ip11-1107pphf11 amend ii final 6.5.12.doc

This is not a solicitation for applications.

Amendment II made May 17, 2012 to the following sections:

Part 1 – Overview Information

· p. 2: Revised Funding Opportunity title to include 2012 PPHF language

Part 2, Section IV Application and Submission Information

· pp. 58-60: Added funding restrictions and appropriations provision based on 2012 PPHF requirements Part 2, Section VI. Award Administration Information

· pp. 76-77: Added 2012 PPHF reporting requirements

Amendment I made April 26, 2011 to the following sections:

Part 2, Section II. Award Information:

· Delete sentence under heading “Approximate Total Project Period Funding” that reads: “Funding awarded during the initial award is intended to cover the entire 24-month project period.” (page 31 of amended FOA)

· Anticipated Award Date: Change from May 31, 2011 to July 31, 2011 (page 33 of amended FOA) Part 2, Section IV. Application and Submission Information:

· Program Area 6: Enhance the sustainability of school-located vaccination, Budget justification, delete sentence in item a. that reads: “Grantees will be provided purchased vaccines according to the projected need and usage.” (page 55 of amended FOA)

Table of Contents Part 1. Overview Information Part 2. Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

PART 1. OVERVIEW INFORMATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Agency Name: Centers for Disease Control and Prevention (CDC) Funding Opportunity Title: PPHF 2012: Immunization Capacity Building Assistance to Strengthen Public Health Immunization Infrastructure and Performance financed in part by 2012 Prevention and Public Health Funds Announcement Type: New – Type 1

Agency Funding Opportunity Number: CDC-RFA-IP11-1107PPHF11 Catalog of Federal Domestic Assistance Number: 93.539 Prevention and Public Health Fund (Affordable Care Act) – Immunization Program Key Dates:

Letter of Intent Deadline Date: April 13, 2011 Application Deadline Date: May 9, 2011, 5:00 pm Eastern Standard Time Executive Summary:

This “transition” cooperative agreement will assist grantees to meet their specific needs as they make the needed changes to be more effective in the Affordable Care Act (ACA) environment. On February 17, 2009, the President signed the American Recovery and Reinvestment Act of 2009 (ARRA). ARRA funds have been used by grantees to improve their immunization information systems, develop plans to bill insurance carriers for immunization services, improve immunization program operations, address school coverage & exemption, enhance the National Immunization Survey (NIS), enhance sentinel immunization information system activities, and strengthen the evidence base.

Presently, and relevant to this FOA, with ARRA funding, 20 grantees are modernizing their immunization information systems’ (IIS) technology infrastructure to enhance interoperability from electronic medical records to immunization information systems using Health Level 7 (HL7) standard messages. Also with ARRA funding, 14 grantees are developing the ability to bill for immunization services rendered to insured individuals in local health departments, which will make their use of Section 317 funding more efficient and effective. Through their H1N1 response, many grantees have started to develop means of extending their immunization activities into schools, augmenting the primary care system. As the Section 317 program is changed under the ACA, the methods for reaching adults and adolescents can be refined and strengthened. This cooperative agreement presents a menu of options that applicants can select for development and action. The options include Program Areas organized in three parts:

Part I: Enhancing Immunization Information Systems (IIS):

Program Area 1: Enhance interoperability between electronic health records (EHRs) and immunization information system (IIS) and reception of Health Level 7 (HL7) standard messages into IIS Program Area 2: Develop a vaccine ordering module in an IIS that interfaces with CDC's VTrckS vaccine ordering and management system Part II: Enhancing Grantees’ Infrastructure to Improve Operations

Program Area 3: Develop strategic plans for billing for immunization services in health department clinics

Program Area 4: Implement strategic plans for billing for immunization services in health department clinics Program Area 5: Plan and implement adult immunization programs

Program Area 6: Enhance the sustainability of school-located vaccination Applicants may apply for any of the Program Areas in this FOA in accordance with applicable eligibility criteria as provided in Section III. Eligibility Information. Applicants must submit one application that clearly identifies each Program Area(s) for which they are applying and addresses the required elements of the corresponding Program Area(s). An overview of each Program Area is provided below.

Part I: Enhancing Immunization Information Systems (IIS) Program Area 1: Enhance interoperability between electronic health records (EHRs) and Immunization Information Systems (IIS) and reception of HL7 standard messages in IIS At the end of 2009, 53 of 56 CDC Immunization Program grantees (50 states, 5 cities and the District of Columbia) with functional IIS reported approximately 18.4 million (77%) U.S. children aged <6 years participated in an IIS. Of those 53, 2 Immunization Program grantees used their state immunization information system. Of the remaining 51, 30 (59%) IIS grantees reported being able to send and receive HL7 messages, 4 of 51 (8%) IIS grantees were partially able to meet HL7 capability by either sending or receiving messages, and 17 of 51 (33%) IIS grantees did not have HL7 functionality. Grantees report many EHR vendors exchange data with IIS electronically, but most EHRs do not use Office of the National Coordinator for Health Information Technology (ONC) endorsed standards for interoperability with IISs. Enhancing the interoperability of EHR-IIS data exchange will increase ONC-endorsed HL7 use and reduce reliance on other electronic formats for immunization data associated with a significant proportion of U.S. children <6 years of age. Providing support for the enhanced interoperability of EHR with IIS with a specific focus on the exchange of vaccination records will reduce the duplicate data entry burden on providers. Enhanced EHR-IIS interoperability will improve the completeness of immunization histories available to clinicians and public health, improve the timeliness of immunization data submission to an IIS, and improve the quality of IIS coverage assessments, and the data available to other public health systems (e.g., vaccine preventable disease surveillance units). Improved interoperability will also reduce extra immunization, thereby saving time and resources.

Outcome measures for this Program Area include:

· Increase the number of grantees (n=53 domestic grantees with an IIS) with enhanced EHR-IIS interoperability using HL7 from 20 (38%) to at least 33 (62%).

· Collect baseline data to measure:

· The number of enhanced EHR-IIS practice-based electronic interfaces available

· The number of practice-based electronic immunization transactions reported/timeframe (week/month) to the IIS

· The number/proportion of practice-based immunization data received and recorded in an IIS within 30 days or less Program Area 2: Develop a vaccine ordering module in IIS that interfaces with CDC's VTrckS vaccine ordering and management system This Program Area will support interfacing grantee IIS vaccine ordering modules with the VTrckS system and thereby leverage the significant investment made in developing and implementing IIS ordering and inventory components. Building on existing infrastructure in grantees’ jurisdictions will minimize the amount of programming and retraining needed for a complete, comprehensive, and robust vaccine ordering and distribution system. Providers already use IIS to document immunizations administered, send return/reminder notices, and report adverse events. This project will allow providers to use a single tool to also track inventory and order vaccine through an efficient, accountable process.

Outcome measures for this Program Area include:

1. Enhanced and deployed data systems that accommodate placing vaccine orders directly in the IIS per grantee’s spend plan or other financial tools; tracking provider inventories including National Drug Code (NDC), lot number, and expiration date; storing provider data including shipping information; and sharing shipping information with providers.

2. Plans for providing the functionality described in #1 above ensuring system security and planning for contingencies if the system becomes unavailable.

3. Trained staff and providers in the use of the new IIS functionality.

4. Improved IIS performance by added database and/or server capacity.

5. Additional technical and operational support for providers who have questions about and issues with the new functionality.

Part II: Enhancing Grantees’ Infrastructure to Improve Operations

Program Area 3: Develop strategic plans for billing for immunization services in health department clinics

Vaccinating insured individuals in local health department clinics and billing third-party payers can allow immunization programs to more efficiently manage their funding and thereby reach additional populations or provide additional vaccines that might not be feasible with existing funds. Funding will aid selected applicants to develop action plans to bill for vaccine administered to fully-insured individuals who are vaccinated in state and local health department clinics. Such plans will enable immunization programs to develop billing systems resulting in savings of program revenue. These savings would enable immunization programs to reach additional populations, provide recommended vaccines that are not currently offered, and may allow programs to address immunization of special under-vaccinated populations with reduced access to vaccination services, such as certain groups of health care providers, racial and ethnic minority populations, adults, and adolescents.

Outcome measures for this Program Area include:

· An executive summary of the proposed action plan.

· Documentation of stakeholders’ strong and active support (to include but not limited to payers, insurance commissioners, local health department (LHD), state Medicaid agency, etc).

· Timeline to complete the final plan within 24 months of award.

· Description of original data describing the environment of the grantee as it relates to billing (including, but not limited to, laws and regulations, health department clinic patients’ insurance status, payer policies and regulations, and financial analysis of potential return on investment).

· Description of existing resources (e.g., financial, IIS, personnel, communications) that can support a billing program.

· Document results of discussions with third-party payers mechanisms for roster billing or other mechanisms to simplify billing public and private insurance providers to cover program costs, and develop billing methods to bill private and public insurers for vaccine and the administration fee as appropriate.

· Description of anticipated barriers and how they will be addressed.

· Submit a final plan, including a description of appropriate mechanisms to bill private health insurance for immunization services provided to plans’ members.

Program Area 4: Implement strategic plans for billing for immunization services in health department clinics Grantees eligible for assistance in this Program Area include the fourteen grantees already funded to develop plans with ARRA funds and any others that can demonstrate their billing capability. The applicants must demonstrate they have organized and developed relationships with stakeholders, have collected and analyzed data to support implementation of a billing program in their jurisdiction, effectively describe existing resources and barriers to implement a billing program, and show evidence their plan can be successful. Grantees will be expected to use financial support from this FOA to 1) train staff on contracting, billing, credentialing, coding, and other components of billing; 2) provide personnel or contractors to support billing, credentialing, coding, and other components of billing; 3) upgrade IIS systems or development of technology to aid the billing process; and 4) evaluate billing systems, data collection systems, and records management to show efficiency in the billing program.

Outcome measures for this Program Area include:

· Staff trained on contracting, billing, credentialing, coding, and other components of billing.

· Personnel and/or contractors identified to support components of billing, including, but not limited to, contracting, billing, credentialing, and coding.

· Upgraded IIS systems or developed technology to aid the billing process.

· Recovered funds obtained through implementation of new billing procedures.

Program Area 5: Plan and implement adult immunization programs The recipient activities in this Program Area address several of the major immunization areas in the ACA. To improve adult immunization rates, grantees should describe how they will accomplish two required activities: establishing collaborations with 1) employers and 2) pharmacies to improve immunization of employees and adult customers, respectively; and two of five optional activities: a) working with the state Medicaid agency to ensure all Advisory Committee on Immunization Practices (ACIP)-recommended vaccines are included as preventive benefits for as many enrolled adults as possible; b) working with hospitals in the grantee’s jurisdiction to improve implementation of influenza and pneumococcal vaccination at hospital discharge for unvaccinated patients; c) working with community health centers to expand adult vaccination efforts; d) working with health care institutions (e.g., long term care facilities, hospitals, ambulatory care settings) to improve health care worker vaccination rates, and e) working with local health department clinics, other clinics which serve patients with STDs, and substance abuse programs to promote hepatitis B vaccination. The activities should target alleviating racial and ethnic disparities in adult immunization wherever possible. At least one chosen activity should address improving vaccine uptake for a vaccine other than influenza (e.g., Tdap, pneumococcal polysaccharide). It is anticipated that any measurement systems established with grantee partners will continue after the project period is completed.

Outcome measures for this Program Area include:

· New and/or enhanced grantee relationships with pharmacies resulting in documented increased vaccination of adults.

· New and/or enhanced grantee relationships with employers resulting in documented increased vaccination of their employees.

Optional outcome measures for this Program Area include:

· Inclusion of all ACIP-recommended vaccines in the state’s Medicaid program, with payments to providers documented as similar to those paid by Medicare or private insurance plans in the grantee’s jurisdiction.

· Documented improved hospital discharge influenza and pneumococcal vaccination rates.

· New or enhanced grantee relationships with community health centers with expanded adult vaccination efforts.

· Improved health care worker influenza vaccination rates at a range of facilities, at a minimum to include hospitals and nursing homes.

· Documented increases in hepatitis B vaccination rates among patients seen at local health department clinics, other clinics caring for STD patients, and substance abuse programs.

Program Area 6: Enhance the sustainability of school-located vaccination School-located vaccination (SLV) can be used for both routine immunization and in the event of a vaccine-preventable pandemic or other public health emergency. The purpose of this Program Area is to support grantees as they work toward SLV program sustainability by billing third-party payers to recover program costs and using innovative methods to increase program efficiency and success. SLV programs must offer influenza vaccinations, but can offer other vaccinations as well. Funds can be used for purchase of a “seed” stock of private vaccine, program implementation, and evaluation. Vaccine used in the SLV projects and intending to be billed to third-party payers will need to be privately purchased and cannot be purchased using CDC contracts.

Outcome measures for this Program Area include:

· Description of the SLV program to include the number of students enrolled in targeted schools and the number of students vaccinated for influenza and, if applicable, other vaccines.

· Description of those processes that were implemented to address sustainability via billing third-party payers and to generally increase the efficiency and success of the SLV program. This description should include the utility, usability, success, and cost of these processes.

· Description of VFC eligibility and insurance status of all participating students.

· Report on the number of insurance claims submitted, denied, and reimbursed, including reasons for denial.

· Report on the total amount billed and total amount reimbursed by third parties.

Measurable outcomes of this cooperative agreement will be in alignment with one (or more) of the following performance goals for the National Center for Immunization and Respiratory Diseases:

· Ensure that children and adolescents are appropriately vaccinated

· Increase the proportion of adults who are vaccinated annually against influenza and ever vaccinated against pneumococcal disease

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address:

http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf

PART 2. FULL TEXT

I. FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority

This project is authorized under sections 301 and 317 of the Public Health Service Act (PHS Act), 42 USC, 241 and 247b as amended and the Patient Protection and Affordable Care Act (PL 111-148). From the Prevention and Public Health Fund of the Affordable Care Act (ACA), FY 2011 funding is available to support this FOA.

This landmark legislation established a Prevention and Public Health Fund (PPHF) to provide for expanded and sustained national investment in prevention and public health programs to improve health, enhance health care quality, and restrain the rate of growth in private and public sector health care costs. The new legislation escalates the need for improving public health as a priority by investing in public health services improvements, establishment of meaningful and measureable health indicators, and achievement of significant health outcomes.

Purpose

The purpose of this FOA is to assist Section 317 grantees’ transitions into a health care environment that is being transformed by the ACA. Section 317 immunization grantees manage the public health workforce that implements and supports immunization practices in the public and private sectors. The ACA has numerous provisions for improving immunization in the public and private sectors. Section 317 grantees (hereafter referred to as “grantees”) vary in their preparation for working in the ACA environment. This FOA will offer all grantees the opportunity to address a variety of immunization improvement opportunities offered by the PPHF. This program addresses the “Healthy People 2020” focus area(s) of Immunization and Infectious Diseases.

Program Implementation

Recipient Activities The recipient activities for each Program Area are provided below. Applicants must submit one application that clearly identifies each Program Area for which they are applying. Program Areas are split into the following two parts.

· Part I: Enhancing Grantees’ Immunization Information Systems (IIS)

· Part II: Enhancing CDC Infrastructure to Assist Grantee Operations Part I: Enhancing Grantees’ Immunization Information Systems (IIS) – Recipient Activities

Applicants applying for Part I may apply for Program Area 1 and/or 2, as follows:

Program Area 1: Enhance interoperability between electronic health records (EHRs) and immunization information system (IIS) and reception of HL7 standard messages into IIS

1. Participate in project calls and meetings as follows:

· Monthly teleconference calls and/or meetings.

· Attend one face-to-face meeting in Atlanta, GA, meeting date and time to be determined at a later date.

2. Develop and submit an implementation plan (as described in the IV.2. Content and Form of Submission section of this announcement) with the application.

3. Develop and submit a sustainability plan with the application that ensures continuation of these activities after the project period ends.

4. Review IIS and ensure that ONC-endorsed EHR-IIS interoperability standards are fully operational by enhancing the current IIS software application if necessary (see Federal Register, Vol. 75, No. 8, January 13, 2010 page 2033, section viii. available from: http://edocket.access.gpo.gov/2010/E9-31216.htm).

5. Attach a master list of all provider practice site EHRs in applicant’s geographic jurisdiction with submission of the application.

6. From the master list, identify and provide a listing of large, high-volume immunization provider practice sites using any or all of the EHR vendor products currently providing immunization data directly to the IIS through an electronic interface.

7. Identify the number of large, high-volume immunization provider practice sites that will implement enhancements to their EHR products based on current ONC and CDC best practices or recommendations for inclusion in the implementation plan as requested in section V. Application Content.

8. Conduct pre- and post-interoperability enhancement benchmarking of all measureable outcomes included in this announcement using CDC and ARRA HITECH 317 grantee-developed variables.

9. Work with selected EHR vendors to implement ONC or CDC best practices, install software enhancements, and provide training at the number of provider practice sites identified in #7 above.

10. Ensure verified implementation of EHR-IIS interoperability specifications at each provider practice site.

Program Area 2: Develop a vaccine ordering module in an IIS that interfaces with CDC's VTrckS vaccine ordering and management system The grantee will develop or enhance an existing vaccine inventory tracking and ordering module for the grantee’s IIS. Specific activities will depend on the maturity of the grantee’s IIS inventory and ordering capability. The grantee must specify the activities it intends to complete and provide a detailed description of its capacity to carry out each activity. Sample activities include:

1. Implement and/or develop program resources (hardware, software, and personnel) to create or enhance current data systems to accommodate placing vaccine orders directly in the IIS per spend plan or other financial tools; tracking provider inventories including NDC, lot number, and expiration date; storing provider data including shipping information; and sharing shipping information with providers.

2. Develop and implement plans for providing the functionality described in #1 above ensuring system security and planning for contingencies if the system becomes unavailable.

3. Deploy the functionality described in #1.

4. Develop training for grantee staff and providers on use of the new functionality.

5. Improve the performance of the IIS by adding database and/or server capacity.

6. Provide technical and operational support to providers who have questions about and issues with the new functionality.

7. Participate in activities that will benefit other grantees who are implementing IIS inventory and ordering components and VTrckS ExIS interfaces.

8. Submit regular progress reports to include activities completed, software purchased and developed, number of providers tracking inventory and ordering vaccines through the IIS, problems encountered, and proposed solutions.

Part II: Enhancing CDC Infrastructure to Assist Grantee Operations – Recipient Activities Applicants applying for Part II may apply for Program Area 3, 4, 5 and/or 6, as follows:

Program Area 3: Develop strategic plans for billing for immunization services in health department clinics Grantees will be expected to conduct the following activities:

1. Develop an executive summary of the proposed action plan.

2. Work with stakeholders and document their strong and active support, (to include but not limited to payers, insurance commissioners, local health department (LHD), state Medicaid agency, etc).

3. Provide a timeline that will result in completion of the plan within 15 months of award.

4. Collect original data describing the landscape of the state as it relates to billing (to include but not limited to, laws and regulations, health department clinic patient insurance status, payer policies and regulations, and financial analysis of potential return on investment).

5. Describe existing resources (financial, IIS, personnel, communications, etc.) that can support a billing program.

6. Describe any anticipated barriers and how they will be addressed.

7. Conduct an assessment of the proposed plan to determine if it will be effective.

8. Provide a final plan that includes a description of appropriate mechanisms to bill private health insurance for immunization services provided to plan members. The plan must include the public health, financial, and other pertinent information that describes how the plan can be successfully implemented in the grantee’s jurisdiction.

Program Area 4: Implement strategic plans for billing for immunization services in health department clinics Grantees eligible for assistance will be required to show that they have organized and developed relationships with stakeholders, have collected and analyzed data to support implementation of a billing program in their jurisdiction, effectively described existing resources and means to overcome barriers to implement a billing program, and show evidence that such a plan can be successful. Grantees will be expected to use this financial support to conduct the following activities: (data provided should directly support the activities that the grantee proposes in the application)

1. Train staff on contracting, billing, credentialing, coding, and other components of billing.

2. Provide personnel or contractors to support contracting, billing, credentialing, coding, and other components of billing.

3. Upgrade IIS systems or development of technology to aid the billing process.

4. Evaluate billing systems, data collection systems, and records management to show efficiency in the billing program.

Program Area 5: Plan and implement adult immunization programs To improve adult immunization rates, grantees should describe how they will accomplish the first two required activities below, and two of the five optional activities. The activities should target alleviating racial and ethnic disparities in adult immunization wherever possible. At least one chosen activity should address improving vaccine uptake for a vaccine other than influenza (e.g., hepatitis B, Tdap, pneumococcal polysaccharide). It is anticipated that any measurement systems established with grantee partners will be continued after the project period is completed.

Required activities:

1. Develop or improve state and local public health immunization program relationships with pharmacies, measured by an initial baseline assessment, followed by an increase in the number of pharmacies offering vaccines to adults and billing health insurance with no co pays or deductibles.

2. Develop or improve state and local public health immunization program relationships with employers. The results of these relationships should be measured by an initial baseline assessment, followed by a measurement of changes in the number of employers who offer vaccination programs. The programs can be in the worksite, or arranged in partnership with pharmacies, mass vaccinators, and/or public health clinics. Ideally, vaccination clinics will accept employers’ health insurance as full payment with no co-pays or deductibles.

3. A recipient program staff member will participate in two reverse site visits at CDC headquarters in Atlanta, Georgia, during the first year of award.

Optional recipient activities include (choose two of five):

1. Work with the state Medicaid agency to ensure all ACIP-recommended vaccines are included as preventive benefits for as many enrolled adults as possible.

2. Work with hospitals in the grantee’s jurisdiction to improve implementation of influenza and pneumococcal vaccination at hospital discharge for unvaccinated patients. An initial baseline assessment should be made, followed by measurement of changes in vaccine uptake in each participating hospital.

3. Work with community health centers to expand adult vaccination activities. An initial baseline assessment of adult vaccine uptake should be made, followed by measurement of change in vaccine uptake. The assessments should include vaccination rates by age and racial/ethnic group to assess disparities in vaccination rates and improvements made.

4. Work with health care institutions (e.g., long term care facilities, hospitals, ambulatory care settings) to improve health care worker vaccination rates. An initial baseline assessment of health care worker immunization coverage should be made by each facility, followed by measurement of improved vaccine uptake. Grantees choosing this option will be encouraged to work with CDC’s Immunization Services Division staff on health care worker vaccination performance measurement activities with the National Quality Forum (NQF). Currently, CDC’s NQF project has activities in California, New Mexico, New York City, and Pennsylvania. To date, only the New York City immunization program is presently participating in this project.

5. Work with local health department clinics and other clinics serving STD patients, and substance abuse programs, in the grantee’s jurisdiction to improve patient hepatitis B vaccination rates. The grantee may accomplish this objective by educating staff serving patients in local health department clinics, other clinics serving STD patients, and substance abuse programs regarding the importance of hepatitis B disease, the vaccines available, their benefits and risks, and billing procedures for vaccination, which would allow local health departments, other clinics serving STD patients, and substance abuse programs to recoup vaccine and vaccine administration costs. Vaccine purchase with these funds is not permitted. An initial baseline assessment of adult vaccine uptake should be made, followed by measurement of change in vaccine uptake. The assessments should include vaccination rates by age and racial/ethnic group to assess disparities in vaccination rates and improvements made.

Program Area 6: Enhance the sustainability of school-located vaccination Successful applicants will implement influenza vaccination (vaccination with additional vaccine is optional) using school-located vaccination (SLV) and targeting students enrolled in elementary, middle, and/or high school. Implementation should occur, to the degree possible, in the 2011-12 school year and continue in the 2012-13 school year. For grantees choosing to implement SLV only during the 2012-13 school year, the 2011-12 school year can be used as a planning year.

Each grantee will determine which schools or school districts within the jurisdiction to invite to participate, but participation of at least 20 schools is expected. The grantee is encouraged to consider targeting schools in areas with low socioeconomic status in order to increase program penetration through use of Vaccines for Children (VFC) vaccine.

Although one of the purposes of this announcement is for grantees to recover costs of program implementation as well as vaccine through billing third-party payers, grantees will be permitted to use funds for privately purchased vaccine only as a “seed stock.” Because sale of vaccine purchased using federal government contracts is strictly prohibited, purchase of vaccine intended to be billed to third-party payers cannot be made using CDC contracts. Therefore, vaccine used in the SLV projects and intending to be billed to third party payers will need to be privately purchased. For those implementing billing during the 2011-12 school year, funds recovered from third-party billing should be used toward vaccine purchases for privately insured students participating in the SLV program planned for the 2012-13 season. For those implementing billing during the 2012-13 school year, funds recovered from third-party billing should be used toward vaccine purchases in future years. No more than 50% of the budget can be used for purchase of seed vaccine. The remainder of the budget should support implementation, evaluation activities, and activities to explore and implement mechanisms to successfully and efficiently bill third-party payers for vaccination services and/or other non-billing procedures and products to improve the success and efficiency of SLV such as, but not limited to, purchase, subscription, or development of interface software for entering immunization records into immunization information systems/provider EHRs.

Activities will include, but are not limited to:

1. Building on previous SLV experience, conduct an SLV program that includes the following basic activities/features, plus new and innovative enhancements that increase the sustainability, efficiency, and success of the program:

a. Partner with state and/or local health departments, school personnel, school governance organizations, parent-teacher associations, community vaccinators, and/or other key stakeholders as needed to plan, promote, and conduct an SLV program. Consideration should be given to staffing arrangements that are acceptable and efficient, but also cost-saving (e.g., strategic use of volunteers and public/private partnerships).

b. Secure either parental consent or refusal with a goal of having at least 50% of targeted students with completed consents. Innovative approaches, such as those that might involve parent and other key stakeholder education and/or on-line consent, are encouraged.

c. Screen for VFC eligibility in order to use VFC vaccine only for eligible children.

d. Offer influenza vaccine—either live, attenuated influenza vaccine (LAIV) and trivalent inactivated vaccine (TIV) or TIV only--to all enrolled and eligible students in participating schools.

e. Assess vaccine eligibility and history (e.g., via parental report, immunization information systems (IIS)).

f. Screen children to determine whether additional doses of vaccines are required. Additional doses can be offered, or students should be directed to health departments or private providers for receipt of the additional dose.

g. Enter SLV data (e.g., doses administered) into the IIS following the SLV clinic. If this process is not already efficient and optimized, the development of new/innovative methods of electronic data transfer is encouraged.

h. Inform vaccinated students’ primary health care providers of vaccination received at school (e.g., by updating the IIS or by direct correspondence).

i. In the case of consented children not being vaccinated, inform parents that their child was not vaccinated.

2. Explore and implement mechanisms to successfully and efficiently bill third-party payers for vaccination services (i.e., receipt of non-VFC vaccine and vaccine administration) rendered. Especially for grantees with some experience billing, innovative approaches are encouraged, such as those that might involve roster billing, proportional reimbursement, pre-arranged contracts with individual payers, partnerships/arrangements with the state insurance commissioners, and the creation of coalitions to facilitate interactions with payers.

3. Submit monthly, detailed progress reports with up-to-date descriptions of SLV program activities/systems development. These reports should include the following topics, for example: partnerships, consent process, consent response rate, software purchased and developed, commercial billing/claims services used, commercial community vaccinators used, vaccine doses ordered and used, vaccine coverage in targeted schools/communities, success with claim reimbursements, and cost estimates for billing and other innovative processes.

4. Conduct an evaluation of the SLV program that includes at least the following measures. If multiple types of vaccines are offered, please evaluate by vaccine type, as applicable. [Note that the grantee must ensure that: staff with responsibility for conducting the evaluation is adequately qualified. Partnership with outside institutions (e.g., a university) is permissible.]:

a. Consent response rate (optional evaluation of method(s) or reasons for parental non-consent)

b. SLV program student participation (number of students vaccinated divided by total student enrollment)

c. Number of vaccine doses ordered and used

d. Summary of usability, utility, success, and cost of software used or developed for billing, IIS interface, consent, and other functions as indicated.

e. Summary of insurance status for all participating students (e.g., among students with completed insurance information, number with private vs. public insurance, number uninsured, number underinsured)

f. Number of participating students who are VFC-eligible

g. Number of claims submitted to public and private payers

h. Number of claims reimbursed from public and private payers

i. Among claims that were denied, summary of the reasons for denial and assessment of possible solutions

j. Total amount billed and total amount reimbursed by third parties

k. Total cost to bill third party payers.

l. Reimbursed and unreimbursed costs of the program

m. Summary of lessons learned about efforts to increase the sustainability, efficiency, and success of SLV.

n. Optional evaluation measures, such as: School absenteeism, influenza-like illness, influenza-related hospitalizations, or more specific outcomes in the targeted schools and communities.

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.

CDC Activities

Part I: Enhancing Immunization Information Systems (IIS) – CDC Activities

Program Area 1: Enhance interoperability between electronic health records (EHRs) and Immunization Information Systems (IIS) and reception of HL7 standard messages in IIS CDC will provide technical and operational support to ensure award recipients make timely and successful progress to meet the goals and objectives of the EHR-IIS Enhanced HL7 Interoperability Program Area.

1. Review and comment on award recipients’ proposed implementation plan and identify gaps.

2. Monitor grantee progress in meeting its milestones. Identify challenges through conference calls, project status reports, implementation plan, milestone checklist, and budget expenditures.

3. Provide technical assistance in awardees’ implementation, budget and evaluation activities, as needed.

4. Develop and provide evaluation variables to achieve the outcomes identified in this FOA.

5. Conduct site visits to provide enhanced technical assistance and address challenges/barriers.

6. Review and provide comments on grantee’s local HL7 implementation guide.

Program Area 2: Develop a vaccine ordering module in IIS that interfaces with CDC's VTrckS vaccine ordering and management system

1. Provide copies of the VTrckS ExIS technical specifications.

2. Provide support to examine test files for import into VTrckS.

3. Provide technical assistance in the form of information, facilitation support, educational and best practice materials.

Part II: Enhancing CDC Infrastructure to Assist Grantee Operations – CDC Activities Program Area 3: Develop strategic plans for billing for immunization services in health department clinics AND Program Area 4: Implement strategic plans for billing for immunization services in health department clinics

1. Provide technical assistance in setting program priorities, implementing and evaluating project activities.

2. Facilitate the communication between programs to problem solve and collaborate on program development.

3. Monitor the recipient’s performance of program activities and progress toward program goals.

Program Area 5: Plan and implement adult immunization programs

1. Provide technical assistance in implementing activities, identifying effective programs, and assistance with setting program priorities.

2. Assist in the review of relevant immunization information.

3. Provide assistance in the evaluation of each plan component (process and outcome) through the analysis and interpretation of coverage and other relevant data.

4. Facilitate the transfer of successful prevention interventions and program models to other areas through meetings of grantees, workshops, conferences, newsletters, and communications with this project area’s project officer(s).

5. Facilitate partnering to enhance the exchange of program information and technical assistance between community organizations, state and local health departments, coalitions, and national and regional organizations. These may include, but not be limited to, groups such as the National Association of Chain Drug Stores, the National Business Group on Health, the Visiting Nurse Associations of America, the American Hospital Association, the American Association of Health Services for the Aging, and the American Health Care Association.

6. Facilitate communication with federal agencies such as the Centers for Medicare and Medicaid Services regarding Medicaid, and the Health Resources and Services Administration regarding federally qualified health centers and rural health centers.

Program Area 6: Enhance sustainability of school-located vaccination

1. Provide an interface, as appropriate and desired by grantees, between CDC’s Division of Adolescent and School Health, Immunization Services Division, and Influenza Division, as well as the U.S. Department of Education and other relevant federal agencies.

2. Facilitate partnering to enhance the exchange of program information and technical assistance between community organizations, state and local health departments, coalitions, and national and regional organizations.

3. Develop metrics that can be used to demonstrate progress toward goals.

4. Provide technical assistance in setting program priorities, implementing and evaluating project activities.

5. Sponsor meetings/teleconferences of recipients to present accomplishments and discuss problems/concerns.

6. Initiate the development of standard reporting framework to be used at all sites.

II. AWARD INFORMATION

Type of Award: Cooperative Agreement. CDC substantial involvement in this program appears in the Activities Section above.

Award Mechanism: H23 – Immunization Projects Fiscal Year Funds: 2011 Approximate Current Fiscal Year Funding: $75,750,000 Approximate Total Project Period Funding: $75,750,000 (This amount is an estimate, and is subject to availability of funds.) This includes direct and/or indirect costs. The government reserves the right to adjust award amounts for various Program Areas as public health priorities change. Funding awarded during the initial award is intended to cover the entire 24-month project period. CDC does not anticipate additional funding beyond the initial award amounts.

Part I: Enhancing Immunization Information Systems (IIS)

Approximate Number of Awards: This will depend on the number and quality of applications for each Program Area and the available funding for each Program Area.

Program Area 1:

Approximate Funding Available: $20,800,000 Average Amount of Award: $900,000 Floor of Individual Award Range: $600,000 Ceiling of Individual Award Range: $1,000,000 Estimated Number of Awards: 20 Program Area 2:

Approximate Funding Available: $12,700,000 Average Amount of Award: $536,000 Floor of Individual Award Range: $200,000

Ceiling of Individual Award Range: $800,000 Estimated Number of Awards: 22 Part II: Enhancing Grantees’ Infrastructure to Improve Operations

Approximate Number of Awards: This will depend on the number and quality of applications and the available funding for each Program Area.

Program Area 3:

Approximate Funding Available: $8,000,000 Average Amount of Award: $500,000 Floor of Individual Award Range: $100,000 Ceiling of Individual Award Range: $600,000 Estimated Number of Awards: 16 Program Area 4:

Approximate Funding Available: $7,250,000 Average Amount of Award: $750,000 Floor of Individual Award Range: $100,000

Ceiling of Individual Award Range: $1,200,000 Estimated Number of Awards: 9 Program Area 5:

Approximate Funding Available: $15,000,000 Average Amount of Award: $1,000,000 Floor of Individual Award Range: $250,000

Ceiling of Individual Award Range: $2,000,000 Estimated Number of Awards: 13 Program Area 6:

Approximate Funding Available: $12,000,000 Average Amount of Award: $1,200,000 Floor of Individual Award Range: $500,000

Ceiling of Individual Award Range: $5,000,000 Estimated Number of Awards: 10 Anticipated Award Date: May 31, 2011 July 31, 2011 Budget Period Length: 12 months Project Period Length: 24 months Throughout the project period, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government.

III. ELIGIBILITY INFORMATION

Eligible Applicants Limited Competition

Eligible applicants that can apply for this funding opportunity are listed below:

Only the current 64 grantees currently funded under RFP IP08-803 are eligible applicants for this funding because those grantees have the necessary infrastructure in place to perform the activities required and have the experience needed to successfully complete the required functions. All current 64 grantees may apply for Program Areas 3, 4, 5, and 6. Special requirements apply to Program Areas 1 and 2 as provided later in this section.

Eligible applicants or their bona fide agents that can apply for Program Areas 3, 4, 5, and 6 of this funding opportunity are listed below:

· All 50 U.S. states

· District of Columbia

· Commonwealth of Puerto Rico

· Virgin Islands

· Commonwealth of the Northern Mariana Islands

· American Samoa

· Guam

· Federated States of Micronesia

· Republic of the Marshall Islands

· Republic of Palau

· Chicago

· Houston

· New York City

· Philadelphia

· San Antonio

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov.

Eligible Applicants for Program Area 1: Enhance interoperability between electronic health records (EHRs) and Immunization Information Systems (IIS) and reception of HL7 standard messages in IIS To address the purpose and measurable outcomes of the EHR-IIS Enhanced Interoperability Section, only CDC Immunization Program grantees that have implemented an IIS and have filed an IISAR for 2010 are eligible to apply to the EHR-IIS Enhanced Interoperability Program Area. Competition is limited to the Section 317 Immunization Program grantees that have not received HITECH/ARRA 317 funding under CDC-RFA-IP10-1002ARRA10, Enhancing the Interoperability of Electronic Health Records (EHR) and Immunization Information Systems (IIS). Therefore, only the following grantees are eligible: Alabama, Alaska, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, San Antonio, South Carolina, Tennessee, Vermont, Virginia, and West Virginia.

Eligible Applicants for Program Area 2: Develop a vaccine ordering module in an IIS that interfaces with CDC's VTrckS vaccine ordering and management system To address the purpose and successful outcomes of this project, only CDC Immunization Program grantees that have indicated they presently do, or will in the near future, support online ordering from their IIS, which they must document in their application, are eligible to apply. Grantees that will benefit most are those that already have or that have near-term plans for a vaccine ordering and inventory tracking module at the NDC, lot number, and expiration date level.

Required Registrations

Registering your organization through www.Grants.gov, the official agency-wide E-grant website, is the first step in submitting an application online. Registration information is located on the “Get Registered” screen of www.Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, the Grants.gov registration process also requires that you register your organization with the Central Contractor Registry (CCR).