Dear friends in protecting people from vaccine injuries,
Please take a few moments to read this and respond - a federal vaccine
mandate for nursing homes for flu and pneumococcal vaccines is being shoved
through right under our noses. If you can forward this or your own comments
through to your contacts too, that would be a huge help in alerting more
people to become involved.
Please consider sending in comments against this proposal. Informed consent
to a pharmaceutical product that has the capacity to injure or kill should
always be the standard, not the exception as it is here. Below is the
Medicare press release and attached is the federal register notice that
gives directions how to send in comments. They've overruled the normal 60
day comment period and reduced it to only 15 days because of the "impending"
flu season. This does not give the public adequate time to register comments
or states to determine the financial impact to their already strained
budgets. First nursing homes then who is next? What is really pending is a
lousy season for vaccine manufactures for flu and pneumococcal vaccines
because more and more people are refusing the shots based on the poor health
and side effects they experience after vaccination and isn't this a perfect
prescription for ailing manufacturers!
Even though the rule says people can refuse, the presumption is on a forced
universal federal vaccination mandate for adults. If a patient says no to
either of these vaccines, the rule says the nursing home has to have a talk
with the refuser about the "benefits" of the vaccine and the refusal and the
"educational" attempt is required to be recorded in the person's medical
record. The rule also says nursing homes will be kicked off of being a
Medicare provider if they don't vaccinate all residents and follow this
procedure whether the resident is on Medicare or not!
Additionally, mandates for vaccines are typically addressed in state law and
this expansion to federal vaccine policy using the hook of the Medicare and
Medicaid system is concerning. There are states that would have their state
legislation usurped by this federal rule. In Texas, nursing homes are only
required to offer the shots, and it was a deliberate decision by the
legislature to not require the shots.
This is a dangerous and expansive precedent in many ways. Please consider
taking the time to look it over and express your concerns to your federal
elected representative and senator along with submitting comments.
Sincerely,
Dawn Richardson Dawn Richardson
PROVE(Parents Requesting Open Vaccine Education)
prove@vaccineinfo.net (email)
http://vaccineinfo.net/ (web site)
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For Immediate Release: Contact:
Thursday, August 11, 2005 CMS Office of Public Affairs
202-690-6145
For questions about Medicare please call 1-800-MEDICARE or visit
www.medicare.gov.
CMS PROPOSAL WOULD REQUIRE NURSING HOMES TO VACCINATE RESIDENTS AGAINST THE
FLU
Nursing homes serving Medicare and Medicaid patients would have
to provide immunizations against influenza and pneumococcal disease to all
residents if they want to continue in the programs, according to a proposed
rule to be released by CMS in the August 15 Federal Register.
Unless refused by the patient or patient's family or for
medical reasons, nursing homes would be required to ensure that each
resident received the immunizations as a condition of participation in the
two programs.
About two million Americans, most age 65 years or older, live
in long-term care facilities. People aged 65 years and older account for
more than 90 percent of influenza-related deaths in the United States and
elderly nursing home residents are particularly vulnerable to
influenza-related complications. In addition, the elderly are more likely
than younger individuals to die from pneumonia.
In light of these statistics and in line with the agency's
Nursing Home Quality Initiative, CMS received input from the Centers for
Disease Control and Prevention (CDC) and two of the nation's largest nursing
home industry trade groups, the American Association of Homes and Services
for the Aging and the American Health Care Association, in developing the
proposed rule.
"Improving immunization is a key element of our quality
improvement strategy—a strategy that is focused on preventing illnesses and
complications in the first place," said Mark B. McClellan, M.D., Ph.D.,
administrator of CMS. "The outstanding commitment of the nursing home
industry, caregivers and other stakeholders makes clear that his commitment
to better quality through more effective immunization is shared and
achievable.
"As a physician, I know the impact that influenza and
pneumococcal infections can have on the elderly, particularly those in
nursing homes," he added. "Greater use of flu shots and pneumococcal vaccine
in nursing homes is a proven approach to better health and fewer costly
complications for one of our most vulnerable groups of beneficiaries."
In its collaborative effort to improve quality of care, CMS is
also encouraging nursing homes to provide influenza vaccine to their
healthcare workers. Although the vaccine for these workers will not be
required in the proposed regulation, immunizing nursing home workers has
been shown to reduce mortality rates among residents of long-term care
facilities. Research from last year's flu season revealed that only 36
percent of all healthcare workers were vaccinated against the illness.
"Healthcare workers play a vital role in protecting the health
of one of our nation's most vulnerable populations—the elderly and disabled
who live in nursing facilities," said Julie Gerberding, M.D., director of
the Centers for Disease Control and Prevention. "This initiative is critical
to ensuring they receive the best quality healthcare."
A 1999 national nursing home survey showed that 65 percent of
residents had documented influenza shots and only 38 percent had been
inoculated against bacterial pneumonia. A goal of this proposed rule is to
attain a target rate of 90 percent for both vaccinations. As an added
incentive to increase immunization rates, in January, CMS increased the
average Medicare payment rate for administering each shot from $8 to $18, in
addition to a separate payment for the cost of the vaccine. Medicaid
payment rates are set independently by each state.
As a Medicare condition of participation, the rule proposes
that long-term care facilities ensure that each resident is:
offered influenza immunization annually;
immunized against influenza unless medically contraindicated or when the
resident or the resident's legal representative refuses immunization;
offered pneumococcal immunization once if there is no history of
immunization; and
immunized against pneumococcal disease unless medically contraindicated or
when the resident or the resident's legal representative refuses
immunization.
In the case of a vaccine shortage as declared by CDC, state
survey agencies would have the discretion not cite facilities for being
out-of-compliance with this requirement.
"Vaccines against these diseases are effective in preventing
hospitalizations and death," said Dr. McClellan. "However, many at-risk
people are not getting the vaccines they need. This initiative will be
critical to maintaining high-quality care in the nation's long-term care
facilities."
Because of the impending influenza season, this expedited
proposed rule will have a 15-day comment period. To review the proposal,
go to the Federal Register Web site at www.gpo.gov.
US_Mandate_Influenza_Pneumococcal_Vaccine.pdf
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.
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/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).
Read the rest of this 13 page article here:
US_Mandate_Influenza_Pneumococcal_Vaccine.pdf
Sample comments for
http:// www.cms.hhs.gov/regulations/ecomments
Letter
The ecomments section had no link to CMS-3198 on August 16th...
http://www.cms.hhs.gov/regulations/ecomments
You may modify and/or us the following letter. It is best to write an original. Keep in mind the August 30, 2005 deadline.
By regular mail. You may mail
written comments (one original and two
copies) to the following address ONLY:
Prewritten for Microsoft word: http://www.vaclib.org/news05/cmsletter.doc
Prewritten for OpenOffice: http://www.vaclib.org/news05/cmsletter.sxw
Centers for Medicare & Medicaid Services,
Department of Health and Human Services,
Attention: CMS-3198-P,
P.O. Box 8010,
Baltimore, MD 21244-8010
Dear Sir or Madam;
Reference: file code CMS-3198-P
Issues: 1. General and 2. BACKGROUND
Issue 1: General.
Two main problems suggest themselves with a program to withhold government finances based on compliance with 'Flu Immunization.'
1. Using government tax money to coercively sell a product.
2. Basing policy on Pharmaceutical company propaganda and financial recommendations rather than real science which is available to the CDC.
Issue: General:
First: our nursing homes today are filled with the generation of individuals which lived through WWII. These people made heroic sacrifices to keep our country free and now they find themselves in need of care givers who are being forced to offer and even coerce the acceptance of a product which has been thoroughly disproven in effectiveness and is clearly more dangerous than the malady which the product is falsely alledged to prevent.
Issue: BACKGROUND:
Secondly: Over the past 25 plus years the combined rate of pneumonia and influenza related deaths has risen in the over 65 population while at the same time the number of flu vaccinations has doubled in this age group. This data effectively makes a long term, large population group study which clearly proves the flu vaccine is not only a failure but very likely is making an actual contribution to the problem, not the solution. The CDC and CMS should reject manufacturers' claims and begin using basic information that is scientifically sound for the purpose of creating national policy.
The article, Prevention and Control of Influenza, Recommendations of the Advisory Committee on Immunization Practices (ACIP) found at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5306a1.htm is used as a justification for the proposed policy under discussion. This proposed policy ignores the fact that the vaccine trials are conducted by vaccine manufacturers who have a record of twisting the truth, the trials are not independently supervised, the word "Placebo" is mentioned several times but in NO vaccine trial is a proper placebo (harmless inactive substance) ever used thus making the methodology of the trials flawed. In addition, data on how the subjects are randomized is not given, leading one to suspect that the placebo is given by area and not by a proper one-by-one randomization. All these biasing factors make the claimed figures for effectiveness meaningless.
In addition, the ACIP is itself fraught with conflicts of interest and must be regarded as nothing more than a vaccine promotion group which makes financial recommendations but never valid scientific recommendations.
Certain figures quoted under the issue, BACKGROUND, are clearly misleading. We are told 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." In fact, the figure of 36,000 is the number of combined flu and pneumonia related deaths. Less than 10% of these deaths are flu related. For children under 5, only about a half of one percent (.5%) of the 36,000 are due to flu. In other words, the deaths related to flu in the under 5 group are about 1 per 100,000 of the age group. The flu vaccine itself can easily kill more than 1 in 100,000, and even more among infants, plus raise the rate of deaths from Influenza Like Illnesses in addition to the direct deaths caused by the vaccine. Recent estimates for the USA place the over 65 population at nearly 36.7 million. If, for a convenient estimate, we put flu deaths in this age group at 3670 (about 10 percent of the 36,000 advertised) then we have flu deaths at 1 per 10,000 in the over 65 population. Vaccinating 36.7 million over 65 individuals, including the most immunocompromised of our population, is a harmful policy which the last 25 years of flu vaccine usage and the accompanying increase in combined flu and pneumonia deaths proves to be an ineffective procedure.
Both legislative mandates and financially coerced vaccination policies are ideas whose time is past. Discontinuing such policies is the choice of informed, free thinking, health achieving and progressive minded persons.
Sincerely yours,
______________________
[Signature is required]
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