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07/23/96 10:17 002 Child Immunization What specifically have we done to increase the number of children receiving immunizations? What statistics can we use to prove that? The President established the Childhood Immunization Initiative (CII) to ensure vaccinations and healthy futures for all children. CII has contributed to the immunization rate of 75% of 2 year-old children in 1995, an historic high. Most childhood vaccine- preventable diseases are at all-time lows (measles, mumps, rubella, diphtheria, etc.). The best known and most controversial part of the CII is the Vaccines for Children (VFC) program. VFC provides an entitlement to free vaccine for children on Medicaid and uninsured and underinsured children. VFC's main advantage is that uninsured children can receive shots at their private doctors' offices, rather than having to make an extra trip to a public health clinic. It is common for private physicians to send uninsured children to clinics for their shots because they are free in that setting. However, often these children do not make it to the clinic, resulting in missed opportunities for immunization. But other parts of CII are equally important. These include grants to states and localities to expand public clinic services, increase clinic hours, and build up local infrastructure; a huge, community- based outreach effort to educate parents and providers; better detection of vaccination levels and outbreaks of infection; and a standardized immunization schedules to make it easier for parents to know when vaccinations are due. The deterioration of the public health system and rapidly rising vaccine costs was one important cause of the measles epidemic of 1989-91 that cost lives How do our efforts compare to the Republican Congress'? They have approved most of our requested increases in the budget for childhood immunization. However, they have tried on a number of occasions to repeal the Vaccines for Children program as part of broader Medicaid legislation. What did GAO conclude about our Child Immunization efforts and why? Did we respond to this report? In June 1995, GAO released a report critical of VFC program (not of the CII overall). It stated that cost of vaccines (which VFC is targeted to address) is not a significant barrier to immunization and that CDC has not managed the program well. They agreed with Senator Bumpers' criticism that the children most likely to be behind on their shots are seen regularly by public clinics and private doctors, and that they miss their shots not because of cost, but because their parents are not aware of the immunization schedule (which is quite complex), or because the parents are not well-organized or responsible enough to see to it that the vaccinations take place. These critics point to the fact that 07/23/96 10:18 003 -2- almost all children get their shots by age 6, when they must have them in order to start school. They would prefer to focus on enhancing public clinic outreach to these families rather than creating a new child entitlement. HHS responded that GAO's report was seriously flawed; that there is considerable evidence that the cost of vaccine creates missed opportunities for immunization; that they agree that cost is not the only barrier, which is why VFC is just one of five parts of the larger CII strategy; and that they are working out the various start-up problems in VFC satisfactorily. GAO charged that HHS's accountability system could not ensure that vaccine goes only to eligible children. HHS responded that GAO's proposed solution would be extremely burdensome to administer. GAO also alleged that enrollment of private doctors in the VFC program was proceeding too slowly. HHS responded they expected some start-up delays. Why have people been advised that the best source for information is the "Vaccines for Children Program" and why does HHS only use the "doubled" funding statistic and are there any other statistics that can be used to describe our efforts? We have not advised people in this way. The VFC program is not a source of information. The Centers for Disease Control and the CII initiative are. There have been a number of problems with the Vaccines for Children program. HAS's original plan to rent a single warehouse to store vaccine was strongly criticized and ultimately dropped. [Jeremy wants me to describe this more fully.] Vaccine manufacturers oppose VFC because of its below-market prices, charging this hurts their ability to do research and development. The statistic of 75% of two-year-olds. appropriately vaccinated is a good one. However, for a number of reasons, we are careful not to take full credit for the increase over the past few years, but rather to say that the CII has contributed to a rate that is the highest ever. First, there is a lag in reporting that means that what we call the 1995 statistics include some vaccinations that took place in 1992 or 1993. In addition, the survey methodology changed in ways that make it very difficult to compare the 75% figure to a prior point. A change in the survey instrument produced a minor uptick in the immunization rate. However asking doctors as well as parents for immunization records, an innovation begun in 1994, increased the estimate from 68% to 73%. Therefore, the statements we have been making represent a prudent balance. 04/23/96 09:51 NO.968 P003/003 Goals 2000 also reduces class size and funds ed ication counseling. [XXX] The Bill Passed Despite Republicans Voting No 66% of the Republicans (115 Republican Members and 21 Republican Senators out of 205 voting Republicans) in Con gress voted against the Goals 2000: Educate America Act (I.R. 1804). [Congressional Record, Mar. 26, 1994, Senate \ ote No. 86, p. S- 14206 ; Congressional Record, Mar. 23, 1994, I louse Vote No. 86, P. H.J Recently, In the 104th Congress, Bob Dole blas ed Clinton- supported Goals 2000 legislation, calling it "a 1 000 page, $65 billion education bill that dictates how schools should discipline students, what parents and teachers should disct SS, and the average salaries of assistant coaches in men's an 1 women's athletics." [Bob Dole for President News Releas e, 11/4/95) And, Appropriations Chairman Bob Livingston ecent proposed to eliminate money for the Goals 2000 program in the FY96 appropriations package currently under consider tion. [New York Times, 3/6/96] Free vaccine to immunize On August 10, 1993, President Clinton signed t LC Omnibus children against disease. Budget Reconciliation Act of 1993 which inclu ed a new President Clinton passed it. initiative, the Vaccines for Children program. he President's Republicans oppose it. efforts have increase childhood immunization TE :cs from 55 percent in 1992 to 75 percent today. [1993 CO Almanac; HHS Report on the Fiscal Year 1997 Budget] Recent 100% of Republicans - every single Republicar in Congress -- voted against OBRA-93. [Congressional Recor 1, Aug. 5, 1993, cite ? House Vote No. 406, P. S-xxx ; Congressional Record, Aug. 8, 1993, Senate Vote No. 247, p. H-xxx] or More recently, Republican Budget (H.R. 2491) ncluded Cuts to attack ? the Vaccines For Children program. HR 2491 yould have repealed the Vaccines for Children program, jeo bardizing $1.5 billion in funding for immunizations over 9 yea S. [cite ?, OMB, 12/6/95] The Republicans will do anything, anything to stop President Clinton. President Clinton. Meeting our challenges. Protecting our values. documents . include that in we Other the could tien document Genis EXECUTIVE OFFICE OF THE PRESIDENT 19-Apr-1996 10:34am TO: Gordon P. Agress FROM: Diana M. Fortuna Domestic Policy Council SUBJECT: numbers We're cancelled today, but here's what I was picturing: Combined Series -- quarter by quarter Q1 Q2 Q3 Q4 current I NHIS X X X X' x' NIS - - y y' y' Q1 would be however far back we think we need to go, probably FY92-ish. In my example, Q4 is the first quarter where both systems had provider verification, so we would draw a vertical line to show where that started. All of this assumes they can't back out the effect of provider verification. To me, this would really lay it out clearly. What do you think? 04/17/96 13:12 202 690 5673 HHS-PUBLIC AFFAI 002 President Clinton Quote on National Infant Immunization Week "Today, more American children than ever before are properly immunized -- and fewer children than ever before are suffering from vaccine-preventable diseases. Yet more than one million American preschoolers are not fully immunized against life-threatening and preventable disease. All of us must continue to work hard to build on our success and ensure that every child in this country gets an equal shot at a healthy life." 04/17/96 13:13 202 690 5673 HHS-PUBLIC AFFAI 003 HHS NEWS U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR IMMEDIATE RELEASE Contact: CDC Press Office (404) 639-3286 Americans have two new records to celebrate--one high, one low--during this year' S National Infant Immunization Week (NIIW), April 21-27. In the United States, the national infant immunization rate is at an all-time high and vaccine-preventable childhood diseases are at historic all-time lows. The Centers for Disease Control and Prevention reports that seven vaccine-preventable diseases were at record lows in the United States in 1995. Fewer children than ever before suffered from measles, mumps, rubella, diphtheria, tetanus, polio and a form of bacterial meningitis. Compared to the pre-vaccine era, these life- threatening diseases have declined 95 percent or more. morestes 1 move According to CDC' S National Immunization Survey, which surveys two parents of preschoolers nationwide, 75 percent of 2-year-olds in the United States received their full series of shots as recommended. Yet, despite this record high, more than one million American children remain vulnerable to disease because they need one or more doses of vaccine. In 1994, President Clinton officially proclaimed "National Infant Immunization Week" as the last week in April every year to focus attention on the target population of the Childhood Immunization Initiative--infants and toddlers. This year communities across the nation will be participating in outreach activities during the week. State and local health departments and - More - 04/17/96 13:14 202 690 5673 HHS-PUBLIC AFFAI 004 2 community immunization coalitions have planned special activities on during NIIW April 22, in Atlanta, the 1996 Olympic Game mascot, Izzy, is going to check his immunization record on April 23, Mi Health and Human Services Secretary Donna Shalala will visit the and Secretary snalala East Valley Clinic in San Jose , and, April 25, will participate in immunization outreach activities at The Maria de los Santos Clinic on in Philadelphia' Empowerment Zone. April 24, Boston' S Commonwealth Housing is presenting holding a health fair that includes free on-site will provide immunizations; Boston' S preschooler immunization rate, at 87 lamong cuties surveyed - if necessary percent, is the highest in the nation, of cities surveyed. to include " Our message during National Infant Immunization Week is one of hope and concern, said Secretary Shalala. "Vaccines work they Vaccines are superb, cost-effective tools to prevent disease. However, with one of every four infants in the United States missing a needed shot, parents can' t be sure their child is fully protected until they check. We encourage parents and health care providers to stop and check their preschoolers' shot records during National Infant Immunization Week and at every health care visit throughout the year. The National Infant Immunization Week is an annual special observance that highlights the importance of public and private partnerships in increasing infant immunization. During the past two years, successful immunization partnerships have been launched with and the kiwanis and Rotan clubs organizat Gerbers, K-Mart MacDonalds, and Hope for Kids. "Deadly viruses do suchas not respect state or community borders; the problem of under - immunization of infants affects every community in this nation," - More - Q4/17/96 13:15 202 690 5673 HHS-PUBLIC AFFAI 005 3 - said CDC Director, Dr. David Satcher. "While no single factor accounts for under immunization, achieving and sustaining high action coverage requires interventions by health-care providers, parents and communities.' Lum at, the decline Bignificant Despite the availability of measles vaccine since 1963 whole when from start of this decade a measles epidemic swept the nation From the nomb ofcases. 1989 to 1991, 55,000 cases of measles were reported, which killed more than 130 children and adults. Nationwide, vaccination levels were estimated at 55 percent and, in some communities, were believed to be as low as 10 percent. ID contrast, In 1995, state lead health departments have reported the lowest number of measles cases w/ decrea since reporting began in 1912. The provisional total for 1995 is 301 cases, down 69 percent from the 963 reported cases in 1994. The National Infant Immunization Week is an important part of the broader outreach effort within the Administration' S Childhood Immunization Initiative. The initiative, launched by CDC in 1994, aims to further increase infant immunization levels and reduce sustain high rates and diseases, like measles, while building a system to deliver new and 1 safer vaccines to generations of children to come. "It is a travesty to have the means to prevent disease and death and not have a system to protect children year after year, said Secretary Shalala. "For too long, children in America did not have a To truly consistent means to ensure equal access to life-saving vaccines. Success we mus That is why this administration has more than doubled the funding breakde for childhood immunizations, helped states and communities reduce all of immunization barriers, and built a national outreach effort the likes the barriers of which this country has never seen." that present our - More - children From bing immunized on Time . 04/17/96 13:16 202 690 5673 HHS-PUBLIC AFFAI 006 4 National, state, and local outreach *initiatives are working to increase vaccination levels to at least 90 percent among preschoolers by the year 2000 These initiatives include 1) increasing immunization clinic hours 2) assessing vaccination practices withined clinic or practice, 3) linking immunization services with the successful Women, Infants, and Children (WIC) services, 4) standardizing strategies to remind parents when vaccinations are needed, and 5) forming partnerships among traditional health partners and community civic, religious and business leaders. ### Information on NIIW and childhood immunization is now available on the Internet. Visit CDC' S home page at http://www.cdc.gov/ for the most current information on childhood immunizations. For more information on 1 NIW activities), please call local . - contact CDCS community Outreach and Planning branch at 20 (404) 639-8375. in your state, REMARKS DONNA E. SHALALA SECRETARY OF HEALTH AND HUMAN SERVICES AT AMERICAN NURSES ASSOCIATION IMMUNIZATION PARTNERSHIP DECEMBER 12, 1995 20'd 94566238 01 FROM 14:51 1 Thank you, Mrs. Promboin, for that gracious introduction. My thanks to Geri Marullo and the ANA for your tireless efforts to bring health and hope to all Americans. I also want to recognize the remarkable contributions of Dr. Redlener; First Ladies Romer and Symington; and my colleague Dr. Orenstein, who is doing a superb job overseeing the National Immunization Program. And I couldn't begin my remarks without paying a special tribute to Rosalynn Carter and Betty Bumpers: Two visionary leaders who understand the importance of both enthusiasm and stamina; leaders who, for nearly two decades, have raised awareness and sparked action; leaders who are teaching Americans that WE must immunize our children - - and we must do it early; and, through it all, leaders who are truly an inspiration to all of us. Whenever I'm preparing to give a speech about children, I am reminded of the great tradition of storytelling in America. I'm talking about the folk tales, the fairy tales, and the down-home wisdom we all heard when we were young - - and pass down to the next generation as we get older. Remember the Native American trickster tales and the African American folk tradition? Golden oldies like Cinderella and The Wizard of OZ? And, the Mexican-American song about a mother duck who protects and provides for her ducklings? These stories have one thing in common. In each case, the children get saved because of the intervention of caring adults: The Fairy Godmother. Glenda the Good Witch. The kindly woodcutter. The loving parents. You are those caring adults. Whether you're teaming up with our schools to make immunizations as common to students as reading, writing, and arithmetic; pounding the pavement to remind parents to get their childrens' shots on time; or helping states climb onto the Information Superhighway with centralized registries that keep track of who's immunized -- and who's not -- you are serving on the frontlines, creating healthier todays and stronger tomorrows for all our children. And we are proud to stand with you. Under our watch, we're fighting to make sure that all children get the right start in life -- with better, stronger Head Start and Child Care. With our historic tobacco initiative, we're fighting to ensure that children get their information about smoking from their parents and other caring adults -- not from Joe Camel. 94562878 P.03 01 FROM DEC-12-1995 14:31 2 We're fighting to stop drug use before it occurs by expanding treatment options for pregnant women and working with thousands of communities to preach a message of real prevention. We're fighting for safer neighborhoods with the Brady Bill and Assault Weapons ban -- the first two curbs on gun violence to be enacted in more than 25 years!! And with your help, we're fighting for a healthier America - - where every child gets all their shots -- not by age five, not by four, not by three but by twoll And that's a children's agenda. Just LWO months after he was sworn into office, President Clinton personally committed his Administration to an historic, comprehensive strategy to immunize our youngest and most vulnerable children. And today - together -- we are making good on that promise. But let me be clear: This is not a one shot burot of energy. This is not a single, short-lived effort. This is not a band-aid approach to a temporary epidemic. It's a comprehensive and lasting shift in priorities and practice. That's why, since 1993, we've increased funding for immunization grants to states every year -- [or a total of almost 50 percent. That's why we've abandoned the old "one size fits all" approach to government -- and helped states develop their own tailor-made action plans -- SO that they can expand clinic hours, hire more staff, and find other new ways to vaccinate more children. That's why we're teaming up with the managed care industry -- as HMO's come to understand that immunizations are good for the bottom lines of people and profits. That's why we're unlocking the scientific mysteries of vaccines - - so that one day our children can get all their immunizations with one shot -- or even by eating a banana. That's why we've worked with you in communities across America to hold conferences, create coalitions and build a national outreach effort the likes of which this country has never seen! And that's why, from Minnesota to South Carolina and from North Dakota to Delaware, under demonstrations approved by HHS, states are finding innovative ways to increase immunization rates now - - and sustain them into the future. P.04 94562878 01 FROM 14:31 3 And that's exactly why all of us are here. When I spoke at this meeting just two years ago, only 55 percent of children under two were fully vaccinated. Today, immunization rates are at their highest levels in history. Today, diseases like measles, mumps, and rubella are nearing all- time lows. And today, we're on the brink of waving one final goodbye to the tragedy of polio in America. That's real progress -- progress we should all be proud of -- but our work is far from done. There are still over one million preschool children in this country who don't have all their shots -- and we cannot rest until they do. Unfortunately, the Republican Leadership in Congress disagrees. Let me be clear: What they are proposing is nothing less than an all-out assault on the health of our neediest families and the values of our country. And what do I mean by values? I mean it's not right to take the promise of Medicaid -- our country's historic guarantee of health care for vulnerable families and children -- and replace it with an ill-conceived, underfunded, block grant. It's not right to end the guarantee of funding for vaccine purchases for the states -- taking away hundreds of millions of dollars that could be used to buy vaccines -- and sending us back to the days when funds for childrens' immunizations had to compete for scarce resources with education, AIDS prevention, drug treatment and other critical efforts. It's not right to slash $163 billion from Medicaid and put nearly four million poor children out in the cold -just to help finance a big tax cut for the wealthy. It's not right to cut immunization grants to states by $28 million next year, as the House Appropriations bill would do. And, under the quise of welfare reform, it's not right to slash child care, school lunches, and aid to disabled children -- and decimate the foundation that keeps families healthy and strong. We must send the message loud and clear: We cannot go back to the days when our children's health needs went unmet, because their parents couldn't afford to take them to a doctor. We cannot go back to the days when anguished children gasped for air from monstrous iron lungs. 94562878 P.05 01 DEC-12-1995 14:32 FROM 4 And we cannot go back to the days when we spent more energy immunizing chickene and dogs than children. WE cannot - and we will not. We believe that Medicaid must remain a guarantee and a promise for all children who need it. We bolieve that we can balance the budget in seven years while still strengthening Medicaid, protecting childhood immunization funding and safeguarding our future. And, most important, we believe that government alone cannot solve our problems -- and that you are the leaders who can help get this job done. so, let us leave here today stronger than ever, more committed than ever, more determined than ever to make good on the promises we've made to each other and to our children. Lel us continue to reach out and join hands across disciplines and across the country -- to ensure that all children get the shots they need -- no matter where they live or how they live. Let us remember the lessons of TB and other public health tragedies and celebrate our successes not by recting on our laurels but with a renewed and re-energized commitment to continue the fight. And, as we engage in this historic debate about the role of government and the character of our country, let us all continue to stand up and speak out for the health of our children. Because as you know, children don't have lobbyists. They don't buy T.V. time. And, they can't vote. All of us are the caring adults that make happy endings come true. We are the Fairy Godmothers and Godfathers. And, we must make sure that the fate of our children rests in everybody's hands. I like the way that the writer Francis Thompson described the imagination of children: "It is to turn pumpkins into coaches, and mice into horses; lowness into loftiness, and nothing into everything. Together, we must keep that power of dreams alive for this generation of children -- and every generation to come. That is our challenge. That is our obligation. And that is our hope for the future. Thank you. 90'd 94566238 01 FROM DEC-12-1995 14:33 CHILDHOOD IMMUNIZATION What is the problem? In order to protect children against disease, toddlers should receive a full series of immunizations by the time they are two years old. One million American children do not. Almost every child in the United States eventually completes the series, but not on time (because immunization is required to enter school). Every child who is incompletely immunized between the ages of two and six is vulnerable to serious illnesses like measles and bacterial meningitis. What is the evidence? While child immunization rates have risen since the 1989-1991 measles epidemic, a 1993 survey found that 33% of pre-school children (with an average age of 27 months) had not received the three most critical vaccines -- MMR (measles/mumps/rubella), DTP (diphtheria/tetanus/pertussis) and polio. Roughly 45% had not received the HIB vaccine, which protects children against bacterial meningitis. An astonishing 84% had not been vaccinated against Hepatitis B, which causes liver disease. Lack of immunization is not only dangerous to children, but expensive as well. Immunizations prevent serious illnesses that require costly treatment. Every dollar spent on the MMR vaccine saves $21 in potential health care costs. The DTP vaccine saves $30 for each dollar spent and the polio vaccine saves $6. Why aren't children properly immunized? Access. Many children do not have a regular doctor or health center. Cost, distance, limited hours, and cultural differences create obstacles to seeking regular "well-child" care. Without a medical home, children are unlikely to complete the full series of immunizations, which require multiple visits and careful record-keeping. Cost. The private cost of a full series of immunizations rose from $27 in 1983 to $270 in 1994. As costs rise, parents are less able to pay for immunizations for uninsured or underinsured children and physicians increasingly refer patients to public clinics for immunizations. Even children who do have a regular doctor are less likely to be properly immunized. Fragmented care. A 1992 survey conducted by the American Academy of Pediatrics showed that 43% of pediatricians had increased their referrals to public clinics for vaccinations in the preceding ten years, primarily because of costs. Nationwide, 55% refer some or all of their patients to a public provider for immunizations. In some states the figure is dramatically higher. For example, in North Carolina 93% of physicians referred patients to a public clinic in 1992. Although public clinics provide free immunizations, the extra step fragments care and poses an obstacle to full immunization. At a time when efforts are being made to improve continuity of care and reduce duplicative services, it makes sense to enable families to get all their children's primary care from one source. What has the Clinton Administration done? The Clinton Administration launched a Childhood Immunization Initiative with two goals: to increase initial and critical immunization doses to 90% for two-year-olds by 1996; and to put in place a system to ensure that over 90% of all two-year-olds are fully immunized by the year 2000. The Childhood Immunization Initiative draws on five strategies to increase immunization rates: improving vaccination delivery services; reducing vaccine costs; increasing awareness, community participation, and partnerships; improving the monitoring of disease and vaccination coverage; and improving vaccines and vaccine use. The Vaccines For Children program is designed to implement the first two strategies by encouraging private physicians to administer vaccines to poor and uninsured children and by making vaccine available to states at a reduced price. How does the Vaccines for Children (VFC) program work? Under the VFC program, vaccines are provided by the federal government so that they can be administered free to every eligible child. To qualify, a child must be Medicaid-eligible, uninsured, a Native American, or an Alaskan Native. Underinsured children are eligible if they go to rural health clinics or Federally Qualified Health Centers. VFC eliminates costs to parents and prevents missed immunization opportunities. Physicians will not have to worry about costs before immunizing their patients and will therefore be less likely to refer their patients to public clinics. VFC prevents the missed immunization opportunities and delays that result from referrals to public clinics. Parents will not have to worry about fees and will be able to choose whether to go to a public clinic or a private provider. VFC saves money for states and allows greater flexibility. Under VFC the federal government pays the full cost of immunizing children enrolled in Medicaid. As a result, states save money that they can use to enhance their immunization program. They may keep clinics open longer, conduct outreach, or purchase more vaccine. Under VFC states may also opt to purchase vaccine at the lower, government price for all children in the state. VFC will improve immunization rates. More than one million infants and toddlers without insurance are guaranteed free vaccines in their doctors' offices. VFC also helps the eight million older uninsured children who need follow up vaccines at ages four and fifteen. 06/27/95 19:33 202 690 5673 HHS-PUBLIC AFFAI 002 Q. Does the Administration oppose folding the Vaccines for Children (VFC) program into a block grant? A. The Clinton Administration has a very simple goal -- to improve preschool immunization rates. Since taking office, the President has lead an aggressive campaign to reach that goal, and we have made great progress. But we believe that our current investment in children's immunizations must be maintained. Childhood immunizations are one of the most cost-effective public health investments we can make -- they save lives and they save money. To take just one example, for every dollar spent on the measles/mumps/rubella vaccine, we save $21 in health care costs. We are willing to work with Congress to make changes to improve the VFC program. But we are not willing to watch as Congress slashes funding for childhood immunizations in just one more shortsighted attempt to cut the budget. Q. Is the Administration's position that VFC must remain an entitlement? A. We believe that the federal budget should be balanced, but in a way that makes sense. The President has laid out a proposal that retains coverage under Medicaid while reducing spending and giving states more flexibility. Medicaid is a critical health care program. It can certainly be improved, but not by cutting it dramatically to balance the budget. The same applies to VFC. If we can improve the way we are going about our childhood immunization efforts, we're certainly willing to work on it. But we must maintain poor and uninsured children's access to life saving and cost-effective vaccines. 06/15/95 11:07 202 690 5673 HHS-PUBLIC AFFAI 002 Talking points - Vaccines for Children The Vaccines for Children program is an important part of the broader Childhood Immunization Initiative. The CII includes five key strategies to improve preschool vaccination rates. These include improving the quality and quantity of vaccination delivery services; reducing vaccine costs; increasing awareness, community participation and partnerships; improving the monitoring of disease and vaccination coverage; and improving vaccines and vaccine use. Improving preschool immunization rates is one of the Clinton Administration's highest priorities. Since taking office, the Clinton Administration has doubled funding, and guaranteed funds for new vaccines. Legislation to launch a new Childhood Immunization Initiative was introduced soon after President Clinton's inauguration. A specific goal was set for 1996: increasing vaccination levels for two-year-old children to 90 percent for the most critical doses. And a new program to provide free vaccines to millions of poor and uninsured children was instituted. While child immunization rates have improved since the 1989-1991 measles epidemic, VFC is a key part of the national strategy to reach the one million American children who are not fully vaccinated by age two. A 1993 survey found that 33 percent of pre-school children (average age 27 months) had not received a full series of the three most critical vaccines (MMR, DTP and polio). About 45 percent had not received the HIB vaccine, which protects children against bacterial meningitis; and 84 percent had not been vaccinated against Hepatitis B, which causes liver disease. As an integral part of the CII, the Vaccines for Children program focuses on making free vaccines more widely available, reducing costs and missed opportunities for immunization. In the past ten years, immunization costs have increased ten-fold: the private cost of a full series of immunizations increased from about $27 in 1983 to $270 in 1994. A Spring 1992 survey by the American Academy of Pediatrics showed that 43 percent of pediatricians had increased their referrals to public clinics for vaccinations in the preceding ten years, primarily because of costs. Under the VFC program, vaccines will be provided free to children who are enrolled in Medicaid or uninsured, and to native Americans and Alaskan natives. That means that physicians will no longer have to refer uninsured children to public clinics, a common practice that means missed opportunities for immunizations and fragmented care. And parents can choose which provider makes the most sense for their child, because the difference in price between the two settings ($270 and $129) won't be a factor. 06/15/95 11:08 202 690 5673 HHS-PUBLIC AFFAI 003 This will make a tremendous difference for nine million uninsured American children. While Medicaid recipients can receive free vaccines under current law, working families have not had the same guarantee. Under VFC, more than one million infants and toddlers without insurance will now be guaranteed free vaccines, and their parents will pay only a modest administration fee. And because ten percent of all American children don't have health insurance, VFC will also help millions more older children who need follow-up vaccines at age four and fifteen. Under VFC, every eligible child will receive vaccinations, even if parents cannot afford to pay the administration fee. Private doctors will continue to serve their regular patients, even if the parent or guardian cannot afford to pay the administration fee. Other needy children will not be charged a fee in public clinics. In addition, VFC will provide free vaccines to children with limited insurance in rural health clinics and Federally Qualified Health Centers. In these settings, additional children whose insurance plans don't cover vaccinations will continue to be eligible for free vaccines. Funds for new vaccines will automatically be provided. Under VFC, new childhood vaccines recommended by a federal advisory committee will automatically be purchased by the federal government and provided free to eligible children -- and budget constraints will never again limit or delay federal purchase of new vaccines. States will be able to save money by ordering vaccines at the lower, government price. Because VFC will lower states' Medicaid costs for vaccines, these savings can be used to keep clinics open longer, or take other measures to increase immunization rates. And more states will be guaranteed the lower CDC price for the vaccines they do purchase. Child immunization protects children and saves money. For example, every dollar spent on the MMR (measles/mumps/rubella) vaccine saves $21 in potential health care costs. For the DTP (diphtheria/ tetanus/pertussis) vaccine, the cost-benefit ratio is 30 to 1. And for polio, it's 6 to 1. 06/15/95 11:08 202 690 5673 HHS-PUBLIC AFFAI 004 Questions and Answers on the VFC Program 6/15/95 Q: The GAO has challenged CDC's assertion that the cost of vaccines is a barrier to childhood immunization. Is cost a barrier or not? A: Cost is a barrier because it contributes to delays in achieving full immunization of preschool children with today's vaccines. The cost of the complete vaccine series has increased ten-fold in the past 12 years. Since parents must pay about $270 in vaccine costs and an additional amount in administration fees for the series, those without adequate insurance may not seek immunizations from their private doctors, but from public health clinics where vaccine is free or available at nominal cost. Having to make extra visits to public clinics can result in delays and missed opportunities for immunization. Numerous surveys of practitioners and health departments have also documented increased referrals of patients from their primary care providers to public clinics, with cost as the most important reason cited. A 1992 American Academy of Pediatrics study revealed that 55 percent of pediatricians refer some or all or their patients to a public provider for immunizations. A 1992 North Carolina survey showed that 93 percent of physicians referred patients to health departments for immunizations, and states such as New York have showed similar trends. Q: The GAO has recommended that the VFC program should be targeted to certain population groups and areas referred to as "pockets of need. Doesn't this make sense? A: We believe, and Congress has agreed, that the proper goal of Federal immunization efforts is to raise immunization levels throughout the nation, and to put in place a sustainable system that will ensure that immunization rates remain high. The GAO conclusion assumes that "general immunization rates" are not now a problem and will not be a problem in the future. While child immunization rates have improved since the 1989- 1991 measles epidemic, VFC is a key part of a national strategy to reach the one million American children under two who are unvaccinated against one or more deadly diseases. A 1993 survey found that 28 percent of pre-school children (average age 27 months) had not received a full series of the three most critical vaccines (MMR, DTP and polio). About 40 percent had not received the HIB vaccine, which protects children against bacterial meningitis; and 84 percent had not been vaccinated against Hepatitis B, which causes liver disease. Q: Does the Administration oppose folding the Vaccines for Children (VFC) program into a block grant? A: The Clinton Administration has a very simple goal -- to improve preschool immunization rates. Since taking office, the President has lead an aggressive campaign to reach that goal, and we have made great progress. But we believe that our current investment in children's immunizations must be maintained. Childhood immunizations are one of the most cost-effective public health investments we can make -- they save lives and they save money. To take just one example, for every dollar spent on the measles/mumps/rubella vaccine, we save $21 in health care costs. We are more than willing to work with Congress to make changes to improve the VFC program. But we are not willing to watch as Congress slashes funding for childhood immunizations in just one more shortsighted attempt to cut the budget. Q: Is the Administration's position that VFC must remain an entitlement? A: We believe that the federal budget should be balanced, but in a way that makes sense. The President has laid out a proposal that retains coverage under Medicaid while reducing spending and giving states more flexibility. Medicaid is a critical health care program; it can certainly be improved, but not by cutting it dramatically to balance the budget. The same applies to VFC. If we can improve the way we are going about our childhood immunization efforts, we're certainly willing to work on it. But we must maintain poor and uninsured children's access to life saving and cost-effective vaccines. [DRAFT - 3/20/95 10:00pm] 8C. CHILDHOOD IMUNIZATION "To guarantee that our children's faith in us is justified. we must renew our commitment to protect them from deadly infectious diseases." President Clinton 8-14 [DRAFT - 3/20/95 -- 10:00pm] Actions to Date The President has launched a comprehensive effort to give our children a healthy start in life by immunizing them against preventable disease. Under the Childhood Immunization Initiative, the Administration has: Provided states and local governments with added support for immunization programs. Federal spending to support immunization infrastructure increased by 213) percent, from $45 million to $141 million. % our nation's Started the Vaccines For Children Program which will provide free vaccines to our nation's neediest children Q about 60% of all children. 1 Helped create information systems to see that all children are properly immunized. Formed innovative partnerships with private organizations that will reach target communities with an immunization message: - Gerber Products Company put an immunization message on the back of baby cereal boxes; - Kiwanis International created a national public awareness campaign, including public service announcements, billboards, and posters; and - McDonalds featured an immunization message in its tray liners. Helped thousands of health care providers improve their immunization procedures by broadcasting information via satellite to 16,000 participants in 44 states. Using this technology, the Centers for Disease Control and Prevention will have trained more providers within six weeks than it had trained in the previous ten years. Simplified what parents and health care professionals need to know to ensure children are properly immunized, by working with leading health professionals to get them to agree on a single recommended immunization schedule. 8 15 [DRAFT - 3/20/95 -- 10:00pm] Background "It's a national tragedy that about one-third of America's two-year-olds are not adequately vaccinated against preventable disease." President Clinton Childhood vaccines prevent nine infectious diseases -- polio, measles, diphtheria, mumps, pertussis, rubella, tetanus, hepatitis-B, and Haemophilus influenzae type B (Hib) (which causes meningitis). Children need 11 to 15 vaccine doses by the age of two, requiring about five visits to a doctor or clinic. Yet, too many of America's two-year-old children do not get the full range of vaccines and full protection from illness and possible death. The cost of immunizing a child is much higher today than it was just a few years ago. The full complement of vaccines has risen from only $28 in 1983 to about $270 in 1994. Costs are up in part because new vaccines are now recommended for all children, and the prices of some vaccines have gone up. These higher costs mean that more because uninsured and underinsured families are unable to pay for vaccines out of their own pockets. In response, private providers now send more children to public health clinics for their shots, where Federal or state supplied vaccines are free. Because these referrals break the continuity of care, children miss opportunities for vaccination. The influx of children referred from the private sector has overburdened the public clinic system. This erosion was a direct cause of a measles epidemic during 1989-1991. Although measles is preventable, failure to provide adequate support for immunization resulted in 55,000 cases of the disease, 11,000 hospitalizations, 44,000 hospital days, and 130 deaths. The epidemic cost an estimated $150 million in direct medical costs alone, without including massive indirect costs stemming from lost time on the job, lost productivity, and lost wages. By preventing expensive treatment of diseases, vaccines save money. For every dollar spent on the measles/mumps/rubella vaccine, an estimated $21 is saved. About $29 is saved for every dollar spent on diphtheria/tetanus/pertussis vaccine. Cases of disease need to be rapidly detected to identify under-immunized Why is populations and to institute disease control efforts. But, surveillance systems often have the whole been inadequate to detect cases of disease quickly. As a result, vaccine-preventable diseases have spread too rapidly, especially within populations that are at greatest risk. lost-- about this and thrown then 1.) at the the to end, 11 without problems, c.g. address hours, that 8-16 other we are trying to [DRAFT - 3/20/95 -- 10:00pm] The Initiative "The initiative is designed to increase immunization rates now, and build a system for sustaining these gains into the future. This is not a single short-lived effort. It is a lasting change in both priorities and practice." President Clinton The President's Childhood Immunization Initiative is building a comprehensive immunization system that marshals the public and private sectors, health care professionals, h nat an and volunteer organizations to increase vaccination rates. First, states and local EFFORTS governments will improve and expand immunization, efforts using added Federal funds. To Second, uninsured children can be immunized by their private physicians through this you mean program. Third, an enormous outreach effort will help providers and families to understand infrastruct the importance of immunization and to know which vaccines are needed and when. Wnat The Initiative's goal is to immunize at least 90 percent of two-year-olds in this country with the initial and most critical doses by 1996 and at least 90 percent of all two- year-olds with the full series of vaccines by 2000. The Childhood Immunization Initiative will: 1. Improve the quality and quantity of vaccination services: This 11 bit vague. In 1993, the Federal government sent $129 million ($83 million in new Federal resources) to states and local health departments to improve existing services based on plans they developed. Each area uses its own discretion to allocate these funds to meet local needs whether longer clinic hours or automating records. Locally tailored systems mean that parents can visit an immunization clinic at more convenient times and be assured of prompt, quality service. Automated record-keeping creates easy reminders for providers and parents that vaccinations are due. whether by lengthening 2. Reduce vaccine costs for parents: The Vaccines for Children program will reach more children with free vaccine than ever before, including many at their own doctor's offices. Sixty percent of our Nation's children will benefit, including the uninsured, those on Medicaid, Native American children, and children served by federally qualified health centers. States can buy vaccines at reduced Federal prices to provide universal access to vaccine for all children in their state. The Federal government will assist states with more than $200 million to purchase IS this vaccines. As a result, cost will no longer be a barrier for our neediest children, and parents the total can get their children vaccinated by their family doctor. program cost? avn't this number stand 8-17 [DRAFT - 3/20/95 -- 10:00pm] 3. Increase participation, education, and partnerships in communities: The Administration's plan sends outreach coordinators around the country to increase awareness of the importance of vaccinating children and to encourage health care providers to use every opportunity to vaccinate children in their care. Community and business groups, religious and service organizations, schools, and the media are joining community-based networks to increase infant vaccination efforts. We are encouraging our immunization partners to take advantage of National Infant Immunization Week (in late April each year) to focus attention on the vaccination needs of infants and young children. 4. Better monitor diseases and vaccinations: We are creating a better system to monitor vaccine-preventable diseases so that we can spot problems early and prevent cases from escalating into epidemics. The Centers for Disease Control and Prevention is working to pinpoint the populations that are not receiving the benefits of infant vaccination. 5. Improve vaccines and how they are used: We are increasing applied research into new vaccines in an effort to reduce the number of shots children must receive and to ensure safe and effective vaccines. We developed a single childhood immunization schedule by working with the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians. This single schedule simplifies what parents and providers must know to ensure proper immunization. Better vaceines mean children are better protected from disease earlier in life. Although available vaccines are very safe and effective, the Centers for Disease Control and Prevention is working with states and selected providers to enhance systems to detect rare adverse events following vaccination. In addition, 8-18 [DRAFT - 3/20/95 -- 10:00pm] Case Study: Kathleen Kathleen, a single parent living in Santa Fe, New Mexico, was worried about juggling her work schedule to take her young son for vaccinations at the Santa Fe County Health Office. "I'm a single parent trying to raise a child alone, and it is not easy to get off work to take him for shots." IV To her pleasant surprise, when she called to find out which day the clinic offered immunizations, she discovered that the Santa Fe County Health Office clinic was now offering immunizations five days a week and had extended the hours. In 1993, New Mexico, along with other states and some urban areas, received an increase in Federal funds to improve their vaccine delivery infrastructure. Santa Fe County chose to use some of the funds to increase the number of days it offered vaccinations to children. Nurse Manager Laurie Spiegel said, "We're trying to be more accessible and people are really responding. We know that both parents may work and it's difficult to get to the clinic. Extending the immunization hours also means we've decreased the waiting time at the clinic." Kathleen was able to vaccinate her son as recommended and wasn't forced to miss work. "It's nice to see that people realize how difficult it can be to get to the clinic during a few fixed hours. I appreciate being able to go for services at more convenient hours. Finally, a consumer-friendly state service." 8-19 SENT BY:Xcrox Telecopier 7020 : 3-24-95 :11:29AM 4044517288- 94567431:# 2 DRAFT National Infant Immunization Week April 22-29. 1995 THE SEVEN DAYS OF IMMUNIZATION "At Least Eleven Shots by Two: How Sure are You?" T he immunization rates for children under two years of age are far too low, and all members of our communities can play a role in making sure that all of our youngest children are properly immunized. Thousands of lives are jcopardized by preventable diseases, and hundreds of thousands of dollars have been spent on the care of stricken children whose illnesses could have been avoided. National Infant Immunization Week (NIIW) offers an opportunity to reach audiences who can help make certain that our nation's children are fully immunized by the age of two. The slogan for NIIW 1995 is "At Least Eleven Shots by Two: How Sure Are You?", supported by the theme: "We need you to get all our babies shots by two." This theme reinforces the need to get all members of our communities involved in appropriately immunizing our children. The "Seven Days of Immunization" provides a guideline for community activities during NIIW. Each of the seven days focuses on a particular scctor of the community and helps to demonstrate that everyone can play a role in making certain that all of our children are protected against vaccine-preventable diseases. April 22 and 23 - Religious Leaders Lead the Way Religious leaders play an important role in the community and reach a loyal audience every week. By incorporating immunization messages into their weekly service, religious leaders can potentially affect a large audience. April 24 . Elected Officials Voice Their Support Elected officials, such as governors, mayors, members of Congress, statc legislators, and city council members, have the ability to reach and mobilize broad cross-sections of the population. On this day, elected officials could highlight the importance of disease prevention and identify childhood immunization goals for their respective state, district or city. Their participation can illustrate the entire community's commitment to our youngest children, and reinforce the message that disease prevention can be measured in both economic terms and health benefits. April 26 - Community Partnerships: A Key Element Public-private partnerships, including health care providers, community-based organizations, businesses, civic and service groups, the media and numerous others, play crucial roles in state and community-based immunization efforts. This day of the week provides an opportunity to SENT BY:Xcrox Telecopier 7020 ; 3-24-95 :11:30AM ; 4044517288- 94567431:# 3 DRAFT highlight some of these pre-existing partnerships. Through the attention focused on the partnership activities, it is hoped that new partners will be encouraged to join these efforts. April 26 . Disease Prevention: The Children's Perspective For this day of the week, we are suggesting use of a school setting to focus on children's understanding of disease prevention. Teachers and children can provide a direct link to parents and younger siblings. The days' activities present an opportunity for teachers and children to educate parents and peers. As a long-term benefit, schools may incorporate disease prevention education as an ongoing part of their curriculum. April 27 . Provider Spotlight: Innovative Strategies Health care providers play the central role in immunizing children. In addition to administering vaccine, many health care providers participate in community-based partnerships and undertake innovative efforts to increase immunization coverage rates. These efforts include extending office hours to accommodate working parents, making reminder phone calls, and auditing their own patient records to check the immunization status of all children under their care. This day of the week provides an opportunity to acknowledge these activities and encourage others to adopt similar efforts. April 28 - Childhood Immunization Across the Nation One barrier to raising childhood immunization rates is the public's lack of awareness that the problem is so serious and wide-spread. Friday's activities are designed to demonstrate that under-immunization is a national issue that affects all of us. In addition, this day's activities provides an opportunity to highlight the different strategies used by states and communities to address the under-immunization problem. April 29 - Community Mobilization: Reaching out for Children Having built up momentum throughout the week, the final day of NIIW will focus on bringing together existing partners for a "grand finale" event -- highlighting the fact that everyone has a role to play in raising immunization rates. One suggested activity includes volunteers, community groups and health care providers combining forces to organize phone banks or canvassing efforts to reach as many parents as possible to discuss the importance and specific timing of the necessary immunizations. Reminding parents of the specific timing for needed immunization has proven to be an effective method for raising infant immunization rates. The community mobilization activities provide a vchicle to rccognize existing efforts, recruit more volunteers to these pre-existing efforts, increase public awareness, highlight effective ways to raise immunization rates, and possibly make the reminder/recall effort an ongoing activity in the community.