Supporting Statement Part A

Assessment of State Public Health Department Immunization Billing Reimbursement Projects

OSTLTS Generic Information Collection Request

OMB No. 0920-0879

Supporting Statement – Section A

Submitted: November 14, 2013

Program Official/Project Officer

CAPT Duane Kilgus, MPH, RS

Billing Team Lead

Centers for Disease Control and Prevention

National Center for Immunization and Respiratory Diseases

Immunization Services Division

1600 Clifton Rd. NE MS-A19 Atlanta, GA 30333

Phone: 404-639-6354

Fax Number: 404-235-1747

Email: [email protected]

Section A – Justification

1. Circumstances Making the Collection of Information Necessary

Background

This data collection is being conducted using the Generic Information Collection mechanism of the OSTLTS Survey Center (OSC) – OMB No. 0920-0879. The respondent universe for this data collection aligns with that of the OSC. Data will be collected from state and local health department professionals acting in their official capacities. This data collection is authorized by Section 301 of the Public Health Service Act (42 U.S.C. 241).

The National Vaccine Advisory Committee (NVAC), a federal advisory committee that provides vaccine and immunization policy recommendations to the US Department of Health and Human Services, studied the financing of child and adolescent vaccinations in the United States. Following its investigation, the NVAC recommended in 2008 that “states and localities develop mechanisms for billing insured children and adolescents served in the public sector.” The NVAC also recommended that the CDC “provide support to states and localities by disseminating best practices and providing technical assistance to develop these billing mechanisms.” It urged states and localities to “reinvest reimbursements from public and private payers back into immunization programs.” (see Attachment A)

As a result of the NVAC recommendations, the CDC began the Billables Project, and since 2009, the agency has provided funding to state and local immunization programs to assist them in developing and implementing billing plans (see Attachment B). The Billables Project is a CDC-funded effort to enable state and local health departments to bill insurance companies for immunization services provided to insured patients. In the planning process of the project, grant awardees are funded to develop a public health action plan that describes activities, protocols, and procedures needed to pilot, initiate, and sustain a successful billing effort within their immunization programs (see Attachment C) for a project outline. As of April 2013, there were 21 awardees in the planning process and 14 awardees had competed successfully for funds to move into the second phase, the implementation process, during which they launch their programs and work to move them as close to full operation statewide as possible (billing Medicaid, Medicare, and private insurance for vaccine administration fees and reimbursement for vaccine costs).

According to a 2012 study by the National Association of County & City Health Officials, in 2011 57% of all US local health departments were forced to reduce or eliminate services in at least one program area and 19% made cuts to immunization services (see Attachment D). Meanwhile, the cost of vaccinating children and adolescents, a service frequently provided free of charge by public health departments, continues to increase as new, more expensive vaccines are added to the recommended immunization schedule. The cost of immunizing one child from birth through adolescence in the public sector—not including the costs of storing or administering vaccine—rose nearly 500% between 2000 and 2011 to $1620.15.2 (see Attachment E).

To help state and local health departments keep pace with these costs, the Centers for Disease Control and Prevention (CDC), through the Billables Project, is assisting them with implementing programs to bill Medicaid, Medicare, and private insurance when immunization services are requested by or recommended for an insured client. Although the number varies widely by geographic area, some health departments report that more than half of patients are fully insured. However, a national survey published in the American Journal of Preventive Medicine found that only 31% of US health departments were billing managed care organizations for the immunization services provided to insured patients (see Attachment F). Through the Billables Project, the CDC aims to encourage more responsible stewardship of tax dollars going into vaccine funding. Agency officials reasoned that since the cost of vaccinating fully insured individuals was already being paid through insurance premiums, government funds should no longer be used to provide vaccinations to individuals covered under a health insurance plan.

The CDC has provided financial support in the development and expansion of billing programs nationwide, and by December 2011, health departments had begun to see the income potential from this investment. Pilot billing programs in just 4 states (Arizona, Arkansas, Georgia, and Montana) had already recovered a total of nearly $5million in administration fees and vaccine costs. As billing programs grow, the income will help offset cuts to public health programs and services resulting from the recession. Revenue generated through billing programs may enable health departments to expand and enhance immunization services they provide to children, adolescents, and adults.

The current assessment will gather information specific to planning, adoption and implementation of public health immunization billing programs. Data will be collected through a web-based data collection instrument with the target population of state immunization billing program managers and coordinators. Participation in the assessment will be voluntary. By asking grant awardees to identify their current processes, to describe how billing activities address these needs, and to identify new activities that they would find helpful, CDC will be better able to improve existing activities as well as prioritize areas for additional or expanded services. The data and information collected will also be used to assess the value of the CDC-funded grant program and gather information to inform improvements to future CDC grants. In addition, the data collected from this assessment are intended to advance evidence-based public health practices around immunization billing program implementation. This information is important for decision-making about the potential future development of immunization billing programs and services designed to support public health agencies. The public health agencies will be assessed on patient intake procedures, health insurance verification practices, billing infrastructure, and claims reimbursement data.

Privacy Impact Assessment

Overview of the Data Collection System

The data collection instrument consists of a web-based assessment (see Attachment G – Data Collection Instrument: Web version and Attachment H – Data Collection Instrument: MS Word version) designed to assess local and state public health professionals in lead roles in immunization billing programs regarding knowledge, use, and implementation of their billing program. The data collection instrument will be administered as a web-based assessment. The data collection instrument was pilot tested by five public health professionals. Feedback from this group was used to refine questions as needed and establish the estimated completion time of 35 minutes. In the pilot test, the average time to complete the assessment, including time for reviewing instructions, gathering needed information, and completing the assessment, was approximately 30 minutes. Based on these results, the estimated time range for actual respondents to complete the assessment is 30-35 minutes. For the purposes of estimating burden hours, the upper limit of this range (i.e., 35 minutes) is used for completion of the entire assessment.

No sensitive information is being collected. No individually identifiable information is being collected. Respondents are participating in their official capacity as health officials in state or local departments of health.

Items of Information to be Collected

The data collection instrument consists of 44 questions of various types, including dichotomous, multiple response, and open-ended. A significant effort was made to limit questions requiring narrative responses and to include narrative optional questions for respondents to elaborate on their feedback if they choose to do so. The assessment will collect information on the following:

1. patient health insurance verification and immunization billing processing information (questions 1-5);

2. claim processing and reimbursement data sources (questions 6-17);

3. claim rejection and denial data (questions 18-21);

4. clinic VFC eligibility and hardship policy information (questions 22-30);

5. private stock information (questions 31-33);

6. claim reimbursement (questions 34-36);

7. other services billed for and legislative barriers (questions 37-39);

8. self-insured plans and credentialing (questions 40-42); and

9. health insurance plan contracts and survey wrap-up+ (questions 43-44)

No individually identifiable information is being collected. Respondents will be sent a link to access the web-based data collection instrument (Survey Monkey ®), including instructions and an estimated amount of time for completion. Survey Monkey ® servers are kept in a locked cage, with digital surveillance equipment monitoring at the data center. Secure Sockets Layer (SSL) technology protects user information using both server authentication and data encryption, ensuring that data are safe, secure, and available only to authorized persons in a password-protected system.

Identification of Website(s) and Website Content Directed at Children Under 13 Years of Age

The data collection system involves using a web-based data collection instrument. Respondents will be sent a link directing them to the online assessment only (i.e., not a website). No website content will be directed at children.

2. Purpose and Use of the Information Collection

The purpose of this information collection is to develop a better understanding of information specific to planning, adoption and implementation of public health immunization billing programs. Information derived from this assessment will help inform both CDC and the states. Importantly, it will be used to determine the processes and outcomes of an immunization billing project. Results of the assessment will be used to strengthen relationships between the public health departments and its state billing partners, enhance the impact and effectiveness of the immunization billing programs, strengthen the support for state billing programs, and, ultimately, enhance the ability to effectively bill third-party payers and get reimbursed for immunizations so that public health departments can increase access to care for the communities they serve.

Furthermore, the results from this assessment will also be used to assess the value of the CDC-funded grant program and gather information to inform improvements to future CDC grants. The proposed data collection activities will result in stronger local and state immunization billing programs and a stronger CDC that is better equipped to meet the needs of its grantee awardees and, subsequently, demonstrate the impact of its activities on public health. In addition, these findings will be used as input for future immunization billing program management. Without collecting this information, it would be difficult to judge the value of the Billables project and determine whether or not future investment is warranted.

3. Use of Improved Information Technology and Burden Reduction

Data will be collected via Survey Monkey, a web-based data collection instrument, allowing respondents to complete and submit their responses electronically. This method was chosen to reduce the overall burden on respondents. Web data collection instruments reduce respondent burden by enabling them easy access and the ability to complete it at a convenient time and location.

A significant effort was made to limit questions requiring narrative responses and include narrative optional questions for respondents to elaborate on their feedback if they choose to do so. The instrument was designed to collect the minimum information necessary for the purposes of this project (i.e., limited to 44 questions).

4. Efforts to Identify Duplication and Use of Similar Information

There have been no previous efforts to assess processes or outcomes of immunization billing programs. This undertaking is unique in that it will allow CDC, for the first time, to query state immunization billing program officials about the impact of billing on public health departments.

The information being collected is specific to immunization billing programs and has never before been previously assessed; to date no articles have been published. There is currently no information available via web or existing literature that can substitute for the desired responses. Thus, this new information collected will fill a gap in allowing CDC to assess its immunization billing grant program and services intended to assist state and local health departments billing for immunizations.

5. Impact on Small Businesses or Other Small Entities

No small businesses will be involved in this data collection.

6. Consequences of Collecting the Information Less Frequently

This request is for a one-time data collection. There are no legal obstacles to reduce the burden.

Specifically, without this data there would be:

• No timely feedback regarding effectiveness of CDC’s support and technical assistance to immunization billing public health agencies.

• Less effective interventions and data-driven decisions that often need to be made between CDC and state and local governmental public health agencies.

• Limitations to effective and timely assessment of capacities of governmental agencies to fulfill their public health mission via immunization billing reimbursement mechanisms.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances with this information collection package. This request fully complies with the regulation 5 CFR 1320.5 and will be voluntary.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

This data collection is being conducted using the Generic Information Collection mechanism of the OSTLTS Survey Center (OSC) – OMB No. 0920-0879. A 60-day Federal Register Notice was published in the Federal Register on October 22, 2010, Vol. 75, No. 204; pp. 65353-54.

CDC partners with professional STLT organizations to ensure that the collection requests under individual ICs are not in conflict with collections they have or will have in the field within the same timeframe. Such professional STLTS organizations include the Association of State and Territorial Health Officials (ASTHO), the National Association of County and City Health Officials (NACCHO), the National Association of Local Boards of Health (NALBOH), and the National Center for Health Statistics (NCHS)

9. Explanation of Any Payment or Gift to Respondents

CDC will not provide payments or gifts to respondents.

10. Assurance of Confidentiality Provided to Respondents

There is no assurance of confidentiality provided to the respondents. Employees of state and local public health agencies will be speaking from their official roles and will not be asked, nor will they provide, individually identifiable information.

11. Justification for Sensitive Questions

The data collection instrument responses will be anonymous. No information will be collected that is of a personal or sensitive nature.

12. Estimates of Annualized Burden Hours and Costs

The estimate for burden hours is based on a pilot test of the data collection instrument by five public health professionals. In the pilot test, the average time for completion, including time for reviewing instructions and completing the assessment, was approximately 35 minutes. Based on these results, the estimated time range for actual respondents to complete the assessment is 30-35 minutes. For the purposes of estimating burden hours, the upper limit of this range (i.e., 35 minutes) is used. Estimates for the average hourly wage for respondents are based on the Department of Labor (DOL) National Compensation Survey estimate for management occupations – medical and health services managers in state government (http://www.bls.gov/ncs/ocs/sp/nctb1349.pdf). Based on DOL data, an average hourly wage of $33.74 is estimated for all 35 respondents.

Table A-12: Estimated Annualized Burden Hours and Costs to Respondents–Immunization Billing Assessment

Type of Respondent	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
State Immunization Billing Program Managers or Coordinators	35	1	35/60	20	$33.74	$674.80
TOTALS	35	1		20		$674.80

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There will be no direct costs to the respondents other than their time to participate in each survey.

14. Annualized Cost to the Government

There are no equipment or overhead costs. The only cost to the federal government would be the salary of CDC staff supporting the data collection activities and associated tasks.

The questionnaire will be prepared by CDC staff (Contractors and FTE). An FTE manager will review and approve the activities. The estimated total cost to the federal government is $11,978.10. Table A-14 describes how this cost estimate was calculated.

Table A-14: Estimated Annualized Cost to the Federal Government

Staff (FTE or Contractor)	Average Hours per Collection	Average Hourly Rate	Average Cost
CDC Health Education Specialist(CC-06) Consultation with OMB package preparation, instrument development, data analysis, quality control and report preparation consultation.	30 hours	$54.87	$1,646.10
Fellow Instrument development, pilot testing, OMB package preparation, web-based data collection programming, data collection, data coding and entry, quality control, data analysis, and report preparation.	400 hours	$25.83	$10,332.00
Estimated Cost of Information Collection			$11,978.10

15. Explanation for Program Changes or Adjustments

This is a new data collection.

16. Plans for Tabulation and Publication and Project Time Schedule

Results of this assessment will be used internally to improve immunization billing materials and provide accountability to CDC. It is anticipated that the findings may be published in a peer-reviewed public health journal. CDC staff would be the primary author of any such publications, with CDC project lead offering assistance as appropriate.

Project Time Schedule

• Design data collection tool (COMPLETE)

• Develop data collection protocol, instructions, and analysis plan (COMPLETE)

• Pilot test data collection tool (COMPLETE)

• Prepare OMB package (COMPLETE)

• Submit OMB package (COMPLETE)

• OMB approval (TBD)

• Conduct data collection (Open 4 weeks)

• Collect, enter, and analyze data (4 weeks)

• Prepare report (4 weeks)

• Disseminate results/publication of findings (8 weeks)

17. Reason(s) Display of OMB Expiration Date is Inappropriate

We are requesting no exemption.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification. These activities comply with the requirements in 5 CFR 1320.9.

LIST OF ATTACHMENTS – Section A

Note: Attachments are included as separate files as instructed.

1. NVAC article

2. CDC-funded grantee awardees map

3. Billables project outline

4. NACCHO report

5. ASTHO article

6. American Journal of Preventive Medicine article

7. Data Collection Instrument: Web version

8. Data Collection Instrument: MS Word version

Page 8 of 8