H1N1 State and Federal Response
Updated January 29, 2009
Contents
Situation Update
What Are the Signs and Symptoms of H1N1 (Swine) Flu in People?
The symptoms of H1N1 (swine) flu in people are similar to the symptoms of regular human flu and include:
- Fever (may not be present)
- Cough
- Sore throat
- Body aches
- Headache
- Chills and fatigue
- Diarrhea and vomiting in some cases.
In the past, severe illness (pneumonia and respiratory failure) and deaths have been reported with H1N1 (swine) flu infection in people. Like seasonal flu, H1N1 (swine) flu may cause a worsening of underlying chronic medical conditions.
In children emergency warning signs that need urgent medical attention include:
- Fast breathing or trouble breathing
- Bluish or gray skin color
- Not drinking enough fluids
- Severe or persistent vomiting
- Not waking up or not interacting
- Being so irritable that the child does not want to be held
- Flu-like symptoms improve but then return with fever and worse cough.
In adults, emergency warning signs that need urgent medical attention include:
- Difficulty breathing or shortness of breath
- Pain or pressure in the chest or abdomen
- Sudden dizziness
- Confusion
- Severe or persistent vomiting,
- Flu-like symptoms improve bu then return with fever and worse cough.
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A new strain of the H1N1 influenza A, or swine flu, emerged in April 2009. It has since spread to more than 168 countries prompting the World Health Organization to declare it a pandemic. As of January 29, 2010, 406695 confirmed cases of H1N1 (swine) influenza have been reported in the United States. Although the cases were largely moderate in severity, at least 4557 people have died. These numbers do not accurately reflect the actual number of cases in the United States, since testing is limited. The medical community has estimated that there actually may have been more than 1 million cases.The President's Council of Advisors on Science and Technology reported that 30 percent to 50 percent of the U.S. population this fall and winter could get the H1N1 virus, with symptoms in approximately 20 percent to 40 percent of the population (60 million to 120 million people), more than half of whom would seek medical attention. It could lead to as many as 1.8 million U.S. hospital admissions, with up to 300,000 patients requiring care in intensive care units (ICUs). These very ill patients could occupy 50 percent to 100 percent of all ICU beds in affected regions of the country at the peak of the epidemic and could place enormous stress on ICU units, which normally operate close to capacity. It could cause between 30,000 and 90,000 deaths in the United States, concentrated among children and young adults. In contrast, the 30,000–40,000 annual deaths typically associated with seasonal flu in the United States occur mainly among people over 65. Finally, it could pose especially high risks for people with certain pre-existing conditions, including pregnant women and patients with neurological disorders or respiratory impairment, diabetes, or severe obesity and possibly for certain populations, such as Native Americans. For additional information, FLU.GOV.
The Latest News and Updates
- January 29, 2010 update, HHS reports that 118,841,120 doses of the H1N1 vaccine have been delivered to the states as of January 26th. The Centers for Disease Control and Prevention (CDC) is still recommending that everyone be vaccinated since the flu season does not end until February or March. CDC reported that as recently as January 15, 7 states were still reporting regional flu activity, so flu is still out there. For example, during the 1957-58 pandemic, flu activity dropped in December and January. Public health officials assumed the worst was over, and stopped encouraging people to get vaccinated. Then flu activity increased abruptly in February and March, and hospitalizations and deaths increased as well. Currently there are no priority groups for available vaccine. They still recommend that those high at risk be vaccinated.
- December 6-12, 2009,CDC reported influenza activity decreased over the previous week across all key indicators. Most indicators, however, remain higher than normal for this time of year. Below is a summary of the most recent key indicators:
- Visits to doctors for influenza-like illness (ILI) nationally decreased slightly this week over last week. This is the seventh consecutive week of national decreases in ILI after four consecutive weeks of sharp increases. While ILI has declined, visits to doctors for influenza-like illness remain slightly elevated nationally.
- Influenza hospitalizations and hospitalization rates decreased in all age groups.
- November 2, 2009. The National Institute of Allergy and Infectious Diseases (NIAID) reported that the initial results show pregnant women in the H1N1 vaccine clinical trial demonstrated a robust response after one dose of the vaccine. "For pregnant women, who are among the most vulnerable to serious health problems from 2009 H1N1 infection, these initial results are very reassuring," says NIAID Director Anthony S. Fauci, M.D. "The immune responses seen in these healthy pregnant women are comparable to those seen in healthy adults at the same time point after a single vaccination, and the vaccine has been well tolerated." The report also included that no safety concerns have arisen in those vaccinated during the trial and the individuals will continue to be monitored in the coming months. According to the Centers for Disease Control and Prevention, since the outbreak began last spring, at least 100 pregnant women have been hospitalized in intensive care units in the United States and at the last official count, 28 pregnant women have died.
The trial began on Sept. 9 and reached its target enrollment of 120 volunteers in mid-October. All participants are between 18 to 39 years old and began the study in their second or third trimester (14 to 34 weeks) of pregnancy. Like the seasonal flu vaccine, the 2009 H1N1 flu vaccine contains a purified portion of the killed virus and therefore cannot cause infection. The vaccine did not contain the preservative thimerosal or an immune boosting substance known as an adjuvant.
- October 27, 2009. In order to fully explain the differences between the various types of emergency declarations available to cope with the effects of the H1N1 outbreak, the Department of Homeland Security Office of General Counsel has prepared an H1N1 Authorities Matrix to aid state and local officials in navigating the Federal system for assistance.
- October 25, 2009. The growing number of H1N1 cases has led President Obama to issue a National Emergency Declaration on H1N1 which allows healthcare systems to quickly implement disaster plans if they should become overwhelmed. This declaration permits the waiver of certain regulatory requirements, easing a health care facilities' abilities to respond to an influx of patients during this period. Two conditions must be met for the Secretary of Health and Human Services (HHS) to be able to issue such “1135 waivers”: first, the Secretary must have declared a Public Health Emergency; second, the President must have declared a National Emergency either through a Stafford Act Declaration or National Emergencies act Declaration. If these conditions are met, then healthcare facilities may petition for 1135 waivers in response to particular needs, and only within the geographic and temporal limits of the emergency declarations.The Secretary may tailor authorities granted under Section 1135 waivers to match the specific situational needs, but the requirements that may be waived include those related to Medicare, Medicaid or the Children’s Health Insurance Program (CHIP), the Emergency Medical Treatment and Active Labor Act (EMTALA), and the Health Insurance Portability and Accountability Act (HIPAA). Additional information regarding the 1135 waiver is available on FLU.gov. HHS has now provided a fact sheet on requesting an 1135 waiver.
- On October 14, 2009, the U.S. Department of Labor Occupational Safety and Health Administration (OSHA) released a statement regarding new standards of workplace safety concerning the H1N1 influenza A virus. OSHA was created in 1971 with the mission to prevent work-related injuries, illnesses, and death through education and regulation of workplace safety standards. These directives will closely follow the Centers for Disease Control and Prevention (CDC) Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection for Healthcare Personnel.
Healthcare employers will be required to implement a hierarchy of controls, including elimination of potential exposures, such as reducing the number of visitors; engineering controls, such as installing partitions in triage areas; administrative controls, such as ensuring that ill employees do not come to work; and personal protective equipment (PPE), which includes wearing masks, gloves, or gowns when coming into close contact with ill patients. Most notably, OSHA emphasizes the need to provide disposable N95 respirators for employees who come in close contact with flu patients. Where respirators are required to be used, the OSHA Respiratory Protection Standard must be followed, including worker training and fit testing. Forecasting a potential shortage of N95 masks, the directives urge healthcare facilities to carefully prioritize their use of the masks.
State Occupational Safety and Health Administrations must set their job safety and health standards that are "at least as effective as" comparable to federal standards. There are currently 22 states and jurisdictions operating complete state plans (covering both the private sector and state and local government employees) and four - Connecticut, New Jersey, New York and the Virgin Islands - which cover public employees only. (Eight other states were approved at one time but subsequently withdrew their programs).
A state must conduct inspections to enforce its standards, cover public (state and local government) employees, and operate occupational safety and health training and education programs. State programs will also need to be well versed on these new standards concerning the H1N1 Influenza A virus. Each program may access free consultative services through the Federal OSHA program to implement the necessary training regarding the standards.
- October 1, 2009--"H1N1 Challenges Ahead", Trust for America’s Health (TFAH) has released a new report that finds 15 states could run out of available hospital beds during the peak of the outbreak if 35 percent of Americans were to get sick from the H1N1 flu virus. Twelve additional states could reach or exceed 75 percent of their hospital bed capacity, based on estimates from the FluSurge model developed by the U.S. Centers for Disease Control and Prevention (CDC).
What is H1N1 (Swine) Influenza?
The growing list of similarities of the virus with the 1918 influenza has raised concerns among scientists, and in the public health community. Recently, an international team of virologists studied the pathogen and believe it is more virulent than previously thought. In fact, the team believes it could become much more virulent as the pandemic runs its course, and the virus evolves. Until now it was thought that there were many similarities between H1N1 and the seasonal flu. The H1N1 virus can infect cells deep in the lungs where it can replicate better than seasonal flu and cause pneumonia. In contrast, seasonal flu typically exhibits initial symptoms in the upper respiratory track. H1N1 also replicates much more efficiently in the respiratory system than seasonal flu and causes severe lesions in the lungs similar to those caused by other more virulent types of pandemic flu.
The CDC guidelines have tightly linked guidance with the occurrence of fever. The science community still feels that the association of fever with the occurrence of H1N1 infections is tenuous. Of the confirmed cases, the CDC estimates anywhere from 10 percent to 40 percent of infected individuals do not have fever. In Chile, approximately 50 percent of people with H1N1 did not have a fever.
CDC also cautions clinicians to consider a diagnosis of seasonal flu or H1N1 in children who have influenza-like symptoms accompanied by unexplained seizures or mental status changes. Four children in Texas experienced seizures or altered mental status and were confirmed as having the H1N1 influenza. Neurologic complications have previously been reported in other forms of respiratory tract infections and seasonal influenza but not H1N1 until now. The good news is that full recovery occurred in all four cases.
Researchers from Canada, Mexico, and Singapore released the results of research conducted on H1N1 confirmed cases. The three groups of experts agree that when coughing stops is a preferred indicator for when a patient is no longer contagious. The new data indicates that the virus may still be spread days after a fever goes away, and in some cases never existed.
Variant H1N1 Strains
Tamiflu resistant strains of the H1N1 virus have been confirmed in 11 other countries. Cases in the United States appeared in Washington, Texas and North Carolina over the summer. The World Health Organization has maintained that resistance is rare. Tamiflu resistance has been noted on the rise in seasonal flu as well over the last two years. In many of these cases the individual had not previously been on Tamiflu.
In order to properly manage any emerging infectious illness, public health officials must predict how that illness will evolve and affect their communities. There is a very narrow timeframe in which to prepare to respond to these conditions. The public health community must rely on predictive models based on the strain of the organism causing the outbreak. If a plan is based on a particular viral strain that mutates, their planning efforts may have been in vain. The unpredictable nature of viruses is cause for concern when looking at a potentially more severe future outbreak.
H1N1 Flu (Swine Flu): State Health Department Websites
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Antivirals
Antiviral drugs are used to kill or prevent the growth of viruses. Viral infections are much harder to treat than bacterial infections because viruses live inside our cells, making it harder for the immune system to locate and attack them. According to the CDC, two groups of antiviral drugs are available for the treatment and prophylaxis of influenza: adamantanes (amantadine and rimantadine) and the neuraminidase inhibitors (oseltamivir or Tamiflu and zanamivir or Relenza). Because of concerns relating to certain adverse affects of adamantanes, the CDC recommendsagainst their use in the treatment of or prophylaxis of influenza A strains.
Use of antivirals in children is unlikely to prevent complications based on randomized trials at Oxford University on children with asthma. Anitvirals in this case provided only a small benefit by shortening the duration of disease by a day and a half. Regardless of the results of this research, the World Health Organization recommends Oseltamivir for treatment of patients one year of age and older.
Updated recommendations for use of antivirals were posted September 8, 2009 on Flu.gov. The revised recommendations differ little from those issued in April, but have been formatted for greater clarity for clinicians. HHS has also posted questions and answers about the key points of the revised recommendations. The
Vaccine Development and Distribution
Vaccination is the most effective method for preventing influenza and influenza-related complications. Since 2004 , the U.S. Department of Health and Human Services has contracted with manufacturers that currently hold U.S. licenses for flu vaccine as part of the National Strategy for Pandemic Influenza. In May 2009, HHS asked manufacturers to produce a bulk supply of vaccine antigen and adjuvant and to produce pilot (also called investigational) lots of a 2009 H1N1 vaccine. Most will be stored in bulk, and a small amount will be used in clinical studies to evaluate vaccine safety and the dosage required for a protective effect. Novartis began trials in July with a cell-based vaccine that was developed in Germany. HHS is working with Novartis on plans to build a plant in North Carolina to increase their vaccine production capacity. Cell-based vaccine technology will be essential to the production of enough vaccine. In addition, cell-based production will be beneficial for those with egg allergies, which includes 2.6 percent of all children in the United States.
Until recently, there has been no commercially available vaccine for the new H1N1. Unfortunately the initial supply of these vaccines might not be enough to meet the demand. The vaccine in production is egg-based. Manufacturers have found they are getting fewer doses per egg than expected, delaying the process. During her remarks at the 2009 Flu Summit in July, HHS Secretary Kathleen Sebelius said that a vaccine should be available sometime in mid-October after which the federal government will distribute vaccines to the states. She recommends that states prioritize their use of the vaccines with the younger population and the elderly with certain health conditions, and the states consider mass vaccination sites. She also said she fully expected the vaccine program to be federally funded.
The CDC's Advisory Committee on Immunization Practice has recommended U.S. population groups to receive the initial H1N1 influenza vaccine in October. People over 65 have the lowest priority. The 15-member ACIP says these five groups should be targeted:
- Pregnant women
- Those living with infants under 6 months
- Health care and emergency-services workers
- Young people between six months and 24 years of age
- Adults under 65 with underlying conditions, such as diabetes and chronic lung disease.
Funding of the H1N1 Vaccination Program
Even though the H1N1 vaccine supply will be federaly funded, administration fees will not. The Centers for Medicare and Medicaid Services (CMS) will provide coverage for all Medicare Part B beneficiaries for the seasonal influenza virus and the H1N1 virus vaccine, and their administration. CMS is planning a conference call for states concerning guidance on payment for vaccine administration of Medicaid beficiaries.
NCSL has received many questions regarding the vaccine program including speculation that vaccination will be mandatory. HHS has stated the H1N1 vaccination program will be strictly voluntary. Other concerns about the vaccine have focused on the presence of the controversial compound Thimerisol within the vaccine. Thimerisol is a mercury-containing organic compound that has been used as a preservative in a number of biological and drug products since the 1930s and questionably linked as a cause of autism. Responding to these concerns, CDC reports that Thimerisol will only be present in the 10 dose vials and not in single dose vials or prefilled syringes of the vaccine. They anticipate there also will be enough Thimerisol-free vaccine in pre-loaded syringes available for young children and pregnant women.
The Association of Professionals in Infection Control and Epidemiology is urging healthcare institutions to require annual flu vaccines for all employees with direct patient contact.
On September 24, 2009 CMS has issued guidance for states regarding receipt of services related to 2009 H1N1 influenza by beneficiaries of the Medicaid and CHIP programs. Here are a few key points from the guidance:
- The vaccine itself will be purchased by the federal government.
- Providers will be allowed to charge a fee for the administration of the vaccine. Medicaid and CHIP programs will be responsible for covering the administration fee for eligible populations.
- The vaccine program will be outside the pervue of the Vaccine for Children program, but states will be required to reimburse the administration fee for the 2009 H1N1 vaccine for individuals under the age of 21 as part of the Medicaid Early and Periodic Screening, Diagnostic and Treatment program (EPSDT).
- Adults in the Medicaid program may receive coverage of the vaccine when furnished by a participating provider under a "mandatory" Medicaid benefit. The guidance recommends that states consider removing barriers to "non-provider" participation and allow vaccine administration in settings that are considered "optional" Medicaid benefits (e.g. freestanding clinics, independent licensed non-physician practitioners). Also review payment methodologies to ensure appropriate payment for vaccine administration. If a state plan amendment (SPA) is necessary an expedited SPA review is available.
- States should ensure that Medicaid and other Federal funding sources are appropriately coordinated to prevent duplicate payments.
States will have an option to provide Medicaid and CHIP services during a presumptive eligibility period. CMS is encouraging states to amend their Medicaid and CHIP state plans to provide for a period of presumptive eligibility for children and pregnant women. States may not limit the populations to whom this option applies but may define the income and ages of children where the option is applicable and the entities permitted to make that determination.
- CMS is also recommending that state programs forgo any prior authorization requirements for use of antivirals or other medications necessary to treat 2009 H1N1 influenza. Antivirals are most effective within a 48 to 72 hour window of onset of symptoms making timing of treatment essential. The CDC recommends that a full 5-day treatment course of antivirals be prescribed and dispensed immediately for severely ill (hospitalized ) and those patients who have flu like illness.
- Effective October 1, 2009, a new ICD-9 diagnosis code for H1N1 influenza virus will be established to identify/code patients with suspected or laboratory confirmed 2009 H1N1 influenza.
On September 11 the Department of Health and Human Services (HHS) has released a statement that preliminary analysis of early data from the National Institute of Allergy and Infectious Disease (NIAID) trials of the 2009 H1N1 influenza vaccines reveals that both vaccines studies induced what is likely to be a protective immune response in most health adults following a single dose. Concerns had existed that single dosing would not be adequate to achieve a robust immune response in recipients and that two injections of the vaccine would be required. Additional information is forthcoming from NIAID regarding additional age groups and pregnant women which may differ. The information from these studies will help inform the development of recommendations for immunization schedules.
H1N1 Vaccine Clinical Trial Results on Children
According to physicians from the National Institutes of Health, early results of trial testing on the vaccine in children looks very promising. Preliminary analysis of blood samples from a small group of trial participants shows that a single 15 microgram dose generates an immune response expected to be protective against the H1N1 vaccine in the majority of 10 to 17 year old recipients eight to 10 days after administration. Younger children had a less robust response. It seems likely based on these results that children 10 to 17 years of age will only require one 15 microgram dose. During a vaccine trial update September 21, 2009 the National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony S. Fauci, M.D. stated children nine years of age and under will require an additional shot in order to achieve full immune response as had been expected from the outset of the trial. They plan to continue to monitor trial participant responses and if the data should change amend the recommendations at that time. In addition, side effects of the vaccine have been minimal and similar to those seen from the seasonal flu vaccine. Trial results on pregnant are not expected until sometime in late October.
Federal Legislation
October 2, 2009--The FY 2010 Agriculture, Food and Drug Administrationm, and Related Agency Appropriations Act, H.R. 2997, became law containing a provision that would provide assistance to school age children in the event school closures occured for at least five consecutive days as a result of the current H1N1 pandemic. The provision focuses on providing children who qualify for school lunch programs, and has been structured to ensure that these children will continue to receive nutritional assistance through the state's Supplemental Nutritional Assitance Program (SNAP) during the period schools are closed. The Secretary of Agriculture has been authorized to approve state plans for temporary emergency standards of eligibility in SNAP and levels of benefits for household with eligible children. The Secretary may also approve waivers of the limits on certification periods, reporting and other administrative requirements otherwise in force and applicable to state agencies during this period. This assistance is only authorized for FY2010, during the current pandemic emergency declaration.
Resources
The White House
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U.S. Department of Health and Human Services
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The Centers for Disease Control and Prevention
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U.S. Department of Education
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U.S. Department of Labor
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U.S. Department of Homeland Security
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NCSL Resources
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State Resources
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Additional Resources
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Federal Affairs Staff
State Information
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