Ssb_10092018

World Trade Center Health Program

Enrollment, Treatment, Appeals & Reimbursement

Revision

Supporting Statement B

Chris Ellison

Member Services and Communications Development Team, Acting Team Lead

National Institute for Occupational Safety and Health

1090 Tusculum Ave., MS: C46

Cincinnati, OH 45226

[email protected]

513-533-6807

August 22, 2018

Revised October 9, 2018

Table of Contents

Section B. Collections of Information Employing Statistical Methods

B1. Respondent Population and Selection of Respondents

B2. Procedures for the Collection of Information

B3. Methods to Maximize Response Rates and Deal with Nonresponse

B4. Tests of Procedures or Methods to be Undertaken

B5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or References

Appendices

Appendix A Zadroga Act (Sec 3301)

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

Appendix C World Trade Center Health Program FDNY Responder Eligibility

Application

Appendix D World Trade Center Health Program Responder Eligibility Application (Other than FDNY) English

Appendix E World Trade Center Health Program Responder Eligibility Application (Other than FDNY) Spanish

Appendix F World Trade Center Health Program Responder Eligibility Application (Other than FDNY) Polish

Appendix G World Trade Center Health Program Pentagon/Shanksville Eligibility Application

Appendix H World Trade Center Health Program Survivor Eligibility Application English

Appendix I World Trade Center Health Program Survivor Eligibility Application Spanish

Appendix J World Trade Center Health Program Survivor Eligibility Application Polish

Appendix K World Trade Center Health Program Survivor Eligibility Application Chinese

Appendix L Web Based Application Screen Shots (samples)

Appendix M Initial Request for Additional Information

Appendix N 30 Day Letter Reminder for Additional Information

Appendix O 60 Day Letter Reminder for Additional Information

Appendix P 90 Day Letter Reminder for Additional Information

Appendix Q 180 Day Letter Reminder for Information

Appendix R Postcard

Appendix S WTC-3 Request for Certification

Appendix T WTC-5 Code or Procedure Request

Appendix U WTC-6 Medication Request for Codebook

Appendix V Prior Authorization Form – Standard

Appendix W Prior Authorization Form – Dental

Appendix X Prior Authorization Form – Transplant

Appendix Y Outpatient Prescription Pharmaceuticals

Appendix Y-1 Non-Formulary Prior Authorization - Prescription (General)

Appendix Y-2 Non-Formulary Prior Authorization – Prescription (Renewal)

Appendix Y-3 Non-Formulary Prior Authorization – Airway Medication

Appendix Y-4 Non-Formulary Prior Authorization – Antidepressant

Appendix Y-5 Non-Formulary Prior Authorization – Antiemetic

Appendix Y-6 Non-Formulary Prior Authorization – Antipsychotic

Appendix Y-7 Non-Formulary Prior Authorization – Epinephrine

Appendix Y-8 Non-Formulary Prior Authorization – Insulin

Appendix Y-9 Non-Formulary Prior Authorization – Methadone

Appendix Y-10 Non-Formulary Prior Authorization – Nucala

Appendix Y-11 Non-Formulary Prior Authorization – Opioid Abuse

Appendix Z Enrollment Denial Letter and Appeal Notification

Appendix AA Certification Denial Letter and Appeal Notification

Appendix BB Treatment Denial Letter and Appeal Notification

Appendix CC WTC Health Program Medical Travel Refund Request

Appendix DD-1 Federal Register Notice

Appendix EE IRB Determination

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

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

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

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

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

Appendix KK Translated Enrollment Denial and Appeal Notification (Spanish)

Appendix LL Designated Representative Form

Appendix MM HIPAA Release

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

Appendix OO Disenrollment Letter and Appeal Notification

Appendix PP Decertification Letter Template—Administrative Error

Appendix QQ Decertification Letter Template—Denial and Decertification Exposure

Appendix RR Decertification Letter Template—Latency Prostate Cancer/Cancer

Appendix SS Overview of WTC Health Program Forms, Standard Correspondence, and Changes to the Information Collection Request

Appendix TT Reimbursement Denial Letter and Appeal Notification

B. Collections of Information Employing Statistical Methods

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, medical monitoring, and treatment to responders of the terrorist attacks that occurred on September 11, 2011 (“9/11”) 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. Healthcare monitoring and treatment services are provided to all eligible and enrolled WTH Health Program members. Information is collected to determine applicants’ eligibility, provide the services and payments authorized by the Program, and adjudicate appeals. Statistical methods are not used to select respondents.

1. Respondent Universe and Sampling Methods

There are five categories of members in the WTC Health Program.

• "FDNY responder" is defined as a member of the Fire Department of New York City (whether fire or emergency personnel, active, or retired) who participated at least one day in the rescue and recovery effort at any of the former World Trade Center sites.

• "General Responder" is a worker or volunteer who provided Rescue, Recovery, Demolition, Debris, Removal and related support services in the aftermath of the September 11, 2001 attacks on the World Trade Center but was not affiliated with the Fire Department of New York.

• "Survivor" is a person who was present in the disaster area in the aftermath of the September 11, 2001 attacks on the World Trade Center as a result of their work, residence, or attendance at school, childcare, or adult daycare.

• “Pentagon Responder” is a person who was a member of a fire or police department (whether fire or emergency personnel, active or retired), who worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, demolition, debris cleanup, or other related services at the Pentagon site of the terrorist-related aircraft crash of September 11, 2001, during the period beginning on September 11, 2001, and ending on November 19, 2001.

• “Shanksville Responder” is a person who was a member of a fire or police department (whether fire or emergency personnel, active or retired), worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, demolition, debris cleanup, or other related services at the Shanksville, Pennsylvania site of the terrorist-related aircraft crash of September 11, 2001, during the period beginning on September 11, 2001, and ending on October 3, 2001.

Respondents also include physicians and other health care providers who practice in designated WTC Clinical Centers or are members of the WTC National Provider Network. Information is collected from and transmitted to providers to ensure that WTC resources are dedicated to health monitoring and treatment services that have been certified by the WTC Health Program. Providers may also request that new conditions or treatments are added to the list of WTC-certified conditions and treatments.

2. Procedures for the Collection of Information

Modes of information collection include web-based forms, hardcopy (mailed) submissions, facsimile submissions, and electronic data transfers. Information collection procedure have been designed to maximize flexibility and convenience to respondents. An overview of WTC forms and supplemental correspondence is provided in Appendix OO.

Enrollment (Required) and Designation of an Authorized Representative (Optional)

3. Methods to Maximize Response Rates and Deal with No Response

WTC Health Program procedures have been designed to maximize flexibility and convenience to users. Modes of information collection include electronic, hardcopy, fax, and oral statements. The majority of requirements can be met through one or more modes of information collection.

To facilitate the initial determination of eligibility for services, the WTC Health Program sends follow-up reminder letters when application forms are incomplete. The WTC Health Program also makes key forms available in multiple languages, and provides translations of other forms or communications as needed.

Finally, the WTC Health Program allows members to identify a Designated Representative to act on their behalf. This provides flexibility to members who experience barriers due to their health conditions, cognitive status, difficulties with language or communication, or other factors.

4. Tests of Procedures or Methods to be Undertaken

The program has been operating since 2011. Current information collection procedures reflect the experience of WTC Health Program members, program management staff, and NIOSH’s data collection contractor.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Roy Fleming, Quality Assurance Officer

World Trade Center Health Program

404-498-2537, [email protected]

Beth Walker, Claims Official

World Trade Center Health Program

404-498-5234, [email protected]

Andrew Garcia, Data Analyst

Karna

Anna Nussio, Enrollment and Eligibility Lead

Karna/CSRA

Lawrence Chang, Administrator

Data Center at NYC

Yongzho Shao, Ph.D., Analytic Director

Data Center at NYC

Rachel Zeig-Owens, Analytic Team Co-Director

FDNY Data Center

Theresa Schwartz, Analytic Team Co-Director

FDNY Data Center

Roberto Lucchini, M.D., Director, Data Center

MSSM Data Center

Susan Teitelbaum, Ph.D., Epidemiologist

MSSM Data Center