[Federal Register: August 15, 2005 (Volume 70, Number 156)]
[Proposed Rules]
[Page 47759-47771]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15au05-19]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 483
[CMS-3198-P]
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: Proposed rule.
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SUMMARY: The goal of this proposed 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 would be
required to ensure that each resident receives an annual immunization
against influenza and receives the pneumococcal immunization 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 proposed 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: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on August 30, 2005.
ADDRESSES: In commenting, please refer to file code CMS-3198-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of three ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments.
(Attachments should be in Microsoft Word, WordPerfect, or
Excel; however, we prefer Microsoft Word.)
2. By regular mail. You may mail written comments (one original and
two copies) to the following address ONLY: Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Attention:
CMS-3198-P, P.O. Box 8010, Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments (one
original and two copies) to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-3198-P, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-9994 in advance to schedule your arrival
with one of our staff members. Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security
Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH Building is not
readily available to persons without Federal Government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A
stamp-in clock is available for persons wishing to retain a proof of
filing by stamping in and retaining an extra copy of the comments
being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Anita Panicker, (410) 786-5646.
Jeannie Miller, (410) 786-3164. Rachael Weinstein, (410) 786-6775.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this rule to assist us in fully considering issues
and developing policies. You can assist us by referencing the file code
CMS-3198-P and the specific ``issue identifier'' that precedes the
section on which you choose to comment.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. CMS posts all electronic
comments received before the close of the comment period on its public
Web site as soon as possible after they have been received. Hard copy
comments received timely will be available for public inspection as
they are received, generally beginning approximately 3 weeks after
publication of a document, at the headquarters of the Centers for
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore,
Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4
p.m. To schedule an appointment to view public comments, phone 1-800-
743-3951.
I. Background
(If you choose to comment on issues in this section, please include
the caption ``BACKGROUND'' at the beginning of your comments.)
A. General
The CDC's Advisory Committee on Immunization Practices (ACIP)
reported on May 28, 2004 (http://www.cdc.gov/mmwr/preview/mmwrhtml/
[[Page 47760]]
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. The ACIP reported
in 2002 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. As the vast majority of the residents in
nursing homes are 65 years and older, or if younger, probably have one
or more chronic medical conditions for which the vaccine is indicated,
one would expect that nearly all residents are candidates for
pneumococcal vaccination. Therefore, it is vital to increase
immunization rates to reduce and eliminate vaccine-preventable causes
of morbidity and mortality.
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 a memorandum of
understanding (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 in those settings
designated as appropriate by the ACIP.
A March 24, 2000 ACIP report recommended the use of standing orders
programs in both outpatient and inpatient settings to increase the
number of individuals who receive the influenza vaccine (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 now can 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 we do not have data on the specific immunization rates of
nursing facility residents since the publication of this rule. 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. These rates demonstrate that
we need to implement strategies to help us achieve the goal set by the
Department of Health and Human Services (DHHS) Healthy People 2010,
which set a target rate of 90 percent for influenza and pneumococcal
vaccination for adults aged 65 years and older. Further information on
preventive services like immunizations are available at the healthy
aging site at http://www.cms.hhs.gov/healthyaging/2a.asp and at http://www
.healthypeople.gov/.
B. Influenza Incidence and Prevention
Numerous studies referenced by the CDC at the Morbidity and
Mortality Weekly Report (MMWR) website 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 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
).
[[Page 47761]]
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,'' states 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
).
The Director of Health Care-Public Health Issues for the General
Accountability Office (GAO) testified before the United States Senate
Special Committee on Aging, on September 28, concerning a 2004 GAO
study titled, ``Infectious Disease Preparedness: Federal Challenges in
Responding to Influenza Outbreaks'' (http://www.gao.gov/new.items/d041100t.pdf
). She 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 state 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.
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 elderly
(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. CDC and National Institute of Health (NIH)
jointly, in a February 15, 2005, press release (http://www.cdc.gov/flu/pdf/statementeldmortality.pdf
) concluded that 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, 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, 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 sharp contrast to 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
studies and published research in order to develop the best
recommendations for protecting all Americans from influenza. The
Simonsen, et al., study is a reminder that there is room for
improvement in how we protect the elderly from influenza, and CDC and
NIH encourage research that strengthens our ability to do so.
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 deaths from
influenza. In the joint press release referenced above, the CDC and
National Institute 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'' states that overall, vaccine 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
[[Page 47762]]
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 life time. 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. In some cases, this may require that
they educate residents about the advantages of being vaccinated so that
the residents will understand the risks of pneumococcal infections and
will be willing to receive the vaccine. 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 state
that pneumococcal vaccination has not been causally associated with
death among vaccine recipients. Additional information about
precautions and contraindications can be attained from CDC and the
vaccine manufacturer's package insert should also be reviewed. (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 states that in 1999, because of concerns about pneumococcal
antimicrobial resistance and underuse 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--INTERIM ProjectRpt--1-
31-03.pdf) states 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 agenda. ``Immunizations and Infectious
Diseases'' is one of the focus areas. Healthy People 2010 set the
target rate for influenza and PPV vaccination of adults aged 65 years
and older at 90 percent. According to CMS's Adult Immunization Project
``despite the fact that influenza and pneumococcal vaccines are
clinically effective, cost-effective, and are Medicare Part B covered
benefits, they remain underutilized'' (http://www.ofmq.com/ user--
uploads/National% 20Immunization%20Project.pdf).
Based on the 1999 National Nursing Home Survey, only 66 percent of
nursing home residents had received the influenza vaccine in the
previous year and only 38 percent had ever had the pneumococcal
vaccine. The October 2004 article in the American Family Physician
titled ``Pneumonia in Older Residents of Long-Term Care Facilities''
stated 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 of American
Family Physician, October 15, 2004, ``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 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 caused by complications from various
infectious diseases, and, as many family members and health care
workers know, they can prevent infection of 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 would facilitate the delivery of appropriate
vaccinations to residents in LTC facilities in a timely manner and
increase vaccination rates, and thereby decrease the morbidity and
mortality
[[Page 47763]]
rate of influenza and pneumococcal diseases. 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 a 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 would
significantly 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 states ``Vaccination of the 23 million elderly people
unvaccinated in 1993 would have gained about 78,000 years of healthy
life and saved $194 million.''
Pneumococcal vaccination saves costs in the prevention of
bacteremia alone and is greatly underused among the elderly population,
on both health and economic grounds. These results support recent
recommendations of the ACIP and public and private efforts under way to
improve 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 who 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 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. Other
groups deemed a priority were nursing homes residents. We understand
that providers of LTC services may be concerned about how they would
meet the requirements of this regulation should an influenza vaccine
shortage occur in the future. In the case of a true vaccine shortage as
declared by CDC, CMS could exercise its enforcement discretion by
instructing the State Survey Agencies (SSAs) not to cite facilities as
out-of-compliance with this requirement if they were unable to obtain
vaccine for their residents.
II. Provisions of the Proposed Rule
On May 28, 2004, the ACIP recommendations on ``Prevention and
Control of Influenza'' (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5306a1.htm
), 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; use of reminder/recall systems; and efforts to
remove administrative and financial barriers that prevent persons from
receiving the vaccines, including use of standing orders programs. We
propose to add Sec. 483.25 (n), that would require LTC facilities to
offer each resident between, October 1 through March 31, immunization
against influenza annually, as well as lifetime immunization against
pneumococcal disease. LTC facilities would be required to ensure that
each resident receives an annual immunization against influenza and
receives the pneumococcal immunization unless medically
contraindicated, based on an assessment, or unless the resident or the
resident's legal representative refuses consent. As an alternative, a
second pneumococcal shot may be given 5 years after the first
pneumococcal immunization if the vaccine was administered prior to age
65, and only according to a practitioner recommendation.
We are not proposing to require the development of protocols nor
specific documentation. However, 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, this rule proposes that the resident's
immunization status be documented in the resident's medical record
including but not limited to the information that the resident received
influenza or/and pneumococcal immunization, or immunization was
medically contraindicated, or immunization was refused. If the
immunization was refused, documention must include that the resident or
the resident's legal representative received appropriate education and
consultation regarding the benefits of influenza and pneumococcal
immunization. Updating and maintaining resident medical records related
to immunization was identified as an issue by the CDC. The National
Nursing Home Survey (NNHS), conducted in 1995 by the CDC, National
Center for Health Statistics, indicated that a large number of nursing
facilities did not maintain complete, easily-accessible information on
the vaccination status of their residents. Nearly 21 percent of the
nursing home residents did not have documentation regarding influenza
vaccination, and 43 percent did not have documentation regarding
pneumococcal vaccination. Thus, it was difficult to reliably estimate
levels of influenza and pneumococcal vaccine use among nursing home
residents in 1995. The 1995 NNHS also indicated that facilities with an
organized immunization program had higher immunization rates than those
without a program. To encourage the development of organized
immunization programs in long-term care facilities, CDC created a ``how
to'' manual. The manual outlines general recommendations for
establishing immunization programs that should integrate seamlessly
into the facility's overall policies and procedures for quality care.
The manual is available on line at http://www.cdc.gov/nip/publications/long-term-care.pdf
.
The March 18, 2005 CDC manual titled ``Prevention and Control of
[[Page 47764]]
Vaccine-Preventable Diseases in Long-Term Care Facilities,'' Section
IV, focuses on the ACIP recommendation related to ``staff immunization
to reduce staff illnesses during the influenza season to reduce the
spread of influenza from workers to residents'' (http://www.cdc.gov/nip/publications/long-term-care.pdf
). We acknowledge the importance of
staff immunization. In a similar vein, our infection control
requirements at 42 CFR 483.65(b)(2) state that ``The facility must
prohibit employees with a communicable disease or infected skin lesions
from direct contact with residents or their food, if direct contact
will transmit the disease.'' The intent of this regulation is to
prevent the spread of communicable diseases from employees to
residents.
Influenza immunizations are given annually. ACIP (May 27, 1994)
recommends that during October and November each year, vaccination
should be routinely provided to all residents of chronic-care
facilities with the concurrence of attending physicians. Consent is
required for vaccination and can be obtained from the resident or their
legal representative at the time of admission to the facility or
anytime afterwards. When possible, all residents should be vaccinated
at the beginning of the influenza season. Residents admitted after the
influenza season begins, must be vaccinated at the time of admission
until the end of March (ACIP, May 27, 1994). Therefore, we propose that
all residents be offered immunization annually from October 1 through
March 31. We hope to have this rule finalized by October 1, 2005,
before the 2005-2006 influenza season.
PPV is given once in a life time, with certain exceptions. This
proposed rule recognizes the exception by including language about a
second shot at Sec. 483.25(n)(2)(iv). This exception states, a second
shot may be given 5 years after the first pneumococcal immunization if
the vaccine was administered before age 65 and only according to a
practitioner recommendation. The following is a simple algorithm ACIP
recommends for pneumococcal polysaccharide vaccine.
[GRAPHIC] [TIFF OMITTED] TP15AU05.021
For further information, please go to the CDC Web site listed
below: http://www.cdc.gov/mmwr/preview/mmwrhtml/00047135.htm#00001211.gif
.
Facilities must assess residents for medical contraindications
before immunizing them to prevent complications and adverse effects.
ACIP recommendations (February 8, 2002) state, ``contraindications and
precautions to vaccination dictate circumstances when vaccines must not
be administered. The majority of contraindications and precautions are
temporary, and the vaccination can be administered later. For example,
persons with acute febrile conditions should not be immunized until
their fever subsides. A medical contraindication is a condition in a
recipient that increases the risk for a serious adverse reaction. For
example, administering influenza vaccine to a person with an
anaphylactic allergy to egg protein could cause serious illness in or
death of the recipient.'' The ACIP recommendations further state that
one universal contraindication applicable to all vaccines is a history
of a severe allergic reaction after a prior dose of vaccine or vaccine
constituent.
If immunization is medically contraindicated, ACIP recommendations
(2002) state that prophylactic use of antiviral agents is an option for
preventing influenza among these persons. Persons who have a history of
anaphylactic hypersensitivity to vaccine components but who are also at
high risk for complications from influenza can benefit from the vaccine
after appropriate allergy evaluation and desensitization. The report on
the ``Use of Standing Orders Programs to Increase Adult Vaccination
Rates,'' in the March 24, 2000 MMWR, states that standing orders
protocols should also specify that vaccines be administered by
healthcare professionals trained to (a) screen patients for
contraindications to vaccination, (b) administer vaccines, and (c)
monitor patients for adverse events, in accordance with State and local
regulations.
It is important for facilities to remember that residents have the
right to refuse immunization. However, educating residents and family
members regarding the benefits of receiving immunizations generally
results in consent.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-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.
[[Page 47765]]
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 each of these issues for the
following sections of this document that contain information collection
requirements:
This proposed rule requires facilities to develop protocols or
policies and procedures. 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 to document in the
resident's medical record information concerning immunization history,
contraindications etc. as a part of the process of immunizing
residents. For example, the facility must indicate in the resident's
medical record that the resident had received an influenza
immunization, or that the vaccination was medically contraindicated, or
that the immunization was refused. If the immunization was refused,
documentation must include that the resident or the resident's legal
representative received appropriate education and consultation
regarding the benefits of influenza immunization.
The initial burden associated with these requirements in the first
year, would be related to the establishment of policies and protocols
for implementation of the immunization rule. This would be
approximately 5 hours of a registered nurse's time per facility i.e.
80,695 hours for the first year (5 hours x 16,139 facilities). In
subsequent years, we estimate that the burden associated with
documentation of the immunization status of the resident in the medical
records would be approximately 5 minutes of the registered nurse's
time, which would be 134,492 hours per year (5 minutes per resident x
100 residents per facility x 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-P, 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-P,
Christopher Martin@omb.eop.gov. Fax (202) 395-6974.
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
V. Waiver of the 60-day Comment Period
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposed rule. The
notice of proposed rulemaking includes a reference to the legal
authority under which the rule is proposed, and the terms and substance
of the proposed rule or a description of the subjects and issues
involved. In accordance with section 1871(b)(1) of the Act, we
routinely allow a comment period of at least 60 days on proposed rules
that affect the Medicare program. This procedure can be waived;
however, if an agency finds good cause that a 60-day comment period is
impracticable, unnecessary, or contrary to the public interest, and
incorporates a statement of the finding and its reasons in the rule
issued. In accordance with section 1871(b)(2)(C) of the Act, we have
shortened the comment period for this proposed rule from 60 to 15 days
to allow us to hopefully finalize these provisions by October 1, 2005
in time for the 2005-2006 flu season. It is our view that a 60 day
delay in receiving public comments on this proposed rule and publishing
the subsequent 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 November. If this
proposed rule is published with a 60-day comment period it is highly
unlikely that a final rule can be issued before October, and even if
that were possible, nursing facilities would not have the lead time
necessary to obtain resident and/or family consent. If expedited and
published with a 15-day comment period, this delay can be prevented and
the rule can be effective in the 2005-2006 flu season, with the
potential of saving many lives.
We anticipate that the affect of this rule will be to increase
immunization rates in nursing homes to 90 percent, which is the Healthy
People 2010 goal. This will enable about half a million frail 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 27-35 percent
reduction in mortality, and a 44-52 percent reduction in all-cause
hospitalizations. Similarly, pneumococcal vaccination is associated
with a 20-26 percent reduction in mortality, and a 12-28 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 proposed rule
is published with a 15-day comment period so that a final rule can be
published and effective in 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 proposed rule would be a vehicle to improve immunization rates and
would be consistent with the Healthy People 2010 objectives.
We believe that a continued 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 comment period is unnecessary
and contrary to public interest. We find on this basis, that there is
good cause for waiving the 60-day comment period under section
1871(b)(2)(C) of the Act.
[[Page 47766]]
VI. Regulatory Impact
(If you choose to comment on issues in this section, please include
the caption ``Impact Analysis'' at the beginning of your comment.)
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 proposed 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 proposed rule. It would not
impose any mandates on State, local, or tribal governments, or the
private sector that would 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.
As previously discussed in this preamble, this proposed rule would
have a substantial 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 table that follows.
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
----------------------------------------------------------------------------------------------------------------
% 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 would be incurred from reduced savings in the
Medicaid program. For every hospitalization of a LTC facility resident,
Medicaid saves $1,000 for nursing home care not provided while the
resident is in the hospital. The weighted average of the Federal
contribution to Medicaid is 57 percent (Office of the Actuary, CMS),
and Medicaid is a primary source of payment for 40 to 59 percent of LTC
facility residents (1999 National Nursing
[[Page 47767]]
Home Survey) and with a mid point of 50 percent. The total federal cost
related to the increased influenza immunizations is the total of the
direct Medicare costs combined with the lost savings to Medicaid.
Table 2.--Estimated Federal Impact of Increased Influenza Immunization on Medicare and Medicaid
----------------------------------------------------------------------------------------------------------------
Current ($) Projected ($) Difference
----------------------------------------------------------------------------------------------------------------
Total Medicare reimbursement for cost of influenza vaccine and 41,588,000 50,580,000 $8,992,000
administration (320,000 x $28.10)................................
Federal share of Medicaid LTC facility savings due to resident (5,802,030) (4,283,550) $1,518,480
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
------------------------------------------------------------------------
In other rules, we have used an average value of a statistical life
of $5 million to monetize the decreased mortality benefits of the rule.
The population affected by this rule has different demographic and
other characteristics from the populations that were addressed in these
other rules. However, due to the lack of data on this specific
population and in order to be consistent with previous rules, we are
assuming a value of $5 million for the average value of a statistical
life for this rule.
Therefore, since we estimate 2,304 lives will be saved by the
influenza vaccination, we estimate the value saved from saving these
lives as $11.52 billion.
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 is needed, for a person only needs to be
immunized once in a life time. 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 45% 70% 75% 80% 85% 90%
pneumococcal immunization...
Number who receive ........... 500,000 100,000 100,000 100,000 100,000
pneumococcal immunization
per year....................
Cumulative number immunized 900,000 1,400,000 1,500,000 1,600,000 1,700,000 1,800,000
(since inception of Medicare
pneumococcal immunization
benefits)...................
Number who develop invasive 970 742 697 651 606 560
pneumococcal disease........
------------------------------
Deaths from invasive pneumococcal disease (or complications related to the disease)
----------------------------------------------------------------------------------------------------------------
Benchmark--number deaths 340 340 340 340 340 340
without increased
immunizations...............
Number deaths following ........... 260 244 228 212 196
implementation of
immunization regulation.....
Number lives saved due to ........... 80 96 112 128 144
pneumococcal immunization...
------------------------------
[[Page 47768]]
Direct Federal costs for treatment of invasive pneumococcal disease
----------------------------------------------------------------------------------------------------------------
Benchmark--costs without $8,246,190 $8,246,190 $8,246,190 $8,246,190 $8,246,190 $8,246,190
increased immunizations.....
Costs following ........... $6,310,740 $5,923,650 $5,536,650 $5,149,470 $4,762,380
implementation of
immunization regulation.....
Savings following ........... ($1,935,450) ($2,322,540) ($2,709,540) ($3,096,720) ($3,483,810)
implementation of increased
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% of AWP). The pneumococcal vaccine is
generally 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 ............ 20,640,000 4,128,000 4,128,000 4,128,00 4,128,000
following increased
pneumococcal immunization*.
Cumulative Medicare cost 37,152,000 57,792,000 61,920,000 66,048,000 70,176,000 74,304,000
(since inception of
Medicare pneumococcal
immunization benefits).....
-----------------------------
Federal share of Medicaid LTC facility savings due to resident hospital stays
----------------------------------------------------------------------------------------------------------------
Federal savings per year (276,490) (276,490) (276,490) (276,490) (276,490) (276,490)
without increased
immunizations**............
Federal savings per year ............ (211,595) (198,617) (185,638) (172,659) (159,680)
following increased
pneumococcal immunization**
Lost Federal savings due ............ 64,895 77,874 90,852 103,831 116,810
to increased
pneumococcal
immunization...........
---------------
Total Federal Costs Not 20,704,895 4,205,874 4,218,852 4,231,831 4,244,810
(annual Medicare costs Available
+ lost Federal savings)
----------------------------------------------------------------------------------------------------------------
* Year 1 (500,000 x $41.28); Years 2-5 (100,000 x $41.28).
** (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 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
--------------------------------------------------------
[[Page 47769]]
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 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 Implementation Related to the Immunization Rule
[This is only a one time expense for the facilities]
------------------------------------------------------------------------
No. of LTC Hours spent per Total burden Total cost per
facilities facility hours agency
------------------------------------------------------------------------
16,139.......... 5 hours first year 80,695 hours 80,695 hours x
only. only first $23.70 * =
year. $1,912,471.
------------------------------------------------------------------------
* $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).
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 for Both Immunizations
[These expenses are annual]
------------------------------------------------------------------------
Hours spent per
No. of LTC resident per Total burden Total cost per
facilities facility hours agency
------------------------------------------------------------------------
16,139.......... 16,139 x 100 ** 134,492 hours.. 134,492 hours x
residents x 5 $23.70 * =
minutes = 8,069,500 $3,187,460.
minutes 134,492
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 would
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 proposed rule except
indirectly, through reduced utilization of care by individuals who do
not, but would otherwise, require hospitalization.
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
[[Page 47770]]
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 proposed rule would 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 proposed rule
would 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 proposed rule
would not significantly affect the rights, roles, or responsibilities
of the States. This proposed rule would 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 would benefit from the
implementation of this proposed rule. The various studies discussed are
evidence that prevention of influenza and pneumonia would 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 (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 reports 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 would 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 two to five
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 proposed rule would 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 proposed 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, Safety.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
1. The authority citation for part 483 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart B--Requirements for Long Term Care Facilities
2. Section Sec. 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 ensure that--
(i) Each resident is offered an influenza immunization between
October 1 through March 31 annually, unless the immunization is
medically contraindicated or the resident has
[[Page 47771]]
already been immunized during this time period; and
(ii) The resident or the resident's legal representative must be
provided the opportunity to refuse immunization. If the resident or the
resident's legal representative refuses immunization, the facility must
ensure the resident or the resident's legal representative receives
appropriate education and consultation regarding the benefits of
influenza immunization.
(iii) The resident's immunization status is documented in the
resident's medical record, including but not limited to; that the
resident received an influenza immunization, or immunization was
medically contraindicated, or immunization was refused. If the
immunization was refused, documentation must include that the resident
or the resident's legal representative received appropriate education
and consultation regarding the benefits of influenza immunization.
(2) Pneumococcal disease. The facility must ensure that--
(i) Each resident is offered a pneumococcal immunization, unless
the immunization is medically contraindicated or the resident has
already been immunized; and
(ii) The resident or the resident's legal representative must be
provided the opportunity to refuse immunization. If the resident or the
resident's legal representative refuses immunization, the facility must
ensure the resident or the resident's legal representative receives
appropriate education and consultation regarding the benefits of
pneumococcal immunization.
(iii) The resident's immunization status is documented in the
resident's medical record, including but not limited to; that the
resident received pneumococcal immunization, or immunization was
medically contraindicated, or immunization was refused. If the
immunization was refused, documention must include that the resident or
the resident's legal representative received appropriate education and
consultation regarding the benefits of pneumococcal immunization.
(iv) Exception. As an alternative, based on an assessment and
practitioner recommendation, a second pneumococcal shot may be given
after 5 years following the first pneumococcal immunization if the
vaccine was administered before age 65, unless medically
contraindicated or the resident or the resident's legal representative
refuses the second shot.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: May 20, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: August 10, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-16160 Filed 8-12-05; 8:45 am]
BILLING CODE 4120-01-P