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Fw: Oppose Federal Adult Flu and Pneumococcal Vaccine Mandates

Mandate Information

Sample Letter

Subject: Fw: Oppose Federal Adult Flu and Pneumococcal Vaccine Mandates
Date: Mon, 15 Aug 2005 23:50:55 -0700

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.

Dawn Richardson Dawn Richardson
PROVE(Parents Requesting Open Vaccine Education) (email) (web site)

For Immediate Release: Contact:
Thursday, August 11, 2005 CMS Office of Public Affairs

For questions about Medicare please call 1-800-MEDICARE or visit

            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



Centers for Medicare & Medicaid Services

42 CFR Part 483


RIN 0938-AN95

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

Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.

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.

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.

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 (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.

Anita Panicker, (410) 786-5646.
Jeannie Miller, (410) 786-3164.
Rachael Weinstein, (410) 786-6775.

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 (, 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 ( 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 and at

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 (

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

Read the rest of this 13 page article here:

Sample comments for


The ecomments section had no link to CMS-3198 on August 16th...

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:

Prewritten for OpenOffice:

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 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]

Vaccination Liberation - Idaho Chapter
Contact: Vaccination Liberation

"Free Your Mind....From The Vaccine Paradigm"

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