SSA-Update-091321

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

Revision

Supporting Statement A

Emily Hurwitz

Communications Unit Chief

Bryn Higdon

Public Health Advisor/Communications Specialist

National Institute for Occupational Safety and Health

World Trade Center Health Program

[email protected] or [email protected]

202-245-0619 or 404-498-1008

September 10, 2021

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

Appendix FFF Notices Regarding WTC Health Program Requirements

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 to revise an ongoing information collection, “World Trade Center Health Program Enrollment, Appeals & Reimbursement” (OMB No. 0920-0891, expiration date 12/31/21). OMB approval of the revised and consolidated information collection plan for 0920-0891 is requested for 3 years.

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (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.

Respondents are WTC Health Program members and potential members. In this Revision request, NIOSH requests OMB approval to update the WTC Health Program Applications for Enrollment for plain language, add a new Member Satisfaction Survey (Appendix N), revise the Designated Representative Appointment and HIPAA Designated Representative forms (Appendices K-L), add WTC Health Program HIPAA Authorization for Deceased Individuals and WTC Health Program General HIPAA Authorization to Third Parties forms (Appendices O-P), and remove documents from the burden table that are not subject to information collection. Such changes include:

• Revised WTC Health Program Applications for Enrollment to improve potential members’ application experience and reduce confusion (Appendices A-I).

• A revised Designated Representative Appointment Form to include instructions to fill out the form (Appendix K).

• A revised Designated Representative HIPAA Authorization Form to include instructions to fill out the form (Appendix L).

The Program has also added:

• A new Member Satisfaction Survey to be mailed to all Program members one time per year (Appendix N).

• A new WTC Health Program HIPAA Authorization for Deceased Individuals Form (Appendix O).

• A new WTC Health Program General HIPAA Authorization to Third Parties Form (Appendix P).

• A new Designated Representative Revocation Form (Appendix Q).

Appendix DDD provides a summary of forms, by type/function; a summary of the changes described in this Revision request; and specifies the impact of these changes on burden estimates.

2. Purpose and Use of Information Collection

This information collection request describes four types of information needed to administer the WTC Health Program: I) information required by NIOSH to determine the eligibility of applicants and to enroll them as members in the WTC Health Program; II) information required by NIOSH to designate a representative (if requested) and authorize the Program to disclose protected health information (PHI) to a designated representative or third person upon request; III) information requested by NIOSH to gain valuable feedback on WTCHP member experience; and IV) petitions for the addition of a new WTC-related health condition to the List of WTC-related health conditions eligible for coverage under the Program; (Appendices A-Q). Appendix DDD provides an overview of WTC Health Program forms, standard correspondence, and changes.

9. Determination of Eligibility

NIOSH developed four different application forms to address the different enrollment criteria for each group covered by the WTC Health Program. In addition, translations are readily available for languages other than English that are highly prevalent among WTC responders and survivors. Prospective members may apply for WTC Health Program benefits using one of the following applications: the Fire Department of New York (FDNY) Responder Application for Enrollment (Appendix A); the WTC Health Program General Responder Application for Enrollment which is used for NYC responders who were not members of the FDNY (see Appendix B; also available in Spanish (Appendix C) or Polish (Appendix D)); the Pentagon/Shanksville Responder Application for Enrollment (Appendix E), and the WTC (NYC) Survivor Application for Enrollment (Appendix F; also available in Spanish (Appendix G), Polish (Appendix H), or Chinese (Appendix I)). The WTC Health Program Applications for Enrollment collect 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 WTC or in NYC, 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.

Letters to applicants requesting more information, as well as enrollment and certification denial letters, are translated on an as-needed basis. Translations are done based on need of each letter and the language the application was submitted. Translations for the current Program letters are attached as supporting documentation (Appendices UU-YY).

Once enrolled, responders in the NY metropolitan area receive a General Responder Clinic Postcard to choose which clinic they would like to attend (Appendix J). Responders receive monitoring benefits and survivors receive an initial health evaluation screening upon enrollment. To receive treatment benefits for a covered condition, a WTC Health Program physician must submit a certification request, WTC-3, for the member’s health condition to the Program for approval (Appendix AA). Once approved, the member can receive treatment benefits. The WTC-3 is provided to OMB as supporting documentation because they are used by our contractors and the information collected does not come back to CDC for their use.

II. Designation of a Representative and Designated Representative HIPAA Authorization

An applicant or member may appoint an individual, called a Designated Representative, to represent their interests under the WTC Health Program. The Designated Representative may be appointed by the applicant or member in writing pursuant to Program regulations at 42 CFR 88.2(a) and once duly appointed, the Program can share information with a Designated Representative. The Program has provided the Designated Representative Appointment Form (Appendix K) to assist applicants and members in designating a representative; in addition, the member must also complete the Designated Representative HIPAA Authorization Form (Appendix L). This form allows WTC Health Program members and those applying to the Program to authorize the Program to disclose protected health information to the Designated Representative. As required under HIPAA regulations, the Designated Representative HIPAA Authorization form is distinct from the Designated Representative Appointment Form.

A member may also choose to share their health information with a third party but may not necessarily want the third party to have the ability to act on their behalf as their Designated Representative. In this circumstance, the member can fill out the WTC Health Program General HIPAA Authorization to Third Parties Form (Appendix P). If a family member and/or personal representative of a deceased applicant or member needs to obtain Program documentation and/or medical records related to the deceased applicant/member, the family member or representative may fill out the WTC Health Program HIPAA Authorization for Deceased Individuals Form (Appendix O). The Designated Representative Revocation Form (Appendix Q) may be used when a WTC Health Program would like to remove or change their designated representative.

III. Member Satisfaction Survey

The Member Satisfaction Survey (Appendix N) is an optional survey for all members of the WTC Health Program to complete. The survey will be mailed to all members and is anonymous. The survey asks for feedback about the member’s satisfaction in the WTC Health Program, at their clinic, and how they would like to receive Program communications in general. Members will mail back their responses for the WTC Health Program to review and evaluate.

IV. Petitioning to Add New Health Conditions for WTC Health Program Coverage

The Petition for the Addition of a New WTC-Related Health Condition for Coverage Form (Appendix M) may be completed by interested parties if they believe there is a health condition(s) that should be eligible for coverage by the Program.

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 and survivors, 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. The Designated Representative Appointment Form, the Designated Representative HIPAA Authorization Form, the Petition for the Addition of a New WTC-Related Health Condition for Coverage Form, the WTC Health Program HIPAA Authorization for Deceased Individuals, the WTC Health Program General HIPAA Authorization to Third Parties, and the Designated Representative Revocation Form (Appendices K-M, O-Q) must be submitted in writing by mail or fax. The Member Satisfaction Survey will be mailed to all members and the Program is exploring electronic options. 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, designating a representative and authorizing the Program to disclose protected health information (PHI) to a designated representative or third person, collecting valuable feedback on WTC Health Program member experience, and information on adding a new WTC-related health condition eligible for coverage under the Program. The information collected in each of these processes 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

A. A 60-day Federal Register Notice was published in the Federal Register on April 30, 2021 [Volume 86, No. 82, pages 22967-22969; see Appendix SS-1].

B. The WTC Health Program consulted with the HHS Office of the General Counsel on the legal requirements needed for data collection. The Program also consulted with Clinical Centers of Excellence (CCEs) and the Steering Committees (both entities created by the Zadroga Act) on the availability of data to applicants supporting their 9/11 activities, clarity of instructions, disclosures, reporting format, and data elements requested.

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 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. The General Responder Clinic Postcard is for the NY metropolitan area responders to choose their clinic selection and is sent with welcome letters (Appendix A-J). The Designated Representative/Designated Representative HIPAA Authorization Forms designate a representative to act on behalf of the applicant or member and authorize the disclosure of protected health information to the representative. The Petition for the Addition of a New WTC-Related Health Condition for Coverage Form permits interested parties to request the addition of a condition to the list of health conditions eligible for coverage under the WTC Health Program. The Member Satisfaction survey is for WTC Health Program members and asks for feedback about their satisfaction in the WTC Health Program, at their clinic, and how they would like to receive Program communications. The WTC Health Program HIPAA Authorization for Deceased Individuals Form authorizes the Program to speak with the selected personal representative of a deceased applicant/member of the WTC Health Program. The WTC Health Program General HIPAA Authorization to Third Parties Form authorizes the Program to disclose protected health information regarding an applicant or member to another individual, such as an attorney. The Designated Representative Revocation Form may be completed by the applicant or member to remove their designated representative (Appendices K-Q).

3. A description of how the information will be shared and for what purpose: See “Privacy Act Statement and Additional Permitted Disclosures of Personally Identifiable Information and Records” in the “Notices Regarding WTC Health Program Requirements” in Appendices A-I.

4. A statement detailing the impact the proposed collection will have on the respondent’s privacy: This information is provided in the notices section of all WTC Health Program Applications for Enrollment.

5. 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).

6. 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).

7. 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.

8. 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 A-I):

World Trade Center Health Program FDNY Responder Application for Enrollment (Appendix A), World Trade Center Health Program Responder Application for Enrollment (Other than FDNY) (Appendix B; new translations in Appendix C and Appendix D), World Trade Center Health Program Pentagon/Shanksville Application for Enrollment (Appendix E), and World Trade Center Health Program Survivor Application for Enrollment (Appendix F; new translations in Appendix G, Appendix H, and Appendix I): Four different application forms were developed to address the different criteria for each group covered by the WTC Health Program: Fire Department of New York Responders, General NYC Responders, Pentagon/Shanksville Responders, and Survivors. In 2019-2020, the WTC Health Program received an average of 15,322 applications. The WTC Health Program enrolled approximately 12,000 members out of the 15,322. The number of applications received is significantly higher than the number of members enrolled due to duplicate applications submitted. The Program is trying to address this issue to reduce the burden on the public. The application numbers for 2020 were much lower than anticipated due to the COVID-19 pandemic. However, weekly application rates have recently increased, and the Program anticipates it will ultimately receive a greater number of application submissions in 2021 than the 15,322 applications submitted in 2020. The Program estimates approximately 16,000 applications in 2021.

The burden table reflects the annualized total burden broken into the four separate applicant groups. We estimate that applications will be submitted by: 140 Fire Department of New York (FDNY) responders (1% of applicants); 6,215 general NYC responders (38%); 242 Pentagon/Shanksville responders (2%); and 9,240 survivors (60%). It is expected that it will take the member 0.5 hours to complete. The burden estimates for these three different forms are: FDNY = 70 hours; general NYC responders = 3,108 hours; Pentagon/Shanksville responders = 121 hours; survivors = 4,620 hours.

General Responder Clinic Selection Postcard (Appendix J): Of the 15,322 WTC Health Program Applications we expect to receive per year, we estimate that 25% (3,830) of them are General Responder Applications from the NY/NJ area and will have to select which clinic they would like to visit. It is expected that it will take the member 0.25 hours to complete the postcard. The burden hours are 3075 hours.

Designated Representative Appointment Form (Appendix K): This item has been revised; however, the extent of the revision was minor and does not impact the burden hours required for this form. Individuals applying to the Program, or members, can designate a representative to act on their behalf. For the Program to speak to a third party about a member’s application or case, we would need the individual to complete both a Designated Representative Appointment Form and a Designated Representative HIPAA Authorization Form (described below) authorizing us to speak with that third person. It is estimated that the Program will receive 1,300 Designated Representative Appointment Forms per year (an increase from our previous estimate of 30). The forms should take no longer than 0.25 hours (15 minutes) to complete. The increase in the estimated number of forms increases the estimated burden from 8 hours to 325 hours.

Designated Representative HIPAA Authorization Form (Appendix L): This item has been revised; however, the extent of the revision was minor and does not impact the burden hours required for this form. Individuals applying to the Program, or members, can designate a representative to act on their behalf. In order for the Program to speak to a third party about a member’s application or case, we would need the individual to complete both a Designated Representative HIPAA Authorization Form and a Designated Representative Appointment Form (described above) authorizing us to disclose protected health information (PHI) to that third person. Pursuant to HIPAA regulations, the HIPAA Authorization Form cannot be combined with any other form. It is estimated that the Program will receive 1,300 Designated Representative HIPAA Authorization Forms per year (an increase from our previous estimate of 30). The forms should take no longer than 0.25 hours (15 minutes) to complete. The increase in the estimated number of forms increases the estimated burden from 8 hours to 325 hours.

Petition for the Addition of a New WTC-Related Health Condition for Coverage under the World Trade Center (WTC) Health Program Form (Appendix M): This form was previously approved under 0920-0929. From the time of previous approval to the current request, the Program can more accurately estimate the number of respondents and the burden hours required for this form. The Zadroga Act identified a list of health conditions for which individuals who are enrolled in the WTC Health Program may be monitored or treated [sec. 3312(a)(3)]; those conditions are codified and and expanded in the associated WTC Health Program regulations at 42 C.F.R. § 88.15. Pursuant to the Zadroga Act and under WTC Health Program regulations (42 C.F.R. § 88.16), interested parties may submit a petition to request that a new health condition be added to the list of conditions specified in § 88.15. It is estimated that the Program will receive 35 petition forms a year. The forms should take no longer than 1 hour to complete for a burden estimate of 35 burden hours.

Member Satisfaction Survey (Appendix N): This is a new survey added to the Program. This survey is for WTC Health Program members and asks for feedback about their satisfaction in the Program, at their clinic, and how they would like to receive Program communications. It is estimated that the Program will send 110,000 surveys a year. The response rate for previous Member Satisfaction Surveys have been approximately 6%, therefore it is estimated that the Program will receive 6,600 surveys a year. The survey should take no longer than 0.5 hours to complete for a burden estimate of 3,300 burden hours.

WTC Health Program HIPAA Authorization for Deceased Individuals (Appendix O): This is a new form added by the Program. This form is intended to be utilized by a family member and/or personal representative of a deceased applicant or member to request program documentation and/or medical records related to the deceased applicant/member from the Program. It is estimated that the Program will receive 30 WTC Health Program HIPAA Authorization for Deceased Individuals forms per year. The forms should take no longer than 0.25 hours (15 minutes) to complete for a burden estimate of 7.5 burden hours.

WTC Health Program General HIPAA Authorization to Third Parties (Appendix P): This is a new form added by the Program. Individuals applying to the Program, or members, can give the Program permission to disclose PHI to a third party. If the individual completes a WTC Health Program General HIPAA Authorization Form, the Program is authorized to provide medical records or information to the third party. This form differs from the Designated Representative Appointment Form and the Designated Representative HIPAA Authorization Form, which are intended to appoint a person to act on the member/applicant’s behalf on an ongoing basis. The WTC Health Program General HIPAA Authorization Form is intended for a one-time release of information to a third party. It is estimated that the Program will receive 30 WTC Health Program General HIPAA Authorization Forms per year. The forms should take no longer than 0.25 hours (15 minutes) to complete for a burden estimate of 7.5 burden hours.

Designated Representative Revocation Form (Appendix Q): This is a new form added by the Program. Individuals applying to the Program, or members, have the option to appointing a designated representative to act on their behalf in the WTC Health Program. Applicants or members may only appoint one individual at a time as their designated representative. This form should be completed and submitted if an applicant/member wishes to remove or replace a currently appointed designated representative. It is estimated that the Program will receive 15 WTC Health Program Designated Representative Revocation Forms a year. The forms should take no longer than 0.25 hours (15 minutes) to complete for a burden estimate of 3.75 burden hours.

The total estimated annualized burden is 12,882 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
FDNY Responder	World Trade Center Health Program FDNY Responder Application for Enrollment	140	1	30/60	70
General Responder	World Trade Center Health Program Responder Application for Enrollment (Other than FDNY)	6,215	1	30/60	3,108
Pentagon/ Shanksville Responder	World Trade Center Health Program Pentagon/Shanksville Responder Application for Enrollment	242	1	30/60	121
WTC Survivor	World Trade Center Health Program Survivor Application for Enrollment (all languages)	9,240	1	30/60	4,620
General responder	Clinic Selection Postcard for new general responders in NY/NJ to select a clinic	3,830	1	15/60	958
Interested Party	Petition for the addition of health conditions	35	1	1	35
Program Applicants or Members	Designated Representative Appointment Form	1,300	1	15/60	325
Program Applicants or Members	Designated Representative HIPAA Release Form to allow the sharing of member information with a third party	1,300	1	15/60	325
Program Members	Member Satisfaction Survey	6,600	1	30/60	3,300
General Public	WTC Health Program HIPAA Authorization for Deceased Individuals	30	1	15/60	8
Program Applicants or Members	WTC Health Program General HIPAA Authorization to Third Parties	30	1	15/60	8
Program Applicants or Members	Designated Representative Appointment Form that removes the members current designated representative.	15	1	15/60	4
Total					12,882

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
FDNY Responder	World Trade Center Health Program FDNY Responder Application	140	1	30/60	$24.08	$1,686
General Responder	World Trade Center Health Program Responder Application for Enrollment (Other than FDNY)	6,215	1	30/60	$18.00*	$55,944
Pentagon/ Shanksville Responder	World Trade Center Health Program Pentagon/Shanksville Responder Application for Enrollment	242	1	30/60	$18.00*	$2,178
WTC Survivor	World Trade Center Health Program Survivor Application for Enrollment (all languages)	9,240	1	30/60	$12.00	$55,440
General responder	Clinic Selection Postcard for new general responders in NY/NJ to select a clinic	3,830	1	15/60	$18.00*	$17,244
Interested Parties	Petition for the addition of health conditions	35	1	1	$41.30**	$1,446
Program Applicants or Members	Designated Representative Appointment Form	1,300	1	15/60	$18.00*	$5,850
Program Applicants or Members	Designated Representative HIPAA Form to allow the sharing of member information with a third party	1,300	1	15/60	$18.00*	$5,850
Program Members	Member Satisfaction Survey	6,600	1	30/60	$18.00*	$59,400
General Public	WTCHP HIPAA Authorization for Deceased Individuals	30	1	15/60	$12.00	$96
Program Applicants or Members	WTCHP General HIPAA Authorization to Third Parties	30	1	15/60	$12.00	$96
Program Applicants or Members	Designated Representative Appointment Form that removes the members current designated representative.	15	1	15/60	$18.00*	$72
Total						$205,302

*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 $205,302.

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)	7,919	$25.00	$197,963
Medical and non-medical staff (Designated Representative forms/HIPAA forms, petitions, and surveys)	1,258	$100.00	$125,800
Total			$323,763

The total cost to the Federal Government is $323,763

15. Explanation for Program Changes or Adjustments

In this Revision, total annualized burden will decrease from 14,063 hours to 12,882 hours (-1,181 hours). A complete summary of WTC Health Program forms, supplementary materials, and changes is provided in Appendix DDD. Highlights are summarized below.

A portion of the decrease in annualized burden (-462 hours) is due to adjusting the burden table to only include documents that are required for OMB Clearance. Some documents were removed because they are letters and there is no requirement for the public to fill them out. These documents are being included as supporting documentation. The letters removed are as follows:

• Denial Letter and Appeal Notification – Enrollment

• Disenrollment Letter and Appeal Notification – Enrollment

• Decertification Letter and Appeal Notification – Health Condition

• Denial Letter and Appeal Notification – Health Condition Certification

• Denial Letter and Appeal Notification – Treatment Authorization

• Reimbursement Denial Letter and Appeal Notification –Providers

Another portion of the decrease in annualized burden (-10,655 hours) is due to removing forms that are not public and are filled out by Program physicians and contractors for the purpose of providing medical care. These were removed because they are forms filled out by physicians and apply to direct patient care. The forms are as follows:

• Physician Request for Certification (WTC-3)

• WTC Health Program Medical Travel Refund Request

• Outpatient Prescription Pharmaceuticals

Another portion of the decrease in annualized burden (-2,540 hours) is due to the over estimation of the number of respondents for the Designated Representative Appointment Form and Designated Representative HIPAA Authorization Form. The average number of forms we received in 2019 and 2020 is 30.

The greatest increase in burden (+7,890 hours) is the result of an increase in WTC Health Program Survivor Applications for Enrollment for enrollment. There are many reasons for this increase including new outreach campaigns to reach this population. Another increase in burden (+3,740 hours) is the result of an increase in General Responder Applications for Enrollment. An additional reason for this increase is due to new outreach initiatives and increased awareness of the WTC Health Program in responder communities.

Another increase in annualized burden (+3,320 hours) is due to the addition of four new forms in the burden table. The new forms are as follows:

• Member Satisfaction Survey

• WTC Health Program HIPAA Authorization for Deceased Individuals

• WTC Health Program General HIPAA Authorization to Third Parties

• Designated Representative Revocation Form

Finally, in addition to the changes in the burden table, the Program updated the WTC Health Program Applications for plain language and improved processing. The Program also added instructions to the Designated Representative Appointment Form and Designated Representative HIPAA Authorization Form to instruct members on how to complete the forms.

Please Note: This Revision includes WTC Health Program Applications that have been translated from English into other languages. The translations are provided as a convenience to WTC Health Program members but do not change the estimated annualized burden. Additionally, the applications will be made available in an online application system. This system has not been updated with the 2021 proposed changes to the applications but will be updated once OMB approves. Screenshots of the 2018 version are included as supporting documentation. The use of the online application does not change the estimated annualized burden.

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

The OMB expiration date will be displayed on the:

• World Trade Center Health Program Applications for Enrollment,

• General Responder Clinic Postcard,

• Designated Representative Appointment Form,

• Designated Representative HIPAA Authorization Form,

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

• Member Satisfaction Survey,

• WTC Health Program HIPAA Authorization for Deceased Individuals,

• WTC Health Program General HIPAA Authorization to Third Parties, and

• Designated Representative Revocation Form

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

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