0920-0891_SSA_Emergency_08212024

World Trade Center Health Program Enrollment, Petitions, Designated Representative/HIPAA Authorization, and Member Satisfaction

Emergency Clearance Submission

OMB Control Number: 0920-0891 Expiration Date: 09/30/2025

Supporting Statement A

Emily Hurwitz

Communications Unit Chief

Cibelle Burgos

Health Communications Specialist

National Institute for Occupational Safety and Health

World Trade Center Health Program

[email protected] or [email protected]

202-245-0619 or 404-498-3243

March 20, 2024

Table of Contents

A. Justification

1. Circumstances Making the Collection of Information Necessary

2. Purpose and Use of Information Collection

3. Use of Improved Information Technology and Burden Reduction

4. Efforts to Identify Duplication and Use of Similar Information

5. Impact on Small Businesses or Other Small Entities

6. Consequences of Collecting the Information Less Frequently

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

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

9. Explanation of Any Payment or Gift to Respondents

10. Assurance of Confidentiality Provided to Respondents

11. Justification for Sensitive Questions

12. Estimates of Annualized Burden Hours and Costs

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

14. Annualized Cost to the Government

15. Explanation for Program Changes or Adjustments

16. Plans for Tabulation and Publication and Project Time Schedule

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

18. Exceptions to Certification for Paperwork Reduction Act Submissions

Appendices

Forms

Appendix A World Trade Center Health Program FDNY Responder

Application for Enrollment

Appendix B World Trade Center Health Program Responder Application for Enrollment (Other than FDNY) English

Appendix C World Trade Center Health Program Responder Application for Enrollment (Other than FDNY) Spanish

Appendix D World Trade Center Health Program Responder Application for Enrollment (Other than FDNY) Polish

Appendix E World Trade Center Health Program Pentagon/Shanksville Application for Enrollment

Appendix F World Trade Center Health Program Survivor Application for Enrollment English

Appendix G World Trade Center Health Program Survivor Application for Enrollment Spanish

Appendix H World Trade Center Health Program Survivor Application for Enrollment Polish

Appendix I World Trade Center Health Program Survivor Application for Enrollment Chinese

Appendix J General Responder Clinic Selection Postcard

Appendix K Designated Representative Appointment Form

Appendix L Designated Representative HIPAA Authorization form

Appendix M Petition for the Addition of a New WTC-Related Health Condition for Coverage under the World Trade Center (WTC) Health Program Form

Appendix N Member Satisfaction Survey

Appendix O WTC Health Program HIPAA Authorization for Deceased Individuals

Appendix P WTC Health Program General HIPAA Authorization to Third Parties

Appendix Q Designated Representative Revocation Form

Supporting Documentation

Appendix R Zadroga Act (Sec 3301)

Appendix S Summary of Covered Health Benefits, Health Conditions, Treatments, and Payments

Appendix T Web Based Application Screen Shots (samples)

Appendix U Initial Request for Additional Information

Appendix V 30 Day Letter Reminder for Additional Information

Appendix W 60 Day Letter Reminder for Additional Information

Appendix X 90 Day Letter Reminder for Additional Information

Appendix Y 180 Day Letter Reminder for Information

Appendix Z WTC-5 Code or Procedure Request

Appendix AA WTC-3 Request for Certification

Appendix BB Prior Authorization Form – Standard

Appendix CC Prior Authorization Form – Dental

Appendix DD Prior Authorization Form – Transplant

Appendix EE Transcranial Magnetic Stimulation (TMS) Treatment Request Form

Appendix FF Non-Emergency General Transportation Request Form

Appendix GG Non-Emergency Medical Transportation Reimbursement Form

Appendix HH Non-Emergency Medical Transportation Request Form

Appendix II Prior Authorization General Level 2

Appendix JJ Prior Authorization General Level 3

Appendix KK Home Health Aid Prior Authorization Level 3

Appendix LL Long-term Care Hospitalization Prior Authorization Level 3

Appendix MM In-Patient Rehabilitation Prior Authorization Level 3

Appendix NN Hospice Respite Care Prior Authorization Level 3

Appendix OO Outpatient Prescription Pharmaceuticals

Appendix OO-1 Non-Formulary Prior Authorization - Prescription (General and Renewal)

Appendix OO-2 Non-Formulary Prior Authorization – Airway Medications

Appendix OO-3 Non-Formulary Prior Authorization – Antidepressants

Appendix OO-4 Non-Formulary Prior Authorization – Antiemetics

Appendix OO-5 Non-Formulary Prior Authorization – Antipsychotics

Appendix OO-6 Non-Formulary Prior Authorization – Epinephrine

Appendix OO-7 Non-Formulary Prior Authorization – Diabetes Insulin

Appendix OO-8 Non-Formulary Prior Authorization – Methadone

Appendix OO-9 Non-Formulary Prior Authorization – Airway Biologics

Appendix OO-10 Non-Formulary Prior Authorization – Abuse Deterrents

Appendix PP Enrollment Denial Letter and Appeal Notification

Appendix QQ Certification Denial Letter and Appeal Notification

Appendix RR Treatment Denial Letter and Appeal Notification

Appendix SS-1 Federal Register Notice

Appendix TT IRB Determination

Appendix UU Translated Initial Request for Information (Spanish, Chinese, Polish)

Appendix VV Translated 30 Day Request for Information (Spanish, Chinese, Polish)

Appendix WW Translated 60 Day Request for Information (Spanish, Chinese, Polish)

Appendix XX Translated 90 Day Request for Information (Spanish, Chinese, Polish)

Appendix YY Translated 180 Day Request for Information (Spanish, Chinese, Polish)

Appendix ZZ Disenrollment Letter and Appeal Notification

Appendix AAA Decertification Letter Template—Administrative Error

Appendix BBB Decertification Letter Template—Denial and Decertification Exposure

Appendix CCC Decertification Letter Template—Latency Prostate Cancer/Cancer

Appendix DDD Overview of WTC Health Program Forms, Standard Correspondence

and Changes to the Information Collection Request

Appendix EEE Reimbursement Denial Letter and Appeal Notification

Goal of the Study: The World Trade Center (WTC) Health Program is a limited healthcare program administered by the National Institute for Occupational Safety and Health (NIOSH) at the Centers for Disease Control and Prevention (CDC). The goal of the WTC Health Program is to provide healthcare monitoring and treatment to responders of the 9/11/2001 terrorist attacks at the World Trade Center in New York City, the Pentagon in Washington, D.C., and Shanksville, Pennsylvania, as well as survivors in the New York City area.

Intended Use of the Resulting Data: As authorized by the James Zadroga 9/11 Health and Compensation Act of 2010, CDC collects information to determine the eligibility of applicants and to enroll them as members of the WTC Health Program, to designate a representative and authorize the Program to disclose protected health information (PHI) to a designated representative or third person, to gain valuable feedback on WTC Health Program member experience, and to petition for the addition of a new WTC-related health condition in order to determine coverage under the Program.

Methods For Collecting Data: Forms will be collected through mail, web, and fax.

Subpopulation to be Studied: Respondents include applicants for enrollment, members of the WTC Health Program, and their designated representative (if appointed).

How Data will be Analyzed: Data will be analyzed to determine eligibility, appoint a designated representative, gain feedback, and petition for the addition of a new WTC-related health condition based on the requirements outlined by Congress in the Zadroga Act.

A. Justification

1. Circumstances Making the Collection of Information Necessary

The National Institute for Occupational Safety and Health (NIOSH) seeks OMB approval for an emergency clearance of an ongoing information collection, “World Trade Center Health Program Enrollment, Appeals & Reimbursement” (OMB No. 0920-0891, expiration date 12/31/21), specifically for the World Trade Center Health Program Pentagon/Shanksville Application for Enrollment. In accordance with the James Zadroga 9/11 Health and Compensation Act of 2010, individuals newly seeking enrollment in the WTC Health Program as responders or survivors may apply to the Program. The recently passed National Defense Authorization Act for Fiscal Year 2024 (NDAA) expands Program enrollment eligibility for Pentagon and Shanksville responders. In this Emergency Clearance Submission, NIOSH requests OMB approval of the revised WTC Health Program Pentagon/Shanksville Application for Enrollment, to include language regarding the expanded eligibility criteria mandated by the NDAA for Fiscal Year 2024 (Appendix E). Appendix E is the only form that is being requested for OMB approval under the Emergency Clearance. All other appendices will be updated through a Revision ICR after the Emergency Clearance IC expires.

Title I of the Zadroga Act (Pub. L. 111–347, as amended by Pub. L. 114–113 and Pub. L. 116-59), added Title XXXIII to the Public Health Service Act (PHS Act), establishing the World Trade Center (WTC) Health Program within the Department of Health and Human Services (HHS) (see Appendix R). The Director of NIOSH serves as the Administrator of the WTC Health Program for most purposes, with certain payment functions carried out by the Centers for Medicare & Medicaid Services. As established by the Zadroga Act, the WTC Health Program is a Federal limited benefit health care program providing medical monitoring and treatment benefits to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), and to eligible persons who were present in the dust or dust cloud on September 11, 2001, or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area (survivors). The WTC Health Program has been authorized for 75 years (through 2090).

In accordance with the Zadroga Act, individuals newly seeking enrollment in the WTC Health Program as responders or survivors may apply to the Program. The WTC Health Program serves as the first payer for certain medical and mental health treatment services deemed necessary for enrolled WTC responders. The Program acts as secondary payer for enrolled WTC survivors for certain medical and mental health treatment services following payment of those individuals’ other health benefit plans. For responders and survivors in the New York metropolitan area (as defined in Program regulation at 42 CFR 88.1), medical monitoring and treatment services are provided to members through WTC-designated Clinical Centers of Excellence. Responders and survivors outside the New York metropolitan area receive medical monitoring and treatment services through a Nationwide Provider Network of affiliated providers.

To receive healthcare monitoring and treatment through the WTC Health Program, responders and survivors must be enrolled as WTC Health Program members and have a covered health condition that has been certified by the Program as a WTC-related health condition or health condition medically associated with a WTC-related health condition. The List of WTC-Related Health Conditions eligible for certification and coverage by the WTC Health Program is established in the Zadroga Act and Program regulations and includes acute traumatic injuries, musculoskeletal disorders, aerodigestive disorders, most cancers, and selected mental health disorders. A summary of WTC-related health conditions, treatments, and covered health benefits is provided in (Appendix S). The Administrator of the WTC Health Program may add new health conditions to the list through rulemaking.

2. Purpose and Use of Information Collection

This information collection request describes the information required by NIOSH to determine the eligibility of applicants who were Pentagon/Shanksville Responders and to enroll them as members in the WTC Health Program.

9. Determination of Eligibility

Pentagon/Shanksville responders may apply for WTC Health Program benefits using the Pentagon/Shanksville Responder Application for Enrollment (Appendix E), The WTC Health Program Application for Enrollment collects general contact information, as well as information pertinent to statutorily established enrollment criteria regarding an individual’s experience on or after the September 11, 2001, attacks at the Pentagon, or in Shanksville, Pennsylvania. Because those on the terrorist watch list are disqualified from the WTC Health Program, some of the information provided is shared with the Federal Bureau of Investigation to screen an individual against the list maintained by the Federal government. This information is shared with the Administrator of the WTC Health Program pursuant to applicable security requirements. If an application is not complete, prospective members receive a letter explaining that more information is needed before a decision can be made. There is an initial request for additional information letter that is mailed (Appendix U), as well as reminder letters regarding incomplete applications to be sent on days 30, 60, 90, and 180, as necessary (Appendices V-Y). These follow-up reminder letters (Appendices V-Y) are being provided to OMB as supporting documentation.

3. Use of Improved Information Technology and Burden Reduction

The WTC Health Program Applications for Enrollment may be collected via online, hard copy mail, or fax. To reduce the burden on the respondents, the WTC Health Program makes the form available to be downloaded from the internet or obtained in hard copy and submitted by mail or fax. The enrollment forms are available for download on the NIOSH website at http://www.cdc.gov/wtc/application.html (Appendices A-I). Additionally, the applications are available to complete online through a secure web-based application system (Appendix T). Offering alternatives for application submission allows applicants to choose the option easiest for them. The burden should be the same regardless of the submission method.

4. Efforts to Identify Duplication and Use of Similar Information

This information in its totality is only being collected to determine eligibility for WTC Health Program services as a Pentagon/Shanksville Responder based on the expanded eligibility from the NDAA. The information collected in this process is distinct and collected for varying reasons. Additional information may be collected by physicians or other health care providers; however, such information is not reported to CDC/NIOSH.

5. Impact on Small Businesses or Other Small Entities

There will be no impact on small business.

6. Consequences of Collecting the Information Less Frequently

Without collection of these data, NIOSH would not be able to implement the provisions of the Zadroga Act, to establish the process for an individual to apply to the WTC Health Program, or to perform administrative functions.

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

There are no special circumstances.

8. Comments in Response to the Federal Register Notice/Outside Consultation

An Interim Final Rule expanding eligibility requirements for Shanksville and Pentagon responders will be published in August 2024.

9. Explanation of any Payment/Gift to Respondents

Respondents will not receive any form of payment or gifts.

10. Assurance of Confidentiality Provided to Respondents

NIOSH’s Information Systems Security Officer reviewed this submission and determined that the Privacy Act does apply. The relevant Privacy Act System of Records Notice (SORN) is Occupational Health Epidemiological Studies and EEOICPA Program Records and WTC Health Program Records, [Federal Register: June 14, 2011 (Volume 76, Number 114) Pages 34706-34711].

1. An overview of the data collection system: The data collection system starts with receipt of the application by either mail, secure fax, or a secure online application system. Once the WTC Health Program Pentagon/Shanksville Application for Enrollment is received, the data will be entered into secure databases at the Program’s Third-Party Administrator Contractor. Hard copies will be saved in a secure location by the Program’s Third-Party Administrator Contractor. Access to data will be limited to authorized NIOSH project staff and authorized Third-Party Administrator Contractor. All electronic data will be stored on secure servers that can be accessed with passwords or by other secure means. The Program’s Third-Party Administrator Contractor will be required to follow equivalent procedures.

Records are retained and disposed of according to the provisions of the appropriate Electronic Records Control Schedule. Any records provided to the Department of Justice for the purpose of screening individuals against the “terrorist watch list” will be destroyed (and not retained by the Department of Justice) once it is determined that an individual is not on the “terrorist watch list.”

2. A description of the information to be collected: The WTC Health Program Applications for Enrollment ask for the member’s demographic information (name, address, email, date of birth, and government ID), as well as information regarding their activities, location, duration, and dates of 9/11-related exposures. The application also requests supporting documentation for the activities listed..

3. A statement detailing the impact the proposed collection will have on the respondent’s privacy: This information is provided in the notices section the WTC Health Program Pentagon/Shanksville Application for Enrollment.

4. Whether individuals are informed that providing the information is voluntary or mandatory: Applying to the Program is voluntary. This is also included in the notices section of the application (see Appendices A-I).

5. Opportunities to consent, if any, to sharing and submission of information: Information regarding sharing of information is included in the initial application (see Appendices A-I).

6. How the information will be secured: All information is secured in accordance with HIPAA and the Privacy Act. All information is collected and transmitted through secure channels and materials are stored in secure databases or locations.

7. Whether a system of records is being created under the Privacy Act: See http://www.gpo.gov/fdsys/pkg/FR-2011-05-27/pdf/2011-13470.pdf and its clarification: http://www.gpo.gov/fdsys/pkg/FR-2011-06-14/pdf/2011-14807.pdf

11. Justification for Sensitive Questions

No sensitive questions will be asked.

12. Estimates of Annualized Burden Hours

World Trade Center Health Program Applications for Enrollment (Appendices E):

World Trade Center Health Program Pentagon/Shanksville Application for Enrollment (Appendix E).

The burden table reflects the annualized total burden. We estimate that applications will be submitted by 742 Pentagon/Shanksville responders. It is expected that it will take the member 0.5 hours to complete.

The total estimated annualized burden is 371 hours.

12A. Estimated Annualized Burden Hours

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Pentagon/ Shanksville Responder	World Trade Center Health Program Pentagon/Shanksville Responder Application for Enrollment	742	1	30/60	371
Total					371

12B. Estimated Annualized Burden Costs

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Average Burden per Response (in hours)	Average Hourly Wage	Total Burden Cost
Pentagon/ Shanksville Responder	World Trade Center Health Program Pentagon/Shanksville Responder Application for Enrollment	742	1	30/60	$18.00*	$6,678
Total						$209,802

*Data from Bureau of Labor Statistics 2001 State Occupational Employment and Wage Estimates New York. We used an adjusted hourly wage rate of $18.00 to represent the responders hourly wage cost.

** Data from Bureau of Labor Statistics 2020 Healthcare Practitioners and Technical Occupations

The total estimated annualized burden cost to respondents is $6,678.

13. Estimates of other Total Annual Cost Burden to Respondents or Record Keepers/Capital Costs

There are no additional recordkeeping/capital costs.

14. Annualized Cost to Federal Government

Type of Federal employee support	Total Burden Hours	Hourly Wage Rate	Total Federal Costs
Contractor (review of applications)	371	$25.00	$9,275
Total			$9,275

The total increase in cost to the Federal Government is $9,275.

15. Explanation for Program Changes or Adjustments

In this Emergency Clearance Request, only the World Trade Center Health Program Pentagon/Shanksville Application for Enrollment will be modified. The total annualized burden is 371 hours. Highlights are summarized below.

Due to the recent NDAA, eligibility for the Program has expanded for Pentagon and Shanksville responders. The Program has updated the WTC Health Program Pentagon/Shanksville Application for Enrollment to reflect the new eligibility criteria mandated by the NDAA. The revised application now includes an additional eligibility question targeting specific groups such as active duty, retired, or reserve members of the military, civilian employees of the Department of Defense (DOD), or certain DOD contractors who responded to the Pentagon or Shanksville sites. The application also now clarifies that in addition to the work status, the responder must have participated in rescue, recovery, demolition, debris cleanup, or other related services in order to be eligible to enroll in the Program.  This may increase the amount of Pentagon and Shanksville responders who may be eligible and reduce confusion.

16. Plans for Tabulation and Publication and Project Time Schedule

Data collection will continue upon approval of this OMB package.

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

Display of the OMB expiration date is appropriate.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

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