[Federal Register: October 7, 2005 (Volume 70, Number 194)]
[Rules and Regulations]
[Page 58833-58852]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc05-9]
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Part III
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 483
Medicare and Medicaid Programs; Condition of Participation:
Immunization Standard for Long Term Care Facilities; Final Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 483
[CMS-3198-F]
RIN 0938-AN95
Medicare and Medicaid Programs; Condition of Participation:
Immunization Standard for Long Term Care Facilities
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: The goal of this final rule is to increase immunization rates
in Medicare and Medicaid participating long term care (LTC) facilities
by requiring LTC facilities to offer each resident immunization against
influenza annually, as well as lifetime immunization against
pneumococcal disease. LTC facilities will be required to ensure that
before offering the immunization, each resident or the resident's legal
representative receives education regarding the benefits and potential
side effects of immunization. The facilities will be required to offer
immunization against influenza annually and immunization against
pneumococcal disease once, unless medically contraindicated or the
resident or the resident's legal representative refuses immunization.
Increasing the use of Medicare-funded preventive services is a goal of
both CMS and the Centers for Disease Control and Prevention (CDC). This
final rule is intended to increase the number of elderly receiving
influenza and pneumococcal immunization and decrease the morbidity and
mortality rate from influenza and pneumococcal diseases.
DATES: Effective Date: These regulations are effective on October 7,
2005.
FOR FURTHER INFORMATION CONTACT: Anita Panicker, (410) 786-5646.
Jeannie Miller, (410) 786-3164. Rachael Weinstein, (410) 786-6775.
SUPPLEMENTARY INFORMATION:
I. Background
A. General
The CDC's Advisory Committee on Immunization Practices (ACIP)
reported on May 28, 2004 (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5306a1.htm
) that epidemics of influenza have been responsible for an
average of approximately 36,000 deaths per year in the United States
between 1990 and 1999. There is an added danger when it comes to people
age 65 or older or with high risk conditions such as individuals
residing in long term care facilities. In 2002, ACIP estimated the
rates of influenza related hospitalization as 392 to 635 per 100,000
among adults with one or more high risk conditions, compared to 13 to
33 per 100,000 among those without high risk conditions.
According to the CDC, influenza and invasive pneumococcal disease
kill more people in the United States each year than all other vaccine-
preventable diseases combined. Influenza and pneumonia combined
represent the fifth leading cause of death in the elderly. Immunization
is the primary method for preventing invasive pneumococcal disease as
well as influenza and its more severe complications. In 2002, the ACIP
reported that the primary target group for influenza vaccination
includes persons who are at high risk for serious complications from
influenza, including approximately 35 million persons who are more than
65 years of age and approximately 33 to 39 million persons less than 65
years of age who have chronic underlying medical conditions. ACIP
recommends that all residents of long term care facilities should be
assessed for their needs for pneumococcal polysaccharide vaccine (PPV)
and that people 65 or older, as well as persons less than 65 who have
chronic illness or who are living in long term care facilities, receive
the immunization, if eligible.
Despite the Federal Government's unified efforts to increase the
availability of safe and effective vaccines and despite substantial
progress in reducing many vaccine-preventable diseases; many
individuals are not receiving influenza and pneumococcal vaccines.
Section 4107 of the Balanced Budget Act of 1997 extended the
influenza and pneumococcal immunization campaign being conducted by CMS
in conjunction with CDC and the National Coalition for Adult
Immunization through fiscal year 2002, authorizing $8 million for each
fiscal year from 1998 to 2002. Although Medicare reimbursement for
influenza and pneumococcal immunizations was increased under this
legislation, rates of immunization did not improve as anticipated.
On April 30, 1999, the CDC and CMS entered into an interagency
agreement (IA 99-87) to establish a program of collaboration between
the two agencies to enhance assessment of health status and delivery of
preventive services to beneficiaries of the Medicare program. One of
the initial areas highlighted for collaboration was improving influenza
and pneumococcal immunization coverage through ``standing orders'' for
those populations and settings designated as appropriate by the ACIP.
A March 24, 2000 ACIP report, which includes implementation
guidelines, recommended the use of standing orders programs in both
outpatient and inpatient settings to increase the number of individuals
who receive the influenza vaccine. See implementation guidelines at
(http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4901a1.htm). On October 2,
2002, (67 FR 61808) CMS published a final rule with comment period that
removed the physician order requirement for influenza and pneumococcal
vaccinations from the Conditions of Participation (CoPs) for Medicare
and Medicaid participating hospitals, (LTC) facilities, and home health
agencies (HHAs). The final rule was effective as of its publication
date. Although the CoPs for these provider types require a physician's
order for drugs and biologicals that must be signed by the practitioner
responsible for the care of the patient or resident, the CoPs make an
exception for influenza and PPV. These vaccines can now be administered
per a physician-approved facility or agency policy, following
assessment of the patient or resident for contraindications. The final
rule was a major step towards increasing the immunization rates in the
LTC population. To date, however, we do not have data on the specific
immunization rates of nursing facility residents following the
effective date of the final rule.
The Medicare Current Beneficiary Survey (MCBS) data shows that the
rate of influenza vaccination of individuals age 65 and older was 70.4
percent in the year 2000, 67.4 percent in 2001, 69 percent in 2002 and
70.4 percent in 2003. MCBS data for pneumococcal vaccination for
individuals age 65 and older was 62.7 percent in 2000, 63.3 percent in
2001, 64.6 percent in 2002 and 66.4 percent in 2003. Nursing facility
residents are included in these figures. These rates demonstrate the
need to implement strategies to help achieve, the goal set by the
Department of Health and Human Service's (DHHS) Healthy People 2010
campaign. The Department's goal in this campaign is to increase the
rate of influenza and pneumococcal vaccination of adults aged 65 years
and older to 90 percent. Further information on preventive services,
like immunizations, are available at the healthy aging site at http://www.cms.hhs.gov/healthyaging/
[[Page 58835]]
2a.asp and at http://www.healthypeople.gov/.
B. Influenza Incidence and Prevention
Numerous studies referenced by the CDC on the Morbidity and
Mortality Weekly Report (MMWR) Web site show that--(1) persons 65 years
and older are at high risk of contracting influenza; (2) they are more
likely than the general population to need hospitalization or to die
from complications of influenza; and (3) immunizations are effective in
preventing influenza and its complications in this population (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5306a1.htm
).
In the May 2004 MMWR referenced above, the ACIP stated that while
rates of influenza infection are high among children, rates of serious
illness and death are highest among persons aged >=65 years and persons
of any age who have medical conditions that place them at increased
risk for complications from influenza. According to ACIP, the primary
target groups recommended for annual vaccination are as follows: (1)
Persons at increased risk for influenza-related complications (for
example, those aged >=65 years and persons of any age with certain
chronic medical conditions); (2) persons aged 50 to 64 years (because
this group has an elevated prevalence of certain chronic medical
conditions); and (3) persons who live with or care for persons at high
risk (for example, health-care workers and individuals within a
household who have frequent contact with persons at high risk and who
can transmit influenza to those persons at high risk).
The ACIP report states that vaccination is associated with
reductions in the following: influenza-related respiratory illness and
physician visits among all age groups, hospitalization and death among
persons at high risk, otitis media among children, and work absenteeism
among adults. Although influenza vaccination levels increased
substantially during the 1990s, further improvements in vaccine
coverage levels are needed. Influenza vaccination remains the
cornerstone for the control and treatment of influenza. (MMWR:
Recommendations and Reports May 28, 2004/53 (RR06); 1-40 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5306a1.htm
).
Although influenza affects persons of all ages, the CDC has
identified several groups who are at increased risk for complications.
One such group is comprised of residents of nursing homes or other
long-term care facilities. An article in American Family Physician,
January 1, 2002 titled, ``Influenza in the Nursing Home,'' notes that
during influenza epidemics, mortality rates among nursing home
residents often exceed 5 percent of the nursing home population in the
country. To lessen the impact of this infectious disease, the CDC
recommends the influenza vaccine as the primary way of preventing the
illness and its complications (http://www.aafp.org/afp/20020101/75.html
).
On September 28, 2004, the Director of Health Care-Public Health
Issues for the General Accountability Office (GAO) testified before the
United States Senate Special Committee on Aging concerning a 2004 GAO
study titled, ``Infectious Disease Preparedness: Federal Challenges in
Responding to Influenza Outbreaks'' (http://www.gao.gov/new.items/d041100t.pdf
). The Director of GAO stated that the study was conducted
to identify the challenges in preventing the spread of the influenza
virus because influenza is associated with an average of 36,000 deaths
and more than 200,000 hospitalizations each year in the United States.
Furthermore, nine out of ten persons who die from influenza and one out
of two who are hospitalized due to influenza are age 65 or older. The
GAO was asked to conduct the study to assess issues related to supply,
demand, and distribution of vaccine during a typical flu season and to
assess the Federal plan to respond to an influenza pandemic. The study
was based on a survey of physician group practices, interviews with
health department officials in all 50 states, as well as information
about CDC activities in the 2003-04 flu season. The GAO found that the
most effective way to prevent influenza is by immunizing individuals
against influenza every fall season.
The 2004 ACIP recommendations referenced earlier note that
influenza vaccine effectiveness varies in the elderly; however,
influenza vaccine is still effective at preventing severe illness,
secondary complications, and death. In the elderly population residing
in nursing homes, the vaccine can be 50-60 percent effective in
preventing hospitalization or pneumonia and 80 percent effective in
preventing death, even though the effectiveness in preventing influenza
illness often ranges from 30 percent to 40 percent.
According to the January 1, 2002 article in American Family
Physician referenced earlier, a number of studies have also shown that
nursing homes with high rates of vaccinated residents have fewer
outbreaks of influenza than nursing homes with lower vaccination rates.
The article further states that many studies have shown that influenza
vaccination of nursing home residents and staff can significantly
decrease rates of hospitalization, pneumonia, and related mortality.
Therefore, it is vital to the well-being of the residents of nursing
homes that they are offered immunization if not medically
contraindicated, and that facilities ensure residents receive the
immunizations at the appropriate time to prevent the spread of the
influenza virus if not refused by the resident or the resident's
representative.
The February 14, 2005, article in the Archives of Internal Medicine
titled ``Impact of Influenza Vaccination on Seasonal Mortality in the
U.S. Elderly Population'' reports the results of the study conducted by
Lone Simonsen and colleagues on flu vaccination rates among the elderly
population (http://archinte.ama-assn.org/cgi/content/abstract/165/3/265
). This study reports that vaccination of the elderly population
against influenza may be less effective in preventing death among the
elderly than previously estimated. A joint CDC and National Institutes
of Health (NIH) press release (February 15, 2005), (http://www.cdc.gov/flu/pdf/statementeldmortality.pdf
), stated that the Simonsen, et al.
study did not show that the flu vaccine is ineffective at protecting
the elderly from influenza. Rather, the study indicated that different
research approaches result in different estimates of influenza vaccine
effectiveness at preventing death among the elderly.
The Simonsen, et al., study does not imply that the elderly should
not receive influenza vaccine. Furthermore, we note that this study
addresses the elderly population as a whole, and does not analyze the
more vulnerable group of nursing home residents addressed by this
regulation and the studies of those residents summarized later in this
preamble. The conclusions in the study are in contrast to most other
peer-reviewed studies that address the same issue (See for example,
JAMA; Chicago; Oct 22-Oct 29 1997; 278; 16; Jane E Sisk; Alan J
Moskowitz; William Whang; Jean D Lin. et al). The CDC and ACIP
continually review their influenza vaccine recommendations as well as
published research in order to develop the best recommendations for
protecting all Americans from influenza.
The study is a reminder that there is room for improvement in how
we protect the elderly from influenza, and the CDC and NIH encourage
research that strengthens our ability to do so. The study conducted by
the CDC and published in the Journal of American Medical Association
(JAMA), ``Impact of Influenza Vaccination on Seasonal Mortality in the
U.S. Elderly Population'' by Simonsen et al.,
[[Page 58836]]
September 2005, looked at hospital data from 1961 to 2001 and found an
overall increasing trend in the number of flu-related hospitalizations
in the United States each year, despite the fact that the number of
immunizations for influenza has increased. The CDC has provided the
following information to explain this phenomenon:
1. The range of illnesses analyzed in the new study is broader than
in the previous study. The new study includes respiratory and heart
diseases associated with influenza infections. The earlier CDC study
published in 2000 analyzed only pneumonia and influenza
hospitalizations. When analyses were restricted to pneumonia and
influenza hospitalizations, however, there was still an increase in
hospitalizations.
2. Influenza A (H3N2) viruses predominated in several recent
influenza seasons, and these viruses generally have been associated
with higher numbers of serious illnesses than influenza A (H1N1) or
influenza B viruses. The higher numbers of people hospitalized during
H3N2 influenza seasons may have increased the average.
3. The U.S. population is growing older and therefore, more
vulnerable to developing severe complications from influenza.
4. During the 1990s influenza viruses have either circulated or
been detected for longer periods of time. (http://www.cdc.gov/flu/about/qa/hospital.htm
). The CDC also provided additional information to
help put the study in context.
The Simonsen et al. study does not show that the flu
vaccine is ineffective at protecting the elderly from influenza.
Rather, the study indicates that different research approaches result
in different estimates of influenza vaccine effectiveness at preventing
death among the elderly.
The Simonsen study has some significant limitations when
it comes to assessing the effectiveness of influenza vaccination.
The study analyzes patterns of influenza vaccination and
death among the elderly from 1961 to 2001 and suggests a relationship
between the two. This type of analysis is called an ``ecologic study''.
Ecologic studies look at overall trends and do not include
information on specific individuals, such as vaccination status and
health conditions.
Since there is no information on which of the individuals
who died were vaccinated or their underlying conditions, the death and
vaccination patterns identified in this study cannot be directly
linked. Apparent associations can be inferred, but may be misleading or
hard to interpret.
Many previously published ``observational studies''
suggest a higher level of influenza vaccine effectiveness against death
in the elderly than indicated in the Simonsen paper.
There are several types of epidemiologic studies,
including ecologic studies, observational studies (for example, studies
that compare vaccinated people to people who choose not to get
vaccinated), and clinical trials (or experiments), where people are
randomly assigned to a treatment or control group. Clinical trials
provide the most reliable and valid data on vaccine effectiveness.
However, conducting a true clinical trial of the effect of influenza
vaccine in the elderly would be unethical, because investigators would
randomly assign participants to get vaccinated or not, despite the fact
that influenza vaccination has been recommended for many years for all
those aged 65 and older. So, to study vaccine effectiveness researchers
have observed what has happened among people who have chosen on their
own to be vaccinated and those who have not (called ``observational
studies'').
The main weakness of observational studies is that they
are likely to be influenced by selection bias (for example, if very
vulnerable elderly people are less likely to get vaccinated than the
relatively healthy elderly, then this bias might lead to overestimates
of vaccine effectiveness for preventing deaths).
The main strength of observational studies is that
information on individuals is analyzed and factors that may bias the
result can be taken into account during the analysis. For this reason,
observational studies have been considered more appropriate than
ecologic studies for evaluating vaccine effectiveness. For the entire
CDC response to the Simonsen study see http://www.amda.com/clinical/immunization/flustudy.htm
.
A meta-analysis of 40 years of studies performed by an
international collaboration of scientists called the Cochrane Review
Group was published in the British journal The Lancet in September
2005. The analysis found that the vaccine is only about 28 percent
effective when given to people over 65. However, the researchers said
that the vaccine is less effective for those elderly who live in the
community and described the vaccine as ``modestly effective'' for
elderly people in long-term care facilities. The study found that when
used in nursing facilities, influenza vaccines prevented up to 42
percent of deaths from influenza and pneumonia. They also found that
for the elderly living in the community, influenza vaccination could
prevent up to 30 percent of hospitalizations. Despite the results of
this most recent study, influenza vaccination is still recommended by
the CDC and the World Health Organization. In response to the study, a
CDC spokesperson stated, ``There are a number of studies published that
report on varying degrees of effectiveness. But there are also a lot of
studies that point to the fact that the vaccines are effective in
preventing the serious complications that lead to hospitalizations and
death, and that's an important note that we should never lose sight of.
If I had a loved one who was in the high risk group, I would strongly
recommend they get vaccinated.'' Further, William Schaffner, who heads
the preventive medicine department at Vanderbilt University's medical
school, pointed out in the September 22, 2005 Washington Post,
``Vaccination is not perfect, but it still is enormously beneficial.
Even 30 percent effectiveness prevents a lot of suffering.'' We agree.
See http://www.thelancet.com/.
The CDC continues to recommend that people aged 65 and older get
vaccinated against influenza each year as persons aged 65 and older are
at high risk for complications, hospitalizations, and death from
influenza. In the joint press release referenced above, the CDC and
National Institutes of Health (NIH) continue to support the ACIP
recommendation that people aged 65 and older get vaccinated against
influenza each year.
C. Pneumococcal Disease Incidence and Prevention
Like influenza, invasive pneumococcal disease is particularly
prevalent and severe in those 65 years and older. This population is at
high risk of contracting invasive pneumococcal disease, with a high
risk of resultant complications, hospitalizations, and deaths.
Pneumococcal immunizations are effective in preventing pneumococcal
disease in this population.
According to CDC's Active Bacterial Core Surveillance for
pneumococcal disease, approximately 5,700 deaths from invasive
pneumococcal disease (bacteremia and meningitis) are estimated to have
occurred in the United States in 2002 (http://www.cdc.gov/ncidod/dbmd/abcs/survreports/spneu02.pdf
). An article in the American Journal of
Preventive Medicine, August 2003, titled ``Standards for Adult
Immunization Practices,'' notes that overall, vaccine
[[Page 58837]]
effectiveness against invasive pneumococcal disease among
immunocompetent people aged 65 years is 75 percent. Based on 1998
projections, annually, 76 percent of invasive pneumococcal disease
cases and 87 percent of resulting deaths occurred in people who were
eligible for pneumococcal vaccine in the United States. (http://www.cdc.gov/nip/recs/rev_stds_adult_AJPM.pdf
).
The ACIP and CDC recommend immunization for pneumococcal disease
for those 65 years old or older, and for people with a serious long-
term health problem, such as heart disease, diabetes, or
immunosuppression due to disease, organ transplantation, or medical
treatment such as chemotherapy. The American Lung Association warns
that people considered at high risk for invasive pneumococcal disease
include the elderly, the very young, and those with underlying health
problems, such as chronic obstructive pulmonary disease (COPD).
Patients with diseases that impair the immune system, such as AIDS, or
patients with other chronic illnesses, such as asthma, or those
undergoing cancer therapy or organ transplantation, are particularly
vulnerable.
According to CDC recommendations, usually one dose of the PPV is
all that is needed to prevent pneumococcal disease or a person only
needs to be immunized once in a lifetime. However, a second dose is
recommended for people 65 and older who received their first dose prior
to 65 years of age, if five or more years have passed since that dose.
A second dose is also recommended for people with a damaged spleen or
without a spleen, sickle-cell disease, HIV infection or AIDS, cancer,
leukemia, lymphoma, multiplemyeloma, kidney failure or nephrotic
syndrome, an organ or bone marrow transplant, or who are taking
medication that lowers immunity (such as chemotherapy or long-term
steroids).
Accordingly, we believe it vital that facilities secure the consent
of their residents or legal representative for vaccination and provide
their residents with vaccinations. Educating residents about the
advantages of being vaccinated allows residents to understand the
benefits of pneumococcal vaccines. The 1997 ACIP recommendations state
that, ``Pneumococcal polysaccharide vaccine generally is considered
safe based on clinical experience since 1977, when the pneumococcal
polysaccharide vaccine was licensed in the United States. Approximately
half of the persons who receive pneumococcal vaccine develop mild,
local side effects (for example, pain at the injection site, erythema,
and swelling). These reactions usually persist for less than 48 hours.
Moderate systemic reactions (for example, fever and myalgias) and more
severe local reactions (for example, local induration) are rare. Severe
systemic adverse effects (for example, anaphylactic reactions) rarely
have been reported after administration of pneumococcal vaccine. In a
recent meta-analysis of nine randomized controlled trials of
pneumococcal vaccine efficacy, local reactions were observed among
approximately one third or fewer of 7,531 patients receiving the
vaccine, and there were no reports of severe febrile or anaphylactic
reactions.'' The 1997 ACIP recommendations further stated that
pneumococcal vaccination has not been causally associated with death
among vaccine recipients. Additional information about precautions and
contraindications can be obtained from the CDC. The vaccine
manufacturer's package insert may also be reviewed for more
information. See: (http://www.cdc.gov/mmwr/preview/mmwrhtml/00047135.htm#00002349.htm
).
CDC's March 24, 2000 MMWR states that in recent years, a rapid
emergence of antimicrobial resistance among pneumococci, especially to
penicillin, has occurred. Increasing pneumococcal vaccination rates
could help prevent invasive pneumococcal disease caused by vaccine-
type, multidrug-resistant pneumococci. Outbreaks of pneumococcal
disease caused by a single drug resistant pneumococcal serotype have
occurred in institutional settings, including nursing homes. The same
MMWR report notes that in 1999, because of concerns about pneumococcal
antimicrobial resistance and under use of pneumococcal vaccine, the
American Medical Association and several partner organizations issued a
Quality Care Alert that supports ACIP's recommendations for
pneumococcal vaccination. (Use of Standing Orders Programs to Increase
Adult Vaccination Rates: MMWR 2000/49 RR01 15-26 March 24).
A CMS/CDC report, ``Respiratory Disease Burden in Nursing Homes''
(http://www.nationalpneumonia.org/sop/RDBNH_INTERIMProjectRpt_1-31-03.pdf
) notes that both influenza vaccine and PPV are protective to
residents in nursing homes. Based on two years of analysis
(multivariate/multilevel), influenza vaccine may be associated with a
27 to 35 percent reduction in mortality, and a 44 to 52 percent
reduction in all-cause hospitalization. Similarly, pneumococcal
vaccination may be associated with a 20 to 26 percent reduction in
mortality, and a 12 to 28 percent reduction in all-cause
hospitalization in nursing home residents. The report also suggests
that a facility-level influenza vaccination of 80 percent of residents
may be independently associated with reduced patient hospitalization
and death.
D. Why a Change in the Conditions of Participation Is Needed
In January 2000, the Department of Health and Human Services
launched Healthy People 2010, a comprehensive, nationwide health
promotion and disease prevention campaign. ``Immunizations and
Infectious Diseases'' is one of the focus areas. Healthy People 2010
set the target rate for influenza and PPV vaccination of adults aged 65
years and older at 90 percent. According to CMS's Adult Immunization
Project ``despite the fact that influenza and pneumococcal vaccines are
clinically effective, cost-effective, and are Medicare Part B covered
benefits, they remain underutilized.'' (http://www.ofmq.com/ user--
uploads/ National%20Immunization%20 Project.pdf).
Based on the 1999 National Nursing Home Survey, only 66 percent of
nursing home residents had received the influenza vaccine in the
previous year and only 38 percent had ever had the pneumococcal
vaccine. The October 2004 article in the American Family Physician
titled ``Pneumonia in Older Residents of Long-Term Care Facilities''
noted that,'' when compared to persons in the overall community,
residents in LTC facilities have more functional disabilities and
underlying medical illnesses and are at increased risk of acquiring
infectious diseases (http://www.aafp.org/ afp/20041015/1495.html). Risk
factors include un-witnessed aspiration, sedative medication, and co-
morbid illnesses. Influenza-associated mortality is a major concern for
persons with chronic diseases; this mortality increase is most marked
in persons 65 years of age or older, with more than 90 percent of the
deaths attributed to pneumonia and influenza occurring in persons of
this age group.
As noted in the October 15, 2004 article, ``Pneumonia in Older
Residents of Long-Term Care Facilities'' in the journal American Family
Physician, ``The number of frail older adults living in LTC facility is
expected to increase dramatically over the next 30 years.'' (http://www.aafp.org/
afp/20041015/1495.html). The article further states
[[Page 58838]]
that an estimated 40 percent of adults will spend some time in a LTC
facility before dying. Unless control measures are more vigorously
implemented, the number of deaths from influenza and pneumonia with
respect to residents in LTC facilities and the number of consequent
complications might increase significantly.
In summary, immunizations save lives and can help avoid needless
suffering and unnecessary costs of complications from various
infectious diseases, and, as many family members and health care
workers know, they can prevent the spread of infection to others.
However, despite the availability of safe and effective vaccines,
substantial portions of susceptible adults are not being immunized. To
reduce morbidity and mortality rates, delivering appropriate
vaccinations in a timely manner is vital. This rule is expected to
facilitate the delivery of appropriate vaccinations to residents in LTC
facilities in a timely manner and increase vaccination rates, thereby
decreasing the morbidity and mortality rate of influenza and
pneumococcal diseases in this population. This rule also has the
potential to reduce overall healthcare costs by reducing the need for
the treatment of influenza and pneumococcal diseases and their
complications.
E. Immunizations and LTC Facilities
According to a June 2002 CDC summary of the National Nursing Home
Survey, 46,000 nursing home residents (2.5 percent) had pneumonia in
1999. The average length of stay in a LTC facility for a resident with
pneumonia as the primary diagnosis was 124 days in 1999 (http://www.cdc.gov/
nchs/data/ series/sr-- 13/sr13--152.pdf).
A November 2000 article in the journal Infection Control and
Hospital Epidemiology titled ``Increasing Pneumococcal Vaccination
Rates Among Residents of Long-Term Care Facilities,'' noted that there
were 1,590,763 individuals over 65 years of age residing in LTC
facilities in the United States in 1990, and the number is estimated to
grow to 2.9 million by 2020 (Infection Control and Hospital
Epidemiology, Volume 21 (11) (705-710) November 2000). A substantial
increase in vaccination rates among such a large population will
decrease the number of cases of influenza and pneumococcal bacteremia
and related death.
A 1999 RAND report stated that the proportion of the U.S.
population over age 65 had increased from 5 percent in 1900 to 13
percent in 1997. This change in demographics, combined with an increase
in average life expectancy, has highlighted the importance of
preventive care services for older individuals. The October 1997
Journal of the American Medical Association (JAMA) article ``Cost-
Effectiveness of Vaccination Against Pneumococcal Bacteremia Among
Elderly People'' indicated that vaccination of elderly people against
pneumococcal bacteremia is one of the few interventions that have been
found to both improve health and save medical costs. Vaccination both
reduced medical expenses and improved health for the overall age group
of 65 years and older (JAMA; Chicago; Oct 22-Oct 29 1997; 278; 16; Jane
E Sisk; Alan J Moskowitz; William Whang; Jean D Lin et al). The article
further noted ``Vaccination of the 23 million elderly people
unvaccinated in 1993 would have gained about 78,000 years of healthy
life and saved $194 million.''
Overall, the literature supports increasing pneumococcal
immunizations. Pneumococcal vaccination saves health care dollars by
preventing bacteremia alone and is greatly underused among the elderly
population. These results support both recent recommendations of the
ACIP as well as public and private efforts to increase vaccination
rates.
F. Vaccine Shortages
In the Fall of 2004, there was a major shortage of inactivated
influenza vaccine in the United States. One of the major manufacturers
of the influenza vaccine informed the CDC in early October 2004 that
none of its flu vaccine would be available for distribution in the
United States. Because of the shortage, Federal health officials
released new guidelines as to whom should receive a flu vaccine,
describing those at high-risk of influenza-related health complications
as priority groups. At that time, the interim recommendations from the
CDC stated that people 65 and older, as well as all those between the
ages of 2 to 64 with chronic medical conditions and 6-23 month old
children, were to be prioritized for receiving influenza vaccination.
Another group deemed a priority was the population residing in nursing
homes.
We understand that providers of LTC services may be concerned about
how they will meet the requirements of this regulation should an
influenza vaccine shortage occur in the future. The September 2, 2005
MMWR, ``Update: Influenza Vaccine Supply and Recommendations for
Prioritization During the 2005-06 Influenza Season,'' states that both
influenza vaccine distribution delays and vaccine supply shortages have
occurred in the United States in three of the last five influenza
seasons. In response, prioritization has been implemented in previous
years to ensure that enough influenza vaccine is available for those at
the highest risk for complications. In the case of a true vaccine
shortage as declared by HHS, CMS would exercise its enforcement
discretion by instructing the State Survey Agencies (SSAs) not to take
enforcement actions against facilities that are out-of-compliance with
this requirement if they were unable to obtain vaccine for their
residents.
G. Requirements for Issuance of Regulations
Section 902 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) amended section 1871(a) of the Act and
requires the Secretary, in consultation with the Director of the Office
of Management and Budget, to establish and publish timelines for the
publication of Medicare final regulations based on the previous
publication of a Medicare proposed or interim final regulation. Section
902 of the MMA also states that the timelines for these regulations may
vary but shall not exceed 3 years after publication of the preceding
proposed or interim final regulation except under exceptional
circumstances.
This final rule finalizes proposed provisions set forth in the
August 15, 2005 proposed rule (70 FR 47759), after considering public
comments. In addition, this final rule has been published within the 3-
year time limit imposed by section 902 of the MMA. Therefore, we
believe that the final rule is in accordance with the Congress' intent
to ensure timely publication of final regulations.
II. Provisions of the Proposed Rule
On August 15, 2005, we published a proposed rule in the Federal
Register (70 FR 47759) to respond to the ACIP recommendations on
``Prevention and Control of Influenza'' (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5306a1.htm
), as well as to promote the DHHS Healthy
People 2010 goals for increasing immunization rates. Specifically, the
ACIP outlined the requirements for a successful vaccination program
including combined publicity and education for health-care workers and
other potential vaccine recipients; a plan for identifying persons at
high risk; and efforts to remove administrative and financial barriers
that prevent persons from receiving the vaccines, including use of
[[Page 58839]]
standing orders programs. Based on the ACIP recommendation, we proposed
the following requirements for LTC facilities at Sec. 483.25(n):
Require LTC facilities to offer each resident immunization
against influenza October 1 through March 31 annually, and facilities
must also offer (without a specified timeframe) lifetime immunization
against pneumococcal disease. A second immunization may be given under
certain circumstances.
Require documentation in the resident's medical record
indicating the resident's influenza and pneumococcal immunization
status including whether influenza and pneumococcal immunizations were
medically contraindicated and whether the influenza and pneumococcal
immunization were refused. If refused, the record must indicate that
the resident or his/her representative received appropriate education
and consultation.
III. Analysis of and Responses to Public Comments
We received 61 comments from individuals, physicians, nurses,
hospitals, long term care facilities, health care associations,
pharmacy associations and state agencies. All comments were reviewed
and analyzed. After associating like comments, we placed them in
categories based on subject matter. Summaries of the public comments
received and our response to those comments are set forth below.
General
Many commenters supported the proposed requirements. We also
received comments suggesting changes in the rule (for example, to
protect residents' rights), and we received requests for clarification
of various issues. In addition, some commenters said they did not
believe the rule was necessary, and some commenters believed the rule
could be harmful to LTC facility residents. The comments and our
responses are listed below.
Comment: Many commenters supported our proposed immunization rule,
which would mandate offering influenza and pneumococcal vaccines to all
residents of LTC facilities. The commenters cited the major impact that
both influenza and pneumococcal diseases have on LTC residents. One
commenter noted, ``We consider this Proposed Rule to be of critical
importance to the long-term care provider community and to the
recipients of nursing facility services, all of whom are entitled to
the ongoing provision of optimal care and services.'' Another commenter
supported the rule because ``* * * the prevention of influenza and
pneumococcal disease is both cost effective and good practice. Simply
put, it is the right thing to do!'
Response: We appreciate commenters recognizing the positive impact
of immunizations on the health of LTC residents.
Comment: Some commenters stated that the influenza vaccine is
contaminated with thimerosal (a vaccine preservative containing
mercury), aluminum, or bacteria. One commenter stated that ``until the
flu shots are cleaned up (at least mercury and aluminum removed) it is
madness to even administer them to long term care patients.'' The
commenter suggested instead investing in building immunity with raw and
fermented food. Another commenter mentioned the influenza vaccine that
was manufactured in England in 2004 and expressed concern about future
bacterial contamination of influenza vaccine.
Response: Some people believe that the mercury in thimerosal, a
preservative used in some vaccines, has caused autism in children.
Although researchers so far have found no evidence of a connection
between the use of thimerosal in vaccines and autism, research is
continuing. In 1999 at the urging of the U.S. Public Health Service and
the American Academy of Pediatrics, vaccine manufacturers agreed to
reduce or eliminate thimerosal in pediatric vaccines. However, the FDA
requires manufacturers to include a preservative in all vaccines
distributed in multi-dose vials to prevent bacterial contamination of
the vaccine. Since most injectable influenza vaccine is dispensed in
multi-dose vials, most influenza vaccine contains thimerosal.
Nevertheless, according to the CDC, there is no convincing evidence of
harm caused by the low doses of thimerosal in vaccines, except for
minor reactions like redness and swelling. Pneumococcal vaccine does
not contain thimerosal. Influenza and pneumococcal vaccines do not
contain aluminum. The CDC points out that, ``Vaccines are held to the
highest safety standards.''
We note that FDA found the influenza vaccine manufactured in
England in 2004 to be unsuitable for use, and the vaccine never reached
the market.
Comment: One commenter asks ``Does anyone remember when President
Ford got on TV to propagandize the masses into getting the Swine Flu
vaccine?'' The commenter said that lives were ruined due to Guillain-
Barr[eacute] Syndrome caused by a vaccine that was supposed to protect
them.
Response: According to the CDC, ``In 1976, swine flu vaccine was
associated with a severe temporary paralytic illness called Guillain-
Barr[eacute] Syndrome (GBS) http://www.cdc.gov/nip/vacsafe/concerns/gbs/default.htm
.
Influenza vaccines since then have not been clearly linked to GBS,
although research suggests a small risk of the syndrome was associated
with the influenza vaccines in 1992-1993 and 1993-1994. However, if
there is a risk of GBS from current influenza vaccines, it is estimated
at 1 or 2 cases per million persons vaccinated * * * much less than the
risk of severe influenza, which can be prevented by vaccination.''
Comment: A few commenters charged that the influenza vaccine can
cause the flu or other illnesses and may even cause death. Some
provided anecdotal information about becoming ill after receiving a flu
shot or said that an elderly parent had died after receiving a flu
shot. One commenter said that some individuals have experienced severe
reactions after receiving more than one pneumococcal immunization. One
commenter raised the issue of the ``substantial injuries and medical
costs that inevitably occur from mass vaccination.''
Response: Both the influenza and pneumococcal vaccines are
inactivated, that is, the virus in the vaccine has been killed;
therefore these vaccines cannot cause influenza or pneumonia. We note
that Flu Mist uses a live vaccine; however, it is not indicated for use
in the elderly. The CDC has stated, ``Most people who receive vaccines
experience no, or only mild, reactions such as fever or soreness at the
injection site. Very rarely, people experience more serious side
effects, like allergic reactions * * * life-threatening allergic
reactions are very rare,'' particularly in relation to influenza
vaccines. The 1997 ACIP recommendations state that pneumococcal
vaccination has not been causally associated with death among vaccine
recipients. As we stated in the preamble to the proposed rule ``In a
meta-analysis of nine randomized controlled trials of pneumococcal
vaccine efficacy, very few local reactions were observed, and there
were no reports of severe febrile or anaphylactic reactions.'' The CDC
article further states that, influenza and invasive pneumococcal
disease kill more people in the United States each year than all other
vaccine-preventable diseases combined. Therefore, the benefits of
immunizations outweigh the small number of significant adverse effects
observed after immunizations are administered.
[[Page 58840]]
Comment: Many commenters stated that nursing home residents must be
able to refuse immunizations. One commenter said, ``Seniors should not
be forced to be immunized since they are free sovereign individuals who
are capable of making their own decisions on such matters.'' Another
commenter said that forced vaccination of American citizens is
unconstitutional. One commenter expressed the fear that there would be
reprisals against residents who refused or whose representatives
refused immunization, including being refused treatment or being forced
to leave the nursing home.
Response: We agree with the commenters that residents of LTC
facilities have the right to refuse immunizations. In fact, the
existing Conditions of Participation (CoP) at Sec. 483.10(b)(4) state
that residents of LTC facilities have the right to refuse treatment. On
admission to an LTC facility, residents or their representatives are
given written documentation about their right to refuse any medication
or treatment. We have further emphasized this right in the text of the
final rule, which states, ``The resident or the resident's legal
representative has the opportunity to refuse immunization.''
Nevertheless, the final rule requires every facility to offer
immunization because a goal of the rule is to prevent the spread of
preventable illness. In addition, in accordance with Sec.
483.10(b)(4), residents have the right to refuse treatment. Therefore,
facilities would not force any resident who refuses to be immunized to
receive the vaccine. The benefits of immunization are evidenced in
numerous studies referenced by the CDC in the Morbidity and Mortality
Weekly Report (MMWR), which show that: (1) persons 65 years and older
are at high risk of contracting influenza, (2) they are more likely
than the general population to need hospitalization or to die from
complications of influenza, and (3) immunizations are effective in
preventing influenza and its complications in this population. (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5306a1.htm
).
Comment: Some commenters stated that this rule is based on
``pharmaceutical company propaganda,'' and it is for their benefit. One
commenter stated that pharmaceutical companies have a strong influence
over U.S. lawmakers and that drug companies spend millions in campaign
contributions. Another commenter stated that ``preying upon
unsuspecting seniors whose care families have entrusted to long term
care facilities to the financial benefit of pharmaceutical companies is
criminal.'' Another commenter stated that ``vaccination is the
quintessential form of medical quackery in our day and age and is
causing untold damage to health, wellbeing and prosperity for all
except those who profit from its use.''
Response: The goal of this rule is to protect the health of LTC
facility residents using a proven preventive measure to stop the spread
of infection and reduce morbidity and mortality. The rule is not being
published based on ``propaganda from pharmaceutical companies,'' but on
data and evidence that the CDC and many other researchers have provided
to the public and health care communities. The ACIP reported on May 28,
2004 that epidemics of influenza have been responsible for an average
of approximately 36,000 deaths per year in the United States between
1990 and 1999. It stated that there is an added danger when it comes to
people age 65 or older or with high risk conditions such as individuals
residing in long term care facilities. According to the January 1, 2002
article in American Family Physician, a number of studies have also
shown that nursing homes with high rates of vaccinated residents have
fewer outbreaks of influenza than nursing homes with lower vaccination
rates. The article further states that many studies have shown that
influenza vaccination of nursing home residents and staff can
significantly decrease rates of hospitalization, pneumonia, and related
mortality.
Consent for immunization
Comment: Many commenters stated that before an immunization is
given to a resident, informed consent must be obtained. Other
commenters specified that a resident's consent should be in writing.
One commenter referenced an article, ``The moral right to
conscientious, personal belief or philosophical exemption to mandatory
vaccination laws'' by Barbara Loe Fisher, (http://www.nvic.org/Loe-Fisher/blfstmt052097.htm
) which states that ``The National Vaccine
Information Center has not advocated the abolishment of vaccination
laws as other groups have proposed. However, we have always endorsed
the right to informed consent as an overarching ethical principle in
the practice of medicine for which vaccination should be no
exception.''
Response: We agree it is vital that facilities secure the informed
consent of their residents or legal representatives for vaccinations
before they are administered. Therefore, we would require that the
facilities document the resident's immunization status and related
information in the resident's medical record. Moreover, we are
requiring LTC facilities to ensure that before offering the
immunizations, each resident or resident's representative receives
education regarding the benefits and potential side effects of
influenza and pneumococcal immunizations. This final rule clearly
states that the resident or the resident's representative has the right
to refuse the immunization.
Comment: Under the proposed rule, we would have required facilities
to educate residents or their representatives about immunization only
if immunization were refused. Some commenters stated that educating
residents or their representatives on the risks and benefits of
immunization prior to giving the immunization is important, too. One
commenter said that a more effective way to educate residents is to
present the information upon admission. The commenter said, ``This
avoids the impression that the facility is trying to talk the resident
into receiving a vaccination that the resident does not want.''
Response: We agree that it is important to provide education prior
to immunization. Therefore, this final rule requires LTC facilities to
educate all residents or resident's representation on the benefits and
potential side effects of the influenza and pneumococcal vaccinations
before offering immunization. At the discretion of the facility, this
education can be provided at any time, including upon admission to the
facility, as long as the education is provided before the immunizations
are offered.
Comment: One commenter asked for clarification of the intent of the
proposed requirement for ``consultation'' with residents who refused
immunization.
Response: We proposed a requirement for education and consultation
in the proposed rule if immunization is refused. This final rule does
not contain a specific requirement for consultation with residents or
their representatives if immunization is refused. Instead, LTC
facilities are required to provide education about immunization to all
residents. We removed the word ``consultation'' so as not to confuse
facilities.
Comment: Commenters had several suggestions to ensure residents
receive adequate education about the immunizations. Some commenters
said we should specify that residents must receive educational
information in writing.
[[Page 58841]]
Response: We are providing flexibility to the facilities on how
they provide educational information to the residents or their
representatives. It is important to note, however, that all health care
providers are required by the National Childhood Vaccine Injury Act to
provide vaccine information sheets (VISs) prior to immunization. These
sheets contain a wealth of information. For example, the influenza VIS
explains how flu is spread, the symptoms, the potential complications,
what types of flu vaccines are available (including vaccines with and
without the preservative thimerosal), how the vaccines work, who should
be vaccinated, contraindications to vaccination, and the risk of
developing a reaction (including rare but life-threatening allergic
reactions and Guillain-Barre Syndrome). Single camera-ready copies of
the vaccine information materials are available from State health
departments. Copies are also available on the CDC Web site at http://www.cdc.gov/nip/publications/VIS.
Copies are available in English and
in other languages. Instructions for using the vaccination information
sheets can be found at http://www.cdc.gov/nip/publications/VIS/vis-instructions.txt.
Facilities may choose to use the VIS documents as a
means of providing education. Note that the National Vaccine Injury
Compensation program (NVICP) requires Vaccine Information Statements
(VIS) be provided to patients or their legal representatives, once a
vaccine is in the program and a final VIS has been developed. The NVICP
provides compensation to adults as well as children for adverse events
related to vaccines covered by the program. To date, pneumococcal
vaccine is not in the program and although influenza vaccine is, the
final VIS will not be available until approximately October.
Comment: One commenter asked for clarification of the word
``consent'' and stated that the Vaccine Information Sheet (VIS) can be
given to the resident or his or her representative and documented in
the medical record to fulfill the requirement for informed consent.
Special written consent is not required for vaccination, according to
the commenter.
Response: We agree that a special written consent is not necessary
for vaccinations. As stated in the previous response, the National
Childhood Vaccine Injury Act (``the Act'') requires health care
providers to provide a current, relevant vaccination information sheet
(VIS) produced by the CDC prior to giving immunizations to children or
adults for diphtheria, tetanus, pertussis, measles, mumps, rubella,
polio, hepatitis B, Haemophilus influenzae type b (Hib), varicella
(chickenpox), or pneumococcal conjugate vaccinations (effective 12/15/
02). Additionally, the Act requires health care providers to make a
notation in each patient's permanent medical record at the time vaccine
information materials are provided indicating: (1) The edition date of
the materials distributed and (2) the date these materials were
provided as per CDC's requirements.
Comment: One commenter stated that verbal discussion with the
resident or the resident's representative may be a problem if the
resident is cognitively impaired and the representative lives out of
state or is difficult to reach.
Response: We understand that providing education prior to offering
influenza and pneumococcal immunizations and obtaining consent may be
difficult under some circumstances. However, as with other procedures
that take place in LTC facilities, facilities should make a reasonable
effort to obtain consent.
Documentation
Comment: One commenter stated that CMS should consider implementing
a mechanism for residents or their representatives to indicate if they
received immunizations within the recommended time frame. Another
commenter stated CMS should create a system that ensures that accurate
immunization information is captured.
Response: We appreciate the comment. CMS is working on adding the
immunization information in the MDS 3.0 version and that will be a
source to capture accurate immunization information for each resident
in the nursing facility. The other elements of resident's medical
record would also be a potential source for information. Another source
of information would be individual State immunization registries.
Comment: One commenter pointed out that it can be difficult or
impossible to obtain a complete immunization history for some LTC
facility residents. The commenter said that most residents have some
degree of cognitive impairment and may not be able to provide a
history. Family members or friends may be unavailable or unaware of a
resident's immunization history.
Response: We agree that there may be difficulties in obtaining the
history of immunizations especially in the case of cognitively impaired
residents. However, we expect that facilities will make reasonable
efforts to obtain immunization histories for their residents.
Comment: One commenter pointed out that it can be difficult or
impossible to obtain a complete immunization history for some LTC
facility residents. The commenter said that most residents have some
degree of cognitive impairment and may not be able to provide a
history. Family members or friends may be unavailable or unaware of a
resident's immunization history.
Response: We agree. This final rule does not contain language
requiring LTC facilities to obtain and document complete immunization
histories for all residents. However, we expect that facilities will
make reasonable efforts to obtain immunization histories for their
residents to avoid giving unnecessary immunizations.
Comment: A few commenters pointed out that individual facilities,
must have the flexibility to develop their own protocols for
immunization and their own formats for documentation. One commenter
said they we should specify that the medical records of residents who
are immunized should be documented with the name and lot number of the
vaccine, the quantity given, the route of administration, the date, and
the signature of the person who administers the vaccine.
Response: We agree that facilities must have some flexibility in
implementing the requirements. The final rule dictates neither the
protocols that need to be in place nor the format for documentation.
However, facilities will need to be able to demonstrate to State agency
surveyors that they have an immunization protocol and that they have
documentation for each resident to show that they have educated
residents or their representatives and offered influenza and
pneumococcal immunizations. Additionally, we expect that facilities
will follow standard practice and when an immunization is given,
document the type of vaccine, the lot number, and other pertinent
information per facility policy.
Vaccine Availability
Comment: Some commenters stated that the final rule should indicate
that if a shortage or substantial delay in vaccine supply occurs, SNFs
and nursing homes will be automatically exempt from compliance with
this CoP during the shortage period.
Response: We understand that providers of LTC services are
concerned about meeting the requirements of this regulation if an
influenza vaccine shortage occurs in the future. In the case of a
vaccine shortage as declared by HHS or documented local or regional
shortages, CMS could exercise its enforcement discretion by instructing
[[Page 58842]]
State Survey Agencies (SSAs) not to take enforcement action against LTC
facilities that are out of compliance with this requirement if the
facilities were unable to obtain vaccine for their residents. We do not
agree that the final rule should include an exemption for all LTC
facilities, because situations and vaccine availability may vary across
the country. We expect that the SSA would need to verify that a
facility was unable to meet the requirement due to a shortage before
determining that enforcement action was not warranted.
Comment: One commenter said that CMS regards a vaccine shortage as
the only relevant variable in exercising enforcement discretion to
alter its mandated immunization of LTC residents. The commenter argued
that a mandate to immunize a target population annually is not an
essential feature of a responsible flu prevention and control strategy
because a new influenza prevention and control strategy must be
tailored to the distinctive characteristics of each year's influenza
strain; the types, effectiveness, and availability of potential
preventive and other interventions; and other practical and ethical
considerations. The commenter said that, in some years, there might be
a better way to protect LTC residents from influenza than achieving a
target vaccination rate. Further, there might be another subgroup for
which access to the influenza vaccine is more scientifically and
ethically justified.
Response: We agree that each new flu season presents a challenge in
terms of how best to prevent and control the spread of influenza
throughout the U.S. population. We will carefully consider CDC's annual
guidance on an ongoing basis to determine whether to exercise our
enforcement discretion for reasons other than a vaccine shortage. In
addition, in contemplating future rulemaking, we will consider whether
there are additional interventions that facilities should put into
place to protect their residents from influenza.
Staff Immunization
Comment: A few commenters stated that staff in LTC facilities need
to be immunized. One commenter pointed out that emerging data indicate
that the best protection for the LTC population is to prevent exposure
by immunizing health care providers and visitors to the facilities.
Response: We agree that it is very important for health care
workers to be immunized. In fact, CMS conditions of participation
(CoPs) for nursing facilities (NFs) at 42 CFR 483.65 require nursing
facilities (NF) to establish and maintain an infection control program
designed to prevent the development and transmission of disease and
infection. The CDC recommends that all health care workers be immunized
annually. The Occupational Safety and Health Administration (OSHA)
strongly supports the CDC guidelines for immunization of health care
workers. OSHA's mission is to assure the safety and health of America's
workers by setting and enforcing standards; providing training,
outreach, and education; establishing partnerships; and encouraging
continual improvement in workplace safety and health. OSHA has placed
links to the CDC guidelines on immunization on the OSHA Web site at
http://www.cdc.gov/flu/professionals/vaccination/hcw.htm and http://www.cdc.gov/flu/index.htm.
We are not requiring health care workers be
equiring health care workers be
adequate incentives for LTC facilities to develop immunization
protocols for their health care workers.
Comment: One commenter stated that CMS should address the
commenter's concern that student nurses are not covered under the OSHA
blood borne pathogens requirements for hospitals.
Response: We agree that it is important for health care workers to
be immunized in order to protect residents. OSHA seeks to assure the
safety and health of America's workers by setting and enforcing
standards; providing training, outreach, and education; establishing
partnerships; and encouraging continual improvement in workplace safety
and health. As indicated above, we require nursing facilities to take
steps to prevent staff transmission of disease. These requirements
apply to all staff, whether or not they are students.
Payment and Coverage
Comment: One commenter stated that after publishing the final
regulation and paying for the program for a year or two, Medicare might
decide that the LTC facilities should be responsible for the
immunizations and stop paying for them.
Response: In accordance with section 1861(s)(10) of the Social
Security Act, Medicare covers both influenza and pneumococcal vaccines.
Medicare began covering annual influenza immunizations in 1993 for
Medicare beneficiaries. Medicare covers both the costs of the vaccine
and its administration. There is no coinsurance or co-payment applied
to this benefit, and a beneficiary does not have to meet his or her
deductible to receive this benefit. Medicare began covering
pneumococcal polysaccharide vaccinations in 1981. Medicare provides
coverage for one pneumococcal polysaccharide vaccine per beneficiary.
One vaccine at age 65 generally provides coverage for a lifetime, but
for some high risk persons, a booster vaccine is needed. Medicare will
cover a booster vaccine for high risk persons if 5 years have passed
since the last vaccination. Medicare covers both the costs of the
vaccine and its administration. There is no coinsurance or co-payment
applied to this benefit, and a beneficiary does not have to meet his or
her deductible to receive it. These programs are described in detail on
the CMS Web site (http://www.cms.hhs.gov/preventiveservices/2.asp). The
Medicare reimbursement for influenza and pneumococcal immunizations has
never been decreased or denied since it was started; in fact, payment
amounts have increased. The 2005 influenza vaccination administration
reimbursement rate is $18 (unweighted average of Medicare ``National
Flu Biller Administration Codes''). The 2005 Influenza vaccine
reimbursement rate is $10.10 (Medicare rate; 95 percent of Average
Wholesale Price (AWP)). Facilities that immunize their residents are
not only reimbursed by Medicare but also experience cost savings
because there is less illness among their residents.
Comment: A few commenters argued that it is wrong to withhold
Medicare payments to LTC facilities that do not provide flu and
pneumococcal immunizations to nursing home residents. One commenter
stated, ``I am frustrated that you would consider linking nursing home
payments to vaccinations.'' However, another commenter praised the
proposed rule as being ``well thought out'' and said that the rule,
``importantly, does not penalize the facility if the resident or the
resident's legal representative refuses immunization or there are
medical contraindications.''
Response: Several commenters misunderstood the proposed rule. This
rule does not penalize a facility financially if the resident or the
resident's representative refuses immunization. In this final rule, we
are making it clear that residents must be immunized unless there is a
medical contraindication or the resident or resident's legal
representative refuses. Therefore, if the LTC facility offers
immunization, but the resident refuses, this would not be considered
non-compliant.
Comment: One commenter recommended that CMS authorize
[[Page 58843]]
Medicare payments to SNFs for the outlier cost of intravenous
antibiotics.
Response: The cost of intravenous antibiotics to SNFs is not within
the purview of this regulation. SNFs are reimbursed as per the PPS
payment rates, which cover all costs of furnishing covered SNF services
(routine, ancillary, and capital-related costs).
Comment: One commenter stated that the nursing facilities should
have information on billing related to immunizations.
Response: Information and guidance about billing for influenza and
pneumococcal vaccinations, including electronic billing, is currently
available to all providers at: http://www.cms.hhs.gov/medlearn/flupdf.pdf.
Alternately, LTC facilities may contact their Medicare
Administrative Contractors.
Comment: One commenter stated that CMS should direct Quality
Improvement Organizations (QIOs) to increase immunization rates among
nursing home residents and staff as a part of the core activities in
the QIO Statement of Work with necessary additional funding apportioned
for these efforts.
Response: QIOs currently conduct projects focused on improving the
health of all Medicare beneficiaries. These projects include, for
example, efforts to improve diabetes care and the delivery of
mammography and adult immunizations (influenza and pneumococcal). The
goals of the adult immunization projects are to increase influenza and
pneumococcal immunization rates for Medicare beneficiaries and improve
treatment for pneumonia. Descriptions of these projects are available
on the Medicare Quality Improvement Center (MedQIC) Web site at (http://www.medqic.org
).
Comment: One commenter stated that CMS should encourage superior
performance on rates of resident and staff immunizations by posting
performance information on Nursing Home Compare and including such
measures as part of any LTC pay-for-performance.
Response: We appreciate the comment. Incentives for high
performance are beyond the purview of this rule. The MDS 3.0 is being
modified to include immunizations, and is part of our effort to collect
data that can be easily accessed for comparative study. Other efforts
may follow including posting of performance information on the Nursing
Home Compare Web site.
Comment: One commenter stated that we do not have enough data on
the number of LTC residents who have medical contraindications to
immunization or who refuse immunization to determine whether we need to
require facilities to offer immunization to all LTC residents. Another
commenter protested the burden associated with the rule and recommended
that immunization be a voluntary program.
Response: We agree that additional data would be useful. By
requiring documentation of these data in residents' medical records, we
expect to have the data available for reference in the future. However,
as we stated in the preamble of the proposed rule, studies indicate
that many LTC facility residents are not being immunized, despite the
fact that these services are covered by Medicare. It is clear that
voluntary immunization of residents is not adequate to ensure that all
residents are being offered immunization.
Comment: One commenter asks for clarification of the qualifications
of the person who educates the resident or their representative on
immunizations.
Response: We believe it is important to give LTC facilities the
flexibility to decide who will provide the education to the residents
or their representatives, based on the resources available at the LTC
facility. We are not requiring health care workers to be immunized in
this rule.
Comment: One commenter expressed concern that time constraints may
result in implementation problems for facilities that must have
policies and procedures in place by the effective date of the
regulation. The commenter also noted that the 15-day comment period was
not adequate for individuals and organizations to provide a thorough
response, especially for organizations that would like their comments
to reflect the opinions of their members.
Response: The rule was expedited and published with a 15-day
comment period so that it would be effective for the 2005-2006 flu
season. We believe this rule will save lives, and a delay in
implementation of the rule would greatly hinder increased immunization
of residents in LTC facilities before the onset of this year's
influenza season. Therefore, a 60-day comment period was considered
contrary to public interest. However, we understand that it may be
difficult for LTC facilities to have their policies and procedures in
place by the effective date of the rule. We expect facilities to begin
implementation of the rule and move their implementation forward as
quickly as possible. If surveyed by the State Survey Agency, they
should be ready to discuss with the surveyors their process and plans.
Since this rule is effective on publication, we expect surveyors will
survey for these requirements with the understanding that facilities
need a certain amount of time to fully implement the requirement.
Surveyors will take the time factor into consideration as they review
facilities for compliance with the CoPs.
Comment: Two commenters asked for clarification regarding what
facilities must do between October 1 and March 31. One commenter asked
whether influenza vaccination must be offered to a resident who is
admitted on March 31, even if the vaccine will not be administered
immediately because it is unavailable.
Response: We expect facilities to use common sense in regard to
residents admitted toward the end of March when supplies of the vaccine
may be limited or unavailable. If the vaccine is unavailable, then the
facility will not be able to vaccinate the new resident, and the
facility can document this in the resident's record.
Comment: One commenter said, ``Let the physicians make the medical
decisions. If inappropriate medical decision making then results in a
pandemic, only then would a Federal mandate be justified.''
Response: The purpose of immunization is to avoid illness or death.
The value of immunization is minimal once influenza is widespread.
Comment: One commenter recommended that CDC and CMS work
collaboratively to create an electronic health record that would
include standard immunization verification information for Medicare
beneficiaries.
Response: CMS is in the process of including immunization status of
all LTC facility residents in MDS 3.0. Also, on May 28, 2004, DHHS
awarded a grant to promote the use of electronic health records to
improve the quality of care provided to Americans by supporting a pilot
project to provide comprehensive, standardized electronic health record
(EHR) software to the health care community. In addition, DHHS has a
recently-appointed National Coordinator of Health Information
Technology, whose mission includes developing, maintaining, and
directing the implementation of a strategic plan to guide the
nationwide implementation of interoperable health information
technology in both the public and private health care. More information
can be found on the DHHS Web site at http://www.dhhs.gov.
Comment: One commenter stated that assisted living residents should
also be immunized because these high risk individuals fall under the
CDC's Advisory Committee on Immunization Practices (ACIP) priority
grouping.
[[Page 58844]]
Response: We agree; however, CMS does not have the statutory
authority, through the Medicare program, to regulate the care provided
in assisted living facilities. Generally, assisted living facilities
are regulated and monitored by the states in which they are located.
Comment: One commenter requested clarification in the final rule on
whether it applies to skilled nursing services provided in hospital
swing beds.
Response: This rule is a Condition of Participation for nursing
facilities and does not apply to skilled nursing services provided in
hospital swing beds. However, there is nothing to prevent hospitals
from immunizing this population.
Comment: One commenter said that our statement in the preamble
that, ``epidemics of influenza have been responsible for an average of
approximately 36,000 deaths per year in the United States between 1990
and 1999'' is incorrect because fewer than 10 percent of the 36,000
deaths were from the flu. The commenter's conclusion was that since
there are not very many deaths from influenza, immunization is not
needed.
Response: The commenter does not explain why the commenter thinks
the statistic we provided in the preamble to the proposed rule
overstates the number of deaths from influenza.
According to ``Prevention and Control of Influenza: Recommendations
of the Advisory Committee on Immunization Practices (ACIP)'' (MMWR 29
July 2005;54[RR08]:1-40), ``Influenza-related deaths can result from
pneumonia and from exacerbations of cardiopulmonary conditions and
other chronic diseases. Deaths of older adults account for > 90 percent
of deaths attributed to pneumonia and influenza. In one study of
influenza epidemics, approximately 19,000 influenza-associated
pulmonary and circulatory deaths per influenza season occurred during
1976-1990, compared with approximately 36,000 deaths during 1990-1999.
Estimated rates of influenza-associated pulmonary and circulatory
deaths/100,000 persons were 0.4-0.6 among persons aged 0-49 years, 7.5
among persons aged 50-64 years, and 98.3 among persons aged > 65 years.
In the United States, the number of influenza-associated deaths might
be increasing in part because the number of older persons is
increasing. In addition, influenza seasons in which influenza A (H3N2)
viruses predominate are associated with higher mortality; influenza A
(H3N2) viruses predominated in 90 percent of influenza seasons during
1990-1999, compared with 57 percent of seasons during 1976-1990.
Comment: One commenter stated that a recent study shows no
decreased morbidity or mortality from the flu, despite rising rates of
vaccination. One commenter specifically cited last year's data as
indicating that the flu vaccine is not effective.
Response: As referenced earlier in this preamble, the Simonsen
study published in September 2005 found an overall increasing trend in
the number of flu-related hospitalizations in the United States each
year, despite the fact that the number of immunizations for influenza
has increased. In response, the CDC has pointed out that (1) The range
of influenza-related illnesses analyzed in the study is broader than in
the previous study; (2) certain influenza viruses that predominated in
several recent influenza seasons are associated with higher numbers of
serious illnesses than other strains; (3) the U.S. population is
growing older and more vulnerable to developing severe complications;
and (4) during the 1990s influenza viruses have either circulated or
been detected for longer periods of time.
It is true that influenza vaccine is not as effective in the
elderly as it is in younger individuals. As discussed earlier in this
preamble, although influenza vaccine effectiveness varies in the
elderly, vaccination is still effective at preventing severe illness,
secondary complications, and death. Recommendations made by ACIP in
2004 state that in the elderly population residing in nursing homes,
the vaccine can be 50-60 percent effective in preventing
hospitalization or pneumonia and 80 percent effective in preventing
death, even though the effectiveness in preventing influenza illness
often ranges from 30 percent to 40 percent. A study published in Lancet
in September 2005 found that when used in nursing facilities, influenza
vaccines prevented up to 42 percent of deaths from influenza and
pneumonia.
Comment: One commenter asked whether Medicare Part B or Part D will
pay for the immunizations.
Response: As we stated earlier, immunization is covered under Part
B coverage, and Medicare will reimburse one flu vaccination per person
per season. This may result in more than one bill per 12-month period
across two flu seasons. Further information can be accessed online on
the ``immunizations toolkits'' Web page at (http://www.medqic.org).
Comment: One commenter requested that CMS provide policy guidance
with respect to immunizing residents who are receiving end-of-life
care. The commenter expressed concern about potential side effects in
residents who may have only weeks to live.
Response: We would expect that when a resident is receiving end-of-
life care, the resident's attending practitioner would decide whether
vaccination should be offered to the resident.
Comment: One commenter stated that we greatly underestimated the
burden associated with documentation because documenting immunization
in residents records will take more than 5 minutes.
Response: After further consideration of the time required for
documentation, we agree with the comment and have increased the
estimated amount of time in the burden estimate from 5 minutes to 10
minutes.
Comment: One commenter stated that influenza vaccine does not work
in the elderly because of their age.
Response: CDC states that ``persons with certain chronic diseases
might develop lower post vaccination antibody titers than healthy young
adults.'' It further states that the vaccine can also be effective in
preventing secondary complications and reducing the risk for influenza-
related hospitalization and death among adults aged >65 years with and
without high-risk medical conditions (for example, heart disease and
diabetes). Among older persons who do reside in nursing homes,
influenza vaccine is most effective in preventing severe illness,
secondary complications, and deaths. See http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5408a1.htm.
The CDC also provided the following
information in its discussion of the Simonsen study. Observational
studies, to date, have generally found that when the ``match'' between
the vaccine and circulating influenza strains is close, the vaccine is
30 percent-70 percent effective in preventing hospitalization for
pneumonia and influenza among elderly persons living outside chronic-
care facilities (such as nursing homes) and those persons with long-
term (chronic) medical conditions. Observational studies have also
found that among elderly nursing home residents, the flu shot can be 50
percent-60 percent effective in preventing hospitalization for
pneumonia and up to 80 percent effective in preventing death from the
flu. See http://www.amda.com/clinical/immunization/flustudy.htm.
Comment: One commenter was concerned that by including October 1 in
the regulation's text, facilities were being required to begin
immunizing residents on that date. The commenter further stated that if
the influenza
[[Page 58845]]
immunization is given too early in the flu season, the resident's
resistance may wane over time. The commenter also stated that
facilities are guided by CDC information on how many early flu cases
are occurring and that often, the best date to begin immunizing for the
flu is November 1.
Response: In choosing the October 1 through March 31 dates, we are
following the guidelines that CDC has provided for the beginning and
end of the flu season. Although flu season can begin as early as
October, facilities should follow CDC guidelines for each flu season to
determine the most efficacious time to begin immunizing their
residents. The CDC states in ``When to Get Vaccinated'' that October or
November is the best time to get vaccinated, but getting vaccinated
even later (before March 31) can still be beneficial.
Comment: One commenter expressed concern regarding possible
consequences that would result from a resident refusing immunization.
Response: The rule clearly gives the right to the residents and
their representatives to refuse immunization if they choose. Therefore,
there would be no adverse effect or consequence because of the refusal.
The existing CoP at 42 CFR 483.10 on resident rights, also provides
freedom of choice to the resident.
Comment: One commenter objected to the estimate of $5 million per
statistical life saved and stated ``While all life is sacred, placing
$5 million per life saved on someone likely to die in a few weeks or
months is exaggerated and unjustified. The commenter further stated
that the savings are grossly inflated through use of this estimate.''
Response: Five million dollars per statistical life saved is a
figure commonly used by Federal agencies. Although the age of the
affected population has been identified as an important factor in the
theoretical literature on the value of a statistical life (VSL), the
empirical evidence on age and VSL is mixed. In light of the continuing
questions over the effect of age on VSL estimates, OMB Circular A-4
recommends that agencies not use an age-adjustment factor in an
analysis using VSL estimates. We could have used an alternative
measure, such as statistical years of lives saved, but that would not
have changed the overall conclusion that the benefits of the rule are
substantial. In fact, the savings to Medicare alone are sufficient to
make the rulemaking cost-beneficial, therefore the choice of how to
value the lives saved due to this rulemaking is not decision critical.
Comment: One commenter stated that CMS, at the very least, should
describe within the rule a standardized format for obtaining required
documentation. This will protect the facility from liability and
provide a guide for surveyors.
Response: The final rule provides flexibility to the facilities on
how to document the information. This flexibility gives facilities the
opportunity to choose the process and format that works best for them.
Comment: One commenter expressed concern that by placing the
requirements of the rule in Sec. 483.25, rather than Sec. 483.65, the
facility could be subject to termination of the nurse aide training
program if documentation deficiencies are widespread and the facility
is found to be providing substandard care.
Response: We believe this new requirement is appropriately placed
under the ``Quality of Care'' CoP. It is more than just a documentation
requirement. The extent of the deficient practices found in meeting
this requirement during a survey will determine the type of enforcement
warranted.
Comment: One commenter wanted us to define a ``legal''
representative.
Response: As they implement the requirements of the rule, we expect
that facilities will be guided by the laws that pertain to the
definition of ``legal representative'' of the states in which the
facilities are located. Due to the variations in state law, we are not
defining the term ``legal representative.''
Comment: One commenter asked for clarification of the ``exception''
under (2)(iv), specifically the requirements for the assessment.
Response: We expect that the residents practitioner would decide on
the degree of assessment necessary to determine if a second
immunization is warranted in order to provide protection for the
resident.
IV. Provisions of the Final Regulations
For the most part, this final rule incorporates the provisions of
the proposed rule. The provisions of this final rule that differ from
the proposed rule are as follows:
1. Based on comments, LTC facilities must provide education to
residents or the resident's legal representative concerning influenza
and pneumococcal immunization prior to immunization. Further we
modified the regulation to include not just the benefits but also the
potential side effects of influenza and pneumococcal immunization when
education is provided to the resident or resident's legal
representative.
2. We have listed some of the minimum documentation requirements
and still provide the facilities the flexibility to document any
additional information they believe is relevant. (See
483.25(n)(2)(iv).)
V. Waiver of the 60-Day Delay in Effective Date
We ordinarily provide a 30-day delay in the effective date of the
provisions of a rule in accordance with the Administrative Procedure
Act (APA) (5 U.S.C. 553(d)), which requires a 30-day delayed effective
date. The Congressional Review Act (5 U.S.C. 801(a)(3)), requires a 60-
day delayed effective date for major rules. As stated in our regulatory
impact analysis below, we believe this is a major rule. However, we can
waive the delay in effective date if the Secretary finds, for good
cause, that such delay is impracticable, unnecessary, or contrary to
public interest, and incorporates a statement of the finding and the
reasons in the rule issued. 5 U.S.C. 553(d)(3); 5 U.S.C. 808(2).
The Secretary finds that good cause exists to implement the
requirements related to the LTC facilities offering each resident
immunization against influenza annually, as well as lifetime
immunization against pneumococcal disease immediately upon publication
in the Federal Register. In accordance with section 1871(b)(2)(C) of
the Act, we have waived the delay in the effective date for this final
rule from 60-day delay to an immediate effective date to allow for
implementation of the requirements in time for the 2005-2006 flu
season. It is our view that a 60-day delay in effective date on this
final rule will be extremely detrimental to the health of nursing home
residents, as epidemics of influenza typically occur during the winter
months and are responsible for an average of approximately 20,000 to
40,000 deaths per year in the United States. Influenza viruses also can
cause pandemics, during which rates of illness and death from
influenza-related complications can increase dramatically. Rates of
infection are highest among children, but rates of serious illness and
death are highest among persons 65 and older and persons of any age who
have medical conditions that place them at increased risk for
complications from influenza and pneumonia. Vaccines are the most
effective means to protect against many complications related to
influenza and pneumonia. The ACIP recommendations for 2004 to 2005, to
decrease the risk of influenza, state that the optimal time for
influenza vaccinations is October through
[[Page 58846]]
November. If expedited and published with an immediate effective date,
a delay can be prevented and the rule can be effective in the 2005-2006
flu season, with the potential of saving many lives and preventing
illness.
One of our goals of publishing this rule is to increase
immunization rates in nursing homes to 90 percent, which is the Healthy
People 2010 goal. This will enable about half a million elderly
individuals who are not currently immunized to be immunized. The CMS/
CDC standing orders project in 2003 found that in nursing home
residents, influenza vaccine is associated with a 31-33 percent
reduction in mortality, and a 38-45 percent reduction in all-cause
hospitalizations. Similarly, pneumococcal vaccination is associated
with a 21-22 percent reduction in mortality, and a 27-28 percent
reduction in all-cause hospitalization. We recognize that these
associations are not necessarily causal because the data are cross-
sectional with no correction for confounding variables. However, the
findings are consistent with findings regarding immunization in the
general population. Therefore, it is imperative that this final rule is
published with an immediate effective date so that the requirements can
be implemented in time for the 2005-2006 flu season. Even though
pneumococcal vaccines can be administered throughout the year, the
percentage of patients and residents immunized remains low. Therefore,
this final rule would be a vehicle to improve immunization rates and
would be consistent with the Healthy People 2010 objective.
We believe that a delay in implementation of this rule would
greatly hinder increased immunization of residents in LTC facilities
before the onset of this year's influenza season. We conclude that, in
this instance, a 60-day delay in effective date is unnecessary and
contrary to public interest. We find on this basis, that there is good
cause for waiving the 60-day delay in effective date under section
1871(b)(2)(C) of the Act.
VI. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on the following information
collection requirements contained in this document.
This rule does require facilities to develop specific
documentation. As a facility develops and implements immunization
protocols or procedures, we expect that obtaining previous immunization
history on each resident, when possible, would be a part of the
process. Additionally, we expect the facility would document in the
resident's medical record information concerning immunization history,
contraindications etc. as a part of the process of immunizing
residents.
The burden associated with these requirements in the first year,
would be approximately 10 hours of a registered nurse's time per
facility that is 161,390 hours for the first year (10 hours x 16,139
facilities). In subsequent years, we estimate that the burden
associated approximately 10 minutes of the registered nurse's time,
which would be 16,139,000 minutes = 268,983 hours per year (10 minutes
per resident x 100 residents per facility x 16,139 facilities). Based
on the latest data in an Online Survey Certification and Reporting
System (OSCAR), there are 16,139 facilities.
If you comment on these information collection and recordkeeping
requirements, please mail copies directly to the following: Centers for
Medicare & Medicaid Services, Office of Strategic Operations and
Regulatory Affairs, Regulations Development Group, Attn: Jim Wickliffe,
CMS-3198-F, Room C4-26-05, 7500 Security Boulevard, Baltimore, MD
21244-1850; and
Office of Information and Regulatory Affairs, Office of Management
and Budget, Room 10235, New Executive Office Building, Washington, DC
20503, Attn: Christopher Martin, CMS Desk Officer, CMS-3198-F,
Christopher_Martin@omb.eop.gov. Fax (202) 395-6974.
VII. Regulatory Impact
A. Overall Impact
We have examined the impacts of this rulemaking as required by
Executive Order 12866 (September 1993, Regulatory Planning and Review),
the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-
354), section 1102(b) of the Social Security Act, Executive Order 13132
(August 4, 1999, Federalism), the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4), and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Order 12866 directs agencies to issue regulations only
after consideration of all costs and benefits of available regulatory
alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety effects, distributive impacts,
and equity). A regulatory impact analysis (RIA) must be prepared for
rules with economically significant effects ($100 million or more in
any 1 year). This final rule is an economically ``significant
regulatory action'' as defined by section 3(f) of Executive Order
12866, and a ``major rule'' as defined in the Congressional Review Act.
We have reached this conclusion because of the substantial life-saving
effects of the rule and its anticipated reduction in the medical costs
associated with influenza and pneumonia. We believe that there are no
significant costs associated with this final rule. It will not impose
any mandates on State, local, or tribal governments, or the private
sector that will result in an expenditure of $100 million in any given
year. Since most program participants comply with the statutory and
regulatory requirements making unnecessary the imposition of
termination from Medicare, Medicaid and, where applicable, other
Federal health care programs, and since Medicare generally pays the
cost of the vaccines that are the subject of this rule we do not
anticipate more than a minimal economic impact on nursing facilities as
a result of this proposed rule. There is a cost to the Medicare program
for the vaccines to the extent that they are provided to Medicare
beneficiaries, as discussed below.
This final rule will have a life-saving effect. We have developed
estimates of these life-saving effects, along with estimated changes in
medical care costs, and present these estimates and the assumptions on
which they are based in the discussion and tables that follows.
[[Page 58847]]
Influenza
Assumptions (Benefit): There are approximately 2 million residents
in LTC facilities. Sixty-five percent had documentation stating they
received influenza immunization per the 1999 National Nursing Home
Survey, National Center for Health Statistics, CDC. An October 2000
article in the Journal of American Geriatric Society ``Influenza
outbreak detection and control measures in nursing homes in the United
States (Zadeh MM, Buxton Bridges C, Thompson WW, Arden NH, Fukuda K.)''
indicated that 83 percent of LTC residents in the study received
immunizations. The midpoint between the two reports is 74 percent. The
projected immunization rate after regulation implementation is 90
percent.
The 2005 influenza vaccination administration reimbursement rate is
$18 (unweighted average of Medicare ``National Flu Biller
Administration Codes''). The 2005 Influenza vaccine reimbursement rate
is $10.10 (Medicare rate; 95 percent of Average Wholesale Price (AWP).
There is a wide variation in the influenza rate year to year, due to
the prevalent strains of influenza virus each influenza season and the
degree to which the vaccine matches prevalent strains as well as other
factors. Effectiveness of influenza vaccine for preventing influenza
illness is 30-40 percent according to ACIP (Harper SA, Fukuda K, Uyeki
TM, Cox NJ, Bridges CB; Prevention and control of influenza:
recommendations of the ACIP. MMWR Recomm Rep. 2004 May 28; 53(RR-6):1-
40).
As stated above, the rate of hospitalization for the LTC population
among those ill with influenza is 25 percent (Arden NH, et al.). The
influenza vaccine is 50-60 percent effective in preventing
hospitalization due to influenza in the LTC population (ACIP, May
2004).
According to (Arden NH, et al.) the case-fatality for influenza
disease in the LTC population is 10 percent of the number of residents
who become ill with influenza. The influenza vaccine is 80 percent
effective in preventing death in LTC residents with influenza illness
(ACIP, May 2004). The average Medicare cost per hospital discharge for
influenza is $8,500 per the Office of the Actuary, CMS (including
medical education, disproportionate share and other pass through). The
data on the influenza related hospitalization of SNF residents is not
available. SNF residents are short term stay therefore we do not think
those numbers are sufficiently large to have a great impact on the
overall Medicare costs.
Table 1.--Estimated Federal Benefits Due to Increased Rate of Influenza Immunizations
----------------------------------------------------------------------------------------------------------------
LTC residents Current Projected Difference
----------------------------------------------------------------------------------------------------------------
Percent who receive influenza immunization............. 74% 90% 16%
Number who receive influenza immunization.............. 1,480,000 1,800,000 320,000
Number ill with influenza.............................. 133,380 123,300 (10,080)
Number hospitalized due to influenza................... 20,358 15,030 (5,328)
Number who die from influenza complications............ 7,344 5,040 (2,304)
Direct Medicare cost of inpatient hospital treatment... $173,043,000 $127,755,000 ($45,288,000)
----------------------------------------------------------------------------------------------------------------
Assumptions (Cost): Influenza vaccine must be administered
annually: however, virtually all influenza vaccinations administered in
LTC facilities are covered under the Medicare Part B program. The cost
to Medicare for provision of the influenza vaccinations is equal to the
cost of the vaccines plus administration costs. In addition to these
direct Medicare costs, an indirect Federal cost will be incurred from
reduced savings in the Medicaid program. For every hospitalization of a
LTC facility resident, Medicaid saves $1,000 for nursing home care not
provided while the resident is in the hospital. The weighted average of
the federal contribution to Medicaid is 57 percent (Office of the
Actuary, CMS), and Medicaid is a primary source of payment for 40 to 59
percent of LTC facility residents (1999 National Nursing Home Survey)
and with a midpoint of 50 percent. The total federal cost related to
the increased influenza immunizations is the total of the direct
Medicare costs combined with the lost savings to Medicaid.
Table 2.--Estimated Federal Impact of Increased Influenza Immunization on Medicare & Medicaid
----------------------------------------------------------------------------------------------------------------
Current ($) Projected ($) Difference
----------------------------------------------------------------------------------------------------------------
Total Medicare reimbursement for cost of influenza 41,588,000 50,580,000 $8,992,000
vaccine and administration (320,000 x $28.10).........
Federal share of Medicaid LTC facility savings due to (5,802,030) (4,283,550) 1,518,480
resident hospital stays\*\............................
--------------------
Total Federal Costs................................ 35,785,970 46,296,450 10,510,480
----------------------------------------------------------------------------------------------------------------
\*\ (Number of residents hospitalized) x ($1000 cost for NH facility per hospitalization) x (57% Federal portion
of Medicaid payments) x (50% portion of all NH patients paid by Medicaid).
Table 3.--Net Federal Savings Due to Increased Influenza Immunization
------------------------------------------------------------------------
------------------------------------------------------------------------
Estimated Federal Savings (from Table 1)............. ($45,288,000)
Estimated Federal Costs (from Table 2)............... $10,510,480
Total Net Federal Savings............................ ($34,777,520)
Lives saved per year................................. 2,304
------------------------------------------------------------------------
\*\ Negative numbers reflect savings.
[[Page 58848]]
We have used an average value of a statistical life of $5 million
to monetize the decreased mortality benefits of the rule, as we have in
other rulemakings. This value is in the middle of the range of $1-$10
million per statistical life saved recommended by OMB Circular A-4. The
population affected by this rule has different demographic and other
characteristics from the populations that were addressed in other CMS
rulemakings. However, due to the lack of data on this specific
population, we are assuming a value of $5 million for the average value
of a statistical life for this rule. In addition, although the age of
the affected population has been identified as an important factor in
the theoretical literature, the empirical evidence on age and VSL is
mixed. In light of the continuing questions over the effect of age on
VSL estimates, OMB Circular A-4 recommends that agencies not use an
age-adjustment factor in an analysis using VSL estimates.
Therefore, since we estimate 2,304 lives will be saved by the
influenza vaccination, we estimate the value saved from saving these
lives as $11.5 billion.
As previously indicated in response to a comment, this estimate
would be lower if we used an alternate measure such as statistical
years lives saved. In addition, VSL is an inherently uncertain measure
of value. By any reasonable measure of the value of these medical
improvements, however, the benefits would, nonetheless, be very
substantial.
Invasive Pneumococcal Disease
Assumptions (Benefit): There are approximately 2 million residents
in LTC facilities. The projected immunization rate after regulation
implementation is 90 percent. The LTC resident vaccination rate is
estimated between 39 percent (1999 National Nursing Home Survey (NNHS))
and 56 percent (community rate, 2003 National Health Interview Survey).
Virtually all residents with invasive disease are hospitalized. The
rate of pneumococcal invasive disease in unvaccinated persons aged
greater than or equal to 65 equals 52-85/100 000, (ACIP, 1997). The
case fatality ratio of invasive pneumococcal disease in persons aged
greater than or equal to 65 (despite appropriate medical treatment) is
30-40 percent. The average cost per hospital discharge for invasive
pneumococcal disease is $8500 (including medical education,
disproportionate share and other pass through) (Office of the Actuary,
CMS). According to CDC recommendations, usually one dose of the
pneumococcal polysaccharide vaccine (PPV) is all that a person needs in
a lifetime. However, in some situations a second dose is recommended
for people 65 and older. Therefore, expense related to this rule is
projected to cost more at the beginning period of implementation.
The 45 percent documented immunization rate in the table below
represents data obtained in the year 1999, and since then the rate may
have increased. Implementing the influenza immunization process is more
challenging than implementing the similar PPV immunization process.
Pneumococcal immunizations can be given all through the year without
time constraints and the vaccine supplies have not been an issue. We
anticipate that implementation of this rule would result in increase in
immunization rate and documentation of the related data for future
comparison. The table below is relating the years 1-5 to the current
data.
Invasive Pneumococcal Disease
Assumptions (Benefit):
Table 4.--Estimated Federal Benefits Due to Increased Rate of Pneumococcal Immunizations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Projected
LTC residents Current year -------------------------------------------------------------------------------
Year 1 Year 2 Year 3 Year 4 Year 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent who receive pneumococcal immunization........... 45% 70% 75% 80% 85% 90%
Number who receive pneumococcal immunization per year... .............. 500,000 100,000 100,000 100,000 100,000
Cumulative number immunized (since inception of Medicare 900,000 1,400,000 1,500,000 1,600,000 1,700,000 1,800,000
pneumococcal immunization benefits)....................
Number who develop invasive pneumococcal disease........ 970 742 697 651 606 560
---------------------------------------------------------
Deaths from invasive pneumococcal disease (or complications related to the disease)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benchmark--Number of deaths without increased 340 340 340 340 340 340
immunizations..........................................
Number of deaths following implementation of .............. 260 244 228 212 196
immunization regulation................................
Number of lives saved due to pneumococcal immunization.. .............. 80 96 112 128 144
---------------------------------------------------------
Direct Federal costs for treatment of invasive pneumococcal disease
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benchmark--costs without increased immunizations........ $8,246,190 $8,246,190 $8,246,190 $8,246,190 $8,246,190 $8,246,190
Costs following implementation of immunization .............. $6,310,740 $5,923,650 $5,536,650 $5,149,470 $4,762,380
regulation.............................................
Savings following implementation of increased .............. ($1,935,450) ($2,322,540) ($2,709,540) ($3,096,720) ($3,483,810)
pneumococcal immunizations.............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Assumptions (Cost): The 2005 pneumococcal vaccination
administration reimbursement rate is $18 (unweighted average of
Medicare ``National Flu Biller Administration Codes'') and the
pneumococcal vaccine reimbursement rate is $23.28 (Medicare rate; 95
percent of AWP). The pneumococcal vaccine is generally
[[Page 58849]]
administered once per beneficiary lifetime. Therefore this is not a
recurring cost, but would cost more up front to give lifetime immunity
to residents (for the cost estimate, we assumed 500,000 people would
receive the vaccine in the first year and 100,000 people each would
receive the vaccine in years two through five). The reason we assume
the higher number the first year is because we expect all the eligible
residents in the facilities in the first year would receive the
pneumococcal vaccine. In the following years only the new residents who
are eligible would need the immunization. Virtually all pneumococcal
immunizations administered in LTC facilities are covered under the
Medicare Part B program. For every hospitalization concerning Medicaid
beneficiaries, Medicaid saves $1000 for nursing home care not provided
while the resident is in the hospital. The weighted average of the
Federal contribution to Medicaid is 57 percent (Office of the Actuary,
CMS). Medicaid is a primary source of payment for 40 to 59 percent in
LTC (1999 National Nursing Home Survey) and the mid point is 50
percent. The total Federal cost related to the increased pneumococcal
immunizations is the total of the direct Medicare reimbursement costs
combined with the lost savings to Medicaid.
Table 5.--Federal Impact of Increased Pneumococcal Immunization on Medicare and Medicaid
--------------------------------------------------------------------------------------------------------------------------------------------------------
Projected ($)
Current year ($) -------------------------------------------------------------------------------
Year 1 Year 2 Year 3 Year 4 Year 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicare reimbursement for cost of pneumococcal vaccine and administration
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Medicare cost following ............................... 20,640,000 4,128,000 4,128,000 4,128,000 4,128,000
increased pneumococcal immunization *.
Cumulative Medicare cost (since 37,152,000..................... 57,792,000 61,920,000 66,048,000 70,176,000 74,304,000
inception of Medicare pneumococcal
immunization benefits).
----------------------------------------
Federal share of Medicaid LTC facility savings due to resident hospital stays
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federal savings per year without (276,490)...................... (276,490) (276,490) (276,490) (276,490) (276,490)
increased immunizations **.
Federal savings per year following ............................... (211,595) (198,617) (185,638) (172,659) (159,680)
increased pneumococcal immunization **.
Lost Federal savings due to increased ............................... 64,895 77,874 90,852 103,831 116,810
pneumococcal immunization.
----------------------------------
Total Federal Costs (annual Not Available.................. 20,704,895 4,205,874 4,218,852 4,231,831 4,244,810
Medicare costs + lost Federal
savings).
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Year 1 (500,000 x $41.28); Years 2-5 (100,000 x $41.28).
** ( of residents hospitalized) x ($1000 cost for NH facility per hospitalization) x (57% Federal portion of Medicaid payments) x (50% portion
of all NH patients paid by Medicaid).
Table 6.--Net Federal Costs Due to Increased Pneumococcal Immunization
------------------------------------------------------------------------
------------------------------------------------------------------------
Year 1:
Estimated Federal Savings (from Table 4)......... ($1,935,450)
Estimated Federal Costs (from Table 5)........... $20,704,895
Total Net Federal Cost in Year 1................. $18,769,445
Years 2-5: Estimated Federal savings (from table 4) +
Estimated Federal costs (from table 5):
Total Net Federal Cost in Year 2 ($2,322,540) + $1,883,334
4,205,874.......................................
Total Net Federal Cost in Year 3 ($2,709,540) + $1,509,312
4,218,852.......................................
Total Net Federal Cost in Year 4 ($3,096,720) + $1,135,111
4,231,831.......................................
Total Net Federal Cost in Year 5 ($3,483,810) + $761,000
4,244,810.......................................
Total Net Federal Cost Years 1-5................. $24,058,202
Lives saved Years 1-5............................ 560
------------------------------------------------------------------------
Using the same $5 million per life value of a statistical life as
before and since we estimate 560 lives will be saved by the
pneumococcal vaccination, we estimate the value saved from saving these
lives as $2.8 billion.
For the purpose of this analysis we have considered the protective
effects of influenza and pneumococcal immunization individually.
However, the combined effect of both immunizations is additive in
preventing hospitalization and deaths. The July 30, 1999 article in the
journal ``Vaccine'' titled ``The additive benefits of pneumococcal
vaccinations during influenza seasons among elderly persons with
chronic lung disease'' reports that both vaccinations together
demonstrated additive benefit as there was a 65 percent reduction in
hospitalization for pneumonia and 81 percent reduction in death versus
the situation when neither had been received. Also excluded in this
analysis is the increased protection against influenza infection
afforded by the ``herd'' effect after 80 to 90 percent of residents are
immunized against influenza. The 2003, CMS/CDC standing orders project
report states that a facility-level influenza vaccination of 80 percent
and more of residents may be independently associated with reduced
patient hospitalization and death. Further, the cost-saving effects of
this
[[Page 58850]]
rule, and the costs of the vaccine doses themselves, are respectively
benefits and costs to the taxpayer. Since Medicare pays virtually all
medical, hospital, and (starting in 2006) drug costs for this
population, the expected savings from reduced hospitalizations would
largely accrue to the Federal budget.
In order to comply with this rule, facilities will develop the
necessary policies and procedures which will be followed by staff as a
standard practice. We estimate the time and cost related to this
process in the following tables:
Policy and Procedure Development Related to the Immunization Rule
[This is only a one time expense for the facilities]
------------------------------------------------------------------------
Number of LTC Hours spent per Total burden
facilities facility hours Total cost
------------------------------------------------------------------------
16,139......... 10 hours first 161,390 hours 161,390 hours x
year only. only first year. $23.70 * =
$3,824,943.
------------------------------------------------------------------------
* $23.70 is the average salary of a registered nurse as per U.S.
Department of Labor at (http://www.bls.gov/oes/current/
oes291111.htm#nat).
This rule proposes that the resident's immunization status be
documented in the resident's medical record therefore, the following
table presents the estimated time and cost related to the
implementation of this process.
Documentation Time of Immunization
[These expenses are annual]
------------------------------------------------------------------------
Hours spent per Total
Number of LTC resident per burden Total cost
facilities facility hours
------------------------------------------------------------------------
16,139........... 16,139 x 100 ** 268,983 268,982 hours x
residents x 10 $23.70 * =
minutes = $6,374,897.
16,139,000 minutes
k= 268,983 hours.
------------------------------------------------------------------------
* $23.70 is the average salary of a registered nurse as per U.S.
Department of Labor (http://www.bls.gov/oes/current/
oes291111.htm#nat).
** 100 is the average number of residents in each facility.
The RFA (15 U.S.C. 603(a)), as modified by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Pub. L. 104-121),
requires agencies to determine whether proposed or final rules will
have a significant economic impact on a substantial number of small
entities and, if so, to identify in the notice of proposed rulemaking
or final rulemaking any regulatory options that could mitigate the
impact of the proposed regulation on small businesses. For purposes of
the RFA, small entities include small businesses, nonprofit
organizations, and small government jurisdictions. Most nursing
facilities are small entities, either by nonprofit status or by having
revenues of $11.5 million or less annually (the applicable size
standard of the Small Business Administration). Individuals and States
are not included in the definition of a small entity, and other medical
care providers are not affected by this final rule except indirectly,
through reduced utilization of care by individuals who do not, but
would otherwise, require hospitalization. For the reasons explained in
this analysis, we have concluded that this final rule will not have
significant impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. We do not believe a
regulatory impact analysis is required here because, for the reasons
stated above, this final rule will not have a significant impact on the
operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates may result in expenditure in any 1 year
by State, local, or tribal governments, in the aggregate, or by the
private sector, of $100 million in 1995 dollars. This final rule will
impose no mandates on State, local, or tribal governments. As indicated
elsewhere in this analysis, costs mandated on nursing facilities, are
minimal, and do not remotely approach this threshold.
Executive Order 13132 on federalism establishes certain
requirements that an agency must meet when it publishes a proposed rule
(and subsequent final rule) that imposes substantial direct requirement
costs on State and local governments, preempts State law, or otherwise
has federalism implications. We have determined that this final rule
will not significantly affect the rights, roles, or responsibilities of
the States. This final rule will not impose substantial direct
requirement costs on State or local governments, preempt State law, or
otherwise implicate federalism.
B. Anticipated Effects
1. Effects on LTC facilities. Based on the various studies and
reports referenced earlier in the preamble, we expect that LTC
facilities will benefit from the implementation of this final rule. The
various studies discussed are evidence that prevention of influenza and
pneumonia will lower the level of acuity, staff time and other expenses
resulting in cost reductions.
2. Effects on beneficiaries. The influenza vaccine is 50-60 percent
effective in preventing hospitalization due to influenza in the LTC
population and increased immunizations are expected to improve health
overall for the age group of 65 years and older. As estimated above
2,304 lives may be saved annually when residents receive influenza
immunizations.
According to CDC's Active Bacterial Core Surveillance for
pneumococcal disease, approximately 5,700 deaths from invasive
pneumococcal disease
[[Page 58851]]
(bacteremia and meningitis) are estimated to have occurred in the
United States in 2002. The October 1997 Journal of the American Medical
Association (JAMA) article ``Cost-Effectiveness of Vaccination Against
Pneumococcal Bacteremia Among Elderly People'' indicated that
vaccination of elderly people against pneumococcal bacteremia is one of
the few interventions that have been found to both improve health and
save medical costs.
3. Effects on the Medicare and Medicaid Programs. The report from
the January 2000, CMS's Adult Immunization Project, indicates that
``despite the fact that influenza and pneumococcal vaccines are
clinically effective, cost-effective, and are Medicare Part B covered
benefits, they remain underutilized.'' Increased immunizations are
expected to reduce the medical expenses and improve health overall for
the age group of 65 years and older as reported in the Oct, 1997 JAMA
article referenced earlier. As stated above, the rate of
hospitalization for the LTC population among those ill with influenza
is 25 percent (Arden NH, et. al.). The average cost per hospital
discharge for influenza is $8,500 per the Office of the Actuary, CMS.
The influenza vaccine is 80 percent effective in preventing death in
the LTC population (ACIP, May 2004). As estimated above the net saving
will be $34,777,520 and 2,304 lives saved when residents receive
influenza immunizations. The net cost related to pneumococcal
immunizations is estimated to be $18,821,360 the first year of
implementation and $3,753,887 in the following 2 to 5 years and 143
lives saved.
C. Alternatives Considered
We considered other alternatives regarding immunizing residents.
1. One alternative would be to keep the present rules, as they are
written. The current regulations, however, have thus far not been
effective at assisting us in increasing the rate of immunization of
institutionalized residents to 90 percent. Despite the Federal
Government's unified efforts to increase the availability of safe and
effective vaccines and despite substantial progress in reducing many
vaccine-preventable diseases, at-risk individuals are not receiving
influenza and pneumococcal vaccines. Section 4107 of the Balanced
Budget Act of 1997 extended the influenza and pneumococcal immunization
campaign being conducted by CMS in conjunction with CDC and the
National Coalition for Adult Immunization through fiscal year 2002,
authorizing $8 million for each fiscal year from 1998 to 2002. Although
Medicare reimbursement for influenza and pneumococcal immunizations was
increased under this legislation, rates of immunization did not improve
as anticipated.
2. Another alternative would be to educate providers on the value
of influenza and pneumococcal vaccines without rule making. However, as
discussed in studies cited earlier in this rule, this has not been
effective in improving immunization rates.
D. Conclusion
Increasing the utilization of cost-effective preventive services is
the goal of both CMS and CDC, and this final rule will facilitate the
delivery of appropriate vaccinations in a timely manner, increase the
levels of vaccination rate, and decrease the morbidity and mortality
rate of influenza and pneumococcal diseases. As a result, the economic
effects of the rule are substantial and overwhelmingly beneficial. In
accordance with the provisions of Executive Order 12866, the Office of
Management and Budget reviewed this final rule.
List of Subjects in 42 CFR Part 483
Grant programs--health, Health facilities, Health professions,
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting
and recordkeeping requirements, and Safety.
0
For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
0
1. The authority citation for part 483 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart B--Requirements for Long Term Care Facilities
0
2. Section 483.25 is amended by adding paragraph (n) to read as
follows:
Sec. 483.25 Quality of care.
* * * * *
(n) Influenza and pneumococcal immunizations--(1) Influenza. The
facility must develop policies and procedures that ensure that--
(i) Before offering the influenza immunization, each resident or
the resident's legal representative receives education regarding the
benefits and potential side effects of the immunization;
(ii) Each resident is offered an influenza immunization October 1
through March 31 annually, unless the immunization is medically
contraindicated or the resident has already been immunized during this
time period;
(iii) The resident or the resident's legal representative has the
opportunity to refuse immunization; and
(iv) The resident's medical record includes documentation that
indicates, at a minimum, the following:
(A) That the resident or resident's legal representative was
provided education regarding the benefits and potential side effects of
influenza immunization; and
(B) That the resident either received the influenza immunization or
did not receive the influenza immunization due to medical
contraindications or refusal.
(2) Pneumococcal disease. The facility must develop policies and
procedures that ensure that--
(i) Before offering the pneumococcal immunization, each resident or
the resident's legal representative receives education regarding the
benefits and potential side effects of the immunization;
(ii) Each resident is offered an pneumococcal immunization, unless
the immunization is medically contraindicated or the resident has
already been immunized;
(iii) The resident or the resident's legal representative has the
opportunity to refuse immunization; and
(iv) The resident's medical record includes documentation that
indicates, at a minimum, the following:
(A) That the resident or resident's legal representative was
provided education regarding the benefits and potential side effects of
pneumococcal immunization; and
(B) That the resident either received the pneumococcal immunization
or did not receive the pneumococcal immunization due to medical
contraindication or refusal.
(v) Exception. As an alternative, based on an assessment and
practitioner recommendation, a second pneumococcal immunization may be
given after 5 years following the first pneumococcal immunization,
unless medically contraindicated or the resident or the resident's
legal representative refuses the second immunization.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital
[[Page 58852]]
Insurance; and Program No. 93.774, Medicare--Supplementary Medical
Insurance Program)
Dated: September 23, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: September 27, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-19987 Filed 9-30-05; 3:51 pm]
BILLING CODE 4120-01-P