AAP Cocooning Expert Meeting * March 23, 2012 “Cocooning” is a strategy to prevent serious pertussis infection by conducting targeted vaccination to ensure that all of an infant’s close contacts and caregivers receive the tetanus, diphtheria toxoid, and acellular pertussis (Tdap) vaccine. Infants younger than 12 months have the highest rates of pertussis infection and pertussis-related deaths. Babies under two months of age are hardest hit: they are too young to be vaccinated and are more likely to become infected, be hospitalized, and die of pertussis. A recent Cocooning Expert Meeting addressed the concept of cocooning babies in a circle of protection as both a family and community priority. The meeting was convened by the American Academy of Pediatrics (AAP), with the support of sanofi pasteur. (For more information, see the Proceedings Report.) Key Issues in Cocooning Throughout the Expert Meeting, participants presented on, and discussed, key issues affecting community-wide cocooning efforts. Major discussion points are listed below, organized by specific challenge area and/or population and potential solutions to address the barrier and/or reach the target population. LACK OF EVIDENCE ON COCOONING BARRIER POTENTIAL SOLUTIONS There is a lack of evidence to support CDC support for studies to generate more data on cocooning. There is a lack of safety data on benefits and answer questions. providing Tdap during pregnancy. There is a Research on different outcomes from immunization need for research on outcomes from vaccinating before conception, during pregnancy, postnatally. at different times (pre-conception, prenatal, More research on what to do for repeat pregnancies postpartum). and on the impact of vaccinating the mother 1-2 years pre-conception. ISSUES AFFECTING PROVIDERS BARRIER POTENTIAL SOLUTIONS If providers do not recommend the vaccine to Provider educational campaign. pregnant women and their families, patients are Updated and clear ACIP guidelines. less likely to seek the vaccine. Providers lack Communication among / between provider groups to awareness of the need, and there is much encourage engagement in immunization efforts. confusion between the Td and Tdap vaccines. Position statements supporting Tdap and cocooning Tdap recommendations have been a moving from key groups (e.g., ACOG, U.S. Dept. of target making it hard for providers to keep up Education) to communicate the importance of with them. immunization and cocooning. Providers should not only offer the vaccine but also promote access to services elsewhere. Assist providers in learning how to effectively use state vaccine registries. Expand existing immunization registries to include Tdap and minimize over-vaccinations. Cocooning Experts Meeting 1 Ensure that health care workers are vaccinated. ISSUES AFFECTING PATIENTS / THE PUBLIC BARRIER POTENTIAL SOLUTIONS Public lacks awareness of Tdap in general and Public education campaigns on pertussis of their own vaccine history, specifically. Many (particularly as an adult illness) and cocooning. Use adults do not know if their last vaccine was Td social media, PSA, texting, patient education, etc. or Tdap. When vaccination recommendations Use of personal stories to raise awareness and change, the public gets confused and concerned. motivate vaccine uptake. Providers to promote cocooning to specific patients and as a general concept. Address language barriers and need for translators to reach non-English speaking populations. Use pharmacy databases for patient outreach and education on immunization. Promote a standardized, universal Tdap vaccine recommendation to simplify expectations. Mandates for Tdap immunization for students at specific grades. Expand the use of vaccine registries. Educate policymakers and school staff to foster support for vaccination and cocooning. Key groups to issue position statements (e.g., ACOG, US Department of Education) on the importance of immunization and cocooning. LACK OF ACCESS TO VACCINE BARRIER POTENTIAL SOLUTIONS Providers may not offer the vaccine to the Work with pharmacies, retail-based clinics, and other patients. Patients may have difficulty finding providers to promote cocooning and refer patients to Tdap providers. Providers may not be able to vaccination services. administer vaccines to caregivers who are not Provide ways for people to find a provider who has their patients (e.g. pediatricians with parents; the Tdap vaccine and can give it to them. OBs with fathers). Track desired behaviors on immunization through an NQF or CDC metric. Engage The Joint Commission (TJC) to include quality measures for facilities and hospitals. Ensure Emergency Rooms carry Tdap (not Td). Offer to vaccinate individuals for cash. FINANCIAL / REIMBURSEMENT ISSUES - PUBLIC BARRIER POTENTIAL SOLUTIONS Td and Tdap vaccines are reimbursed under Simplify reimbursement of vaccines under CMS different CMS programs (Part B vs. Part D). regulations. Some state Medicaid programs do not cover Encourage states to provide adult vaccines by vaccines for adults. States that use Section 317 expanding funding for these services. funding for cocooning may have to change Expand VFC to authorize coverage of adult vaccines. strategy; after 2013, 317 funds cannot be used for insured individuals. VFC is limited to those 19 and under and may not cover adult vaccines. Cocooning Experts Meeting 2 FINANCIAL / REIMBURSEMENT ISSUES- PRIVATE BARRIER POTENTIAL SOLUTIONS Global fees for delivery typically only include Cover vaccine and immunization charges (i.e., add pre-natal care and delivery and do not cover into the global delivery fee). (Updated and clear vaccination (they certainly do not cover ACIP guidelines will help, since private payers may cocooning for the whole family). follow ACIP recommendations in vaccine coverage.) Immunizations and vaccines are usually Reimburse at levels equal to, or greater than, CMS’ covered under medical, not pharmacy, benefits, Medicare rates. presenting barriers to pharmacists being Tdap Recognize pharmacists as immunization providers immunization providers. by removing differential co-pays (secondary providers). LEGAL / REGULATORY ISSUES BARRIER POTENTIAL SOLUTIONS Some providers need specific authority that Expanded definition of which providers can give the would allow them to provide Tdap. Some Tdap vaccine. statewide registries are prohibited from sharing Legislative / regulatory changes to enable information with cities / communities, or pharmacists to provide Tdap more broadly (i.e., restrict access to registries (e.g., for pharmacists remove age restrictions for pharmacist or schools). administration of vaccine). Allow information-sharing between / among registries. Ensure pharmacists have access to registries and medical records on vaccinations. Mandates / requirements for vaccination of certain populations (health care workers, students at specific grades). Approve Tdap for more than a single use. Breakout Group Discussion & Report Back The participants divided into four groups to brainstorm and report back on the following questions: Are there certain elements of successful programs that might serve as a model to implement community-based cocooning? What are the top three models to pursue? Which stakeholder groups should be targeted, and what are the key messages that need to be communicated? What educational pieces, internal supports, and/or other tools are necessary to succeed? What policy changes are needed at the Federal, state, and local levels to ensure successful adoption and implementation of community-wide cocooning strategies? Are there certain elements of successful programs that might serve as a model to implement community-based cocooning? What are the top three models to pursue? Using standing orders. Health care workers’ adopting vaccination themselves and promoting immunization. Providing employers with education about benefits: producing an ROI (return on investment) case study on absenteeism, “presentism”, cost of employee sick leave, etc. Cocooning Experts Meeting 3 Having a strong champion for a program. Creating a stronger evidence base about what works, where, and what has the best impact. Gather data in a formal way; it will take time but has to start at some point. Vaccinating pregnant women with Tdap after 20 weeks of gestation: this has the most bang for the buck. It also includes the strongest evidence of positive impact on infant morbidity in the first 4-8 weeks after birth and on protecting the mother. Vaccinating women post-partum is a second-best model; there is a clear audience and provider group to get this started. Stepping back from cocooning and emphasizing a universal pertussis vaccine recommendation. Which stakeholder groups should be targeted and what are the key messages that need to be communicated? Stakeholders for promoting family cocooning goals: First: Ob-gyns, nurse midwifes, nurse practitioners: people who treat pregnant women. This reaches the goal to immunize women prenatally. Second: Providers who treat women and babies post-partum. Third: Providers who treat women of childbearing age and children: pediatricians, family physicians, etc. Fourth: Providers who treat women pre-conception (all women of childbearing age). Providers: get education and communication to patients in a fast and impactful way. Providers: clarify recommendations for when to give the shots, especially in terms of pregnancy vs. right after birth, one time only vs. for every pregnancy, etc. Providers need more information on what works best. Public health field. Emergency Room staff: the ER setting provides many opportunities for vaccination. Physician groups: particularly groups that focus on adult populations (including OBs and ACOG); providers need help with billing and vaccine/cocooning implementation. Employers: engage them through business coalitions and national groups on health and show the ROI for their leadership on this issue. Community members and the public. Consumers: provide information about risk factors and risks from pertussis. Fathers: Medicaid covers births and reaches the baby and mother, but fathers also need to be reached; these men are often uninsured and may stay uninsured after the Accountable Care Act (ACA) is fully implemented. It is critical to engage fathers to make cocooning work. Involve “non-traditional” groups on messaging for the patients / public. Partner with those who specialize in communication. What educational pieces, internal supports, and/or other tools are necessary to succeed? Engage resources from which parents seek information (i.e., Every Child by Two, Baby Center.com, etc.). Conduct marketing with baby-targeted products (i.e., Pampers box) and retailers (i.e., Babies R Us) to provide educational information to families. Create educational pieces that reach the public (not just providers). Create information and incentives for health care workers to get immunized. Give adult providers assistance on how to code and bill for this. Cocooning Experts Meeting 4 Issue stronger language from ACOG supporting cocooning, as it does with the flu vaccine. What policy changes are needed at the Federal, state, and local levels to ensure successful adoption and implementation of community-wide cocooning strategies? Implement more flexibility in the use of Federal funds. Reduce barriers so vaccines can be made available at pharmacies, be covered by Medicaid for adults, and be billed for by other providers. Address payment as a barrier: if reimbursement occurs through a bundled payment, then vaccines have to be included in the payment bundle. ACOG needs to be front and center on this and to set the standard; it should issue a statement that OBs can vaccinate anyone. Create quality measures and safety measures to help improve health care workers’ vaccination rates. Create statewide registries to eliminate duplicate doses and create alerts on needed doses. Work on the state level to create school entry requirements for teens: mandatory requirements for school entry at grade 7 or 10 to increase immunization rates. Pass state laws to enable providers to vaccinate others (e.g., OBs can give vaccines or treatment to men). Take Home Points & Suggested Future Activities While no clear recommendations on cocooning emerged from the meeting, there were specific needs identified in order to advance Tdap vaccine uptake as well as cocooning as a general practice. First and foremost, there is a clear need for additional evidence on cocooning outcomes. There are good data (including safety data) on vaccinating pregnant women and thereby protecting infants early on, at a time when there is a lot of mortality. More research is needed, however, on how much coverage there needs to be to confer protection to the baby. People want definite evidence that the vaccination process is working and is a cost-effective strategy — and this is currently lacking. The forthcoming CDC 10-state study will be useful in assessing both vaccination outcomes and the extent of protection. (This study will examine the effectiveness of maternal vaccination during pregnancy vs. post-partum and of vaccinating family members.) Until more is known about outcomes and benefits, a conclusive strategy cannot be selected among the various possibilities: prenatal vaccination, cocooning, and universal Tdap vaccine recommendation. Although there was no consensus on the best strategy, the meeting participants agreed that there is a need for key stakeholders to engage in pertussis prevention efforts. These stakeholders include the public; parents and other family members; policymakers; and a wide range of providers, including those who treat pregnant women (i.e., ob-gyns, nurse midwifes, nurse practitioners); those who treat babies (i.e., pediatricians); those who treat families (i.e., family physicians); and those who treat members of the public (i.e., pharmacists). While additional research is being conducted, these groups can work to promote vaccination in general. Health care organizations groups like ACOG and the AAP can communicate with their members about the importance of the Tdap vaccination. Providers can communicate with their Cocooning Experts Meeting 5 patients about this issue, and health care facilities can ensure that their employees are vaccinated. There is a need for some legislative / regulatory changes that could be addressed while data are being gathered. If the ACA is fully implemented, vaccination services will be included in covered prevention services and offered through the exchanges. But, if the ACA is struck down, there will be a need for expanded Federal funding for promotion and facilitation of vaccination, particularly for adults. Reducing barriers so vaccines can be provided by a range of health care providers (including pharmacists) is an important action step. Creation of quality and safety measures can encourage facilities and practices to be attentive to this issue. Cocooning Experts Meeting 6