004 to 2005, to
the choice of how to value the lives pneumococcal immunization when decrease the risk of influenza, state that
saved due to this rulemaking is not education is provided to the resident or the optimal time for influenza
decision critical. resident’s legal representative. vaccinations is October through

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

November. If expedited and published Reduction Act of 1995 requires that we VII. Regulatory Impact
with an immediate effective date, a solicit comment on the following issues:
delay can be prevented and the rule can A. Overall Impact
• The need for the information
be effective in the 2005–2006 flu season, collection and its usefulness in carrying We have examined the impacts of this
with the potential of saving many lives out the proper functions of our agency. rulemaking as required by Executive
and preventing illness. Order 12866 (September 1993,
One of our goals of publishing this • The accuracy of our estimate of the
information collection burden. Regulatory Planning and Review), the
rule is to increase immunization rates in Regulatory Flexibility Act (RFA)
nursing homes to 90 percent, which is • The quality, utility, and clarity of (September 19, 1980, Pub. L. 96–354),
the Healthy People 2010 goal. This will the information to be collected. section 1102(b) of the Social Security
enable about half a million elderly • Recommendations to minimize the Act, Executive Order 13132 (August 4,
individuals who are not currently information collection burden on the 1999, Federalism), the Unfunded
immunized to be immunized. The CMS/ affected public, including automated Mandates Reform Act of 1995 (Pub. L.
CDC standing orders project in 2003 collection techniques. 104–4), and the Congressional Review
found that in nursing home residents, Act (5 U.S.C. 804(2)).
influenza vaccine is associated with a We are soliciting public comment on
31–33 percent reduction in mortality, the following information collection Executive Order 12866 directs
and a 38–45 percent reduction in all- requirements contained in this agencies to issue regulations only after
cause hospitalizations. Similarly, document. consideration of all costs and benefits of
pneumococcal vaccination is associated This rule does require facilities to available regulatory alternatives and, if
with a 21–22 percent reduction in develop specific documentation. As a regulation is necessary, to select
mortality, and a 27–28 percent facility develops and implements regulatory approaches that maximize
reduction in all-cause hospitalization. immunization protocols or procedures, net benefits (including potential
We recognize that these associations are we expect that obtaining previous economic, environmental, public health
not necessarily causal because the data immunization history on each resident, and safety effects, distributive impacts,
are cross-sectional with no correction when possible, would be a part of the and equity). A regulatory impact
for confounding variables. However, the process. Additionally, we expect the analysis (RIA) must be prepared for
findings are consistent with findings facility would document in the rules with economically significant
regarding immunization in the general resident’s medical record information effects ($100 million or more in any 1
population. Therefore, it is imperative concerning immunization history, year). This final rule is an economically
that this final rule is published with an contraindications etc. as a part of the ‘‘significant regulatory action’’ as
immediate effective date so that the process of immunizing residents. defined by section 3(f) of Executive
requirements can be implemented in Order 12866, and a ‘‘major rule’’ as
The burden associated with these defined in the Congressional Review
time for the 2005–2006 flu season. Even requirements in the first year, would be
though pneumococcal vaccines can be Act. We have reached this conclusion
approximately 10 hours of a registered because of the substantial life-saving
administered throughout the year, the nurse’s time per facility that is 161,390
percentage of patients and residents effects of the rule and its anticipated
hours for the first year (10 hours × reduction in the medical costs
immunized remains low. Therefore, this 16,139 facilities). In subsequent years,
final rule would be a vehicle to improve associated with influenza and
we estimate that the burden associated pneumonia. We believe that there are no
immunization rates and would be approximately 10 minutes of the
consistent with the Healthy People 2010 significant costs associated with this
registered nurse’s time, which would be final rule. It will not impose any
16,139,000 minutes = 268,983 hours per mandates on State, local, or tribal
We believe that a delay in year (10 minutes per resident × 100
implementation of this rule would governments, or the private sector that
residents per facility × 16,139 facilities). will result in an expenditure of $100
greatly hinder increased immunization Based on the latest data in an Online
of residents in LTC facilities before the million in any given year. Since most
Survey Certification and Reporting program participants comply with the
onset of this year’s influenza season. We System (OSCAR), there are 16,139
conclude that, in this instance, a 60-day statutory and regulatory requirements
facilities. making unnecessary the imposition of
delay in effective date is unnecessary
and contrary to public interest. We find If you comment on these information termination from Medicare, Medicaid
on this basis, that there is good cause for collection and recordkeeping and, where applicable, other Federal
waiving the 60-day delay in effective requirements, please mail copies health care programs, and since
date under section 1871(b)(2)(C) of the directly to the following: Centers for Medicare generally pays the cost of the
Act. Medicare & Medicaid Services, Office of vaccines that are the subject of this rule
Strategic Operations and Regulatory we do not anticipate more than a
VI. Collection of Information Affairs, Regulations Development minimal economic impact on nursing
Requirements Group, Attn: Jim Wickliffe, CMS–3198– facilities as a result of this proposed
Under the Paperwork Reduction Act F, Room C4–26–05, 7500 Security rule. There is a cost to the Medicare
of 1995, we are required to provide 30- Boulevard, Baltimore, MD 21244–1850; program for the vaccines to the extent
day notice in the Federal Register and and that they are provided to Medicare
solicit public comment before a Office of Information and Regulatory beneficiaries, as discussed below.
collection of information requirement is Affairs, Office of Management and This final rule will have a life-saving
submitted to the Office of Management Budget, Room 10235, New Executive effect. We have developed estimates of
and Budget (OMB) for review and Office Building, Washington, DC 20503, these life-saving effects, along with
approval. In order to fairly evaluate Attn: Christopher Martin, CMS Desk estimated changes in medical care costs,
whether an information collection Officer, CMS–3198–F, and present these estimates and the
should be approved by OMB, section Fax assumptions on which they are based in
3506(c)(2)(A) of the Paperwork (202) 395–6974. the discussion and tables that follows.

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

Influenza $18 (unweighted average of Medicare influenza vaccine is 50–60 percent

Assumptions (Benefit): There are ‘‘National Flu Biller Administration effective in preventing hospitalization
approximately 2 million residents in Codes’’). The 2005 Influenza vaccine due to influenza in the LTC population
LTC facilities. Sixty-five percent had reimbursement rate is $10.10 (Medicare (ACIP, May 2004).
documentation stating they received rate; 95 percent of Average Wholesale According to (Arden NH, et al.) the
influenza immunization per the 1999 Price (AWP). There is a wide variation case-fatality for influenza disease in the
National Nursing Home Survey, in the influenza rate year to year, due to LTC population is 10 percent of the
National Center for Health Statistics, the prevalent strains of influenza virus number of residents who become ill
CDC. An October 2000 article in the each influenza season and the degree to with influenza. The influenza vaccine is
Journal of American Geriatric Society which the vaccine matches prevalent 80 percent effective in preventing death
‘‘Influenza outbreak detection and strains as well as other factors. in LTC residents with influenza illness
control measures in nursing homes in Effectiveness of influenza vaccine for (ACIP, May 2004). The average
the United States (Zadeh MM, Buxton preventing influenza illness is 30–40 Medicare cost per hospital discharge for
Bridges C, Thompson WW, Arden NH, percent according to ACIP (Harper SA, influenza is $8,500 per the Office of the
Fukuda K.)’’ indicated that 83 percent of Fukuda K, Uyeki TM, Cox NJ, Bridges Actuary, CMS (including medical
LTC residents in the study received CB; Prevention and control of influenza: education, disproportionate share and
immunizations. The midpoint between recommendations of the ACIP. MMWR other pass through). The data on the
the two reports is 74 percent. The Recomm Rep. 2004 May 28; 53(RR–6):1– influenza related hospitalization of SNF
projected immunization rate after 40). residents is not available. SNF residents
regulation implementation is 90 As stated above, the rate of are short term stay therefore we do not
percent. hospitalization for the LTC population think those numbers are sufficiently
The 2005 influenza vaccination among those ill with influenza is 25 large to have a great impact on the
administration reimbursement rate is percent (Arden NH, et al.). The overall Medicare costs.


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 an indirect Federal cost will be incurred payment for 40 to 59 percent of LTC
must be administered annually: from reduced savings in the Medicaid facility residents (1999 National Nursing
however, virtually all influenza program. For every hospitalization of a Home Survey) and with a midpoint of
vaccinations administered in LTC LTC facility resident, Medicaid saves 50 percent. The total federal cost related
facilities are covered under the $1,000 for nursing home care not to the increased influenza
Medicare Part B program. The cost to provided while the resident is in the immunizations is the total of the direct
Medicare for provision of the influenza hospital. The weighted average of the Medicare costs combined with the lost
vaccinations is equal to the cost of the federal contribution to Medicaid is 57 savings to Medicaid.
vaccines plus administration costs. In percent (Office of the Actuary, CMS),
addition to these direct Medicare costs, and Medicaid is a primary source of

Current ($) Projected ($) Difference

Total Medicare reimbursement for cost of influenza vaccine and administration

(320,000 × $28.10) ................................................................................................. 41,588,000 50,580,000 $8,992,000
Federal share of Medicaid LTC facility savings due to resident hospital stays* ....... (5,802,030) (4,283,550) 1,518,480

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

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


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.

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

We have used an average value of a lower if we used an alternate measure Actuary, CMS). According to CDC
statistical life of $5 million to monetize such as statistical years lives saved. In recommendations, usually one dose of
the decreased mortality benefits of the addition, VSL is an inherently uncertain the pneumococcal polysaccharide
rule, as we have in other rulemakings. measure of value. By any reasonable vaccine (PPV) is all that a person needs
This value is in the middle of the range measure of the value of these medical in a lifetime. However, in some
of $1–$10 million per statistical life improvements, however, the benefits situations a second dose is
saved recommended by OMB Circular would, nonetheless, be very substantial. recommended for people 65 and older.
A–4. The population affected by this Therefore, expense related to this rule is
Invasive Pneumococcal Disease
rule has different demographic and projected to cost more at the beginning
other characteristics from the Assumptions (Benefit): There are
approximately 2 million residents in period of implementation.
populations that were addressed in
other CMS rulemakings. However, due LTC facilities. The projected The 45 percent documented
to the lack of data on this specific immunization rate after regulation immunization rate in the table below
population, we are assuming a value of implementation is 90 percent. The LTC represents data obtained in the year
$5 million for the average value of a resident vaccination rate is estimated 1999, and since then the rate may have
statistical life for this rule. In addition, between 39 percent (1999 National increased. Implementing the influenza
although the age of the affected Nursing Home Survey (NNHS)) and 56 immunization process is more
population has been identified as an percent (community rate, 2003 National challenging than implementing the
important factor in the theoretical Health Interview Survey). Virtually all similar PPV immunization process.
literature, the empirical evidence on age residents with invasive disease are Pneumococcal immunizations can be
and VSL is mixed. In light of the hospitalized. The rate of pneumococcal given all through the year without time
continuing questions over the effect of invasive disease in unvaccinated
constraints and the vaccine supplies
age on VSL estimates, OMB Circular A– persons aged greater than or equal to 65
have not been an issue. We anticipate
4 recommends that agencies not use an equals 52–85/100 000, (ACIP, 1997).
The case fatality ratio of invasive that implementation of this rule would
age-adjustment factor in an analysis result in increase in immunization rate
using VSL estimates. pneumococcal disease in persons aged
greater than or equal to 65 (despite and documentation of the related data
Therefore, since we estimate 2,304
lives will be saved by the influenza appropriate medical treatment) is 30–40 for future comparison. The table below
vaccination, we estimate the value percent. The average cost per hospital is relating the years 1–5 to the current
saved from saving these lives as $11.5 discharge for invasive pneumococcal data.
billion. disease is $8500 (including medical Invasive Pneumococcal Disease
As previously indicated in response education, disproportionate share and
to a comment, this estimate would be other pass through) (Office of the Assumptions (Benefit):
LTC residents Current year
Year 1 Year 2 Year 3 Year 4 Year 5

Percent who receive pneumococcal im-

munization ............................................ 45% 70% 75% 80% 85% 90%
Number who receive pneumococcal im-
munization per year .............................. ........................ 500,000 100,000 100,000 100,000 100,000
Cumulative number immunized (since in-
ception of Medicare pneumococcal im-
munization benefits) ............................. 900,000 1,400,000 1,500,000 1,600,000 1,700,000 1,800,000
Number who develop invasive pneumo-
coccal disease ...................................... 970 742 697 651 606 560

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

Benchmark—Number of deaths without

increased immunizations ...................... 340 340 340 340 340 340
Number of deaths following implementa-
tion of immunization regulation ............ ........................ 260 244 228 212 196
Number of lives saved due to pneumo-
coccal immunization ............................. ........................ 80 96 112 128 144

Direct Federal costs for treatment of invasive pneumococcal disease

Benchmark—costs without increased im-

munizations .......................................... $8,246,190 $8,246,190 $8,246,190 $8,246,190 $8,246,190 $8,246,190
Costs following implementation of immu-
nization regulation ................................ ........................ $6,310,740 $5,923,650 $5,536,650 $5,149,470 $4,762,380
Savings following implementation of in-
creased pneumococcal immunizations ........................ ($1,935,450) ($2,322,540) ($2,709,540) ($3,096,720) ($3,483,810)

Assumptions (Cost): The 2005 $18 (unweighted average of Medicare reimbursement rate is $23.28 (Medicare
pneumococcal vaccination ‘‘National Flu Biller Administration rate; 95 percent of AWP). The
administration reimbursement rate is Codes’’) and the pneumococcal vaccine pneumococcal vaccine is generally

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administered once per beneficiary receive the pneumococcal vaccine. In the Federal contribution to Medicaid is
lifetime. Therefore this is not a recurring the following years only the new 57 percent (Office of the Actuary, CMS).
cost, but would cost more up front to residents who are eligible would need Medicaid is a primary source of
give lifetime immunity to residents (for the immunization. Virtually all payment for 40 to 59 percent in LTC
the cost estimate, we assumed 500,000 pneumococcal immunizations (1999 National Nursing Home Survey)
people would receive the vaccine in the administered in LTC facilities are and the mid point is 50 percent. The
first year and 100,000 people each covered under the Medicare Part B total Federal cost related to the
would receive the vaccine in years two program. For every hospitalization increased pneumococcal immunizations
through five). The reason we assume the concerning Medicaid beneficiaries, is the total of the direct Medicare
higher number the first year is because Medicaid saves $1000 for nursing home reimbursement costs combined with the
we expect all the eligible residents in care not provided while the resident is
lost savings to Medicaid.
the facilities in the first year would in the hospital. The weighted average of


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 in- ........................... 20,640,000 4,128,000 4,128,000 4,128,000 4,128,000
creased pneumococcal immuniza-
tion *.
Cumulative Medicare cost (since incep- 37,152,000 ....... 57,792,000 61,920,000 66,048,000 70,176,000 74,304,000
tion of Medicare pneumococcal im-
munization benefits).

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

Federal savings per year without in- (276,490) .......... (276,490) (276,490) (276,490) (276,490) (276,490)
creased immunizations **.
Federal savings per year following in- ........................... (211,595) (198,617) (185,638) (172,659) (159,680)
creased pneumococcal immuniza-
tion **.
Lost Federal savings due to increased ........................... 64,895 77,874 90,852 103,831 116,810
pneumococcal immunization.

Total Federal Costs (annual Medi- Not Available .... 20,704,895 4,205,874 4,218,852 4,231,831 4,244,810
care costs + lost Federal sav-
* Year 1 (500,000 × $41.28); Years 2–5 (100,000 × $41.28).
** (# of residents hospitalized) × ($1000 cost for NH facility per hospitalization) × (57% Federal portion of Medicaid payments) × (50% portion of
all NH patients paid by Medicaid).


Year 1:
Estimated Federal Savings (from Table 4) ............................................................................................................................ ($1,935,450)
Estimated Federal Costs (from Table 5) ................................................................................................................................ $20,704,895
Total Net Federal Cost in Year 1 ........................................................................................................................................... $18,769,445
Years 2–5: Estimated Federal savings (from table 4) + Estimated Federal costs (from table 5):
Total Net Federal Cost in Year 2 ($2,322,540) + 4,205,874 ................................................................................................. $1,883,334
Total Net Federal Cost in Year 3 ($2,709,540) + 4,218,852 ................................................................................................. $1,509,312
Total Net Federal Cost in Year 4 ($3,096,720) + 4,231,831 ................................................................................................. $1,135,111
Total Net Federal Cost in Year 5 ($3,483,810) + 4,244,810 ................................................................................................. $761,000
Total Net Federal Cost Years 1–5 ......................................................................................................................................... $24,058,202
Lives saved Years 1–5 ........................................................................................................................................................... 560

Using the same $5 million per life hospitalization and deaths. The July 30, received. Also excluded in this analysis
value of a statistical life as before and 1999 article in the journal ‘‘Vaccine’’ is the increased protection against
since we estimate 560 lives will be titled ‘‘The additive benefits of influenza infection afforded by the
saved by the pneumococcal vaccination, pneumococcal vaccinations during ‘‘herd’’ effect after 80 to 90 percent of
we estimate the value saved from saving influenza seasons among elderly residents are immunized against
these lives as $2.8 billion. persons with chronic lung disease’’ influenza. The 2003, CMS/CDC standing
For the purpose of this analysis we reports that both vaccinations together orders project report states that a
have considered the protective effects of demonstrated additive benefit as there facility-level influenza vaccination of 80
influenza and pneumococcal was a 65 percent reduction in percent and more of residents may be
immunization individually. However, hospitalization for pneumonia and 81 independently associated with reduced
the combined effect of both percent reduction in death versus the patient hospitalization and death.
immunizations is additive in preventing situation when neither had been Further, the cost-saving effects of this

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

rule, and the costs of the vaccine doses savings from reduced hospitalizations followed by staff as a standard practice.
themselves, are respectively benefits would largely accrue to the Federal We estimate the time and cost related to
and costs to the taxpayer. Since budget. this process in the following tables:
Medicare pays virtually all medical, In order to comply with this rule,
hospital, and (starting in 2006) drug facilities will develop the necessary
costs for this population, the expected policies and procedures which will be


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

Number of
LTC Hours spent per facility Total burden hours Total cost

16,139 ...... 10 hours first year only ............................. 161,390 hours only first year .................... 161,390 hours × $23.70 * = $3,824,943.
* $23.70 is the average salary of a registered nurse as per U.S. Department of Labor at (

This rule proposes that the resident’s the resident’s medical record therefore, estimated time and cost related to the
immunization status be documented in the following table presents the implementation of this process.


[These expenses are annual]

Number of Total bur-

LTC Hours spent per resident per facility Total cost
den hours

16,139 ...... 16,139 × 100 ** residents × 10 minutes = 16,139,000 268,983 268,982 hours × $23.70 * = $6,374,897.
minutes k= 268,983 hours.
* $23.70 is the average salary of a registered nurse as per U.S. Department of Labor (
** 100 is the average number of residents in each facility.

The RFA (15 U.S.C. 603(a)), as significant impact on the operations of governments, preempts State law, or
modified by the Small Business a substantial number of small rural otherwise has federalism implications.
Regulatory Enforcement Fairness Act of hospitals. This analysis must conform to We have determined that this final rule
1996 (SBREFA) (Pub. L. 104–121), the provisions of section 604 of the will not significantly affect the rights,
requires agencies to determine whether RFA. For purposes of section 1102(b) of roles, or responsibilities of the States.
proposed or final rules will have a the Act, we define a small rural hospital This final rule will not impose
significant economic impact on a as a hospital that is located outside of substantial direct requirement costs on
substantial number of small entities a Metropolitan Statistical Area and has State or local governments, preempt
and, if so, to identify in the notice of fewer than 100 beds. We do not believe State law, or otherwise implicate
proposed rulemaking or final a regulatory impact analysis is required federalism.
rulemaking any regulatory options that here because, for the reasons stated
could mitigate the impact of the above, this final rule will not have a B. Anticipated Effects
proposed regulation on small significant impact on the operations of 1. Effects on LTC facilities. Based on
businesses. For purposes of the RFA, a substantial number of small rural the various studies and reports
small entities include small businesses, hospitals. referenced earlier in the preamble, we
nonprofit organizations, and small Section 202 of the Unfunded expect that LTC facilities will benefit
government jurisdictions. Most nursing Mandates Reform Act of 1995 also from the implementation of this final
facilities are small entities, either by requires that agencies assess anticipated rule. The various studies discussed are
nonprofit status or by having revenues costs and benefits before issuing any evidence that prevention of influenza
of $11.5 million or less annually (the rule whose mandates may result in and pneumonia will lower the level of
applicable size standard of the Small expenditure in any 1 year by State, acuity, staff time and other expenses
Business Administration). Individuals local, or tribal governments, in the resulting in cost reductions.
and States are not included in the aggregate, or by the private sector, of 2. Effects on beneficiaries. The
definition of a small entity, and other $100 million in 1995 dollars. This final influenza vaccine is 50–60 percent
medical care providers are not affected rule will impose no mandates on State, effective in preventing hospitalization
by this final rule except indirectly, local, or tribal governments. As due to influenza in the LTC population
through reduced utilization of care by indicated elsewhere in this analysis, and increased immunizations are
individuals who do not, but would costs mandated on nursing facilities, are expected to improve health overall for
otherwise, require hospitalization. For minimal, and do not remotely approach the age group of 65 years and older. As
the reasons explained in this analysis, this threshold. estimated above 2,304 lives may be
we have concluded that this final rule Executive Order 13132 on federalism saved annually when residents receive
will not have significant impact on a establishes certain requirements that an influenza immunizations.
substantial number of small entities. agency must meet when it publishes a According to CDC’s Active Bacterial
In addition, section 1102(b) of the Act proposed rule (and subsequent final Core Surveillance for pneumococcal
requires us to prepare a regulatory rule) that imposes substantial direct disease, approximately 5,700 deaths
impact analysis if a rule may have a requirement costs on State and local from invasive pneumococcal disease

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

(bacteremia and meningitis) are 2002, authorizing $8 million for each potential side effects of the
estimated to have occurred in the fiscal year from 1998 to 2002. Although immunization;
United States in 2002. The October 1997 Medicare reimbursement for influenza (ii) Each resident is offered an
Journal of the American Medical and pneumococcal immunizations was influenza immunization October 1
Association (JAMA) article ‘‘Cost- increased under this legislation, rates of through March 31 annually, unless the
Effectiveness of Vaccination Against immunization did not improve as immunization is medically
Pneumococcal Bacteremia Among anticipated. contraindicated or the resident has
Elderly People’’ indicated that 2. Another alternative would be to already been immunized during this
vaccination of elderly people against educate providers on the value of time period;
pneumococcal bacteremia is one of the influenza and pneumococcal vaccines (iii) The resident or the resident’s
few interventions that have been found without rule making. However, as legal representative has the opportunity
to both improve health and save discussed in studies cited earlier in this to refuse immunization; and
medical costs. rule, this has not been effective in (iv) The resident’s medical record
3. Effects on the Medicare and improving immunization rates. includes documentation that indicates,
Medicaid Programs. The report from the at a minimum, the following:
January 2000, CMS’s Adult D. Conclusion (A) That the resident or resident’s
Immunization Project, indicates that Increasing the utilization of cost- legal representative was provided
‘‘despite the fact that influenza and effective preventive services is the goal education regarding the benefits and
pneumococcal vaccines are clinically of both CMS and CDC, and this final potential side effects of influenza
effective, cost-effective, and are rule will facilitate the delivery of immunization; and
Medicare Part B covered benefits, they appropriate vaccinations in a timely (B) That the resident either received
remain underutilized.’’ Increased manner, increase the levels of the influenza immunization or did not
immunizations are expected to reduce vaccination rate, and decrease the receive the influenza immunization due
the medical expenses and improve morbidity and mortality rate of to medical contraindications or refusal.
health overall for the age group of 65 influenza and pneumococcal diseases. (2) Pneumococcal disease. The facility
years and older as reported in the Oct, As a result, the economic effects of the must develop policies and procedures
1997 JAMA article referenced earlier. As rule are substantial and overwhelmingly that ensure that—
stated above, the rate of hospitalization beneficial. In accordance with the (i) Before offering the pneumococcal
for the LTC population among those ill provisions of Executive Order 12866, immunization, each resident or the
with influenza is 25 percent (Arden NH, the Office of Management and Budget resident’s legal representative receives
et. al.). The average cost per hospital reviewed this final rule. education regarding the benefits and
discharge for influenza is $8,500 per the potential side effects of the
Office of the Actuary, CMS. The List of Subjects in 42 CFR Part 483 immunization;
influenza vaccine is 80 percent effective Grant programs—health, Health (ii) Each resident is offered an
in preventing death in the LTC facilities, Health professions, Health pneumococcal immunization, unless the
population (ACIP, May 2004). As records, Medicaid, Medicare, Nursing immunization is medically
estimated above the net saving will be homes, Nutrition, Reporting and contraindicated or the resident has
$34,777,520 and 2,304 lives saved when recordkeeping requirements, and Safety. already been immunized;
residents receive influenza (iii) The resident or the resident’s
■ For the reasons set forth in the legal representative has the opportunity
immunizations. The net cost related to
pneumococcal immunizations is preamble, the Centers for Medicare & to refuse immunization; and
estimated to be $18,821,360 the first Medicaid Services amends 42 CFR (iv) The resident’s medical record
year of implementation and $3,753,887 chapter IV as set forth below: includes documentation that indicates,
in the following 2 to 5 years and 143 at a minimum, the following:
PART 483—REQUIREMENTS FOR (A) That the resident or resident’s
lives saved.
STATES AND LONG TERM CARE legal representative was provided
C. Alternatives Considered FACILITIES education regarding the benefits and
We considered other alternatives ■ 1. The authority citation for part 483 potential side effects of pneumococcal
regarding immunizing residents. continues to read as follows: immunization; and
1. One alternative would be to keep (B) That the resident either received
the present rules, as they are written. Authority: Secs. 1102 and 1871 of the
the pneumococcal immunization or did
The current regulations, however, have Social Security Act (42 U.S.C. 1302 and
1395hh). not receive the pneumococcal
thus far not been effective at assisting us immunization due to medical
in increasing the rate of immunization Subpart B—Requirements for Long contraindication or refusal.
of institutionalized residents to 90 Term Care Facilities (v) Exception. As an alternative, based
percent. Despite the Federal on an assessment and practitioner
Government’s unified efforts to increase ■ 2. Section 483.25 is amended by recommendation, a second
the availability of safe and effective adding paragraph (n) to read as follows: pneumococcal immunization may be
vaccines and despite substantial given after 5 years following the first
progress in reducing many vaccine- § 483.25 Quality of care. pneumococcal immunization, unless
preventable diseases, at-risk individuals * * * * * medically contraindicated or the
are not receiving influenza and (n) Influenza and pneumococcal resident or the resident’s legal
pneumococcal vaccines. Section 4107 of immunizations—(1) Influenza. The representative refuses the second
the Balanced Budget Act of 1997 facility must develop policies and immunization.
extended the influenza and procedures that ensure that— (Catalog of Federal Domestic Assistance
pneumococcal immunization campaign (i) Before offering the influenza Program No. 93.778, Medical Assistance
being conducted by CMS in conjunction immunization, each resident or the Program)
with CDC and the National Coalition for resident’s legal representative receives (Catalog of Federal Domestic Assistance
Adult Immunization through fiscal year education regarding the benefits and Program No. 93.773, Medicare—Hospital

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

Insurance; and Program No. 93.774, Dated: September 23, 2005.

Medicare—Supplementary Medical Mark B. McClellan,
Insurance Program) Administrator, Centers for Medicare &
Medicaid Services.

Approved: September 27, 2005.

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

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