Administrative Manual

Chapter 1—Overview of the WTC Health Program

Chapter 2—Eligibility and Enrollment

1. Purpose and Scope

2. Statutory and Regulatory References

Procedures for the determination of eligibility and enrollment of WTC Health Program members are guided by the following sections of Title XXXIII of the Public Health Service Act (Act):

• Section 3311, Identification of WTC Responders and Provision of WTC-Related Monitoring Services;
  and
• Section 3321, Identification and Initial Health Evaluation of Screening-Eligible and Certified-Eligible WTC Survivors.

Program eligibility criteria are established in the following sections of 42 C.F.R. Part 88:

• Section 88.3, Eligibility--currently identified responders;
• Section 88.4, Eligibility criteria--WTC responders;
• Section 88.5, Application process--WTC responders;
• Section 88.6, Enrollment decision--WTC responders;
• Section 88.7, Eligibility--currently identified survivors;
• Section 88.8, Eligibility criteria--WTC survivors;
• Section 88.9, Application process--WTC survivors;
• Section 88.10, Enrollment decision--screening-eligible survivors;
• Section 88.11, Initial health evaluation for screening-eligible survivors;
• Section 88.12, Enrollment decision--certified-eligible survivors; and
• Section 88.13, Disenrollment.

3. Responsibilities

Many parts of the WTC Health Program have responsibilities related to eligibility and enrollment in the Program.

1. Clinical Centers of Excellence (CCEs) are responsible for providing information on responders and survivors enrolled in the WTC predecessor programs [WTC Medical Monitoring and Treatment Program (MMTP) and the WTC Environmental Health Center (EHC) Community Program] so that the members may be enrolled in the WTC Health Program and continuity of care ensured. The CCEs also provide support for enrollment of new members in the WTC Health Program through outreach programs, education, and assistance to potential applicants completing the enrollment forms.
2. Data Centers (DCs) are responsible for processing all new members into the appropriate cohort (responder or survivor). Once an applicant is determined to be eligible, his/her name is added to the list of new enrollees that the Health Program Support (HPS) contractor sends to the DC each week. The DC inputs new enrollees into its database. The Mount Sinai School of Medicine (MSSM) DC which services the responder program [except for Fire Department of New York City (FDNY) responders who receive services through the FDNY CCE and DC] will also include the CCE selection made by the member and will notify the CCE of the new member that has been assigned to its clinic.
3. The Nationwide Provider Network (NPN), administered by Logistics Health Incorporated (LHI), is the WTC Health Program’s provider network for members living outside of the New York (NY) metropolitan area, including those from Shanksville, PA and Arlington, VA (the site of the Pentagon). The NPN received from the Program a list of responders living outside of the NY metropolitan area who were in the predecessor WTC MMTP, and receives weekly updates on NPN enrollees from the HPS contractor. After receiving the list of new NPN enrollees, the NPN enters the members into its system and reaches out to the new members to educate them regarding NPN processes for obtaining covered benefits.
4. The Business Services Outsourcing Center (BSOC), part of the HPS contractor’s organization, scans the enrollment forms and any attachments sent with the application, and assigns a Document Control Number (DCN) to each.
5. The WTC Health Program HPS contractor receives new enrollment applications, captures information in the claims processing system, examines the enrollment packages for completeness, requests additional information as needed, and makes referrals to the Program’s Member Services Team for the final enrollment certification decisions. After the Member Services Team has made a final decision to approve, the HPS contractor sends notification of approval to the applicant and to the correlating DC or, when the enrollee lives outside the NY metropolitan area, the NPN. When a member is determined to be eligible, the HPS contractor sends out welcome packages and follows up with the new enrollees to select a CCE. If an applicant is determined not to be eligible for the Program, the applicant receives a letter explaining why enrollment was denied and is provided an opportunity to appeal. In addition, during the initial implementation of the WTC Health Program, the HPS contractor worked with the DCs and CCEs to enroll the previously enrolled (grandfathered) members in the Program.
6. The Program’s Member Services Team reviews the finalized enrollment packages and, after the clearance of the applicant again the Terrorist Watch List (TWL), makes the final eligibility decision. For all eligibility denials, the Member Services lead will review the denial package and letter to approve the reason(s) for denial before replying to the applicant. The Program also processes any appeals of enrollment decisions.

4. Overview—Eligibility and Enrollment

1. Eligibility

   The PHS Act identifies multiple member groups eligible to participate in the WTC Health Program. Membership groups include: responders from the Fire Department of New York City (FDNY); other specified New York responders; New York survivors; surviving immediate family members of the 343 FDNY responders who perished on September 11, 2001; Pentagon responders; and Shanksville, PA responders.

   Some responders and survivors were enrolled in predecessor programs prior to the start date of the WTC Health Program (July 1, 2011). Responders who were enrolled with FDNY or the MMTP prior to July 1, 2011 and survivors who were enrolled in the EHC Community Program prior to January 2, 2011, were automatically enrolled (following Terrorist Watch List screening) in the WTC Health Program. These members were enrolled in batches.

   Responders and survivors who newly enroll in the WTC Health Program on or after July 1, 2011, and survivors who enrolled in the predecessor program between January 2, 2011 and June 30, 2011, are required to use the WTC Health Program Office of Management and Budget (OMB)-approved application forms to enroll in the Program. The application forms are specific to each member group, and describe the criteria necessary to qualify for the Program. FDNY responders, general New York responders, Pentagon and Shanksville responders, and survivors each have a distinct application form that is unique to the eligibility requirements for each group. These forms may be found in Appendices 2-A through 2-D.

   The “responder” member group of surviving immediate family members of the 343 FDNY responders who perished on September 11, 2001 is generally considered to be a closed group; however, if someone believes s/he is eligible for this cohort, that person may use the FDNY responder application and complete the appropriate sections (Appendix 2-A). Because of the Supreme Court decision in U.S. v. Windsor, 133 S.Ct. 2675 (2013), striking down Section 3 of the Defense of Marriage Act, there may be individuals who were in same-sex marriages as of September 11, 2001, who are newly eligible for certain benefits within the WTC Health Program. The WTC Health Program is also extending this eligibility to certain persons who were in same-sex or opposite-sex domestic partnerships as of September 11, 2001. Specifically, an applicant may be eligible if s/he (a) were in a same-sex marriage (see the following paragraph), civil union, or domestic partnership, with a member of the FDNY who was killed at the WTC site on September 11, 2001; and (b) received any treatment for a WTC-related mental health condition on or before September 1, 2008.

   For purposes of eligibility, the WTC Health Program recognizes a same-sex marriage or civil union if it was legally valid under the laws of the state or other jurisdiction, whether foreign or domestic, when and where the marriage or civil union was performed. The WTC Health Program follows this approach regardless of where the couple lived on September 11, 2001. In addition, the WTC Health Program recognizes as a surviving immediate family member an individual who will attest via affidavit that, on September 11, 2001, s/he was in a same-sex or opposite-sex domestic partnership with a member of the FDNY who was killed at the WTC site on that date, regardless of where the domestic partners lived on September 11, 2001, or where the surviving domestic partner lives now. This policy is consistent with a post-Windsor policy of treating same-sex marriages on the same terms as opposite-sex marriages to the greatest extent reasonably possible.

2. Application Forms: Completion, Submission, and Records Creation

   Information for WTC Health Program applicants, including application forms, can be found on the How to Apply page. Individuals can also call the WTC Health Program Call Center and request that an application be mailed to them.

   If applicants have questions about how to complete their enrollment application, they can contact the WTC Health Program Call Center. Trained Customer Service Representatives at the WTC Health Program Call Center are able to answer questions regarding the enrollment process. Assistance in languages other than English is available. The CCE outreach teams and the outreach and education contractors (see Chapter 9) also provide enrollment assistance to individuals as part of outreach activities.

   Responder and survivor application forms are sent to the WTC Health Program mailroom (BSOC) at the following address:
   
   WTC Enrollment
   PO Box 7000
   Rensselaer, NY 12144-7000
   
   

   Alternatively, applications may be faxed to 1-877-646-5308. BSOC scans the enrollment form and any attachments, and assigns a Document Control Number (DCN), a 12-character length field, in the following format: W (for World Trade Center); 2-digit year; 3-digit Julian date; 4-digit batch number; 3-digit sequential number. The scanned enrollments are delivered to the Enrollment Operations Team via a secure File Transport Protocol (SFTP) server.

   The Enrollment Operations Team, which is part of the HPS Member Services Team (MST), receives the application forms and attachments, assigns them to enrollment processors, and tracks the inventory. The enrollment processor creates the Member Record and the Enrollment Record in the claims processing system.

3. Enrollment Determination

   Applications go through multiple assessment stages. The applications are accepted, entered in the claims processing system, and reviewed by the Enrollment Operations Team. By applying the processes outlined in 42 C.F.R. §§ 88.5 and 88.9, the team determines if more documentation is required to adequately support an application. If more documentation is needed, an enrollment processor reaches out to the applicant immediately to offer guidance. Once adequate documentation is attached to the application, and the application has been entered into the system, the application is sent to the Program’s Member Services Team to make a formal enrollment decision.

   Information on all applicants who are deemed eligible for membership in the Program is then sent to the Federal Bureau of Investigation (FBI) to confirm, per the requirements of the Act, §§ 3311(a)(5) and 3321(a)(4), that they are not on the TWL. Once the applicant is cleared against the TWL, the Enrollment Operations Team is given the direction to officially enroll new members into the Program and the system is updated. The DCs are sent a list of all new enrollees and the NPN is notified of any new NPN enrollees on a weekly basis.

4. Notification to Members

   Notification of membership status is provided to all new members; however, the method by which the members are notified is dependent upon their membership group. Methods have been developed between each member cohort and the Program, as described below.

   1. Responders receive a letter from the WTC Health Program, signed by the Administrator of the WTC Health Program, informing them of their acceptance into the WTC Health Program. They also receive a phone call from an Enrollment Processor to help them understand the network of CCEs that is available to them, and to help them select the CCE that is right for them.
   2. Survivors receive a letter from the WTC Health Program, signed by the Administrator, informing them of their acceptance into the WTC Health Program. This letter details the three hospital locations that treat WTC Health Program survivors in the NY metropolitan area, and provides a centralized booking phone number the members may call to set up their screening appointment.
   3. Responders and survivors who live outside the NY metropolitan area receive a letter signed by the Administrator of the WTC Health Program, informing them of their acceptance into the Program and notifying them that the NPN will be in touch to discuss next steps.
   4. The WTC Health Program may deny Program enrollment if the enrollment criteria are not met; the Program may disenroll a member if the member was mistakenly enrolled or the enrollment was based on incorrect or fraudulent information. Sections 6 and 7 below provides more detail on enrollment and disenrollment, respectively. Denials and disenrollments may be appealed to the Administrator. The Administrator will ensure an appeal review is conducted in a timely manner and notify the applicant of the decision made. Section 8 below provides more detail on the appeal process.

5. Eligibility Criteria

1. Eligibility criteria are defined by the Act in §§ 3311 and 3321, and found at 42 C.F.R. Part 88.

   Eligibility for currently identified responders (PHS Act, § 3311(a)(1)(A); 42 C.F.R. § 88.3).
   
   Responders who were identified as eligible for monitoring and treatment under the arrangements in effect on January 2, 2011, between NIOSH and the MMTP) or FDNY were enrolled in the WTC Health Program without being required to submit a new application.
2. Eligibility criteria for WTC responders (PHS Act, § 3311(a)(2); 42 C.F.R. § 88.4).
   
   Responders to the September 11, 2001, terrorist attacks at the WTC who had not been previously identified as eligible may apply for enrollment in the WTC Health Program, as long as they meet the criteria in one of the following categories:
   1. Firefighters and related personnel:
      1. The individual was an active or retired member of the FDNY (whether firefighter or emergency personnel), and participated at least 1 day in the rescue and recovery effort at any of the former WTC sites (including Ground Zero, the Staten Island Landfill, or the NYC Chief Medical Examiner's Office), during the period beginning on September 11, 2001, and ending on July 31, 2002; or
      2. The individual:
         1. Is a surviving immediate family member of an individual who was an active or retired member of the FDNY (whether firefighter or emergency personnel) who was killed at the Ground Zero on September 11, 2001, and
         2. Received any treatment for a WTC-related mental health condition on or before September 1, 2008.
   2. Law enforcement officers and WTC rescue, recovery, and cleanup workers:
      1. The individual worked or volunteered onsite in rescue, recovery, debris cleanup, or related support services in lower Manhattan (south of Canal), the Staten Island Landfill, or the barge loading piers, for at least:
         1. 4 hours during the period beginning on September 11, 2001, and ending on September 14, 2001; or
         2. 24 hours during the period beginning on September 11, 2001, and ending on September 30, 2001; or
         3. 80 hours during the period beginning on September 11, 2001, and ending on July 31, 2002.
      2. The individual was an active or retired member of the NYC Police Department or an active or retired member of the Port Authority Police of the Port Authority of New York and New Jersey who participated onsite in rescue, recovery, debris cleanup, or related support services, for at least:
         1. 4 hours during the period beginning September 11, 2001, and ending on September 14, 2001, in lower Manhattan (south of Canal Street), including Ground Zero, the Staten Island Landfill, or the barge loading piers; or
         2. 1 day during the period beginning on September 11, 2001, and ending on July 31, 2002, at Ground Zero, the Staten Island Landfill, or the barge loading piers; or
         3. 24 hours during the period beginning on September 11, 2001, and ending on September 30, 2001, in lower Manhattan (south of Canal Street); or
         4. 80 hours during the period beginning on September 11, 2001, and ending on July 31, 2002, in lower Manhattan (south of Canal Street).
   3. Office of the Chief Medical Examiner of NYC employee. The individual was an employee of the Office of the Chief Medical Examiner of NYC involved in the examination and handling of human remains from the WTC attacks, or other morgue worker who performed similar post-September 11 functions for such Office staff, during the period beginning on September 11, 2001, and ending on July 31, 2002.
   4. Port Authority Trans-Hudson Corporation Tunnel worker. The individual was a worker in the Port Authority Trans-Hudson Corporation Tunnel for at least 24 hours during the period beginning on February 1, 2002, and ending on July 1, 2002.
   5. Vehicle-maintenance worker. The individual was a vehicle-maintenance worker who was exposed to debris from the former WTC while retrieving, driving, cleaning, repairing, and maintaining vehicles contaminated by airborne toxins from the September 11, 2001, terrorist attacks; and conducted such work for at least 1 day during the period beginning on September 11, 2001, and ending on July 31, 2002.
   6. Pentagon responders.
      1. The individual was an active or retired member of a fire or police department (fire or emergency personnel), worked for a recovery or cleanup contractor, or was a volunteer; and
      2. Performed rescue, recovery, demolition, debris cleanup, or other related services at the Pentagon site of the September 11, 2001, terrorist attacks, for at least 1 day beginning September 11, 2001, and ending on November 19, 2001.
   7. Shanksville, PA responders.
      1. The individual was an active or retired member of a fire or police department (fire or emergency personnel), worked for a recovery or cleanup contractor, or was a volunteer; and
      2. Performed rescue, recovery, demolition, debris cleanup, or other related services at the Shanksville, Pennsylvania site of the September 11, 2001, terrorist attacks, for at least 1 day beginning September 11, 2001, and ending on October 3, 2001.
3. Eligibility for currently identified survivors (PHS Act, § 3321(a)(1)(A)(i); 42 C.F.R. § 88.7). Survivors, including WTC responders, who were identified as eligible for medical treatment and monitoring within the WTC EHC Community Program as of January 2, 2011, are considered certified-eligible in the WTC Health Program and are not required to submit a new application.
4. Eligibility criteria for WTC survivors (PHS Act, § 3321(a)(1)(B); 42 C.F.R. § 88.8)
   1. Criteria for status as a screening-eligible survivor. An individual who is not a WTC responder, claims symptoms of a WTC-related health condition, and who has not been previously identified as eligible may apply for a determination of eligibility for an initial health evaluation.
      1. The applicant's eligibility for an initial health evaluation is determined based on one of the following criteria:
         1. The screening applicant was present in the dust or dust cloud in the NYC disaster area on September 11, 2001;
         2. The screening applicant worked, resided, or attended school, childcare, or adult daycare in the NYC disaster area, for at least:
            1. 4 days during the period beginning on September 11, 2001, and ending on January 10, 2002; or
            2. 30 days during the period beginning on September 11, 2001, and ending on July 31, 2002.
         3. The screening applicant worked as a cleanup worker or performed maintenance work in the NYC disaster area during the period beginning on September 11, 2001, and ending on January 10, 2002, and had extensive exposure to WTC dust as a result of such work;
         4. The screening applicant:
            1. Was deemed eligible to receive a grant from the Lower Manhattan Development Corporation Residential Grant Program;
            2. Possessed a lease for a residence or purchased a residence in the NYC disaster area; and
            3. Resided in such residence during the period beginning on September 11, 2001, and ending on May 31, 2003;
         5. The screening applicant is an individual whose place of employment—
            1. At any time during the period beginning on September 11, 2001, and ending on May 31, 2003, was in the NYC disaster area; and
            2. Was deemed eligible to receive a grant from the Lower Manhattan Development Corporation WTC Small Firms Attraction and Retention Act program or other government incentive program designed to revitalize the lower Manhattan economy after the September 11, 2001, terrorist attacks.
   2. Criteria for status as a certified-eligible survivor. Survivors who have been determined to have screening-eligible status may seek status as a certified-eligible survivor. Status as a certified-eligible survivor is based on a certification by the WTC Health Program that, pursuant to an initial health evaluation, the screening-eligible survivor has a WTC-related health condition and is eligible for follow-up monitoring and treatment.

6. Enrollment

1. Acknowledgement
   

   Each application will be acknowledged with an appropriate letter, as follows. Letter templates may be found in the “Eligibility Determinations, Health Condition Certifications, & Treatment Determinations Subject to Member Appeals” policy and procedure document, found in the Program’s file of record.

   1. Acknowledgment of Receipt of Application
   2. Acknowledgement of Receipt + Information Needed
2. Reminder Letters
   

   If additional information is needed to complete an application, the Enrollment Operations Center will make repeated attempts to obtain the information. Letters are sent at 30 and 90 day intervals, as follows. Templates may be found in the “Eligibility Determinations, Health Condition Certifications, & Treatment Determinations Subject to Member Appeals” document:

   1. 30-Day Information Needed Reminder
   2. 90-Day Reminder/Warning Letter
3. Screening
   

   Upon receipt of a completed application, the Enrollment Operations Team prepares summary information for the HPS Member Services Team to review in considering the application. Each eligibility determination gives consideration to:

   1. All information provided by the applicant in the enrollment application;
   2. All other materials that are in the application record held by the Enrollment Operations Team that are related to the requirements for the particular eligibility category or categories for which the applicant may be eligible (for example, supporting documentation which provides proof of presence at the site);
   3. The “WTC Health Program Policy and Procedures for Eligibility Determinations, Health Condition Certifications & Treatment Determinations Subject to Member Appeals” document, as well as any other guidance, protocols, or procedures promulgated by the WTC Health Program; and
   4. Prior enrollment decisions impacting survivors who re-enroll in the WTC Health Program

   As the Enrollment Operations Team processes applications for final decisions, the Enrollment Operations Team Manager will perform quality assurance by reviewing for accuracy all aspects of the application, including data entry and the decision logic for each recommendation sent to the Program’s Member Services lead. After review of the final application, the Enrollment Operations Team makes one of the following recommendations for dispensation of the application:

   1. Recommend Enroll — Eligible and qualified for enrollment;
   2. Recommend Deny — Not eligible and/or qualified for enrollment;
   3. Status Defer — Survivor otherwise eligible, but applicant does not claim symptoms in application;
   4. Status Inactive — 180 days after application receipt and request for needed information, information to complete application has not been provided;
   5. Status Closure — Applicant withdrew application or another reason exists to administratively close file; or
   6. Status Incomplete — Enrollment Operations Team has requested needed information and is awaiting more information.
4. WTC Program Administrator’s Determination of Enrollment Eligibility. One of three enrollment determinations will be made for each application:
   1. Enroll;
   2. Deny; or
   3. Suspend determination until more information is available (used in the case of Enrollment Operations Team applicant status of "defer," "inactive," "closure," or incomplete").
5. Enrollment Approval
   Prior to final approval of an applicant’s enrollment, the Program transmits the applicant’s information to the FBI to ensure that the applicant is not on the TWL, in compliance with the requirements of the PHS Act and 42 C.F.R. §§ 88.6(c)(3) and 88.10(b)(3).
6. Potential Enrollment Denial Any enrollment denial recommendation shall be based on a thorough evaluation of the application record by the Enrollment Operations Team before presentation to the WTC Health Program Member Services staff for an enrollment eligibility determination. Applicant enrollment is favored unless clear evidence exists that the applicant does not meet one or more of the eligibility criteria established in the PHS Act and described in 42 C.F.R. §§ 88.4 and 88.8.
7. Notification to Applicant of Enrollment Determination The Program notifies the applicant of the status of his/her application with the appropriate letter, as follows. Templates may be found in the “Eligibility Determinations, Health Condition Certifications, & Treatment Determinations Subject to Member Appeals” document. The following statuses are possible:
   1. Enroll
      1. Responder Enrollment
      2. Screening — Eligible Survivor Enrollment
   2. Deny The notification of a denial of enrollment will be sent whenever contact information is available and will contain the following information:
      1. The reason(s) for denial of enrollment
      2. Detail regarding any insufficient documentation to determine the applicant’s eligibility for enrollment:
         1. Insufficient documentation about time, location, activity or exposure elements;
         2. Insufficient explanation of how the applicant attempted but was unable to obtain the documentation to support time, location, activity or exposure elements; or
         3. Failure to sign the application attesting that all of the information provided is truthful.
      3. Information about the right to appeal a denial of enrollment and how to file an appeal.
   3. Defer
   4. 180-Day/Inactive
   5. Closure

7. Disenrollment

1. WTC Health Program Disenrollment Decision.

   The WTC Health Program may disenroll a WTC Health Program member, pursuant to 42 C.F.R. § 88.13, in the following circumstances:

   1. The WTC Health Program mistakenly enrolled an individual who did not provide sufficient proof of eligibility consistent with the required eligibility criteria; or
   2. The WTC Health Program member’s enrollment was based on incorrect or fraudulent information.
2. Notification to Disenrolled Member.

   A disenrolled WTC Health Program member will be notified in writing by the WTC Health Program of a disenrollment decision, provided an explanation, as appropriate, for the decision, any administrative actions resulting from the decision, and provided information on how to appeal the decision. A disenrolled WTC Health Program member may appeal the disenrollment decision in accordance with Section 8 below.

8. Appeal of Enrollment Denial

All applicants have the right to appeal an enrollment denial or disenrollment decision, pursuant to 42 C.F.R. § 88.14.

Requests to appeal a denial of enrollment or a disenrollment decision must be postmarked within 120 calendar days of the date of the letter from the Administrator notifying the denied applicant or disenrolled member of the adverse decision. A valid request for an appeal must (1) be made in writing and signed; (2) identify the denied applicant or disenrolled WTC Health Program member and designated representative (if applicable); (3) describe the decision being appealed and state the reasons why the denied applicant, disenrolled WTC Health Program member, or designated representative believes the enrollment denial or disenrollment was incorrect and should be reversed; and (4) be sent to the WTC Health Program at the address specified in the notice of denial or disenrollment. The appeal request may include relevant new information not previously considered by the WTC Health Program. ¹

An appeal request that meets the above requirements, however, will still be considered invalid and outside the scope of the WTC Health Program’s administrative appeal process if its sole argument is a challenge to existing law, regulations, or Program policies. In other words, if the issues raised in the appeal have already been determined by law, regulation, or Program policy, then the appeal may not move forward because there are no outstanding issues for the Program to resolve with respect to the individual appellant. For example, an appeal request may not challenge the enrollment criteria established in the Zadroga Act or the Program’s regulation because those criteria are established by law and may only be changed by an act of Congress amending the law or the Program promulgating an amendment to the regulation, respectively.

Similarly, an appeal request may not challenge a Program policy that has been established by the Administrator and is applicable to all Program applicants and/or members. Any challenge to criteria established by law, regulation, or Program policy through the appeal process would be ineffectual because revisions to such criteria require a broader legal, regulatory, or policy action that would be applicable to all Program members; therefore, the challenge cannot be addressed in the appeal of an individual applicant or member. An appeal request may, however, challenge the Program’s application of the enrollment criteria (e.g., the individual could argue that the Program incorrectly determined the number of hours he/she worked or volunteered during a covered time period).

An individual wishing to voice concerns or request that the Administrator change a Program regulation or Program policy may write to the Administrator (separate and distinct from any individual appeal process). Changes to the Zadroga Act require an act of Congress.

In accordance with the regulations, the Administrator will appoint a Federal Official to review the appeal request. The Federal Official is independent of the WTC Health Program and not engaged in any enrollment and eligibility or disenrollment decisions other than appeals, allowing for an objective third-party review of the facts.

The appeal request can be mailed or submitted electronically to the appeal coordinator at:
Appeal Coordinator
WTC Health Program
P.O. Box 7000
Rensselaer, NY 12144
Fax: 1.404.471.8338

The appeal procedure is as follows:

1. The WTC Health Program Appeal Coordinator reviews the appeal of enrollment denial or disenrollment and, in a timely manner, determines if the appeal is valid. Valid appeals are referred to the appointed Federal Official for review and recommendation.
2. The Federal Official will review all available records and assess whether the appeal should be granted. The Federal Official may consider additional relevant new information submitted and will provide a recommendation regarding the disposition of the appeal to the Administrator.
3. After receipt of the Federal Official’s recommendation, the Administrator will make a final decision on the appeal.
4. The applicant is notified of the appeal outcome, as well as any actions taken by the WTC Health Program resulting from the decision, with the appropriate letter from the Administrator of the WTC Health Program.
5. Pursuant to 42 C.F.R. § 88.25, the Administrator is permitted to reopen a final determination at any time and to affirm, vacate, or modify that determination in any manner he or she deems appropriate.

Templates of these letters may be found in the “Eligibility Determinations, Health Condition Certifications, & Treatment Determinations Subject to Member Appeals” document:

1. Appeal of Enrollment Denial Granted — Notice that appeal of enrollment eligibility denial was granted
2. Appeal of Enrollment Denial Denied — Notice that appeal of enrollment denial was denied
3. Appeal Received — Appeal is referred to the appropriate Federal agency

¹42 C.F.R. § 88.14(b)(1)-(2).

Appendices

Chapter 3—Certification of Health Conditions

1. Purpose and Scope

The purpose of this chapter is to describe the circumstances in which a health condition may be certified under Title XXXIII of the PHS Act, the certification process, responsibilities in the certification process, conditions that may be certified, communications regarding certifications, and appeals of certification decisions. Further detail on the certification process is provided in the WTC Health Program Member Services Operations Manual, found in the Program’s file of record.

2. Statutory and Regulatory References

The following sections of Title XXXIII of the PHS Act are applicable to this Chapter:

1. Section 3312(a)(1)(A) defines a WTC-related health condition as:
   1. “[A]n illness or health condition for which exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, based on an examination by a medical professional with experience in treating or diagnosing the health conditions included in the applicable list of WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition…;” or
   2. “[A] mental health condition for which such attacks, based on an examination by a medical professional with experience in treating or diagnosing the health conditions included in the applicable list of WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to, or causing the condition….”
2. Section 3312(b)(1) states that if a physician at a Clinical Center of Excellence (CCE) makes a determination that a WTC responder has a WTC-related health condition included in the List of WTC-Related Health Conditions (List) and that exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 11, 2001, terrorist attacks is substantially likely to be a significant factor in aggravating, contributing to, or causing the condition, then the physician is to transmit that determination and the medical facts supporting the determination to the WTC Health Program. After review of the CCE physician’s determination, the WTC Health Program will certify the health condition if he finds that it is on the List of WTC-Related Health Conditions and that exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 11, 2001, terrorist attacks is substantially likely to be a significant factor in aggravating, contributing to, or causing the health condition. The WTC Health Program will pay for medically necessary treatment of certified WTC-related health conditions (see § 3312(c)(1)). In addition, the Administrator must establish a process to appeal certification decisions.
3. Section 3312(b)(5) authorizes treatment pending certification for responders, and section 3322(a) extends the same benefits to survivors.
4. Section 3321(a)(2)(B) requires the Administrator of the WTC Health Program to establish a certification process for screening-eligible WTC survivors who are eligible for further monitoring and treatment after their initial screening exam.

The following provisions in the WTC Health Program regulations in 42 C.F.R. Part 88 are also applicable to this Chapter:

• Section 88.1 includes definitions of the following relevant terms: Aggravating, Certification; Health condition medically associated with a WTC-related health condition; List of WTC-Related Health Conditions; Medically necessary treatment; WTC-related acute traumatic injury; WTC-related health condition; and WTC-related musculoskeletal disorder.
• Section 88.15, List of WTC-Related Health Conditions.
• Section 88.16, Addition of health conditions to the List of WTC-Related Health Conditions.
• Section 88.17, Physician’s determination of WTC-related health conditions.
• Section 88.18, Certification.
• Section 88.19, Decertification.
• Section 88.20, Authorization of treatment.
• Section 88.21, Appeal of certification, decertification, or treatment authorization decision.
• Section 88.25, Reopening of WTC Health Program final decisions.

3. Responsibilities

The parties involved in certifying health conditions and their responsibilities are detailed below.

1. The Clinical Centers of Excellence/Nationwide Provider Network (CCEs)/(NPN) provide monitoring and screening examinations for eligible responders and survivors. The CCE/NPN ensures that requests for certification of a member’s health condition are completed using the appropriate forms and procedures. The CCE/NPN transmits the completed health condition certification request in a secure manner to the Program’s Health Program Support (HPS) contractor for processing (see Section 6, below for more information regarding secure data transfer). The WTC Health Program’s certification decision is sent to the member and CCE/NPN via letter. Upon receipt of a decision by the Program to certify a health condition, the CCE/NPN is authorized to provide medically necessary treatment to the member for that condition and shall be responsible for providing adequate treatment services or referrals, which will be scheduled by the CCE/NPN.
2. The Program’s Medical Benefit Manager (MBM) has been designated by the Administrator to determine whether a health condition meets the requirements for certification. The MBM reviews an official request by the CCE/NPN to certify a member’s health condition for treatment to be covered by the Program and leads the Certification Team that conducts this function. The MBM consults with the Administrator regarding certifications as necessary.
3. The Program’s HPS contractor is responsible for receiving and processing certification requests from the CCE/NPN for the Program’s Certification Team to evaluate. The HPS contractor also receives the Program’s decisions, updates the system of records, and supports the communication process with the CCE/NPN and member.

4. Covered Conditions

1. The following WTC-related health conditions covered by the WTC Health Program are established in 42 C.F.R. § 88.15:
   1. Aerodigestive disorders:
      1. Interstitial lung diseases;
      2. Chronic respiratory disorders – fumes/vapors;
      3. Asthma;
      4. Reactive airways dysfunction syndrome (RADS);
      5. WTC-exacerbated or new-onset chronic obstructive pulmonary disease (COPD);
      6. Chronic cough syndrome;
      7. Upper airway hyperreactivity;
      8. Chronic rhinosinusitis;
      9. Chronic nasopharyngitis;
      10. Chronic laryngitis;
      11. Gastroesophageal reflux disorder (GERD);
      12. Sleep apnea exacerbated by or related to a condition described in i-xii.
   2. Mental Health Conditions:
      1. Posttraumatic stress disorder (PTSD);
      2. Major depressive disorder;
      3. Panic disorder;
      4. Generalized anxiety disorder;
      5. Anxiety disorder (not otherwise specified);
      6. Depression (not otherwise specified);
      7. Acute stress disorder;
      8. Dysthymic disorder;
      9. Adjustment disorder;
      10. Substance abuse.
   3. Musculoskeletal Disorders (only for WTC responders to the New York City disaster area)::
      1. Low back pain;
      2. Carpal tunnel syndrome(CTS);
      3. Other musculoskeletal disorders.
   4. Cancers :
      1. Malignant neoplasms of the lip, tongue, salivary gland, floor of mouth, gum and other mouth, tonsil, oropharynx, hypopharynx, and other oral cavity and pharynx.
      2. Malignant neoplasm of the nasopharynx.
      3. Malignant neoplasms of the nose, nasal cavity, middle ear, and accessory sinuses.
      4. Malignant neoplasm of the larynx.
      5. Malignant neoplasm of the esophagus.
      6. Malignant neoplasm of the stomach.
      7. Malignant neoplasm of the colon and rectum.
      8. Malignant neoplasm of the liver and intrahepatic bile duct.
      9. Malignant neoplasms of the retroperitoneum and peritoneum, omentum, and mesentery.
      10. Malignant neoplasms of the trachea; bronchus and lung; heart, mediastinum and pleura; and other ill-defined sites in the respiratory system and intrathoracic organs.
      11. Mesothelioma.
      12. Malignant neoplasms of the peripheral nerves and autonomic nervous system, and other connective and soft tissue.
      13. Malignant neoplasms of the skin (melanoma and non-melanoma), including scrotal cancer.
      14. Malignant neoplasm of the female breast.
      15. Malignant neoplasms of the corpus uteri and uterus, part unspecified.
      16. Malignant neoplasm of the prostate.
      17. Malignant neoplasm of the urinary bladder.
      18. Malignant neoplasm of the kidney.
      19. Malignant neoplasms of the renal pelvis, ureter and other urinary organs.
      20. Malignant neoplasms of the eye and orbit.
      21. Malignant neoplasm of the thyroid.
      22. Malignant neoplasms of the blood and lymphoid tissues (including, but not limited to, lymphoma, leukemia, and myeloma).
      23. Childhood cancers: Any type of cancer diagnosed in a person less than 20 years of age.
      24. Rare cancers: any type of cancer that occurs in less than 15 cases per 100,000 persons per year in the United States (based on 2005–2009 average annual data age-adjusted to the 2000 U.S. population).
   5. Acute Traumatic injuries:
      1. Eye injury.
      2. Burn.
      3. Head trauma.
      4. Fracture.
      5. Tendon tear.
      6. Complex sprain.
      7. Other similar acute traumatic injuries.
2. Special Note on Malignancy for Cancers
   1. Solid Neoplasms
      1. To qualify as a malignant neoplasm, a solid neoplasm must:
         1. Have been diagnosed after September 11, 2001 and meet the WTC Health Program’s minimum latency criteria for the specific cancer see Minimum Latency & Types or Categories of Cancer); [12 pages, 517 KB] and
         2. Be characterized histopathologically as malignant and “invasive,” i.e., having evidence of growth or spread beyond the layer of tissue in which it first developed or in which it was first diagnosed.
      2. To qualify as a malignant neoplasm, non-invasive neoplasms including carcinomas in situ must:
         1. Have been diagnosed after September 11, 2001 and meet the WTC Health Program’s minimum latency criteria for the specific cancer.
         2. Be characterized histologically as malignant and be regarded in the peer-reviewed scientific literature as having an increased risk of developing into an invasive neoplasm. Non-invasive neoplasms, including carcinomas in situ, will be evaluated on a case-by-case basis. The review will include consideration of the treatment recommendations made by the National Comprehensive Cancer Network (NCCN). Such reviews will be documented and included in the member file where relevant to a specific cancer certification evaluation.
      3. Non-invasive neoplasms ineligible for certification:
         1. A non-invasive neoplasm that is completely removed surgically during an excisional biopsy or resection of an organ or body part containing the lesion may be curative (i.e., NCCN Guidelines recommend no further treatment). The following carcinomas in situ have been determined to be examples of such types of non-invasive neoplasms and are, therefore, ineligible for certification:
            • Breast: Lobular carcinoma in situ (CIS) [except pleomorphic lobular CIS]
            • Colon and rectum: CIS [including high grade intraepithelial and intramucosal neoplasia]
            • Gallbladder: CIS
         2. Non-invasive neoplasms of the cervix uteri are ineligible for certification but may be eligible for medical benefits related to surveillance, management, and/or treatment. The following lesions have been determined to be examples of such types of non-invasive neoplasms and are, therefore, ineligible for certification:
            • Cervical intraepithelial neoplasia (CIN): CIN grade I, CIN grade II, and CIN grade III
            • Carcinoma in situ of the cervix uteri
      4. Histologically benign neoplasms are ineligible for certification.
   2. Liquid neoplasms
      To qualify as a malignant neoplasm, a liquid neoplasm must:
      1. Have been diagnosed after September 11, 2001 and meet the WTC Health Program’s minimum latency criteria for the specific cancer see Minimum Latency & Types or Categories of Cancer); [12 pages, 517 KB] and
      2. Exhibit uncontrolled clonal growth of a specific type of hematopoietic cell.
   3. Cancers of Unknown Primary Origin (CUPs)

      These are histologically-proven, metastatic, malignant neoplasms the primary origin of which cannot be identified during pre-treatment evaluation. The date of diagnosis of the metastatic disease will be used to evaluate eligibility for certification of CUPs.

   4. Metastasis or recurrence of a pre-existing malignant neoplasm

      For malignant neoplasms diagnosed before September 11, 2001, and those diagnosed after September 11, 2001 but with insufficient latency, any recurrence or metastasis from such malignant neoplasms will not be considered for certification regardless of the amount of time that passes between remission of the pre-existing neoplasm and its recurrence or metastatic spread. An exhaustive search of the scientific literature has failed to identify evidence that toxic exposures aggravate, cause, or contribute to a pre-existing cancer resulting in a recurrence or metastasis that requires a change in treatment.

   5. Second primary cancers

      A second primary cancer is a histologically-proven, new primary malignant neoplasm developing in a person with a history of cancer. The term applies to malignant neoplasms that have arisen independently and not as a result of recurrence or metastasis of the original primary malignant neoplasm. A second primary cancer is considered eligible for certification if it was diagnosed after September 11, 2001 and meets the WTC Health Program’s minimum latency criteria for the specific cancer. Alleged cases of second primary cancers originating from the same tissue and/or of the same histological type as a malignant neoplasm that is certified, certifiable, or ineligible for certification will be evaluated on a case-by-case basis. The review will include consideration of the peer-reviewed scientific literature and Surveillance, Epidemiology, and End Results (SEER) Program Multiple Primary and Histology Coding Rules. Such reviews will be documented and included in the member file where relevant to a specific cancer certification evaluation.

3. Special Note on Acute Traumatic Injuries and Musculoskeletal Disorders
   

   1. Acute Traumatic Injuries
      
      A WTC-related acute traumatic injury (ATI) is physical damage to the body caused by and occurring immediately after a one-time exposure to energy, such as heat, electricity, or impact from a crash or fall, resulting from a specific event or incident. Such health conditions include eye injuries, burns, head trauma, fractures, tendon tears, complex sprains, and other similar acute traumatic injuries.
      
      In order for an ATI to be certified by the Program, the injury must be directly related to a member’s 9/11 exposures and activities and must have occurred during one of the following time periods: September 11, 2001 – July 31, 2002 for acute traumatic injuries occurring at one of the New York City Area Sites; September 11, 2001 – November 19, 2001 for acute traumatic injuries occurring at the Pentagon Site; or September 11, 2001 – October 3, 2001 for acute traumatic injuries occurring at the Shanksville, Pennsylvania Site. In addition, the WTC responder or screening-eligible or certified-eligible survivor must have received medical treatment for the acute traumatic injury on or before September 11, 2003.
   2. Musculoskeletal Disorders
      
      A WTC-related musculoskeletal disorder (MSD) is a chronic or recurrent disorder of the musculoskeletal system caused by heavy lifting or repetitive strain on the joints or musculoskeletal system occurring during rescue or recovery efforts in the New York City disaster area in the aftermath of the September 11, 2001, terrorist attacks. Such health conditions include low back pain, carpal tunnel syndrome (CTS), and other musculoskeletal disorders. 
      
      In order for an MSD to be certified by the Program, the injury must be directly related to a member’s 9/11 exposures and activities and must have occurred during the following time period: September 11, 2001 – July 31, 2002.  The Zadroga Act only allows coverage of MSDs for WTC Responders; therefore, Survivors and Pentagon and Shanksville, PA Responders cannot be certified for an MSD. In addition, the WTC responder must have received medical treatment for a WTC-related musculoskeletal disorder on or before September 11, 2003.

4. Health Conditions Medically Associated with WTC-Related Health Conditions
   

   A condition that is medically associated with a WTC-related health condition is also eligible for certification and treatment within the WTC Health Program. In order for a medically associated health condition to be certified, the condition must result from the treatment or progression of a WTC-related health condition. The underlying WTC-related health condition must first be certified by the WTC Health Program before any conditions may be certified as medically associated with the underlying condition. Medically associated conditions are evaluated and certified on a case-by-case basis

   The WTC Health Program requires that the CCE or NPN physician provide a detailed explanation in the WTC-3 Certification Request form (Appendix 3-A), and medical records as appropriate, that the health condition under consideration as medically associated resulted from either treatment or progression of the underlying certified WTC-related health condition. See Health Conditions Medically Associated with World Trade Center-Related Health Conditions. [5 pages, 484 KB]

   
   
   1. Establishing that the Medically Associated Health Condition “Results from” Treatment of a Certified WTC-Related Health Condition.
      
      The WTC Health Program will review the CCE or NPN’s explanation to determine if: (i) the relationship linking the medically associated health condition the WTC-related health condition occurs without the influence of an intermediary health condition or event; and (ii) the linkage between the certified WTC-related health condition and the medically associated health condition resulting from treatment of the certified WTC-related health condition has been well-established by published peer-reviewed scientific literature.
      1. “Results from” Treatment. The CCE or NPN physician must demonstrate by means of a detailed narrative (including medical records when appropriate) that the health condition “results from” medical treatment of the underlying certified WTC-related health condition without the influence of an intermediary health condition or event. The WTC Health Program will certify as medically associated only those conditions which directly result from treatment of a WTC-related health condition, i.e., that the medically associated condition occurred in absence of intervening medical events.
         

         Note: CCE and NPN physicians are encouraged to consult with the Director, WTC Health Program Medical Benefits, about medically associated health conditions that result from treatment of a certified WTC-related health condition as certification will depend on the particular medical facts of each case.

      2. Previously Published in Peer-Reviewed Literature. The CCE or NPN physician must demonstrate that the medical association between the underlying [certified WTC-related] health condition and the medically associated health condition resulting from treatment of the underlying [certified WTC-related] health condition has been established in previously published peer-reviewed medical literature. The establishment of this medical association in the literature must be documented in the member file, whether included as part of the physician’s narrative or otherwise captured by Program staff.
      
      
   2. Establishing that the Medically Associated Health Condition “Results from” Progression of a Certified WTC-Related Health Condition.
      
      

      The WTC Health Program will review the CCE or NPN physician’s explanation to determine if: (i) the relationship linking the medically associated condition with the WTC-related health condition occurs without the influence of an intermediary health condition or event; and (ii) the linkage between the certified WTC-related health condition and the medically associated condition resulting from progression of the certified WTC-related health condition has been well-established in published, peer-reviewed scientific literature.

      
      
      1. “Result from” Progression. The CCE or NPN physician must demonstrate by means of a detailed narrative (including medical records when appropriate) that the health condition ”results from” progression of the underlying certified WTC-related health condition without the influence of an intermediary health condition or event.
         

         Note: CCE and NPN physicians are encouraged to consult with the Director, WTC Health Program Medical Benefits, about medically associated health conditions that are the result of progression of a certified WTC-related health condition as certification will depend on the particular medical facts of each case.

      2. Previously Published in Peer-Reviewed Literature. The CCE or NPN physician must demonstrate that the medical association between the underlying [certified WTC-related] health condition and the medically associated health condition resulting from progression of the underlying [certified WTC-related] health condition has been established in previously published peer-reviewed medical literature. The establishment of this medical association in the literature must be documented in the member file, whether included as part of the physician’s narrative or otherwise captured by Program staff.

5. CCE/NPN Physician Determination and Request for Certification of Health Conditions

When a member is diagnosed with a health condition that the provider believes is related to a 9/11 exposure, the member may be eligible for medical treatment for that condition under the Program.

1. CCE/NPN Physician Determination

   If, following an initial health evaluation or monitoring or treatment exam, the treating CCE or NPN physician determines that the member has a health condition which is a qualifying condition covered by the Program, as described in Section 4, and that member’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition or mental health condition, then the physician must submit this determination to the Program and request certification of the health condition in order to provide treatment under the Program.

2. Secondary Review of Negative Physician Determination

   Where a member’s CCE/NPN makes a negative determination (a finding that exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, is not substantially likely to be a significant factor in aggravating, contributing to, or causing the health condition or mental health condition) and declines to request certification of the health condition by the WTC Health Program, the member may request a secondary review of this decision by writing the Clinical Director of the CCE or NPN. However, a request for a secondary medical review for a health condition that does not meet WTC Health Program policy is not permitted. Disagreement with Program policy is not a valid reason for secondary review. The procedure for a secondary review is as follows:

   1. The member is informed by the CCE/NPN of the decision to not request certification in a timely manner and is informed of his/her right to obtain secondary review; this should occur ideally through a Clinic visit.
   2. If the member disagrees with the decision to not request certification, s/he shall be given counsel regarding the secondary review process and provided a brochure detailing his/her rights in terms of obtaining a secondary review. To initiate the secondary review process, the member must send a letter to the CCE/NPN Clinical Director, or designee, which clearly indicates his/her request to obtain secondary medical review.
   3. The CCE/NPN Clinical Director or designee then performs a review of the case. This designee can be a CCE physician at another CCE.
   4. If the secondary review upholds the original decision to not request certification, then the CCE /NPN Clinical Director must send a written letter to the member (within 4 weeks) which summarizes the decision and provides an explanation of how this decision was made. A copy of this letter should be sent to the Administrator of the WTC Health Program.
   5. If the secondary review finds that WTC-relatedness is supported, the CCE/NPN Clinical Director must send a written letter to the member informing him/her of this decision. This letter should state that a WTC-3 request for certification will now be sent to the WTC Health Program, with an attestation coming from the physician who performed the secondary review.
   6. The CCE/NPN shall track all secondary review decisions and may make recommendations to the Administrator of the WTC Health Program, as appropriate, when such decisions point to a need for an evaluation or change to Program policies and procedures.
3. CCE/NPN Requests Certification from the Program Using the WTC-3 Form

   The WTC-3 Certification Package is the standard documentation completed by a CCE/NPN physician to request certification for a member’s health condition; it provides the medical rationale linking the exposure to the stated health condition. A sample of the form is provided in Appendix 3-A. This form must be used for any condition which a physician has determined to be WTC-related since the Program CCE contracts were implemented [i.e., as of July 1, 2011 for enrolled responders; as of September 29, 2011 for enrolled survivors; and as of October, 2013 for enrolled members assigned to the Nationwide Provider Network (NPN)]. The Clinical Director of the CCE or the NPN reviews, approves and securely submits the completed WTC-3 Certification Package signed by the examining or responsible physician to the Program. Such forms are also used to request certification of health conditions as medically associated with a WTC-related health condition.

   The WTC-3 Certification Package contains identifying information for the member and examiner, diagnostic codes for the condition(s) for which the member is requesting certification, and either a medical rationale linking 9/11 exposure to the health condition or the medical rationale linking the medically associated health condition to an existing WTC-related health condition. For a health condition medically associated with a WTC-related health condition, the physician’s determination shall contain information on how the health condition has resulted from treatment of a previously certified WTC-related health condition, or how it has resulted from progression of the certified WTC-related health condition. All cancer certification requests require a pathology report to be submitted with the WTC-3 Certification Package. Specific guidance regarding how to complete the WTC-3 Certification Package, including reasonable practice examples using Program-approved templates, is provided below.

   When providing a rationale for the certification, requesters use an explanatory narrative that may be combined with Program-approved template within the WTC-3 form. The rationale should contain pertinent information about 9/11 exposure and time-linked emergence of symptoms. Facts available from the standardized monitoring or screening examination, including exposure assessment, presenting symptoms and temporal relationship of these symptoms relative to 9/11 exposure, should be included. Medical findings should be documented in the institutional medical record, which include the screening or monitoring exams and any additional medical testing or imaging studies required to establish the diagnosis. By procedure, the member’s institutional medical record is incorporated by reference when the CCE provider or NPN Clinical Director requests certification using the WTC-3 Certification Package. This process provides the Program with all relevant information required to make an informed decision regarding the member’s certification. See Appendix 3-B for instructions specific to completing the WTC-3 form for cancer.

   The WTC-3 submission must include a signed affirmative statement by the physician that the member’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition or mental health condition. If the physician is unable to make such and affirmative finding, then the WTC-3 cannot be submitted or considered.

4. Previous Program Members Certified Using WTC-2 Batch Process

   The WTC-2 batch certification process was used for a subset of program members who had treatment initiated for qualifying conditions as part of the previous federally-sponsored programs (the Medical Monitoring and Treatment Program (MMTP) for responders and/or the Environmental Health Clinic (EHC) for community members). This process was implemented to ensure treatment continuity for members already receiving care under predecessor programs and is no longer being used.

   If the certifications for qualified conditions were supported by documentation in the members’ medical records, the Clinical Director of the CCE or the NPN submitted an attestation for all members and their associated conditions via electronic spreadsheet. The spreadsheet contained identifying member information and diagnostic codes for each qualifying WTC-related or medically associated condition that required certification. The CCE/NPN then transmitted the WTC-2 batch certification request to the Program in a secure manner (as described in Section 6, below). The Program verified the requested conditions against the Codebook (described further in Section 9, below) and returned any discrepant data to the submitter for rectification. Periodic summary reports of certified conditions by member were then sent to the CCE/NPN by the HPS contractor.

   The CCE/NPN is responsible for maintaining a record of a member’s certifications to enable appropriate service authorization decisions. As part of their Quality Assurance Program the CCE/NPN conducts internal audits of their contracted part of the WTC Health Program at a minimum of every quarter. These data are made available to the Administrator of the WTC Health Program or designee. Where data is obtained, through a quality assurance audit or otherwise, that indicates that the certification issued through the WTC-2 process was incorrect, the Administrator of the WTC Health Program may de-certify a condition as appropriate.

6. Overview of the Certification Process

Certification is the lynchpin by which the Program ensures members receive appropriate services and that all services are provided in accordance with statutory and regulatory requirements. A CCE/NPN is responsible for submitting requests for health condition certification using the WTC-3 form. The WTC Health Program then reviews and evaluates the request (WTC-3) and makes one of three possible decisions for each health condition contained within the request:

1. The health condition is certified, enabling the member to receive treatment for the certified health condition;
2. The health condition is denied certification, which gives the member the right to request an appeal of the denial decision; or
3. The request is suspended and categorized by the WTC Health Program as a “re-do” pending receipt of additional information about the request from the CCE or NPN physician submitting the request.

1. The certification process begins when the CCE/NPN examines the member and makes a determination regarding whether the member has an illness which is covered in the WTC Health Program and that the member’s 9/11 exposure is related to his or her illness.
2. The CCE/NPN completes and submits the WTC-3 package (including supporting documents) to the Program in one of three ways:
   1. By mail to the WTC Health Program mailroom;
   2. By fax to the secure WTC Health Program fax number; or
   3. By placing a PDF version of the WTC-3 package on the Program’s secure file transfer protocol (SFTP) server.
3. For paper and fax submissions, the mailroom scans the package, assigns a document control number (DCN), uploads the scanned document to the SFTP server for the HPS Member Services Team (MST) to access, and notifies the MST that certification requests are available for review. In this way, the MST accesses all submitted packages from one consolidated location – the SFTP server.
4. The MST reviews the submitted WTC-3 package to determine whether it is complete and can be processed. A WTC-3 package is considered to be complete if:
   1. The WTC-3 form is legible and fully filled out;
   2. A supporting narrative/assessment is provided;
   3. The WTC-3 form is signed and dated by the member’s health provider and includes the required physician determination and attestation that the member’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition or mental health condition; and
   4. The member for whom certification is being requested is enrolled as a member in the Program.
5. If the CCE/NPN request for certification is found to be incomplete, the request will be categorized as a “re-do” (neither certified nor denied), and held in a suspended status until specific facts are either supplied (when missing) or clarified (when too vague or misleading) by the CCE or NPN submitting the request for certification. As a result of the request for certification being suspended, the member is not eligible to receive medical or pharmacy benefits for the health condition subject to request for certification (see section below regarding the request for a time-limited authorization of treatment pending certification). If a certification is made via a follow up submission, the effective date of the certification will always be assigned as the signature date of the original submission.
6. If the MST determines that the WTC-3 package is complete and the member is properly enrolled, the package is forwarded to the NIOSH MBM for review and approval. Certifications are forwarded to the MBM on a weekly basis.
7. The NIOSH MBM reviews the certification requests and makes determinations to approve or deny the certification or to request a “redo,” when necessary (e.g., due to missing information). The MBM also determines the effective date for medical benefits, and notifies the MST of the decisions.
8. Upon approval by the MBM, the MST updates the claims processing system, assigns benefit plans as appropriate, and notifies the CCE/NPN of the decisions.

7. Authorization of Treatment Pending Certification

Authorization of Treatment Pending Certification is permitted pursuant to Sections 3312(b)(5) (responders) and 3322(a) (survivors) of the PHS Act and 42 C.F.R. § 88.20(c). Treatment pending certification is offered, where specifically requested by a CCE/NPN physician, in order to provide timely institution of therapy or continuity of care while a certification request is being reviewed.

1. In the past, the WTC-1 Form was used to request this authorization as a means of providing “continuity of care” for the subgroup of members receiving treatment in the previous federally sponsored programs (MMTP and EHC) until the new certification process was implemented. This process expired in November 2011, and the form was retired.
2. Under the current WTC-3 certification process, while certification is pending, authorization for time-limited treatment of a WTC-related health condition or a health condition medically associated with a WTC-related health condition may be requested at the CCE/NPN physician’s discretion through the WTC-3 Form. Such authorization must be obtained from the WTC Health Program before treatment is provided, except for the provision of treatment for a medical emergency.
3. Treatment rendered after WTC-3 submission but prior to certification will only be covered if the request for treatment pending certification was included in the WTC-3 submittal, the care delivered does not require a Level 3 Prior Authorization, the request for certification is ultimately granted, the treatment provided is medically necessary and follows Program guidelines, and the care is rendered by a CCE/NPN-affiliated provider. In the event that the condition is denied certification, any care provided for the condition that is outside the parameters of the Diagnostic Plan will not be covered and the CCE or NPN providing the care will be responsible for the costs of such care.
4. If the certification request is determined to be unsatisfactory, then the authorization for treatment pending certification is discontinued immediately and related claims are pended for up to three weeks, during which time the CCE or NPN will work with the MST to rectify any deficiencies in the request, if possible. After 3 weeks, unsatisfactory certification requests will convert to a denial of certification and appropriate Program actions (see Sections 8 and 10, below).

8. Certification Decisions

1. Potential Outcomes Following a Request for Certification

   A CCE or NPN physician is responsible for submitting requests for certification of a health condition using the WTC-3 form. The WTC Health Program then reviews and evaluates the request (WTC-3) and makes one of the three following decisions for each health condition contained within the request:

   1. The member’s health condition is certified, enabling the member to receive treatment for the certified health condition;
   2. The member’s health condition is denied certification, which gives the member the right to request an appeal of the denial decision; or
   3. The request for certification is “suspended” pending receipt of additional or clarifying information regarding the certification request submitted by the CCE or NPN.
2. Communicating Certification Request Outcomes to Members

   The Program makes every effort to make informed decisions regarding WTC-related health condition certifications in a timely manner and to communicate those decisions to the member efficiently. For certification requests of health conditions medically associated with a WTC-related health condition, the Program will render a decision and notify the member in writing of the decision and the reason for the decision within 60 calendar days after the date the physician’s determination was received. To that end, the Program has developed decision letters addressing the range of decisions that could be made in the certification process (e.g., approval or denial of certification request, the need for additional information to inform the certification decision, etc.). When a member’s health condition is approved for certification as either a WTC-related health condition or a medically associated health condition, the Program sends the member a letter informing him/her of the certification and provides electronic notification to the CCE/NPN that requested the certification. When a member’s requested health condition is denied certification, the Program sends the member letter informing him/her of the denial and provides an electronic copy of the letter to the requesting CCE/NPN. The denial letter discusses the condition requested, the reason for the denial, and the information submitted to the Program for review from the CCE or NPN. The letter also answers frequently asked questions and provides instructions about how appeal the denial decision.

3. Suspended Requests for Certification

   A suspended request for certification is neither certified nor denied, but has been placed in an administratively pended status until specific facts are either supplied (when missing) or clarified (when too vague or misleading) by the CCE or NPN submitting the request for certification.

   1. Time to Provide Information to Resolve a Suspended Request for Certification

      The WTC Health Program will notify the CCE or NPN that submitted the request for certification when more information is required to complete processing of the request for certification. This notification will be made in writing by electronic message (via secure portal). The CCE or NPN has 60 days from the date of the written notification from the WTC Health Program to provide the Program with the requested additional information. The WTC Health Program will provide weekly updates to each CCE or NPN regarding any outstanding requests for certification that have been suspended pending additional information and the number of days that have elapsed since the notification and request for additional information for each case was sent to the CCE or NPN.

   2. Effect of Suspended Request for Certification on Authorization of Treatment Pending Certification

      As a result of the request for certification being suspended, the WTC Health Program member is generally not eligible to receive medical or pharmacy benefits for the health condition subject to request for certification. However, if the original submission requesting certification of a given condition included a time-limited authorization of treatment pending certification, the requesting CCE or NPN may choose to continue providing benefits to the member at their own expense. In the event that the suspended request for certification is subsequently approved through timely rectification of the record, reimbursement of treatment services will be permitted with an effective date of the signature date of the original WTC-3 submission. In the event that the condition is denied certification, any care provided outside the parameters of the Diagnostic Plan will not be covered and the CCE or NPN providing the care will be responsible for the costs of such care. If the concerns resulting in the suspended request are not resolved after 60 days as outlined above, then any authorization for treatment pending certification is terminated and the member is notified as per protocol.

   3. Resolution of a Suspended Request for Certification

      There are five potential outcomes for a request for certification that has been placed in a suspended status; those outcomes are as follows:

      1. Certification After Receipt of Additional Information from the CCE or NPN

         The CCE or NPN responds to the notification of a suspended request for certification with additional or clarifying information. Based on this information, the Program is able to certify the health condition.

      2. Denial of Certification After Receipt of Additional Information from the CCE or NPN

         The CCE or NPN responds to the notification of a suspended request for certification with additional or clarifying information. This additional information does not satisfy the requirements for certification, however, and results in a denial of certification for the health condition. The member has the right to appeal the denial decision.

      3. Administrative Closure Following a Request by the CCE or NPN to Withdraw the Certification Request

         The CCE or NPN responds to the notification of a suspended request for certification by indicating in writing that they would like to withdraw the original request for certification. If a withdrawal is requested, the WTC Health Program will no longer evaluate the request for certification and will administratively close the request file. Reasons for withdrawal may include the CCE/NPN determining that the requested information cannot be supplied in a timely manner or newly recognizing that the request for certification cannot be supported based on established WTC Health Program criteria. The CCE/NPN will inform the member of the withdrawal of the request for certification, and advise the member of their right to a secondary review.

      4. Denial of Certification Following an Insufficient Response from the CCE or NPN After Request for Additional Information

         If the CCE or NPN responds to the WTC Health Program’s notification of suspended request for certification but is unable to provide the requested information necessary to resolve the suspended certification request within the 60 day time limit allowed for final resolution of the request, then the WTC Health Program will take the following actions. The WTC Health Program will send a written communication to the CCE/NPN (via electronic message) asking for confirmation that they cannot provide additional information but that they still wish to request certification for the health condition. If the CCE/NPN responds in writing (via electronic message) that this is the case, then the WTC Health Program will deny the request for certification of the health condition due to lack of sufficient information to make a definitive evaluation of the link between 9/11 exposure and the requested health condition or between the WTC-related health condition and the requested medically associated health condition. The WTC Health Program will inform the member of the denial and his or her right to request an appeal of the denial decision.

      5. Administrative Closure Following No Response from the CCE or NPN After Request for Additional Information

         If the CCE or NPN does not respond at all to the notification of a suspended request for certification within the 60 day time limit allowed for final resolution of the request, then the WTC Health Program will administratively close the request for certification of the health condition due to lack of sufficient information to support a physician’s determination (upon which a certification decision could be based). Similarly, if the WTC Health Program asks the CCE/NPN for a confirmation that they cannot provide additional information but that they still wish to request certification for the health condition (as outlined above) and the response from the CCE/NPN is unclear or equivocal as to the intent to request certification, then the WTC Health Program will administratively close the request for certification of the health condition due to lack of sufficient information to support the physician’s determination. In either case, the WTC Health Program will notify the CCE or NPN in writing via electronic message that the request for certification has been administratively closed. The CCE/NPN will inform the member of the administrative closure of the request for certification, and advise the member of his or her right to a secondary review. The CCE/NPN may submit a new WTC-3 at a later date should additional or clarifying information becomes available.

4. Certification of Deceased Members

   The WTC Health Program does not certify health conditions for deceased members. The WTC Health Program may cover medically necessary treatment for certified health conditions from the effective date of the certification (or from the effective date of the certification request in cases of appropriately requested treatment pending certification). The WTC Health Program will not review certification requests dated after a member’s death.

9. Linking Member Health Benefits to Certified Health Conditions

WTC-related health conditions identified in 42 C.F.R. § 88.15 have been grouped into certification categories to align the limited coverage intent of the Program with standards of care and principles of medical necessity. The WTC Health Program defined the business rules used in the processing (adjudication) of healthcare claims to ensure compliance with the limited coverage intent of the Program. Each member category – General Responder, Screening-eligible Survivor, Certified-eligible Survivor, FDNY Responder, and FDNY Family Member – is associated with one or more designated benefit plans. The WTC Health Program Codebook contains the covered diagnosis codes (ICD-9, or if after October 1, 2015, ICD-10), procedural codes (CPT-4 and HCPCS), and pharmaceutical codes (Rx) for the Program. Providers are responsible for working with the CCE/NPN to determine allowable services. A more complete description of these categories and benefit plans may be found in Chapter 4.

1. The Program Codebook describes the diagnoses and services covered under the Program and consists of accepted medical coding for the following:
   1. Health condition diagnoses – defined by the current World Health Organization’s (WHO’s) International Classification of Disease, 10th edition and Clinical Modification (ICD10-CM) and the World Health Organization’s International Classification of Diseases for Oncology, 3rd edition (ICD-O-3);
   2. Health services – defined as procedures by the American Medical Association’s Current Procedural Terminology (CPT®);
   3. Provider-administered pharmaceutical products or durable medical equipment (DME) by the Centers for Medicare & Medicaid Services’ (CMS’s) Healthcare Common Procedural Coding System (HCPCS); and
   4. WTC Health Program Formulary – medications by therapeutic class, brand name, and generic name.
2. Medical coding is regularly updated as per source coding references (ICD, CPT, and HCPCS) and as per requirements published by HHS (e.g., transition to WHO’s International Classification of Diseases, 10th edition [ICD-10] on October 1, 2015). The Codebook is updated through a systems change management process (see Chapter 4), and version control is maintained through regular electronic dissemination and posting on a centralized Program website. The official version of the Codebook is found in the Program’s file of record.
3. Care Suites have been developed by the Program to link the adjudication of healthcare claims with a member’s health benefits, including the care required to manage certified health condition(s). Care Suites are defined by the medical coding that comprises both the allowable conditions within a certification category, and the medical care required to manage these conditions via allowable procedures and products. The Care Suites guide the processing of healthcare claims. Further discussion of Care Suites can be found in Chapter 4, and a full discussion of the claims processing system is found in Chapter 5.
4. D. The System of Records for the WTC Health Program is housed within the claims processing system, which contains file links to scanned images of source member enrollment and certification paperwork. The System of Records Notice may be found at: https://www.cdc.gov/SORNnotice/09-20-0147.htm and was last updated in June 2011 (76 Fed. Reg. 34706 (June 14, 2011)).

10. Appeals of Certification Denials and/or Decertifications

Requests to appeal a denial of certification of a health condition as a WTC-related health condition or as a health condition medically associated with a WTC-related health condition, a decertification of a health condition, or a denial of authorization for treatment must be postmarked within 120 calendar days of the date of the letter from the Administrator notifying the member of the adverse decision. A valid request for an appeal must (1) be made in writing and signed; (2) identify the WTC Health Program member and designated representative (if applicable); (3) describe the decision being appealed and the reasons why the member or designated representative believes the decision is incorrect and should be reversed; and (4) be sent to the WTC Health Program at the address specified in the notice of denial.¹

The description in the request may include scientific or medical information correcting factual errors that may have been submitted to the WTC Health Program by the CCE or NPN; information demonstrating that the WTC Health Program did not correctly follow or apply relevant WTC Health Program policies or procedures; or any information demonstrating that the WTC Health Program’s decision was not reasonable given the facts of the case. The basis provided in the appeal request must be sufficiently detailed and supported by information to permit a review of the appeal. Any new information not previously considered by the WTC Health Program must be included with the appeal request, unless later requested by the WTC Health Program.² For more detailed information about what may or may not be considered during the appeal process, please see Chapter 4, Section 3.6 of this Administrative Manual.

An appeal request that meets the above requirements, however, will still be considered invalid and outside the scope of the WTC Health Program’s administrative appeal process if its sole argument is a challenge to existing law, regulations, or Program policies. In other words, if the issues raised in the appeal have already been determined by law, regulation, or Program policy, then the appeal may not move forward because there are no outstanding issues for the Program to resolve with respect to the individual appellant. For example, an appeal request may not challenge a denial of certification of a health condition where the denial was based on certification requirements established in the Zadroga Act or the health condition not being included on the List of WTC-Related Health Conditions (List) in the Program’s regulation at 42 C.F.R. § 88.15 because those criteria are established by law and may only be changed by an act of Congress amending the law or the Program publishing an amendment to the regulation, respectively. Similarly, an appeal request may not challenge a denial of certification based on a Program policy that has been established by the Administrator and is applicable to all Program members, such as the latency requirements in the Program’s Minimum Latency & Types or Categories of Cancer. Any challenge to criteria established by law, regulation, or Program policy through the appeal process would be ineffectual because revisions to such criteria require a broader legal, regulatory, or policy action that would be applicable to all Program members; therefore, the challenge cannot be addressed in the appeal of an individual member. An appeal request may, however, challenge the Program’s application of the certification criteria (e.g., the member could argue that the Program incorrectly determined the amount of time that elapsed between the member’s initial 9/11 exposure and the date of his/her initial cancer diagnosis).

An individual wishing to voice concerns or request that the Administrator change a Program regulation or policy may write to the Administrator. An individual may also petition the Administrator to add a health condition to the List of WTC-Related Health Conditions (List); for more information on the petition process, see https://www.cdc.gov/wtc/petitions.html. The petition process can only be used to request the addition of a WTC-related health condition to the List. It cannot be used to request that the Program cover a specific health condition medically associated with a certified WTC-related health condition, cover a certain type of treatment, or amend Program regulations or policies. Changes to the Zadroga Act require an act of Congress.

When a denial of health condition certification or a decision to decertify a health condition is issued by the Program, the member may appeal the decision. An appeal must be made in writing within 120 calendars days from the date of the WTC Health Program’s letter notifying the member of the denial or decertification decision. The written, signed appeal request should include a full explanation of why the member (or the member’s designated representative) believes that the denial decision is incorrect. See Overview of the Appeal Process for Denial of Health Condition [PDF, 9 pages, 684 KB] The following mailing address or fax number should be used to submit a request for appeal:

Appeal Coordinator
WTC Health Program
Po Box 7000
Rensselaer, NY 12144
Fax: 1-404-471-8338

1. Within 14 days of receiving an appeal request, the appeals coordinator will notify the individual by letter whether the appeal request is accepted or not. If the appeal request is accepted, the letter will provide the individual with the name of the Federal Official who will review the appeal. If the appeal request is not accepted, the letter will inform the individual and provide the reason(s) the appeal was not accepted.
2. An individual may request the opportunity to make an oral statement to the Federal Official during the appeal review within the appeal request letter to the appeals coordinator. The individual may also request to make an oral statement within 14 calendar days of receiving the letter from the appeals coordinator notifying him/her that the appeal request was accepted.
3. The Federal Official will review the appeal. If the appeal review is going to take longer than 60 calendar days from the date of the letter notifying the individual that his/her appeal request was accepted, the appeals coordinator will send a letter to the individual providing a written explanation of the delay and the estimated date the review is expected to be completed.
4. The Federal Official will review all available records and assess whether the appeal should be granted. The Federal Official may consider additional relevant new information and will provide a recommendation to the Administrator of the WTC Health Program. After receipt of the Federal Official’s recommendation, the Administrator will make a final decision on the appeal. The Administrator will notify the member and/or designated representative in writing of the decision and an explanation of the reason(s) for the decision, as well as any actions taken by the WTC Health Program resulting from the decision.
5. Pursuant to 42 C.F.R. § 88.15(c), the WTC Program Administrator is permitted to reopen a final determination at any time and to affirm, vacate, or modify that determination in any manner he or she deems appropriate.

¹42 C.F.R. § 88.21(b).
²42 C.F.R. § 88.21(b)(2)(iii).

Appendices

Chapter 4—Medical Benefits

1.0 Administration of Medical Benefits and Services

1.1 Purpose and Scope

This chapter describes the medical benefits that are available through the World Trade Center (WTC) Health Program under the James Zadroga 9/11 Health and Compensation Act of 2010 (the Act), including: (1) the Program’s responsibilities regarding the provision of medical benefits and the roles of various parties; (2) the types of medical benefits and treatment provided; (3) communications regarding medical benefits; (4) appeals of treatment authorization decisions; (5) the process for requesting changes to medical treatment that is permitted under the WTC Health Program; and (6) unique considerations relative to certain permitted services.

1.2 Statutory and Regulatory References

The following Sections of the Act are applicable to this chapter:

1. Section 3311(b) of the Act authorizes monitoring benefits for WTC responders;
2. Section 3312(b)(1)(A)(ii) provides that the WTC Health Program shall pay for medically necessary treatment for certified WTC-related health conditions, assuming certain conditions are met;
3. Section 3312(b)(3)-(5) explains the requirement of medical necessity for treatment, the need to use rulemaking to specify a standard for determining medical necessity and for appealing such determinations, the scope of treatment, and the provision of treatment pending certification;
4. Section 3321(b) provides for initial health evaluations (screening) for screening-eligible WTC survivors; and
5. Section 3322 allows for follow-up monitoring and treatment of certified-eligible WTC survivors.

Program regulations relating to medical benefits are established in the following sections of 42 C.F.R. Part 88:

1. Section 88.11 regarding initial health evaluation for screening-eligible survivors;
2. Section 88.17 regarding physician’s determination of WTC-related health conditions;
3. Section 88.20 regarding authorization of treatment;
4. Section 88.21 regarding appeal of certification, decertification, or treatment authorization decision; and
5. Section 88.22 regarding reimbursement for medical treatment and services.

1.3 Roles and Responsibilities

The parties involved in providing WTC Health Program medical benefits and their roles are detailed below:

1. The Administrator of the WTC Health Program or Designee (e.g., WTC Health Program MBM) establishes medical and pharmaceutical policy for the WTC Health Program, certifies health conditions for treatment, establishes a process for members’ appeals of medical denials, designates a Federal Official independent of the WTC Health Program to review member appeals, issues final decisions on appeals regarding medical treatment, considers additions of health conditions to the List of WTC-Related Health Conditions (List), and conducts any necessary rulemaking. The Administrator of the WTC Health Program or Designee also authorizes requests for certain levels of prior authorization (PA), as discussed in Section 3.4, Prior Authorizations.
2. The Clinical Centers of Excellence (CCEs) and the Nationwide Provider Network (NPN) provide monitoring and initial health evaluations for eligible responders and survivors. The CCEs/NPN also provide treatment for certified WTC-related and medically associated health conditions, and make referrals for treatment to other medical experts (external network providers) that work with the CCEs/NPN as part of their WTC Health Program-affiliated provider networks. The CCEs/NPN provide medical services to WTC Health Program members including treatment, writing and approving prescriptions, and providing prior authorizations when necessary. The CCEs/NPN authorize medical treatment that is consistent with established treatment protocols and review claims for payment from external network providers to ensure adherence to coding requirements and WTC Health Program guidelines. The CCEs/NPN document decisions requiring prior authorization from their respective CCE/NPN Clinical Directors and submit information to the Program for services that require prior authorization from the WTC Health Program Medical Benefits Manager (MBM). For pharmacy benefits, the CCEs/NPN provide prior authorization or perform overrides for certain medications (see Chapter 14 for further details). Further information regarding CCE/NPN responsibilities, including provider enrollment, may be found in Chapter 6 of this manual.
3. The Health Program Support (HPS) Contractor is responsible for receiving and processing claims for medical benefits, enrolling providers in the WTC Health Program-affiliated provider networks, processing requests for prior authorization from the WTC Health Program MBM, providing technical assistance with any changes to medical benefits, providing expert research and recommendations to inform policy decisions, providing communication support regarding Program medical policy and appeals arising from denials of treatment due to medical necessity, ensuring that medical claims are processed in accordance with WTC Health Program policy, and, unless specific exemptions apply, standard American Medical Association (AMA) and Centers for Medicare and Medicaid Services (CMS) billing practices.

1.4 Scope of Treatment Services

The WTC Health Program provides medical treatment services for the conditions specified in the Act and 42 C.F.R. § 88.15, as well as any other condition added to the List through the rulemaking procedures specified by the Act.

Pursuant to Section 3312(b)(4) of the Act, the scope of treatment covered includes services of physicians and other health care providers, diagnostic and laboratory tests, prescription drugs, inpatient and outpatient hospital services, and other medically necessary treatment. Transportation expenses to secure medically necessary treatment through the NPN, involving travel of more than 250 miles, are also authorized under Section 3312(b)(4)(C).¹

1.5 Medically Necessary Treatment

Section 3312(b)(3)(A) requires physicians and other providers to provide medically necessary treatment that is in accordance with medical treatment protocols when providing treatment for a WTC-related health condition. Medical treatment protocols, also referred to as “medical guidelines,” are developed by the Data Centers (DCs) in accordance with accepted medical practice and recommendations from professional organizations, such as the American Medical Association, American College of Chest Physicians, and the like. The protocols are subsequently approved by the Administrator of the WTC Health Program or Designee for use with WTC Health Program members. Protocols are maintained by the DCs/CCEs as well as in NIOSH’s official file of record.

Section 3312(b)(3)(B) requires that the Administrator of the WTC Health Program issue regulations specifying a standard for determining medical necessity, a process for determining whether the standard is being met, and an appeals process for medical necessity determinations. ²

2.0 Approved Benefit Plans

The WTC Health Program uses benefit plans to determine the type of medical procedures or treatment a member is eligible to receive. “Benefit plans” are groupings developed by the WTC Health Program that define the acceptable ranges of care for specific categories of covered health conditions. The WTC Health Program offers multiple benefit plans, which are open to members based on their status as defined in the Act (e.g., Responder or Survivor) and their certified health condition(s). The WTC Health Program Codebook also lists approved medical procedures and treatment by benefit plan (For further information, see Section 3.2 WTC Health Program Codebooks).

The benefit plans include procedures for the initial health evaluation for survivors, annual medical monitoring for responders and certified-eligible survivors, diagnostic evaluation to enable a nonspecific symptom or abnormal finding to be properly diagnosed for the purpose of certification, and treatment benefit plans organized by the category of certified health condition(s).

2.1 Survivor Screening Benefit Plan (Initial Health Evaluations)

Section 3321(b)(1) of the Act provides for an initial health evaluation (screening) for screening-eligible WTC survivors. The purpose of the screening is to determine whether the member has a WTC-related health condition and is eligible for follow-up monitoring and treatment benefits under the WTC Health Program. Unlike annual monitoring exams, the screening is a one-time evaluation. However, the member may seek additional screenings at his or her own expense. ⁴

Upon enrollment in the WTC Health Program, survivors are classified as screening-eligible survivors without a certified health condition and are eligible for the Survivor Screening Benefit Plan. As screening-eligible survivors, they have access to all of the services in the Survivor Screening Benefit Plan and the services in the Cancer Screening Benefit Plan. The initial health evaluation for screening-eligible survivors is listed in the WTC Health Program Codebook, Volume B, under the Survivor Screening Benefit Plan. Use of codes included under the Survivor Screening Benefit Plan indicates to the claims processing system that a given procedure is part of the survivor’s initial health evaluation. The initial health evaluation includes all of the following elements, which have been implemented for the WTC Health Program responder and survivor populations based largely on USPSTF guidelines:

1. Initial Health Evaluation: Included at no cost to member once per lifetime. Includes completion of a set of detailed questionnaires evaluating 9/11 exposure, health complaints, and medical history, using age-appropriate codes.
2. Laboratory analyses of blood: Includes comprehensive metabolic panel or basic metabolic panel, lipid panel, and complete blood count when clinically indicated.⁵
3. Urinalysis: May be conducted when clinically indicated.
4. Spirometry/Chest Radiography: Includes spirometry with or without bronchodilation. Chest radiography may also be conducted when clinically indicated. Separate billings for technical and professional components may be submitted for these medical tests.
5. Electrocardiogram (EKG): May be performed once per year but only for members aged 40 years or older when clinically indicated.^{6, 7}

Once a health condition is certified, the screening-eligible survivor’s status changes to certified-eligible survivor and they are authorized to receive annual medical monitoring and medically necessary treatment to manage that condition following the medical protocols approved by the Program. ⁸ Under rare circumstances, a survivor may obtain certification prior to completion of the full initial health evaluation exam if specific requirements, including medical record documentation and other certification requirements are met.⁹ The member is still required to receive the appropriate initial health evaluation to identify other health conditions that may be a result of exposure.¹⁰

2.2 Monitoring Benefit Plan

Sections 3311(b) and 3321(b)(1) authorize monitoring benefits for enrolled WTC responders and certified-eligible survivors, respectively. These monitoring benefits consist of yearly medical examinations and long-term health monitoring and analysis. Monitoring benefits are provided through the CCEs, or the NPN for enrolled members who live outside of the New York metropolitan area.¹¹ The purpose of medical monitoring is to identify health concerns for early intervention, characterize the health of Program members over time, facilitate efforts for continuous quality improvement in the healthcare rendered by the Program, and inform emergency preparedness efforts for future disasters.¹²

Monitoring benefits for WTC responders and certified-eligible survivors are listed in the WTC Health Program Codebook, Volume B, under the Monitoring Benefit Plan. Use of procedure codes included under the Monitoring Benefit Plan indicates to the claims processing system that a given procedure is part of the standard monitoring exam. The monitoring exam includes the following elements, which have been implemented for the WTC Health Program responder and survivor populations based largely on USPSTF guidelines:

1. Initial monitoring examination: Included at no cost to member once per lifetime. Includes completion of a set of detailed questionnaires evaluating 9/11 exposure, health complaints, and medical history along with health education counseling by a registered nurse.
2. Follow-up monitoring examinations: Conducted once per year. The follow-up exam reassesses for health complaints and the intervening medical history occurring since the prior monitoring exam or initial health evaluation. Both the initial and follow-up examinations include items C-E below.
3. Laboratory analyses of blood: May be conducted once per year. Includes comprehensive metabolic panel or basic metabolic panel, complete blood count, and lipid panel.
4. Urinalysis: May be conducted once per year and/or when clinically indicated
5. Spirometry/Chest Radiography: Spirometry may be performed, once per year. Spirometry with bronchodilation is to be performed on the initial visit only unless the monitoring exam indicates otherwise. Chest radiography may be conducted when clinically indicated and/or once every two years. Separate billings for technical and professional components may be submitted for these medical tests.
6. Electrocardiogram (EKG): May be performed once per year but only for members aged 40 years or older when clinically indicated.^13,14

2.3 Diagnostics Benefit Plan

All members are eligible for the Diagnostics Benefit Plan, including members who have a certified health condition(s) and members who do not have a certified health condition(s). Screening-eligible survivors who do not have a certified health condition(s) have access to the Diagnostics Benefit Plan only during the initial health evaluation period. Codes in this benefit plan should be used when evaluating a member’s symptoms to determine whether a member has a WTC-related health condition, including both cancer and non-cancer conditions. Mental health conditions under the Diagnostics Benefit Plan are also available to FDNY family members.

All diagnostic claims should be coded using an approved ICD-10 code in the Diagnostics Benefit Plan. Following certification of the WTC-related health condition (as appropriate), the ICD-10 codes available for that condition can be used as part of the Treatment Benefit Plan.

2.4 Treatment Benefit Plan

Under the Treatment Benefit Plan, the WTC Health Program provides coverage for medical diagnoses and procedures related to a member’s certified WTC-related health condition, or health condition medically associated with a certified WTC-related health condition. The Treatment Benefit Plan should be used for all non-cancer certifications, while the Cancer Treatment Benefit Plan should be used for all cancer certifications. FDNY family members are eligible for treatment of mental health conditions under the Treatment Benefit Plan.

For responders and certified-eligible survivors, providers may use any of the procedure codes located in the Treatment Benefit Plan, as long as the codes correspond with the condition-specific Care Suite. Care Suites are used in the Treatment Benefit Plan to further group medical diagnosis codes (ICD-10) into specific treatment categories. When a member is certified for a WTC-related health condition, the member is assigned to a Care Suite that correlates with their certified health condition(s). The medical services associated with each covered condition arise from standard coding references, including the American Medical Association’s (AMA’s) Current Procedural Terminology (CPT®) codes, and the Centers for Medicare and Medicaid Services’ (CMS’) Healthcare Common Procedural Coding System (HCPCS) Level II codes.

The table below provides an example of ICD-10 diagnosis codes that are in the Gastroesophageal Reflux Disorder (GERD) Care Suite. Certification of any of the following WTC-related ICD-10 diagnosis codes opens up the GERD Care Suite, so that the member has access to all the medical services within the GERD Care Suite.

Chapter 5—Claims Processing and Billing

1. Purpose and Scope

This Chapter provides a high level overview of the process for submitting and processing claims for medical benefits under the WTC Health Program. This process is managed by the Health Program Support (HPS) contractor. A more complete description of the claims processing function is found in the WTC Health Program Claims Processing Procedure Manual, found in the WTC Health Program file of record.

2. Statutory and Regulatory References

The sections of the Public Health Service (PHS) Act applicable to this Chapter include Section 3312(c), Payment for Initial Health Evaluation, Monitoring, and Treatment of WTC-Related Health Conditions, and Section 3331, Payment of Claims. The sections of the WTC Health Program regulations applicable to this Chapter include 42 C.F.R. §§ 88.20, 88.22, 88.23.

3. Responsibilities

The parties involved in developing, submitting, processing, and paying claims are described below.

1. The Clinical Centers of Excellence (CCEs) and Nationwide Provider Network (NPN) develop and submit claims for medical benefits to the WTC Health Program HPS contractor and ensure that they are submitted in accordance with established requirements and guidelines, described further in Chapter 4. The CCEs/NPN provide and make referrals to affiliated external medical providers to provide treatment, monitoring, and screening services. They authorize medical treatment, monitoring, and screening services. Additionally, they provide information to the HPS contractor to enable it to enroll external medical providers in the WTC Health Program, and validate the professional qualifications of those providers. Some of the CCE/NPN functions may be performed by a third party administrator (TPA), if engaged by the CCEs/NPN.
2. The HPS contractor receives and processes claims for medical benefits, resolves claims that pend due to system edits (for example, when a claim requires review by the Medical Benefits Manager (MBM) or requires follow up for missing information), prices claims, generates the data used to make payments to medical providers, submits a weekly payment file to the payment contractor using a standard format, and maintains the provider file for the WTC Health Program. The HPS contractor works with the submitting CCE/NPN, when necessary, to resolve any issues preventing successful processing of the claim and works with the payment contractor to resolve any issues identified with the payment file. The HPS contractor also creates and provides special reports regarding claims outcomes to the CCEs/NPN, and notifies the CCEs/NPN of any issues encountered by the payment contractor that might impact payments.
3. The Centers for Medicare & Medicaid Services (CMS) payment contractor receives the payment file from the HPS contractor and issues payments via Electronic File Transfer (EFT) to providers. The payment contractor also issues Remittance Advices (RAs), documents that provide notice of and reasons for payment, adjustment, denial and/or uncovered charges of a claim, to the medical providers. The payment contractor then communicates payment information back to the HPS contractor, notifying the HPS contractor if there are any problems with the payment data. To ensure compliance with requirements in the Zadroga Act (Section 3306(14)(B)), the payment contractor is engaged via an inter-agency agreement with CMS.
4. The MBM reviews and takes actions on medical claims appeals and is in the process of establishing a more formal process for appeals of reimbursement denials (see section 13 of this chapter).
5. The electronic data interchange (EDI) clearing house provides a mechanism for medical claims to be transmitted electronically between CCEs/NPN and the HPS contractor.
6. The pharmacy benefits manager (PBM) receives claims from the pharmacies, applies adjudication rules according to standards developed by the WTC Health Program, and compiles and communicates payment and denial data.

4. Overview

The Program uses Plexis Healthcare System’s Quantum Choice claims processing software to manage enrollee and provider information and to process claims. The claims processing function is scaled to the relatively small size of the WTC Health Program and is designed to quickly, efficiently, and accurately process claims submitted for payment, in accordance with the provisions of the Act.

1. The various functions in the payment process are separated both physically and functionally, in accordance with industry best practices. The HPS contractor maintains separation of functions by having different teams for mail handling and imaging, enrollment, eligibility, claims processing, provider enrollment, and auditing. In this way, the risk of fraud is minimized, since no one individual/team can both submit and approve or pay a claim.
2. Medical monitoring and treatment claims are submitted to the HPS contractor either by or through the CCEs/NPN or subcontractors, such as a TPA, working on behalf of the CCEs/NPN.
3. Claims are submitted in a variety of ways, depending on the CCEs’ preferences and technical infrastructure. They are accepted when submitted using one of the following methods: (1) on paper using the appropriate forms (i.e., CMS-1500 or UB-04); (2) on spreadsheets that have been structured to capture the data required by the CMS-1500 or UB-04 form; or (3) electronically through EDI.
4. The CMS-1500 form (seen in Appendix 5-A) is used by outpatient healthcare professionals and suppliers and the UB-04 (seen in Appendix 5-B) is used by healthcare institutions (such as hospitals, rehabilitation centers, and skilled nursing facilities). Both are standard forms developed by CMS and used regularly in other federal programs such as Medicare. The WTC Provider Manual provides guidance on how the forms are to be completed for claims under the Program.
5. Paper claims are first created or, in the case of claims coming from affiliated external providers, reviewed by the CCEs/NPN, then approved for submission. The CCEs/NPN indicate their authorization of a claim by affixing a special authorization stamp or by attaching a notice of authorization. The claims are then mailed or faxed to the HPS contactor, which scans the paper claim and uploads the images to a secure server so that the claims processing staff can access and enter the data into the claims processing system.
6. Claims submitted using structured spreadsheets are sent directly to the claims processing team by the CCE/NPN, along with its authorization, using a secure server. The claims processing team is notified of the transmission by the data management team, and processes the data in the same manner as paper claims.
7. EDI claims are sent to the HPS contractor electronically using the 837 5010 American National Standards Institute (ANSI) standard format, and are uploaded into the claims processing system. When a CCE submits EDI claims using the approved process, it acknowledges that the claims are authorized to be paid. EDI claims received from external providers are pended, and a report is forwarded to the providers’ associated CCE/NPN to obtain their authorization so that the claims can be processed.
8. All claims are processed by the HPS contractor using the system configurations and processes developed for use by the Program. Data from the enrollment and certification processes are used along with other industry-standard and WTC Health Program-specific parameters to determine whether the claim is payable. Certain types of claims, such as inpatient care, emergency room visits, and cancer treatment, are reviewed by the MBM for approval before they are paid. Claims may also pend for review for other reasons, such as when additional information is needed to complete the claim. Payable claims are priced according to the fee schedule, described in section 8 below. Additional information concerning the claims process may be found in the WTC Health Program Claims Operations Manual, located in the WTC Health Program file of record.
9. The HPS contractor compiles data from the claims processing system for both approved and denied claims, which are transmitted to the payment contractor on a weekly basis. Payments to providers are issued weekly via EFT. The payment contractor also issues the RAs for claims. Section 10 below provides more detail.
10. Pharmacy claims are submitted electronically by the pharmacies to the PBM and are then sent to the HPS contractor weekly for further processing. After the HPS contractor forwards a payment file to the payment contractor, the payment contractor issues payments to the PBM, which then forwards the payments to the pharmacies.
11. Payment reconciliation, payment adjustments, and audits are performed by the HPS contractor, as further described in section 10 below.

5. EDI Claims

Approximately 90 percent of all claims are submitted to the HPS contractor via EDI using the 837 5010 ANSI standard format. The Program encourages use of EDI as it improves the efficiency and effectiveness of claims processing, reduces the potential for error, and speeds transaction times. CCEs/NPN, their TPAs, and approved external providers submit claims to the EDI clearing house using the 837 format. The clearing house then delivers the claims to the HPS contractor for claims processing.

6. Pharmacy

Prescriptions covered under the Program are issued in accordance with the WTC Health Program-approved pharmaceutical guidelines and the Program’s formulary. The formulary and guidelines are aligned with the Program’s pharmacy benefit plans, which are described in WTC Health Program Bulletin No. 13-2, “Implementing Pharmacy Benefit Plans by Health Condition Certification Status.” These plans, implemented to improve programmatic oversight and minimize fraud, waste and abuse, are documented in the WTC Health Program file of record.

1. Prescription drugs are approved at the point of sale (POS). Members provide their WTC Health Program coverage information to the pharmacy, which validates their enrollment through the PBM. The PBM also checks to ensure that the prescribing provider is authorized to prescribe under the Program and that the prescribed drug is covered under the WTC Health Program formulary. After filling the prescription, the pharmacy submits claims electronically to the PBM. Pharmacy claims data are accumulated on a weekly basis and transmitted by the PBM to the HPS contractor which processes the claims and sends them to the payment contractor. The payment contractor pays the PBM, which then issues payments to the pharmacies.
2. If the prescription is rejected at the POS, the rejection may be overridden, when necessary, by the CCEs/NPN or by the HPS contractor’s pharmacy team after consultation with the CCE/NPN. CCEs/NPN have access to an online program offered by the PBM which allows online adjudication of pharmacy transactions. Inquiries regarding rejected prescriptions are received via the Program’s Call Center, which either resolves the reason for the rejection (e.g., the pharmacy has an incorrect enrollee number) or routes the issue to the HPS’ Member Services team for resolution.
3. The WTC Health Program’s pharmacy network is open, and any pharmacy may submit a claim to the WTC Health Program.
4. The physicians who are permitted to prescribe under the WTC Health Program are limited to those providers who have been authorized by the CCEs. Weekly updates of permitted prescribers are sent by the CCEs to the PBM, which shares this information with the HPS contractor. If a provider is permitted to prescribe medications under the WTC Health Program, the provider’s prescriber status is recorded in the claims processing system’s Provider Module.
5. Prescription drugs may also be provided through mail-order. Mail-order is encouraged, when feasible, as it adds efficiency to the Program. The member must register and can do soat the mail-order provider’s Website online, via telephone, or through the CCE/NPN. Once the member is registered, the prescribing physician can e-prescribe, fax, or mail the prescription to the mail-order provider. Mail-order is generally used for maintenance medications only, and they are provided in a 90-day supply. Once a prescription is filled through the mail-order service, the member receives a form for refill. Refills may also be obtained online or by phone, and members may elect to auto-refill. To ensure accuracy and prevent fraud, prescribers cannot call in an initial mail-order prescription.
6. In response to concerns about significant barriers to care for members with systemic cancers that are likely to receive their care through extended care networks (affiliated with but separate from the CCE/NPN), the WTC Health Program broadly expanded the therapeutic classes available in the Cancer Treatment Pharmacy Plan, opened the prescriber network, and removed prior authorization restrictions. To assist in the alignment of certification activities justifying drug coverage or member counseling about the pharmacy benefit, the CCEs and the NPN conduct weekly retrospective drug utilization reviews for these members as part of their quality assurance activities.
7. Pharmacy claims must be submitted within 180 days of the fill date. Older claims must have prior authorization, in order to help prevent untimely filing of claims.
8. Prescription medications are available according to the pharmacy benefit plan to which the member is assigned. Medications that are covered under the WTC Health Program are listed in the formulary (Part C of the WTC Health Program Codebook).

7. Fee Schedule

1. The Zadroga Act requires that the payment rate for an initial health evaluation, medical monitoring, and/or medically necessary treatment or services for a WTC-related or medically associated health condition be in accordance with the rates paid under the Federal Employees’ Compensation Act (FECA), administered by the U.S. Department of Labor (DOL). Pursuant to 42 C.F.R. § 88.22(b), treatment for which FECA rates have not been established will be reimbursed at the applicable Medicare fee for service rate, as determined appropriate by the Administrator. Treatment for which neither FECA nor Medicare fee for service rates have been established will be reimbursed at rates determined appropriate by the Administrator. More information about FECA, including the methodologies used to calculate FECA rates, can be found at https://www.dol.gov/agencies/owcp/regs/feeschedule/fee . Maximum payments under the WTC Health Program are the lesser of the calculated fee schedule amount or the billed amount.
2. The WTC Health Program also follows DOL’s medical fee schedule used by the FECA program for covering inpatient hospital services. These services are subject to a reimbursement schedule based on the Medicare Inpatient Prospective Payment System (IPPS). That system assigns services to Diagnosis-Related Groups (DRGs) and adjusts rates for individual hospitals according to their specific cost index. Inpatient services not covered under the Medicare IPPS are reimbursed under a formula that is based on the cost-to-charge ratio (CCR) data tables published by CMS for rural and urban hospitals in each state. The full explanation of how fees are calculated under FECA may be found at: https://www.dol.gov/owcp/regs/feeschedule/fee/fee12/READ_ME_FIRST_fs12_instructions.htm .

8. Billing

As noted in the Overview above and in Chapter 4, Medical Benefits, billing for covered services under the program is consistent with industry best practices and uses standard procedures and forms. The categories of health conditions are defined by ICD-10 diagnosis codes. The medical services associated with each covered condition/diagnosis code are defined by Current Procedural Terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), DRG, and Revenue Coding Center (RCC) codes. These codes, documented appropriately on standard CMS-1500, UB-04, and EDI claims, are the basis by which member claims are paid. The codes acceptable for submission of claims for healthcare services for covered conditions under the Program have been defined and are documented in the Codebook, found in the WTC Health Program file of record.

9. Unlisted and Miscellaneous Procedure Codes

Special circumstances apply when considering the use of a procedure or service code that is not currently listed in the Codebook.

1. Unlisted codes are CPT or HCPCS codes that are not associated with a specific procedure or service. Miscellaneous codes are used for procedures, devices or supplies, and services that have not been assigned a unique CPT code. Because both of these types of codes are not usually associated with a single service, they are typically not priced and reimbursement must be determined on a case-by-case basis. Providers should only use these codes when a more specific code is not available. The unlisted codes provide the means of reporting and tracking services and procedures until a more specific code is established, and are not typically used for reimbursement purposes. When these codes are used, they should be accompanied by documentation to support medical necessity. The MBM will determine on a case-by-case basis whether a particular code will be covered and, if covered, the Program price the code depending on the procedure or service performed.
2. If a CCE/NPN requests that an unlisted code or miscellaneous code be added to the WTC Health Program Codebook through the medical change request process, the Program’s Medical Benefits Team will determine if there is a more appropriate procedure or service code available that closely approximates the service or procedures needed to be performed.
3. Since unlisted codes and miscellaneous codes lack definition, they will be reviewed by the WTC Health Program for proper code use. All unlisted and miscellaneous codes require supporting documentation, which must be submitted with the claim to facilitate review as to code use justification. If use of the code is justified, the claim will be approved, and a reimbursement amount will be calculated. In the course of the medical review process, the WTC Health Program may ask for additional documentation.
4. When submitting supporting documentation, the medical provider or CCE/NPN should underline or highlight the portion of the note or report that identifies the test or procedure associated with the unlisted or miscellaneous procedure code. Required information must be legible and clearly marked. Documentation must clearly describe a condition and the medical need for the procedure or service. It should also include an explanation of the following:
   1. Whether the service was performed alone or in conjunction with other services;
   2. Whether the procedure was performed at the same surgical site or through the same surgical opening as another procedure;
   3. Any extenuating circumstances which may have complicated the service or procedure;
   4. The time, effort, and equipment necessary to provide the service;
   5. The number of times the service was provided; and
   6. Evidence of cost or charges expected for the procedure.
5. No fee schedule amount has been established for unlisted and miscellaneous codes, and they are carried in the system as having a zero dollar amount. If use of the code is approved, the amount payable for the service will be determined on a case-by-case basis, using the documentation provided by the submitter. Therefore, it is important for the submitter to provide enough detail on the cost and charges for the unlisted or miscellaneous procedure so that the Program is able to arrive at a reasonable decision regarding the reimbursable amount.
6. No additional reimbursement is provided for special techniques/equipment submitted with an approved unlisted procedure code.
7. Unlisted CPT-4 procedure codes should not be billed with a modifier or they will be denied. However, unlisted codes for DME, orthotics, and prosthetics require appropriate NU (for new equipment), RR (for rental equipment) or MS (for maintenance and servicing) modifiers.
8. When performing two or more procedures that require the use of the same unlisted CPT code, the unlisted code should only be reported once to identify the services provided (excludes unlisted HCPCS codes—for example, DME/unlisted drugs). If the procedures or services are the same, then the code would be listed once and the units used to describe how many times the service or procedure was performed or rendered. If the procedures or services are different, but require the use of the same unlisted code, then the additional instance of the code must be billed in a separate claim.
9. If claims with unlisted or miscellaneous procedure codes are submitted without supporting documentation, a reasonable attempt will be made by the Program to obtain supporting documentation. If no documentation is forthcoming, or documentation is insufficient, the claim will be denied.
10. The Program will not routinely accept retrospectively amended medical records or physician queries beyond 60 days from the service date. The Program determines the extent of medical documentation required to support use of the code as a basis for coverage or reimbursement upon review or physician query.
11. Clinical documentation or physician queries amended over 60 days from the service will not be accepted to defend reimbursement, increase reimbursement, or consider a previously denied claim. If there are extenuating circumstances, the CCE/NPN must contact the Program to present their circumstances, and the Program will consider each situation on a case by case basis.
12. The following chart shows the type of documentation required for different codes (in addition to the list found in item d above):
    
    

    Procedure Code	Documentation
    10021–69990: Surgical Procedures	Operative or Procedure Report
    70010–79999: Radiology/Imaging Procedures	Imaging Report
    80048–89356: Laboratory & Pathology Procedures	Laboratory or Pathology Report
    90281–99602: Medical Procedures	Office Notes and Report
    Unlisted DME HCPCS Codes: Equipment/Supply	Provide Narrative on the Claim

10. Payments and Remittance Advice

On a weekly basis, claim lines are gathered into a claim payment run (or file) which is transmitted to the payment contractor. The process is outlined in the below graphic.

Claims data are entered into the claims processing system.

Claims are adjudicated to determine net pay amounts.

Claim lines are pulled into Claim Payment Runs to be transferred to accounting.

The Transfer to Accounting Process (TAP) pulls in Claim Payment Runs and creates an AP Accounting Transaction for each amount. Accounts are assigned to transactions based on the user-defined account assignments.

All available transactions created by TAP are bundled into payments ready to be paid. Manual payments and transactions may also be created.

1. The HPS contractor forwards two files to the payment contractor—a file that generates payments and a file to generate RAs.
2. The payment contractor runs the data through a series of edits to ensure 1) format compliance and 2) correct calculations for payments. It also conducts a “pre-note” process, in which it sends a $0 payment to each provider’s bank account to verify all banking information. If any errors are found, the payment contractor notifies the HPS contractor so that their Member Services team can be engaged to correct the information.
3. The payment contractor then processes the data through established channels at CMS to send a payment file to the Treasury Department, which issues EFT payments to the providers. The payment contractor issues RAs detailing the claims processing outcomes to providers in either an electronic or paper format, or both, depending on the provider’s preference.
4. The payment contractor sends a confirmation file back to the HPS contractor after each week’s payment run which documents what was paid and whether any payments were rejected. The HPS contractor then updates the claims processing software with this data so that the status of all claims can be tracked.
5. Payments for pharmaceuticals are sent to the PBM, which forwards them to the dispensing pharmacies.

11. Payment Reporting

Using MicroStrategy’s business intelligence reporting tool, Microstrategy 9, and Quantum Choice, a variety of reports are generated to provide the WTC Health Program insight into the claims and payments processed, and to ensure quality assurance of the claims processing function.

1. Claims and payment reports for the WTC Health Program’s and providers’ use include a breakdown of medical claims, claim metrics report, medical claim dollars, denied/returned claims, and so forth.
2. Reports for use by the HPS contractor to ensure quality assurance and allow resolution of unique claims include reports of pended claims by age and institutional claims with National Correct Coding Initiative (NCCI) edits.
3. In addition to standardized reports, ad hoc reports may be generated, as necessary, to provide the Program with detailed insight into the characteristics of Program enrollees, providers, and claims.

12. Payment Reconciliation and Auditing

Accurate payments and timely payment corrections, when necessary, are important to maintain the integrity of the WTC Health Program. The Program has an established process to ensure payments are accurate.

1. The HPS contractor reconciles payment data with the payment contractor on a monthly basis to ensure accuracy and alignment of records.
2. If a discrepancy or imbalance is found, the HPS contractor researches and resolves the issue.
3. Over payments are recovered by withholding from future payments. Checks and cash are not to be sent to the HPS contractor to correct over payments.
4. Under payments are rectified by payment adjustments, i.e., making an additional payment.
5. Processed claims are regularly audited to ensure accuracy of payments under the Program. Prior to the implementation of auto-adjudication, 100 percent of processed claims were audited for accuracy. With the implementation of auto-adjudication in September 2012, audits are performed on 2 percent of the claims that are not auto-adjudicated, and focuses on both ensuring processors are resolving edits correctly and on keying accuracy, in accordance with industry standards. Processes for measuring the quality of auto-adjudicated claims and post-payment utilization review are currently in development.

13. Appeal of Reimbursement Denial

After exhausting procedural and/or contractual administrative remedies, a CCE or NPN Clinical Director or affiliated provider may submit a written appeal of a WTC Health Program decision to withhold reimbursement or payment for treatment found to be not medically necessary or not in accordance with approved Program medical treatment protocols. Appeal procedures will be published on the WTC Health Program website.

Appendices

Policy and Procedures for Coordination of Benefits for Treatment Costs for Non-Work-Related, Certified WTC-Related Health Conditions: Coordination with Health Insurance

Policy and Procedures for Recoupment: Lump-Sum Workers' Compensation Settlements

Policy and Procedures for Recoupment & Coordination of Benefits: Workers’ Compensation Payment

Chapter 6—CCEs and Providers

1. Purpose and Scope

The purpose of this chapter is to provide a high-level overview of the Clinical Centers of Excellence's (CCEs') roles, responsibilities and processes for the WTC Health Program. In addition to this procedure manual, further details regarding CCE operations can be referenced in the CCE Clinical Guide and the CCE Operations Manual developed by each CCE, both found in the Program's file of record. Of note, the Nationwide Provider Network (NPN) is discussed separately in Chapter 7 of this manual.

2. Statutory and Regulatory References

This chapter is guided by Sections 3305(a)(1) and 3305(b)(1) of the PHS Act, which describe requirements for the contracts put in place with the CCEs, as well as various sections of 42 C.F.R. Part 88. In addition, the CCEs play a pivotal role in implementing the general provisions of the Act, as described below.

3. Roles and Responsibilities

The roles and responsibilities associated with the CCEs and providers in the WTC Health Program are detailed below.

1. CCEs are the NY metropolitan area-based medical facilities that, in accordance with the Act, operate under individual contractual relationships with NIOSH to provide medical monitoring examinations, diagnosis, and treatment services for eligible persons in the NY metropolitan area. Members are each assigned a CCE which is responsible for coordinating their care under the WTC Health Program. CCE responsibilities include, but are not limited to:
   1. Using an integrated, centralized health care provider approach to create a comprehensive suite of health services that are accessible to enrolled WTC responders, screening-eligible survivors, or certified-eligible survivors;
   2. Having experience in caring for WTC responders and screening-eligible survivors, or includes health care providers who have received WTC Health Program training
   3. Employing health care provider staff with expertise that includes, at a minimum, occupational medicine, environmental medicine, trauma-related psychiatry and psychology, and social services counseling; and
   4. Meeting such other requirements as specified by the Administrator of the WTC Health Program. For example, each CCE must:
      • Manage a provider network to ensure members have access to the necessary expertise required to treat their certified covered conditions;
      • Submit periodic reports to the Program regarding its compliance with WTC Health Program regulations, guidelines, and contract requirements; and
      • Coordinate with the WTC Health Program Data Centers (DCs) in collecting and analyzing programmatic data.
2. With regard to the CCEs, the Program has the responsibility to certify conditions submitted by the CCEs, informing members of the acceptance or denial of coverage and ensuring WTC Health Program claims submitted by the CCEs and their external providers are paid. The Program also communicates regularly with the CCEs to clarify, modify, or establish WTC Health Program policies and procedures, and is responsible for oversight of CCE operations to determine if the CCEs are operating within the WTC Health Program regulations, guidelines, and contract requirements.
3. The Health Program Support (HPS) Contractor, under the direction of the WTC Health Program leadership, provides the information technology and program management support that are essential to WTC Health Program CCE operations. The HPS contractor processes claims submitted by the CCEs and their associated providers, coordinates member enrollment and eligibility, supports the authorization of CCE providers, provides call center support, and coordinates with CCEs to provide requested reports and data analysis.

4. CCE Experience and Personnel

The WTC Health Program CCEs offer unique expertise in the provision of healthcare services to NY metropolitan area-based members. Currently, there are seven CCEs that provide WTC Health Program services:

• Five CCEs serving general responders:

  • Northwell Health (Northwell)
  • Mount Sinai School of Medicine (MSSM)
  • New York University School of Medicine (NYU)
  • State University of New York, Stony Brook (SUNY)
  • Rutgers University (RU)
• One CCE devoted specifically to Fire Department of New York (FDNY) Responders (FDNY)
• One CCE devoted specifically to survivors of the WTC attacks in NYC – NYC Health + Hospitals System (H+H) WTC Environmental Health Center

1. CCE Experience
   Each CCE is experienced in providing healthcare services of a type similar or greater in scope, size, and complexity to those required under the WTC Health Program. Relevant experience includes providing initial and medical monitoring evaluations, diagnostic and treatment services, member services, and administrative services. The current CCEs demonstrated this experience through participation in the predecessor programs described in the “History of the WTC Health Program” section of Chapter 1.
2. Personnel
   Each CCE must provide personnel necessary to accomplish all activities within the scope of the CCE contract (e.g., physicians, nurses, and support staff), including healthcare provider staff with expertise that includes, at a minimum, occupational medicine, environmental medicine, trauma-related psychiatry and psychology, and social services and benefits counseling.
   Each CCE employs a Clinic Director and a Clinic Administrator to oversee medical and administrative aspects of the CCE’s participation in the WTC Health Program. The Clinic Administrator is responsible for all operational aspects of the WTC Health Program at the CCE.

5. CCE Operations Overview

Each CCE operates under contract with the federal government to administer healthcare (within the limited care model defined by Title XXXIII of the PHS Act) to the responders or survivors of the September 11, 2001, terrorist attacks. (The NPN, discussed in Chapter 8, provides care for enrolled members residing outside the NY metropolitan area, including responders to the plane crashes in Shanksville, PA, and Arlington, VA – the site of the Pentagon.) Each CCE is responsible for all aspects of WTC Health Program-related care for each member they serve. In addition to services provided directly by the CCEs, services are also provided through the CCEs by external providers who have expertise in the diagnosis and treatment of 9/11-related health conditions and have been approved by the CCEs and the Program to provide WTC Health Program benefits. Section 6 below provides more detail regarding external providers.

Each CCE educates its staff and network providers in WTC Health Program policies and procedures such as the proper completion of paperwork, limitations of coverage, protocol changes, and benefits counseling, and maintaining a complete Operations Manual to document them. CCE representatives participate in periodic meetings with the Program leadership, their associated data center, the HPS contractor, and other vendors, as required, to coordinate activities, address and resolve issues, and share information.

The work performed by CCEs is grouped into the following four categories and is discussed in detail, below:

• Monitoring and Initial Health Evaluations
• Treatment Services
• Member Services
• Administrative Services

As provided by the PHS Act, the WTC Health Program reimburses providers for healthcare expenses for health conditions that have been certified by the Administrator of the WTC Health Program as WTC-related or as medically associated to a certified WTC-related health condition. Health condition certification is required for treatment services to be paid by the Program. The certification of a WTC-related or medically associated condition is based on a review of a CCE physician’s clinical assessment of the relationship between a given Program member’s WTC exposure and the type and temporal sequence of symptoms, or diagnosis, of a qualifying health condition. This review must find that the member’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks is substantially likely to be a significant factor in aggravating, contributing to, or causing the health condition.

A list of the ICD-10 diagnosis codes that correlate with the List of WTC-Related Health Conditions and medically associated health conditions covered by the Program is found in the WTC Health Program Codebook. CCEs provide guidance to external providers on allowable benefits, including proper use of the WTC Health Program Codebook if disseminated.

A member’s health benefit profile is comprised of all Care Suites and certification gates that reflect the conditions that have been certified for that member (Care Suites are discussed in section 9 of Chapter 3 of this manual). The member benefit profile continues to be updated to reflect any new conditions that are certified over time. The claims processing system verifies that each health care service claim line maps a medical procedure to a diagnosis contained within the Care Suites and certification gates comprising a member’s benefit profile.

A.   Monitoring and Initial Health Evaluations
Each CCE schedules and provides a baseline exam for new enrollees and follow-up monitoring examinations to WTC responder and certified-eligible survivor members as applicable. The purpose of the monitoring exams is to: (1) provide periodic physical and mental health assessment designed to identify acute and latent health effects that are WTC-related; (2) serve as an avenue for clinical data collection, analysis and reporting to ensure that all services provided adhere to the appropriate protocols; and (3) inform the diagnosis of WTC-related diseases that could lead to a referral for treatment. The table below describes the extent of these exams.

If a test result indicates the presence of a WTC-related condition, or is inconclusive, the monitoring physician will refer the member for additional diagnostic testing and/or treatment.

1. Monitoring Exam Process and Protocols
   
   Monitoring services performed by the CCE must addhere to the following processes
   and protocols:
   
   
   • The CCE must use a form such as a Medical History Questionnaire (MHQ), which comprises standardized assessment instruments for multiple physical and mental health conditions.
   • The MHQ must be administered by a Registered Nurse (RN) who has received training in the proper completion of the MHQ.
   • To ensure quality assurance, all spirometry results are reviewed by appropriate CCE/NPN staff to determine if they meet quality criteria.
   • When all exam inventories and tests are completed, the RN prepares a summary report for the monitoring physician. The summary report contains information from the MHQ and results from the laboratory tests, chest X-ray, and spirometry, as well as a summary of the member’s past medical records on file at the CCE.
   • The monitoring physician reviews the summary report, conducts a clinical interview and a physical examination, and synthesizes the clinical information for discussion of findings and any needed treatment referrals with the program member. The clinical interview must be conducted by a qualified physician, preferably one specializing in occupational medicine.
2. Medical Monitoring Evaluation Process
   
   

   The CCE medical monitoring evaluation process consists of the following tasks:

   • Scheduling the exam for the member with a provider in the CCE.
   • Summarizing prior medical records (including prior claims information) and ensuring that the medical monitoring exam physician has a copy of the summary report prior to the scheduled physical exam appointment.
   • Conducting the Medical History Questionnaire interview using RNs.
   • Performing the required lab work, chest radiograph, and spirometry test.
   • Ensuring that the medical monitoring physician has a summary of the Medical History Questionnaire interview, a summary of the prior treatment records, if available, and the prior medical monitoring exam records in time for the scheduled physical exam.
   • Issuing a letter which reports the results of the medical monitoring examination to the member.
   • The CCE is required to ensure that medical monitoring examinations are coded correctly, using appropriate formats as described in Chapter 5, and that claims are submitted promptly to the HPS contractor for claims processing.
   • The monitoring exam provider coordinates with the CCE Clinic Director to obtain additional testing or subspecialty evaluation, when necessary, for further diagnosis of suspected WTC-related conditions.
   • If a physician determines that a member has a WTC-related health condition, the CCE completes the WTC-3 package and submits it to the WTC Health Program MBM for certification, following the procedure outlined in Chapter 3.
   • The CCE must follow appropriate authorization channels for treatment services and prescriptions issued under the program, as described in Chapter 4, as well as for coordinating referrals for treatment of covered conditions.
   • Each CCE must explain to the members it serves what monitoring and treatment benefits are provided under the WTC Health Program, and that no treatment benefits are provided under the Program for non-covered conditions.
   • CCEs provide social services to its members that are applicable to their coverage under the Program. For example, the CCE may offer case management services or assistance with locating community support for members who need it.
   • In order to ensure quality assurance, CCEs conduct regular checks on their implementation of the medical monitoring process, as well as the appropriateness and completeness of the medical records maintained by the CCE, and the Program conducts quarterly audits
   • CCEs prepare and submit claims for processing and payment to the PM&A contractor after reviewing and approving each for accuracy.
   • Working with its associated DC, each CCE reviews and transmits treatment data to the DC for use in WTC Health Program-related research.
   • The CCE must develop protocols or procedures for the following medical monitoring exam-related issues, working in conjunction with their respective DC. These protocols or procedures are approved by the Administrator of the WTC Health Program or designee and communicated by the CCE to its staff, as appropriate. The protocols and procedures include:
     • Obtaining relevant CCE medical records for individuals previously served by another CCE
     • Quality assurance protocols which are built upon accepted practice guidelines
     • Scheduling medical monitoring exams
     • Determining the methodology by which monitoring examination services are delivered
     • Ensuring that proper data from the exams are sent to the DC for research and analysis purposes
     • Ensuring that a letter is sent to the member informing him or her of the exam results within two weeks of the completion of the monitoring exam
     • Preparing and submitting claims for all medical monitoring exam-related services
     • Collecting and maintaining all records required for project management and reporting
     • Handling emergency situations or managing crises that may arise during monitoring, treatment, case management, or other member interaction
3. Diagnosis
   
   1. Non WTC-Related Health Condition. If the medical monitoring exam does not lead to the diagnosis of a WTC-related covered health condition, or if no treatment is required, the member will be scheduled for the next medical monitoring exam in 12 months.
   2. WTC-Related Health Condition. If the medical monitoring exam reveals a health condition that is on the List of WTC-Related Health Conditions and the physician determines it relates to exposure from the September 11, 2001, terrorist attacks, the CCE prepares a WTC-3 certification package as described in Chapter 3, and promptly transmits it to the Program for certification of the member’s health condition.
4. Additional Medical Testing Required
   
   In order to ensure adherence to monitoring protocols, the CCE Clinic Director must approve any additional medical testing proposed by the examining physician to confirm a diagnosis of a WTC-related health condition. Once the CCE Clinic Director’s authorization has been obtained, CCE staff assists the member in scheduling appointments to obtain the additional medical testing.
   
5. Records, Member Notification and Claims
   
   
   1. Records. After a medical monitoring exam has been completed, the CCE ensures that all completed medical monitoring records are maintained by the CCE in accordance with best-practice medical records storage and privacy standards.
   2. Member Notifications. The CCE provides a letter to each member informing him or her of the results of the medical monitoring exam within 2 weeks of the completion of the exam.
   3. Claims. In accordance with the processes described in Chapter 5, the CCE submits a claim for the monitoring exam and services to the HPS contractor for claims processing, using the codes identified in the WTC Health Program Codebook for monitoring.
   
   
6. Treatment Services
   
   Once a member has been diagnosed with a WTC-related health condition and that condition is certified by the Program, the member is eligible to receive treatment for that condition when treatment is indicated. Diagnostic and treatment services for members are delivered through an assigned provider at the member’s CCE or its referral network of authorized external providers.
   
   1. Treatment Covered By Codebook. Treatment is provided in accordance with the procedures and services authorized for the care of each certified condition, as established in the WTC Health Program Codebook. Care must meet the medically necessary criteria of the WTC Health Program, guided by the Program’s treatment protocols and outlined in multiple source documents, including the WTC Health Program Codebook, WTC Health Program policy bulletins, and in the Clinical Center and Provider Guides, all maintained in the WTC Health Program file of record.
      
      It is incumbent upon CCE providers to understand the logic of the Codebook, and to be familiar with the codes that are covered by the Program so they can assign them properly for data analysis, reporting, and billing purposes.
      
      
   2. Treatment Not Covered by Codebook. When a CCE determines that a treatment or prescription medication that is not covered by the Program is a legitimate, medically necessary requirement for treatment of an enrolled member’s certified condition, the CCE may submit a request to add the service to the Codebook via the Change Management Process described in Chapter 4.
      
      The CCE is responsible for ensuring that all treatment providers are knowledgeable about the specific health conditions, procedures, and medications covered by the Program, including the appropriate procedures for handling non-covered health conditions, medical emergencies and appeals.
      
      
7. Claims
   
   Providers may submit claims as an individual provider or as part of a provider group. If medical treatment services are provided in a group setting, the group must be enrolled in the WTC Health Program as a group provider. Each of the CCEs has established methods for claims submission with the WTC Health Program. For specific guidance between an external provider and a CCE, it is always best to consult with the respective CCE directly. In general:
   
   
   • Claims submitted through a third party administrator (TPA) are considered to be authorized by the CCE which has engaged the TPA.
   • Claims submitted from external providers directly to the WTC Health Program are not considered to be authorized, unless other arrangements have been made with the Program.

   For services provided by a clinician in his or her offices, claims submitted on paper rather than Electronic Data Interchange (EDI) must use a Professional claim form (CMS-1500). For inpatient or outpatient hospitalizations, claims submitted on paper rather than EDI should use an Institutional claim form (UB-04). Professional services provided in a hospital setting that are not included in the institutional billing should be billed on the CMS-1500 form.

   Paper claims originating with external providers must first be submitted to the appropriate CCE. The CCE is responsible for authorizing treatment for the member. Therefore, the CCE must review and authorize claims to be processed. A stamp provided to the CCE by the WTC Health Program is used for this purpose, along with initialing by an authorized CCE approver. Once approved by the CCE, paper claims should be submitted to the WTC Health Program for processing and disposition (i.e., payment, partial payment, or denial). The information entered on the claim form is captured through an automated data collection process; therefore, all paper claim submissions must be legible and of sufficient quality for imaging. Information must be completed in the appropriate field on the billing form in order to expedite claims processing.

8. Pharmacy Benefit
   
   

   Pharmacy benefit plans have been implemented to improve oversight and minimize fraud, waste, and abuse.

   1. The CCE is expected to follow the WTC Health Program-approved Routine Diagnostic Plan and the four treatment plans that govern the pharmacy benefits to which members are entitled. Further details regarding the specifics of the pharmacy benefit may be found in Chapter 4, as well as in the Program’s Codebook and bulletins, specifically WTC Health Program Bulletin 13-2 titled, “Implementing Pharmacy Benefit Plans by Health Condition Certification Status,” both located in the Program’s file of record.
   2. Should a prescription be denied, the CCE has the opportunity to override the denial using the PBM’s online adjudication tool. Chapter 5 provides more detail.
   3. The physicians who are permitted to prescribe under the WTC Health Program are limited to those providers who have been authorized by the CCEs. Weekly updates of permitted prescribers are sent by the CCEs to the PBM, which shares this information with the HPS contractor. If a provider is permitted to prescribe medications under the WTC Health Program, the provider’s prescriber status is recorded in the claims processing system’s Provider Module.
9. Member Services
   
   

   Each CCE develops and implements procedures for providing services to its members.

   1. Member Retention
      
      Each CCE is responsible for conducting activities that enable the CCE to maintain contact with enrolled members and promote their continued participation in the Program. Each CCE must attempt to update contact information for all members assigned to that CCE on an annual basis. Contact methods include mailings, telephone calls, or emails and contact attempts should continue until the member is contacted or until three attempts have been made using at least two methods of contact.
      
      
   2. Outreach and Education
      
      CCEs conduct outreach and education to ensure that those persons who are eligible for care through the WTC Health Program are made aware of their eligibility and know how to enroll in the Program. Outreach is specifically not intended to advertise one CCE over another, but rather to advertise the existence of the WTC Health Program and to ensure the Program’s benefits are communicated to all eligible participants. CCE outreach and education activities are undertaken in coordination with Program leadership and the HPS contractor, which operates the Program’s call center. Types of outreach and education services include:
      
      
      • Answering general questions in regard to program eligibility processes
      • Collaborating with the Program leadership, appropriate DC, and other CCEs in standing up and maintaining a Section 508-compliant Website to provide WTC Health Program information for the members being served. Explaining members’ rights and responsibilities under the Program
      • Collaborating with the Program leadership, appropriate DC, and other CCEs in providing program information updates to members and providers (e.g., newsletters, letters, brochures, email)
      • Explaining the process for obtaining WTC Health Program services
      • Providing information on the providers from whom WTC Health Program members may obtain services
      • Fielding and responding to member questions and complaints received regarding the WTC Health Program benefits and/or services (i.e., captured from member satisfaction survey, a resource line, or Case Managers)
      • Advising members of the available appeals process and the member’s rights to a fair review
      • Providing program benefits counseling, which includes explaining the benefits and covered services offered under the WTC Health Program, including WTC-related health conditions and medically associated WTC-related health conditions and limitations, and any conditions associated with the receipt or use of benefits
   3. Case Management
      
      Each CCE provides case management services to all members in treatment. The role of the Case Manager is to address the unique healthcare needs of individual members and improve client satisfaction with the program. Case Managers assist in scheduling visits, coordinating care between providers, and facilitating appeal requests.
   4. Social Services Support
      
      CCEs must provide social service evaluations and assistance to Program members, when needed. These services include assistance with identifying and completing applications to access social programs outside the WTC Health Program when assistance is needed with housing, transportation, food, or medical services that are not covered by the Program.
      
      
   5. Medical Reviews
      
      If a member's CCE physician is unable to make the necessary findings regarding WTC-relatedness of a condition and/or refuses to submit a request for certification to the WTC Health Program, or refuses to provide or seek authorization for a particular treatment for a covered condition, the member may request a review of that physician decision by the CCE Clinic Director. The member is instructed to send a letter to the CCE Clinic Director describing why he or she believes the physician's decision was incorrect. The CCE Clinic Director reviews the request and provides the member with the final decision and the rationale for it. The CCE furnishes a copy of the letter to the Program and keeps records of the review process in its files for audit purposes. The CCE also tracks such decisions and makes recommendations to the Administrator of the WTC Health Program, as appropriate, when such decisions may require adjustments to program treatment protocols.
      
      
   6. Workers’ Compensation Assistance
      
      WTC Health Program members who experienced a health condition resulting from work they performed as part of their job duties when responding to the WTC attacks may be eligible to apply for workers’ compensation benefits. Upon request, CCEs must provide assistance to members who are applying for workers’ compensation benefits due to a WTC-related health condition, such as helping to document the member’s health condition and treatment needed. CCEs must also provide requested assistance to providers in completing required workers’ compensation paperwork. Because there may be an extended period of time between the time a claim is filed and when benefits are awarded, the CCE’s provision of care and submission of claims must not be influenced by or changed due to expected workers’ compensation benefits.
      
      In general, the overall order of payors for responders in the WTC Health Program is as follows: Workers’ compensation (for a WTC-related or medically associated health condition that is work-related),* followed, in order, by the WTC Health Program, private health insurance, Medicare, and Medicaid. In most cases involving WTC-related health conditions that are work-related, however, only Workers’ Compensation and the WTC Health Program will be called upon to make payments for Program members’ care.
      
      The exception to the order of payors provided above is where a Program member’s WTC-related or medically associated health condition is eligible for workers’ compensation or another illness or injury benefit plan to which New York City is obligated to pay. In this case, the WTC Health Program is the primary payer.
      
      The WTC Health Program follows the provisions in Title XXXIII of the PHS Act regarding Coordination of Benefits (COB) for survivors. Workers’ compensation is a required part of COB for responders and, in certain limited situations, survivors.
      
      The overall order of payors for survivors in the WTC Health Program is as follows: Workers’ compensation (applicable only if WTC-related condition is a work-related illness for which a claim has been established),* private health insurance, followed by Medicare, then Medicaid, and finally the WTC Health Program. Requirements for billing under the COB policy for survivors provide that, where applicable, payment for services must first be sought from:
      
      
      • Private Health Insurance: Where the WTC- related or medically associated health condition is not work-related, and where the member has private health insurance coverage, the private health insurance must be billed prior to billing the WTC Health Program.
      • Public Health Insurance (Medicare/Medicaid): Where the WTC-related or medically associated health condition is not work-related, and where the member does not have private health insurance but is covered by Medicare or Medicaid, those entities must be billed (in that order) prior to billing the WTC Health Program.
      
      The total payment, including any amounts paid by other entities and by the WTC Health Program, will not exceed the fee schedule used by the WTC Health Program. If the primary payor already paid up to the fee schedule amount, no additional payment is made under the WTC Health Program.
      
      If prior payments were made by another entity, those payments should be shown when the claim is submitted to the WTC Health Program.
      
      *Note: The WTC Health Program established a process to recoup from workers’ compensation after payment of claims to the CCEs. Therefore, the CCEs are not responsible for billing workers’ compensation for WTC Health Program claims prior to either submission to the Program in the case of responders or private/public insurance in the case of survivors.
   7. Member Transfers
      
      In the event that a member requires transfer from one CCE to another, the CCEs follow their established procedures for assisting with the transfer by coordinating with each other. The “sending” CCE will share appropriate medical records and other data and provide any information the member and “receiving” CCE may need to ensure seamless care. Transfers between the NY metropolitan area CCEs are available to any non-FDNY responder. FDNY responders who are active members of FDNY are not eligible for transfer to another CCE as care is provided through the FDNY at its Bureau of Health Services. All NY metropolitan area survivors are initially assigned to HHC; all non-NY metropolitan area members are initially assigned to the NPN. Additional information on member transfers can be found in Chapter 8, Member Services.
10. Administrative Services
    
    Each CCE must develop and implement certain procedures for providing administrative services to support the WTC Health Program. These procedures are documented in each CCE’s Operations Manual.
    
    
    1. Healthcare Provider Network
       
       Each CCE has established and maintains an adequate healthcare provider network to serve all members who are assigned to the CCE. This network may include, but is not limited to, hospitals, specialty clinics, trauma centers, specialists, and primary care physicians. The CCEs are responsible for providing healthcare expertise in sufficient numbers and at convenient locations for the members. Providers may be either internal or external to the CCE establishment. An example of an internal provider is a respiratory therapist on the CCE’s staff; an example of an external provider is a psychiatrist in private practice who has been authorized to provide WTC Health Program services on behalf of the CCE. Each CCE is responsible for ensuring that all healthcare providers serving the WTC Health Program meet all requirements of the CCE’s contract, including that they comply with all workers’ compensation requirements and are properly licensed and insured. The physicians who conduct the medical monitoring assessments and physicals must be experienced in practicing occupational medicine (e.g., conducting occupational health screening and medical surveillance)—preferably credentialed as occupational medicine specialists. Additional information on the Provider Network is found in Section 6 below.
    2. Credentialing
       
       Each CCE has established and implements a credentialing process for its provider network to ensure all providers are qualified to provide care under the WTC Health Program. Each CCE submits key information on each provider to the HPS contractor so the providers can be entered into the claims processing system. The credentialing process is documented in each CCE’s Operations Manual.
       
       
    3. Training
       
       Each CCE ensures that all providers and other personnel who perform work for the WTC Health Program are properly trained – both initially and on an ongoing basis – to perform their assigned functions. This training includes:
       
       
       • Potential exposures and health outcomes that have been associated with the WTC terrorist attacks
       • The conditions and services covered by the WTC Health Program
       • Proper coding of and billing for WTC Health Program services
       • How to ensure compliance with the WTC Health Program policies and procedures
       • Avenues for problem-solving, escalation of concerns, etc.
       
       Training processes and procedures are further described in each CCE’s Operations Manual.
    4. Pharmacy Benefit Management (PBM)
       
       Each CCE works with the WTC Health Program PBM to provide pharmacy benefits to its members, as described in Chapters 4 and 5. By providing names of and pertinent data on authorized prescribers to the PBM, each CCE validates to the Program that those writing prescriptions under the WTC Health Program are authorized to do so. CCEs also play a role in the management of pharmacy benefits when overrides or prior authorizations are needed to ensure members receive needed medications. These processes are described further in Chapter 5.
       
       
    5. Quality Assurance and Internal Audits
       
       Each CCE has established a quality assurance function to ensure high-quality care of WTC Health Program members in accordance with all Program policies and procedures. Responsibilities for quality assurance include:
       • Ensuring adherence to monitoring and treatment protocols
       • Providing benefits counseling for workers’ compensation and other insurance programs, as necessary
       • Appropriately billing for only WTC-related health conditions and medically associated health conditions
       • Ensuring appropriate diagnostic and treatment referrals for members, when necessary
       • Verifying prompt communication of test results to members
       • Reviewing all claim forms and other contract deliverables for completeness and accuracy
       • Measuring, monitoring, and increasing member satisfaction
       • Improving overall program success
       • Ensuring early identification and resolution of problems, issues, and risks
       • Monitoring of adherence to established policies and procedures
       • Continuous process improvement and implementation of lessons learned
       1. Quality Assurance Program (QAP)
          
          Each CCE is responsible for developing, implementing, and documenting its approach to quality assurance. CCEs each have developed a WTC Health Program-specific Quality Assurance Program (QAP) which describes the procedures used to monitor and improve all Program activities, including reporting. To ensure consistency among CCEs and alignment with WTC Health Program goals and objectives, each CCE’s QAP must be approved by the Administrator of the WTC Health Program or designee.
       2. Customer Satisfaction Survey Program (CSSP)
          
          A Customer Satisfaction Survey Program (CSSP) is part of every CCE’s QAP. In this program, members are given the opportunity on an annual basis to complete a customer satisfaction survey.
          
          Each CCE must report findings from its customer satisfaction survey to the Administrator of the WTC Health Program or designee. These findings include frequency and method of surveys, survey results, and corrective actions to be taken based on survey results
       3. Internal Audits
          
          As a part of its QAP, each CCE conducts an internal audit at least once a quarter. These audits include:
          
          
          • Targeted Health Care Compliance – The Targeted Health Care Compliance audit focuses on evaluating the adequacy of the procedures used by the CCE to ensure that only approved WTC health conditions and approved health care services (including provider visits, procedures, medication and durable medical equipment) are reimbursed by the Program. This includes a review of documentation justifying payment history for medically associated health conditions.
          • Medical Management Review – The Medical Management Review audit looks to ensure that medical practice guidelines developed for the Program are being followed.
          • Claims History – The Claims History audit focuses on irregularities in the claims history of any particular provider or member.
          • Medical Records Review – The Medical Records Review audit focuses on determining if appropriate procedures are being followed related to the collection, review, and storage of medical records.
          • Personnel Training – The Personnel Training audit focuses on ensuring that all personnel performing work on the Program are properly trained.
    6. Records Management
       
       Each CCE is responsible for administering a comprehensive records management program which ensures that all Program records, including medical records, are maintained in such a manner that the information is secure and readily accessible to authorized parties. For all protected health information (PHI), this includes compliance with all Health Insurance Portability and Accountability Act (HIPAA) requirements. The CCEs must provide the Administrator of the WTC Health Program with a copy of their Notice of Use and Disclosures of Protected Health Information required by the HIPAA privacy rule and ensure in that notice that the members are aware that the Administrator of the WTC Health Program and/or his designee will have access to the members’ protected health information for the purposes of the treatment provided by and administration of the WTC Health Program. The records management program includes providing assistance to members in obtaining medical records and processing member requests to release protected information. In addition, each CCE has the capability for a medical records locator to facilitate the retrieval of all medical records from any provider for any member within the CCE or their referral network.
    7. Other Administrative Responsibilities
       
       Additional responsibilities of the CCE include:
       • Attending administrative, steering, benefits, and clinical WTC Health Program meetings
       • Writing reports and Institutional Review Board (IRB) submissions
       • Entering data for claims submission and to meet reporting requirements
       • Entering data of healthcare information into the DC’s data system
       • Providing intellectual input on the refinement of medical guidance and protocols as needed by the program (and coordinated by the DC), or in support of member treatment needs
       • Providing administrative personnel and facilities to support the CCE’s contract
       • Providing translational and interpretive services for non-English-speaking members, as appropriate to the CCE’s member population

6. Provider Networks

The establishment and management of the internal and external provider network are coordinated through the respective CCEs. In order for a provider to have a claim for WTC Health Program services paid, the CCE must have enrolled the provider as a participating provider in the WTC Health Program. Provider enrollment into the WTC Health Program and the management of a reliable provider network are critical to efficient claims processing. The complete and accurate enrollment of providers ensures that claims are not suspended for review of provider validity issues, and that claims may be promptly adjudicated.

Each CCE is responsible for submitting provider enrollment requests to the HPS contractor and updating provider details when necessary. All medical providers, including physicians, group practices, hospitals, Durable Medical Equipment (DME) suppliers, nursing facilities, hospice services, and others, must enroll as participating providers in the WTC Health Program for claims to be adjudicated through the Program’s claims processing system. Each CCE determines the nature of its provider relationships (i.e., internal or external) and is also responsible for providing the appropriate level of education and information regarding the Program to external providers so that they may provide an approved level of care for WTC Health Program-certified conditions.
The HPS contractor uses the information provided by the CCEs to add providers to the claims system.

1. Internal Provider
   
   The internal provider network is comprised of healthcare providers (both individuals and groups) that have established relationships as internal medical providers with the medical institutions that are managed by each respective CCE. For example, the Mount Sinai School of Medicine (MSSM) is a medical facility within the purview of the MSSM CCE; most, if not all, of the physicians and groups who practice at the MSSM are enrolled as internal MSSM providers. The designation of “internal” provider is relevant during claims processing, as a claim received by an internal provider is considered to be already authorized by the managing CCE through the nature of the provider’s relationship to that CCE’s affiliated institution(s).
   


2. External Provider
   
   The majority of the enrolled WTC Health Program providers are external to a CCE. The external provider network comprises healthcare providers (both individuals and groups) that have contractual relationships to provide medical services for members assigned to a particular CCE. External providers may be affiliated with more than one CCE. The designation of “external” provider is relevant during claims processing, as a claim received by an external provider is not considered to be authorized by the managing CCE unless the claim shows an official stamp indicating CCE authorization is submitted by EDI. Claims submitted by the TPA are assumed authorized because of procedures established by the CCEs and the TPA ensuring claims are authorized before they are submitted to the program for payment. The process for authorizing claims is described in Chapter 5.
   
   After a CCE has established either an internal or external relationship with a provider, the CCE must submit a provider enrollment request to the HPS contractor for processing. CCEs must provide the following data:
   
   
   • Provider/Practice Name
   • Provider/Practice Address (must not be a PO Box)
   • Provider/Practice Telephone/Fax Number
   • Provider/Practice National Provider Identifier (NPI) Number
   • Provider/Practice Social Security Number (SSN)/Employer Identification Number (EIN)
   • Provider Medicare Number (if provider will be submitting institutional claims)
   • Billing Provider/Practice Name
   • Billing Provider/Practice Address (can be a PO Box) where Remittance Advice (RA) may be sent
   • Billing Provider/Practice NPI Number
   • Billing Provider/Practice EIN
   • Financial Information (can be submitted on an Electronic Funds Transfer [EFT] Form), including:
     • Financial Institution Name
     • Financial Institution Address
     • Financial Institution Routing Transfer Number
     • Depositor Account Number

   Financial information is also provided using an EFT Form or other document provided by the Program so that providers may receive payment for their claims.

   Before submitting the provider enrollment, the CCE confirms: 1) that all data are complete and accurate; 2) that the provider’s status as either an internal or external provider is documented; and 3) whether the provider should also be enrolled with the following specialties:

   • Rx Prescriber—this is not a required data element, but if this information is not provided, the record will default to “Not an Rx prescriber” and the provider will not be able to write prescriptions for members.
   • Cancer Care Provider—this is not a required data element, but if this information is not provided, the record will default to "Not a cancer provider." As of April 26, 2013, an open prescriber network for members assigned to the Cancer Treatment Plan became effective, permitting cancer care providers to prescribe certain drugs for cancer care. For all other non-cancer formulary drugs, a provider must be flagged as "Rx prescriber" in order to authorize prescriptions.

   Once a provider enrollment has been received and validated by the CCE, the CCE submits the enrollment to the HPS contractor for processing. If incomplete information is received, the enrollment form will be returned to the CCE for completion. Chapter 8 provides more detail regarding the steps taken to complete the enrollment process.

   The management and maintenance of the information in a provider record are the CCEs’ responsibility. Changes to provider information may be necessary over time (e.g., an address or financial information changes, or a provider ceases her association with the WTC Health Program). Any changes to provider information that are received by the CCEs are processed in the same way as for an initial enrollment. Changes to provider information that are not first identified by the CCE must be routed to the CCE for validation and to ensure consistency among, and accuracy of, Program records. This could occur, for example, when a claim being processed for payment reveals that the provider’s EFT information has changed

3. Annual Confirmation of Authorized Providers
   
   

   Enrollment and management of a reliable provider network is critical to ensure that claims will efficiently and accurately adjudicate. In the interest of supporting the CCEs’ responsibility to manage their provider and prescriber enrollees, the HPS contractor annually distributes to each CCE a list of all its providers enrolled in the Program. The CCE must review the list and make any updates or note any discrepancies between the providers held on record by the Program and those held on record by the CCE. The HPS contractor is responsible for working with the CCE to resolve any discrepancies in a timely fashion.

7. Reporting Requirements

1. Monthly Reports

   Each CCE submits to the Program monthly status reports on member and administrative services activities to allow Program leadership to track the CCE’s program activities and progress. In addition to summarizing the activities and accomplishments of the past month, the report identifies any potential risks to continued program success and communicates the CCE’s plans to mitigate those risks. A variety of reports are required, as detailed below.

   1. Member Services Monthly Report. The content of the Member Services Monthly Report is reflected in the following table.
      

      Member Service Function

      Information to Be Reported

      Member Retention

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Member Retention services performed during the period and the associated cost for these services invoiced to the government.

      Member Outreach and Education

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Member Outreach and Education services performed during the period and the associated cost for these services invoiced to the government.

      Program Benefits Counseling

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Program Benefits Counseling services performed during the period and the associated cost for these services invoiced to the government.

      Case Management

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Case Management services performed during the period and the associated cost for these services invoiced to the government.

      Social Services Functions

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Social Services Functions performed during the period and the associated cost for these services invoiced to the government.

      Member Transfers

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Member Transfer services performed during the period (including the status of all outstanding requests for medical records) and the associated cost for these services invoiced to the government.

      Medical Reviews

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Administrative Services related to Medical Reviews that were performed during the period and the associated cost for these services invoiced to the government.

      Workers’ Compensation Assistance

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Workers’ Compensation Assistance performed during the period and the associated cost for these services invoiced to the government.

      Other Member Services

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Other Member services performed during the period and the associated cost for these services invoiced to the government.

   2. Administrative Services Monthly Report. The content of the Administrative Services Monthly Report is reflected in the following table.
      
      

      Administrative Service Function

      Information to Be Reported

      Healthcare Provider Network

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Healthcare Provider Network services performed during the period and the associated cost for these services invoiced to the government.

      Pharmacy Benefit Management

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Pharmacy Benefit Management services performed during the period and the associated cost for these services invoiced to the government.

      Quality Assurance and Internal Audits

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Quality Assurance and Internal Audits performed during the period and the associated cost for these services invoiced to the government.

      Records Management

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Records Management services performed during the period and the associated cost for these services invoiced to the government.

      Transfer of Data and Information (at the end of the contract)

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Transfer of Data and Information services performed during the period and the associated cost for these services invoiced to the government.

      Attending administrative, steering, benefits, and clinical WTC meetings

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all attendance at administrative, steering, benefits, and clinical WTC meetings during the period and the associated cost for these services invoiced to the government.

      Report Writing and IRB Submissions

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Report Writing and IRB Submissions that were performed during the period and the associated cost for these services invoiced to the government.

      Data Entry for Claims Submission and to Meet Reporting Requirements

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Data Entry services performed during the period and the associated cost for these services invoiced to the government.

      Data Entry of Healthcare Information into the DC’s Data System

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Case Management services performed during the period and the associated cost for these services invoiced to the government.

      Healthcare Protocol Development—provide intellectual input on the refinement of medical guidance and protocols as needed by the program (and coordinated by the DC), or in support of member treatment needs

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Healthcare Protocol Development services performed during the period and the associated cost for these services invoiced to the government.

      Providing Translational and Interpretive Services

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Providing Translational and Interpretive Services performed during the period and the associated cost for these services invoiced to the government. General and Administrative Charges

      General and Administrative Charges

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all General and Administrative Charges during the period and the associated cost for these services invoiced to the government.

      Other Administrative Services

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Other Administrative Services performed during the period and the associated cost for these services invoiced to the government.

   3. Other sections of the Monthly Report are reflected in the below table.
      

      Operations Manual

      Difficulties encountered and proposed updates to the Operations Manual. Updates shall be approved by the Administrator of the WTC Health Program after review and discussion of the issues, as needed.

      Complaints

      A summary of all complaints received by the CCE during the preceding month and the status of their resolutions.

      Fraud and Abuse Report

      A) The CCE shall submit monthly the number of complaints of fraud or abuse made to the CCE related to covered services that warrant preliminary investigation by the CCE. B) The CCE shall also submit to the Administrator of the WTC Health Program the following on an ongoing basis for each confirmed case of fraud or abuse it identifies through complaints, organizational monitoring, contractors, subcontractors, providers, and members, etc. related to covered services: 1) The name of the individual or entity that committed the fraud or abuse; 2) The source that identified the fraud or abuse; 3) The type of provider, entity, or organization that committed the fraud or abuse; 4) A description of the fraud or abuse; 5) The approximate dollar amount of the fraud or abuse; 6) The legal and administrative disposition of the case including actions taken by law enforcement officials to whom the case has been referred; and 7) Other data/information as prescribed by the Administrator of the WTC Health Program. Such report shall be submitted when cases of fraud or abuse are confirmed, and shall be reviewed and signed by an executive officer of the CCE.

      
      
      
2. Additional Administrative Reports
   
   Other operational data reports may be required from time to time to support the needs of the Program. In such cases, the Administrator of the WTC Health Program or designee will work with the CCEs to coordinate the content of the report and delivery details, as necessary. An example of such a report is the Customer Satisfaction Survey report.

8. CCE Operations Manual

• Protocols for medical monitoring exam-related issues, working in conjunction with the CCE’s respective DC
• Protocols for treatment-related issues
• Procedures for providing member services: member retention; outreach and education; benefits counseling; case management; social services; and medical appeals
• Details of the medical review process and records system
• Details of the Workers’ Compensation Assistance program
• Details of the member transfer process
• Details of the quality assurance program
• Details of establishing and credentialing the CCE’s provider network
• Details of the training program
• Details of the records management program
• Details of the transfer of data and information and turnover of services procedure
• Details of other administrative services provided

Chapter 7—Nationwide Provider Network

1. Purpose and Scope

2. Statutory and Regulatory References

• Section 3313, which describes the national arrangement for benefits for eligible individuals outside the New York (NY) metropolitan area:
• Section 3312(b)(4)(C), which includes coverage for certain transportation expenses incurred by members securing medically necessary treatment through the NPN, and
• Section 3305(a)(2)(A)(iv), which calls for the Data Centers (DCs) to establish the criteria for credentialing medical providers who participate in the NPN.

3. Roles and Responsibilities

The roles and responsibilities with respect to the NPN are detailed below.

1. The NPN is operated by Managed Care Advisors (MCA)-Sedgwick to provide healthcare services for members who reside outside the New York metropolitan area, including Shanksville, PA, and Arlington, VA, the site of the Pentagon. Healthcare services include initial health evaluations for screening-eligible WTC survivors, as well as monitoring and treatment benefits for enrolled WTC responders or certified-eligible WTC survivors. After receiving information regarding approved enrollees from the Health Program Support (HPS) contractor, the NPN enrolls the new members into its system and educates them on NPN processes for obtaining covered benefits. The NPN must maintain a viable provider network to provide monitoring and treatment to NPN members with services available across the country to ensure access near a member’s area of residence. The Program defines NPN network adequacy as having a healthcare provider available within 30 miles in urban areas and 75 miles in rural areas. The NPN will work with members to bring a provider into the network or identify a provider who will meet both member needs and the requirements of the Program. The NPN forwards all medical claims to the Centers for Medicare & Medicaid Services (CMS) contractor responsible for disbursing payment for the program.
2. The Program has the responsibility to communicate regularly with the NPN to clarify, modify, or establish WTC Health Program policies and procedures, and provides oversight of NPN operations to verify that the NPN is operating within the WTC Health Program regulations, guidelines, and contract requirements. It also ensures that claims submitted by the NPN’s providers are paid by the CMS contractor.
3. The HPS contractor, under the direction of the WTC Health Program leadership, provides the information technology and program management support services that are essential to WTC Health Program NPN operations. The HPS contractor provides weekly updates on new enrollees to the NPN, provides contact center support, and coordinates with the NPN to provide requested reports and data analysis.

4. Overview of NPN Services

The NPN manages a network of providers who are licensed, credentialed, insured and/or certified in accordance with the WTC Health Program requirements. Participating providers receive training on WTC Health Program covered health conditions and protocols from the NPN. In many cases, an enrollee may receive care from more than one NPN provider. The chart below describes the process used by the NPN to select and maintain providers within the NPN provider network.

1. Clinical Management Team Searches for Provider

2. Provider Contacted

3. Complete Services Confirmation Checklist

4. Provider Qualification

5. Provider Completes Subcontractor Agreement

6. Collect and Verify Credentialing Information

• Unrestricted, valid current licensure and certification [Fraud and Abuse Control Information Systems (FACIS) query]
• Ensure all credentials meet all standards for local, state, and federal requirements
• Accredited Credentialing Verification Organization (CVO)
  • Criminal Search Felony Background – State/ County
    • Found Wants and Warrants (open cases)
    • Felony and/or Misdemeanor Convictions
  • Criminal Search Felony Background – National
    • Includes Office of Foreign Assets Control (OFAC) Specially Designated Nationals (SDN) List
    • Includes Sex Offender Registries from all 50 states
    • Office of Inspector General (OIG) Excluded Individuals/Entities
    • Collect all required credentials
• General Service Administration (GSA) List of Excluded Parties
• Criminal History Background Check as Required Military Affairs Policy HA97-036

7. Update Provider Information Using Workflow Management Technology

• Documents scanned in
  • Subcontractor agreement
  • W-9
  • Statement of affirmation
  • Signed non-disclosure form
  • Facility information form
  • Credentialing documents
  • Initial Application for Clinical Privileges
  • Proof of current malpractice coverage
  • Statement of Affirmation/Release of Information
  • Credentialing Primary Source Verifications Conducted:
  • Proof of Current State licensure(s) and renewal
  • License/malpractice/Medicare or Medicaid sanction history
  • Current DEA registration for any prescribing clinician
  • Proof of degree and state licensure
  • Board certification
  • Certifications such as Basic Life Support/Cardiopulmonary Resuscitation (BLS/CPR) or Advanced Cardiovascular Life Support (ACLS)

8. Provider Training

• Government guidelines and federal regulations
• Center for Personalized Education for Physicians (CPEP)
• NPN contractor standardized procedures

9. Information Retrieval

All contracting documents, training history, credentialing and licensing reports are maintained for audit access upon request

4.1 Credentialing and Re-credentialing Process

The NPN has a team of individuals whose responsibility it is to ensure all Healthcare Practitioners (HCPs) within the NPN are licensed within the state where they will be performing services. The NPN ensures that all HCPs have unrestricted, valid current licenses, certifications, and registrations as required for their particular profession within the state, district or territory in which they are performing services. The NPN uses both trained credentialing staff and an accredited Credentialing Verification Organization (CVO) to meet the provider credentialing requirements of its WTC Health Program contract.

The NPN tracks the credentialing requirements in its data system for each provider to ensure all documentation is accurate and current.

A qualifying practitioner is not activated within the NPN until the credentialing verification process is complete and the NPN Clinical Director has provided final approval. The NPN performs ongoing monitoring to identify any sanctionable activities or instances of malpractice, fraud, waste or abuse. HCPs are re-credentialed every 36 months.

All subcontracted providers receive training and monitoring of their quality of care and overall performance in the provision of clinical services. All providers receive training from the NPN’s Medical Provider Training department prior to scheduling appointments. Forms, procedures, and expectations are reviewed in the initial training session to ensure compliance with WTC Health Program processes.

4.2 NPN Member Eligibility and Enrollment

As Chapter 2 details, eligibility for all members of the WTC Health Program is determined by the Program. Members are assigned to the NPN by the Program based on their geographic location. These WTC Health Program members may be newly enrolled members or members who transfer from a CCE.

Newly enrolled WTC Health Program members are assigned to the NPN by the WTC Health Program’s Member Services Team based on the new member’s location outside the NY metropolitan area. If a newly enrolled WTC Health Program member who has not been assigned to the NPN contacts the NPN directly, the NPN will work with the member and the Program to confirm eligibility and assignment.

If a WTC Health Program member wishes to transfer from a CCE to the NPN or from the NPN to a CCE, the NPN and relevant CCE will work together to coordinate the transfer using the established WTC Health Program transfer policy, detailed in the Member Services Operations Manual.

• Welcome letter;
• Frequently Asked Questions handout;
• Workers’ compensation application¹; and
• Medical record release forms (only for members transferring from a CCE to ensure continuity of care).

4.3 Scheduling, Intake Interview, Testing, and Monitoring Exams

Coordination of member intake is managed by the NPN case manager. Ongoing communication with a WTC Health Program member occurs through a variety of media, as necessary, including telephone, email, and fax, and may include the use of Integrated Voice Recognition (IVR) technology.

New Member: The NPN contacts the member to answer questions and schedule an initial monitoring exam or initial health evaluation. Since the member is not transferring from a WTC Health Program CCE, there are no prior medical records to retrieve.

Transfer Member: The NPN contacts the member to answer questions and encourage the member to return the Medical Record Release Form(s), provided in the Welcome Packet. The NPN makes up to six call attempts to reach the member to obtain the completed Medical Record Release Forms, as necessary. Once the forms are received, the NPN coordinates with the member’s CCE to collect the medical records via trackable shipping service, enters information from the records into the NPN database and assigns a case manager to review the records and document the member’s WTC-certified health conditions and medical history. Upon completion of documentation, the case manager schedules the intake interview.

The intake process consists of three parts: an intake interview; testing; and a monitoring exam or initial health evaluation.

Intake Interview
Since NPN members are located throughout the country, face-to-face meetings are not feasible, so the NPN case manager conducts intake interviews by telephone. During the intake interview, the case manager verifies all demographic information with the member, making updates when necessary, in order to ensure proper identification and confidentiality. A Medical Health Questionnaire (MHQ) is completed by the case manager and typically takes between 45 minutes to 1 ½ hours. The MHQ is completed for both new WTC Health Program members and transfers into the NPN to ensure completeness of NPN documentation. If a member uses English as a second language and prefers to speak his/her primary language, the NPN engages a company that offers interpreter services to assist in interpreting the interview.

After the MHQ is conducted, the case manager schedules testing and monitoring exam or initial health evaluation appointments with the assigned provider. These appointments are scheduled immediately for new members; for transfers into the NPN, the appointments are scheduled based on the due date of the member’s next exam. All eligible members are encouraged to have an annual monitoring exam.

Testing and Monitoring Exams
The initial monitoring exam or health evaluation is consistent with those performed by the CCEs and includes a review of the completed MHQ, a general health assessment, vital signs assessment, spirometry testing, blood work, urine collection, and a chest X-ray. The follow-up monitoring exam, where appropriate for the type of member, includes the same components as the initial monitoring exam with the exception of the chest X-ray, which is performed every two years unless an increased frequency is clinically indicated. Follow-up exams or additional testing, scheduled through the case manager, may be required as a result of the monitoring exam to complete a diagnosis. Chapter 6 provides more detail on the components of the monitoring exams.

Within 48 hours of a member completing his/her appointment(s), all documentation is forwarded from the provider to the NPN so that the NPN Clinical Director may determine whether or not to request certification of a health condition. Chapter 3 provides detailed information regarding the certification process. The NPN scans all received documents and archives them in its database. The completeness of the documents is reviewed using a system-generated checklist. If any required materials are missing, the NPN contacts the provider to retrieve the missing component(s) and/or to complete any missing exam elements. In the event providers are not completing the exams/evaluations accurately or completely, re-training may be recommended.

Inform Member of Results
Once all documents are received by the NPN and quality reviews are completed, the case manager conducts a thorough review of the exam findings and drafts a letter to the member informing him/her of the results and any referrals to the treatment program that stemmed from their exam. All exam results are sent no later than two weeks after the monitoring exam or health evaluation services have been completed.

If referrals are identified, the case manager follows up with the member within five days after the letter and exam/evaluation documentation has been sent to the member to discuss the conclusions reached from the initial work-up and the member’s ongoing participation in the Program. The case manager discusses covered health conditions and assists in the coordination of treatment, as necessary. Additionally, the case manager outlines those health conditions that the member may have that are not covered under the WTC Health Program and instructs the member to see his/her primary care provider for treatment of those health conditions. If necessary, the case manager engages the NPN social worker who assists in the processing of social work referrals and benefits counseling for the member.

The NPN’s Social Services Specialist will reach out to provide assistance when a member’s answer to the MHQ either in the mental health section or social benefits section indicates it may be needed, when a need is identified by the case manager through conversation with the member, or when a monitoring exam/initial health evaluation physician identifies the need for a social service referral. Areas of need addressed may include utility needs such as electricity and heating, transportation needs, mental health needs, assistance with Victim Compensation Fund questions, coordination of benefits with other programs such as Medicaid or workers’ compensation, provision of guidance in accessing resource programs such as food stamps or financial assistance, offering guidance in accessing medication assistance or medical assistance programs, providing assistance in accessing local resources in other regions of the country, or other items as requested by the member.

If referrals are not indicated as part of the monitoring exam/initial health evaluation, the NPN will begin the process for scheduling the next monitoring exam 60 days prior to its due date, where appropriate.

4.4 Treatment Services

If a member is referred for treatment, the NPN will begin the request for certification process for all covered health conditions which the clinical director determines that the member’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition. Chapter 3 describes the process for certifying covered conditions under the program. When a member’s health condition is approved for certification by the WTC Health Program, the Program notifies the NPN electronically and sends the member a letter to inform him/her of the Program’s decision.

The NPN also issues a Member ID Card to all NPN members consistent with the Program’s practices for all members. The card contains a member identification number and the customer service telephone numbers for the NPN and for the Pharmacy Benefits Manager (PBM).

4.5 Processing and Paying Claims

The NPN reimburses every subcontracted provider within 30 days of receipt of their invoice. In order to receive reimbursement, the services rendered must be medically necessary, performed completely and in accordance with the NPN’s authorization, protocols, and direction.

Upon receipt of an invoice, the NPN reviews it for accuracy and completeness. Once the NPN determines that the invoiced services are appropriate and in accordance with WTC Health Program requirements, the invoice is electronically submitted to the HPS contractor for processing and payment. If the NPN determines that the invoiced services are not in accordance with Program requirements, it denies the invoice and sends the provider a letter of explanation permitting the provider to correct any errors and, if appropriate, resubmit a corrected claim to the NPN. See Chapter 5 for more detail on how NPN medical and pharmaceutical claims are processed, paid and can be appealed.

Chapter 8—Member Services

1. Purpose and Scope

The purpose of this chapter is to provide an overview and description of the member services provided through the WTC Health Program under the James Zadroga 9/11 Health and Compensation Act of 2010 (the Act). A member is defined as an individual who is enrolled in the WTC Health Program as a responder, certified-eligible survivor, screening-eligible survivor, or eligible family member of an FDNY responder.

2. Statutory and Regulatory References

The following Sections of the Act are applicable to this chapter (42 C.F.R. pt. 88 does not include any language specifically applicable to this chapter):

1. Section 3303 of the Act describes the education and outreach services that are required under the WTC Health Program. These services include the following activities and are conducted in a manner intended to reach all affected populations and to support culturally and linguistically diverse populations:
   1. Establish public Website with information about the WTC Health Program;
   2. Meet with potentially eligible populations;
   3. Develop and disseminate outreach materials informing people about the Program; and
   4. Establish phone information services.
2. Sections 3305(a)(1)(B-D) and 3305(a)(2)(A)(iii) of the Act discuss the roles of the Clinical Centers of Excellence (CCEs) and Data Centers (DCs) in providing outreach activities.

3. Responsibilities

Member services are a key function of most WTC Health Program entities.

1. The CCEs are responsible for working with newly enrolled WTC Health Program members to assist them in accessing the benefits of the Program, including scheduling appointments, as needed. Member services provided by the CCEs include conducting member retention activities, supporting member transfers, reviewing and transmitting completed health certification requests to the WTC Health Program, issuing social services referrals, providing workers’ compensation assistance, conducting internal audits, managing media relations, and ensuring accurate records management. In addition to providing medical care, CCEs have an integral role in providing a range of member services to the people they serve. CCE staff meet with potentially eligible populations and existing members face-to-face to provide benefits counseling and other information regarding the services available to them. They assist members in completing application forms and, when requested, submit the forms to the Program on the members’ behalf. The CCEs also work closely with community, labor union, and governmental stake holders to develop a variety of materials and plans for educating members and the public about the Program.
2. The Nationwide Provider Network (NPN) is responsible for working with newly enrolled Program members who live outside the New York (NY) metropolitan area to assist them in accessing the benefits of the program, including scheduling appointments, as needed. Member services provided by the NPN include conducting member retention activities, supporting member transfers, reviewing and transmitting completed health certification requests to the WTC Health Program, issuing social services referrals, providing workers’ compensation assistance, conducting internal audits, managing media relations, and ensuring accurate records management.
3. The DCs help coordinate activities with the CCEs, as appropriate.
4. The Health Program Support (HPS) contractor receives and processes enrollment forms, requests for certification of health conditions, claims for payment of medical benefits, and other correspondence and inquiries from members, CCEs, medical providers, pharmacies, and others. As part of its support, the HPS contractor manages phone information services through its contact center.
5. The WTC Health Program Member Services Team serves as the government lead in providing Program-wide oversight for member services, including outreach and education, communications, retention, member complaints, and appeals. It also manages the WTC Health Program Website, which serves as a primary source of information about the program, providing links to CCEs, the NPN, the contact center, and a wealth of resources for members’ use. The team establishes standards and templates for communicating Program decisions to members, responds to email inquiries, processes enrollments, maintains provider enrollments, and develops informational materials and communications.

4. Communication Activities

A variety of activities are implemented to ensure effective and full communication with all Program stakeholders.

1. A comprehensive public Website is maintained at https://www.cdc.gov/wtc/. This Website provides background information on and news about the WTC Health Program; information, links, and downloadable forms for those who wish to apply; resources specific to each category of member; links to guiding legislation, regulations, and supporting documents; and the location and links to each of the CCEs and the NPN.
2. A WTC Health Program newsletter is published periodically by the Program and includes benefit updates, health information, details on enrollment procedures, and other articles of interest to Program participants. The newsletter is mailed to every enrolled member of the Program, with additional copies distributed to CCEs and outreach and education contractors (described further in Section 5 below) for recruitment and outreach activities, and is also posted on the WTC Health Program Website.
3. A variety of letters are sent to members, including welcome letters that are sent to new members when they are enrolled in the Program; update/status letters that are sent to members at various points during the enrollment, certification, and appeal processes; and periodic special mailings to inform members of Program-wide matters. The Member Services Team is responsible for developing all letters sent to WTC Health Program members, with final review and approval by the Member Services Team Lead and the Office of the General Counsel (OGC).
4. Email communication with members is managed to ensure accuracy and transparency in Program communications. In addition to individual Program staff email accounts, the WTC Health Program maintains a general mailbox that is accessible from the WTC Health Program Website (WTC@CDC.gov).
   1. The WTC inbox is checked daily. Most responses are personalized and sent within 24-hours after receipt of an inquiry.
   2. As needed, responses that require input from other WTC Health Program team members (e.g., the claims manager, a particular CCE or the NPN) will be routed accordingly.
   3. Member personal and medical information is handled in a manner that preserves and protects privacy and confidentiality in accordance with all legal requirements. This includes, but is not limited to, the maintenance of medical records in a secure environment and the education of Program staff regarding privacy and confidentiality. The Program will not release medical information without authorization, except as required or permitted by law to administer benefits, comply with government requirements, or if you consent to participate in research or education.
5. Additional communication mechanisms are described below in Section 5, Outreach and Education.

5. Outreach and Education

The Program has a variety of mechanisms in place to communicate Program benefits to and meet with potentially eligible populations.

1. Outreach materials are developed in English, Spanish, Chinese, and Polish and are widely disseminated through a variety of mechanisms to inform potentially eligible populations about the Program and to encourage those eligible to apply. A comprehensive list of current material can be found online at https://www.cdc.gov/wtc/outreach-materials.html. Materials are also created to communicate changes in Program benefits or procedures to current members. Examples include, but are not limited to:
   1. A flyer describing the enrollment process for eligible members;
   2. Palm cards and bus ads to encourage enrollment;
   3. A letter and Frequently Asked Questions (FAQ) document regarding the addition of cancer to the list of covered conditions; and
   4. A detailed FAQ document describing the NPN;
   5. Video testimonials for the WTC Health Program Website.
2. Several organizations have been funded through contracts to provide additional outreach and education services on behalf of the Program. These contractors are detailed at https://www.cdc.gov/wtc/outreach.html and in the following table:
   
   
   Contractor

   WTC Health Program Outreach and Education Activities

   9/11 Environmental Action

   WTC Health Program Outreach and Education Activities: 9/11 Environmental Action's outreach project will use innovative social networking techniques, short upbeat videos, as well as traditional grassroots outreach methods, to reach 9/11-affected residents, students and area workers, referred to as WTC survivors. 9/11EA will utilize its relationships and networks within the NYC Disaster Area to disseminate information about the World Trade Center (WTC) Health Program, who is eligible and how to apply. 9/11 EA will closely partner with the survivor organization, StuyHealth, to reach a population of former students, now young adults, locally and nationally. Both organizations will offer enrollment guidance.

   FealGood Foundation, Inc.

   WTC Health Program Outreach and Education Activities: FealGood Foundation |Outreach & Education (FGF OnE) will assist First Responders in the NYC Area and other identified areas of need who may have been injured, physically or mentally as a direct result of their rescue, recovery and clean-up efforts at the World Trade Center Site. FGF OnE will conduct four large events to assist in registering the Responders in World Trade Center Health Program.

   New York Committee for Occupational Safety and Health (NYCOSH)

   WTC Health Program Outreach and Education Activities: NYCOSH will reach responders through one-on-one engagement directed at union members. Establishing one-on-one contact with these individuals through their organizations and working to ensure that they understand their potential benefits, how to apply to the program, and are guided through the application process itself is the critical next phase of this project.

   Voices of September 11th

   WTC Health Program Outreach and Education Activities: Voices of September 11th (VOICES) provides a wide range of support services and programs to address long-term needs of those impacted by 9/11. The plan for outreach is broad-based and uses proven engagement techniques, direct-contact printed materials, web-based activities and social networks as well as community-based and corporate presentations, conferences and forums. The plan targets outreach to companies, organizations, local residents, and subgroups such as parents, immigrants, seniors, retirees and children.

   
   
3. Various events are planned and conducted by the CCEs and contractors to inform potential members and the general public about the program. The CCEs and contractors also participate in health fairs and forums and prepare additional outreach materials, as necessary.
4. Public service advertisements aimed primarily at survivors are developed. Informational posters have been placed in prominent locations, such as free tax preparation sites, where potentially eligible survivors may be more likely to see them.
5. In addition to print materials and advertising, the Program uses Web-based platforms like Wikipedia and Twitter as well as regularly updating the Program Website to keep information about the Program current.

6. Member Retention

The CCEs and the NPN are responsible for undertaking activities designed to retain members in the Program. These activities include maintaining regular contact with currently enrolled members and encouraging these members to continue to participate in the program. See Chapter 6 for additional information about CCE member retention activities, and Chapter 7 for additional information about NPN member retention activities.

7. Phone Information Services

The Program has established comprehensive phone information services via its Member Call Center to support education and outreach activities.

1. The Program’s Call Center is available at 1-888-982-4748 (1-888-WTC-HP4U), Monday through Friday 9:00am—5:00pm Eastern Standard Time to answer questions from members, providers, pharmacies, and others.
2. Call Center staff have access to information on a variety of Program-related services and resources, making the Call Center a primary vehicle through which the Program answers individual questions regarding Program benefits, activities, eligibility, enrollment, claims, and so forth.
3. In addition to the Program’s Call Center, each CCE and the NPN also maintain phone information services to meet the needs of their member-specific populations. All contact information is accessible at www.cdc.gov/wtc/clinics.html.

8. Appeals

The Member Services team also coordinates appeal processes for the Program. Members may appeal decisions made regarding denial of enrollment, a decision to disenroll the member from the Program, a decision not to certify a health condition as a WTC-related condition, a decision not to certify a health condition as medically associated with a WTC-related health condition, a decision to decertify a health condition, or a decision not to authorize treatment due to a determination by the WTC Health Program that the treatment is not medically necessary for the certified health condition. Appeals are specific to the type of decision rendered. A comprehensive discussion of the appeals process may be found at www.cdc.gov/wtc/appeals.html.

Summaries of the appeals processes may be found in Chapter 2, Eligibility and Enrollment, for denials of enrollment and disenrollments; Chapter 3, Certification of Health Conditions, for denials of certification of a health condition and decertification; and Chapter 4, Medical Benefits, for denial of treatment authorization. Appendix 9-A contains a fact sheet, distributed to any members receiving a denial decision for certification of a health condition, which outlines the appeals process.

9. Member Concerns

Member concerns are addressed through a variety of mechanisms. In addition to the regular communication channels available to members (described above) through which concerns may be expressed, the Program also hears concerns through ad hoc meetings with stakeholders and community groups and via individual communications on a case-by-case basis. Because of the close working relationships and frequent communication between the Program and member groups, the Program has multiple, regular opportunities to identify and address member concerns. Member concerns are also reviewed through congressional inquiries and through letters sent by members directly to the Program or to the Administrator.

Appendix

9-A—An Overview of the Appeal Process for Denial of Health Condition Certification

Chapter 9—Fraud, Waste, and Abuse

Chapter 10—Governmental Affairs

1. Purpose and Scope

The purpose of this chapter is to describe the relationships and actions among the World Trade Center (WTC) Health Program, other parts of the National Institute for Occupational Safety and Health (NIOSH), the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), and other government agencies. The WTC Health Program is responsible for providing health care benefits according to the provisions of the Zadroga Act, including those provisions related to WTC Health Program member eligibility, enrollment, benefits, and responsibility for determining the payment amounts to be disbursed. The Administrator, Centers for Medicare & Medicaid Services (CMS), is responsible for disbursing payment for the program. Administration of the WTC Health Program involves cooperation and coordination with HHS and other government agencies, some of which are specified in the Zadroga Act. The WTC Health Program must also cooperate with, and respond to, program oversight evaluations and audits performed by the Government Accountability Office (GAO) and HHS Office of the Inspector General (IG). In addition, the WTC Health Program collaborates with other 9/11 programs such as the September 11th Victim Compensation Fund (VCF) administered by the Department of Justice.

2. Oversight and Counsel

1. Department of Health and Human Services

   1. Office of the Inspector General (IG) (The Zadroga Act, 42 U.S.C. § 300mm(d))

      Responsibility:
      The Zadroga Act requires the HHS Office of the Inspector General (IG) to manage certain oversight responsibilities, including the review of the WTC Health Program health care expenditures to detect fraudulent or duplicate billing and payment for inappropriate services, as well as the review of the WTC Health Program for unreasonable administrative costs, including with respect to infrastructure, administration and claims processing. In addition, the IG can initiate a review, not specifically required by the Zadroga Act, of other components of the WTC Health Program.

      Activity:
      In August 2011, the HHS IG initiated an audit to review the WTC Health Program’s controls for awarding and monitoring the Clinical Centers of Excellence (CCEs) and determine whether the CCEs’ financial systems can provide reliable financial and performance data, including medical service claims data. As of July 2013, the results of this review had not yet been published.

   2. Office of the General Counsel (OGC)
      

      The Office of the General Counsel (OGC) provides representation and legal advice for the Department of Health and Human Services (HHS). OGC supports the development and implementation of the Department's programs by providing legal services to the Secretary of HHS and the organization's various agencies and divisions. OGC provides legal support and assistance to the WTC Health Program to ensure the Program is administered in accordance with the Zadroga Act and other applicable Federal laws and regulations.

2. Government Accountability Office (GAO) (Exhibit 1, 42 U.S.C. § 300mm-4 and § 300mm-22)

   Responsibility:
   The Zadroga Act required the Comptroller General to submit an analysis to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate no later than July 1, 2011 on whether the Centers for Clinical Excellence (CCEs) have financial systems that allow for the timely submission of claims data (Exhibit 1, 42 U.S.C. § 300mm-4(d)). In addition, the Zadroga Act requires the GAO to study feasibility, efficiency and effectiveness issues related to the WTC Health Program, including:

   1. The feasibility of the WTC Health Program using one consolidated data center rather than multiple data centers (Exhibit 1, 42 U.S.C. § 300mm-4(a)(5));
   2. Whether the Department of Veterans Affairs (VA) can provide monitoring and treatment services to WTC Health Program members outside the New York metropolitan area more efficiently and effectively than the nationwide provider network (Exhibit 1, 42 U.S.C. § 300mm-23(d)(2));
   3. Whether use of an existing federal prescription drug purchasing program would provide member prescription drugs benefits more efficiently and effectively than through the WTC Health Program (Exhibit 1, 42 U.S.C. § 300mm-22(c)(1)(B)(iv)).

   The GAO, like the IG, can also initiate a review, not specifically required by the Zadroga Act, of other components of the WTC Health Program.

   Activity:
   The Zadroga Act required GAO to report by July 1, 2011, on whether the CCEs under contract with the WTC Program Administrator hadfinancial systems that would allow for the timely submission of health care claims data as envisioned by the act. According to the WTC Program Administrator’s CCE contract awards schedule, the Administrator would not have awarded any contracts with the CCEs until at least June 30, 2011. Therefore, they could not perform a review of CCE contractors’ financial systems because no CCE contractors were in place to assess by July 1, 2011. On July 15, 2011, GAO issued a briefing that focused on (1) the CDC/NIOSH schedule for awarding contracts to the CCEs, (2) health care claims data for the CCEs and planned procedures, and (3) the Administrator’s plans for evaluating each CCE system’s health care claims data capabilities during and after the award of the contracts. (Exhibit 3)

   The results of the briefing found that:

   1. Schedule for awarding contracts to the CCEs
      • At the time of review, CDC/NIOSH officials were pursuing a CCE contract awards schedule driven by the Zadroga Act’s implementation date of July 1, 2011, and anticipated awarding multiple cost-plus, fixed-free contracts for the CCEs on June 30, 2011.
      • As of June 21, 2011, all acquisition milestone dates had been met and subsequent to the GAO briefing, CDC awarded seven CCE contracts on July 1, 2011.
   2. Health Care claims data for the CCEs and planned procedures
      • The WTC Program Administrator plans to develop program-wide procedures to be used by the CCEs for collecting and reporting of health care claims data after the program is implemented and the CCEs begin submitting health care claims for payment.
      • CCEs will be expected to use the CMS 1500 form, or a similar form, to collect the needed health care claims data.
      • CCEs will be expected to electronically submit, within specified timeframes, all valid health care claims for payment. Each CCE is required to implement a quality assurance program that includes a review of all health claims forms for completeness and accuracy before the claims are submitted.
   3. Administrator’s plans for evaluating each CCE system’s health care claims data capabilities
      • The compressed CCE contract awards schedule could not accommodate site visits by NIOSH personnel or personnel from an outside entity, such as the Defense Contract Audit Agency (DCAA), to assess potential CCEs’ financial systems’ health care claims data capabilities.
      • NIOSH officials may consider having DCAA assess the CCEs’ financial systems after the contracts are awarded.
      • The WTC Program Administrator plans to establish procedures to randomly monitor and/or periodically inspect a CCE’s compliance with the timely submission of health care claims data as part of assessing a CCE’s contract performance.

   On August 4, 2011, GAO issued its report regarding (1) the consolidated data center, (2) the use of VA health care facilities for members living outside the New York metropolitan area, and (3) the use of an existing federal prescription drug purchasing program. (Exhibit 2) While the GAO report did not offer any formal recommendations, its analysis stated that:

   1. Consolidated data center
      • A consolidated data center could lead to cost savings and enhanced research opportunities; however, consolidation could require upfront expenditures.
      • A consolidated data center could result in loss of responders’ clinical data from the WTC Health Program because of the potential need to have responders sign new consent forms to enable use of their data for research.
   2. Use of VA health care facilities
      • Use of VA facilities for the WTC Health Program could affect access to health services for members because not all types of clinical expertise are available at all VA facilities, VA facilities do not always have space available to serve nonveterans, and it would take an undetermined length of time to implement an agreement between VA and HHS.
      • Use of VA facilities for the WTC Health Program could affect retention for a number of reasons because WTC Health Program members might need to change health care providers. For example, members may be required to receive medical care from a particular physician who the member does not wish to see.
   3. Use of an existing federal prescription drug purchasing program
      • Use of an existing federal prescription drug purchasing program to provide prescriptions to WTC Health Program members could reduce drug prices. It might also affect the availability of options for filling prescriptions and members’ access to certain prescription drugs, such as the administration of the generic over brand -name versions of a particular drug.
      • Use of drug purchasing programs, such as those of the VA and the Department of Defense, for WTC Health Program members would require administrative changes to their programs.

   On July 23, 2014, the GAO completed an audit on the WTC Health Program's approach to add cancers to the list of WTC-covered conditions (See Exhibit 4). The main objectives of this audit were:

   1. To determine the extent to which the methodology used by the WTC Program Administrator for adding certain cancers to the program’s list of covered conditions is comprehensive and balanced
   2. To determine the extent to which the scientific and medical evidence used to support expansion of the WTC Health Program’s list of covered conditions suggests that the cancers added to the program may result from an exposure to the 9/11 attacks
   3. To determine the potential effects of coverage additions on the WTC Health Program and the September 11th Victim Compensation Fund

3. Grants and Contract Management

1. Department of Health and Human Services
   1. Centers for Disease Control and Prevention (CDC)
      1. Office of the Director

         The Director of CDC oversees CDC/NIOSH responsibilities under the WTC Health Program. CDC Office of the Director staff, as well as other CDC Offices as appropriate, are involved in reviewing performance plans, documenting progress, identifying risks, and interceding as necessary to ensure the highest standards of performance.

      2. Procurement and Grants Office (PGO)

         The CDC Procurement and Grants Office provides assistance with acquisitionand related activities to enable the centers, institutes, and offices at CDC to implement health-related programs, initiatives, and acquisitions. PGO is the only entity within CDC which can obligate federal funds. PGO contributes to the implementation of initiatives and acquisitions related to the WTC Health Program through non-programmatic management for all Program financial assistance (grants and cooperative agreements) and contract activities.

      3. National Institute for Occupational Safety and Health (NIOSH)
         1. Office of Extramural Programs (OEP)

            The NIOSH Office of Extramural Programs (OEP) facilitates the management of extramural grant and cooperative agreement portfolios. OEP is located within the NIOSH Office of the Director under the direction of the Associate Director for Research Integration and Extramural Performance. OEP manages the extramural portfolio of cooperative agreements for all NIOSH activities, including the WTC Health Program. OEP, in coordination with the WTC Health Program, facilitates the solicitation, review, and issuance of cooperative agreements related to the September 11th terrorist attacks. This portfolio includes the awards for the WTC Health Registry, research projects, and outreach and education activities (Exhibit 1, 42 U.S.C. §§ 300mm-2, 300mm-51, 300mm-52).

4. Eligibility and Enrollment

1. Department of Health and Human Services (HHS)
   1. Centers for Disease Control and Prevention (CDC) and National Institute for Occupational Safety and Health (NIOSH)

      Responsibility:
      The Secretary of HHS delegated authority to the WTC Health Program to assume enrollment and eligibility functions (Exhibit 5). Required eligibility and enrollment activities that were delegated under the Zadroga Act include:

      • Establishing and conducting a procedure to enroll individuals who meet eligibility requirements as WTC responders or survivors (42 U.S.C. §§ 300mm-21(a)(3)(A), 300mm-31(a)(1)(C)(i));
      • Screening applicants prior to enrollment against the terrorist watch list (42 U.S.C. §§ 300mm-21(a)(5), 300mm-31(a)(4)) (see next section, b. (Department of Homeland Security (DHS)/Department of Justice (DOJ)); and
      • Setting up an appropriate appeal process for applicants denied enrollment (42 U.S.C. §§ 300mm-21(a)(3)(A)(vi), 300mm-31(a)(1)(C)(i)(IV));

      Activity:
      The procedures and protocols used to perform WTC Health Program eligibility and enrollment functions are detailed in Chapter 2, Eligibility and Enrollment. The procedures and protocols used to perform Program oversight are detailed in Chapter 12 , Quality Assurance and Program Evaluation.

2. Department of Homeland Security (DHS)/Department of Justice (DOJ) ( 42 U.S.C. §§ 300mm-21(a)(5), 300mm-31(a)(4))
   

   Responsibility:
   The Zadroga Act mandates that any individual who is on the terrorist watch list maintained by the Department of Homeland Security (DHS) be disqualified for eligibility within the WTC Health Program. The Zadroga Act incorrectly states that DHS maintains the terrorist watch list. The Federal Bureau of Investigation (FBI), housed within the Department of Justice (DOJ), administers the Terrorist Screening Center (TSC). As such, the WTC Program Administrator collaborates with the TSC to meet the requirements of the Zadroga Act regarding qualification for enrollment in the WTC Health Program.

   Activity:
   The WTC Health Program established a process to share WTC Health Program member and applicant information with DOJ in order to meet the requirements of the Zadroga Act. The WTC Health Program Contractor prepares a list of new WTC Health Program applicants on a weekly basis and the list is transferred to the TSC. Based on the information provided by the TSC, the applicant is qualified or not qualified for enrollment into the WTC Health Program. Only qualified applicants will be considered for enrollment into the WTC Health Program based on the Program’s eligibility criteria. (See Chapter 2, Eligibility and Enrollment)

5. Payment

1. Centers for Medicare and Medicaid Services (CMS)

   Responsibility:
   The Zadroga Act prohibits NIOSH from making payments for the provision of WTC Health Program health care benefits (Exhibit 1, 42 U.S.C. § 300mm-5(14)(B)).

   Activity:
   The Secretary, HHS, delegated authority for disbursing payments in the WTC Health Program to the Administrator, Centers for Medicare & Medicaid Services (CMS) in May 2011. (Exhibit 5, 76 Fed. Reg. 31337 (May 31, 2011)). The WTC Health Program and CMS established an interagency agreement for this activity. See Chapter 5, Claims Processing, for details regarding the CMS payment function.

2. Department of Labor (DOL) (Exhibit 1, 42 U.S.C. § 300mm-22(c)(1)(A))

   Responsibility:
   As required by the Zadroga Act, the WTC Health program reimburses costs for medically necessary treatment for WTC-related health conditions according to the payment rates that would apply to the provision of such treatment and services by the facility under the Federal Employees Compensation Act (FECA). For treatment for which FECA rates are not available, the WTC Health Program administrator is required to establish a treatment reimbursement rate (Exhibit 6, 42 C.F.R. § 88.16). In no case are the payments for WTC Health Program products or services made at a rate higher than the Office of Worker’s Compensation Programs (OWCP) in DOL would pay for such products or services rendered at the time such products or services were provided.

   Activity:
   The WTC Health Program consulted with DOL to determine the best policies and procedures to reimburse for the provision of health care under the WTC Health Program. Based on those policies and procedures, the WTC Health Program established a system to process WTC Health Program claims, ensuring claims are paid in accordance with the Zadroga Act. In addition to establishing audits to ensure compliance, the WTC Health Program performs periodic retrospective reviews and analyses of claims to audit the Program’s performance. More detailed information regarding claims processing can be found in Chapter 5.

6. Other 9/11- Related Programs

1. Department of Justice (DOJ) September 11th Victim Compensation Fund (VCF) (Exhibit 1, 49 U.S.C. § 40101 note)

   Responsibility:
   Title II of the Zadroga Act reactivates the September 11th Victim Compensation Fund of 2001 (VCF) that operated from 2001-2004 and requires a Special Master, appointed by the Attorney General, to provide compensation for any individual (or a personal representative of a deceased individual) who suffered physical harm or was killed as a result of the terrorist-related aircraft crashes of September 11, 2001 or the debris removal efforts that took place in the immediate aftermath of those crashes. On August 31, 2011, DOJ published a Final Rule regarding the operation of the VCF, as revised by the Zadroga Act, in the Federal Register (76 Fed. Reg. 54112).

   The VCF only provides compensation for losses due to personal physical injury or death. An individual who elects compensation from the VCF waives his or her rights to pursue litigation to seek damages for the physical injury or death resulting from the September 11, 2001 attacks.

   Activity:
   The WTC Health Program assists DOJ as outlined by a Memorandum of Understanding (MOU) between the VCF and the WTC Health Program. With the specific authorization and consent of an individual VCF claimant, the MOU facilitates: 1) for those VCF claimants participating in both the WTC Health Program and the VCF, transmission of the individual’s WTC Health Program medical information, including the WTC Health Program’s decisions regarding certification and authorization for treatment, to the VCF for purposes of facilitating the VCF’s evaluation of the individual’s VCF claims; and 2) for those VCF claimants who do not receive care within the WTC Health Program, review by the WTC Health Program of VCF claimants’ exposure and health information to assist the VCF, for the purposes of making compensation determination, in verifying whether claimants’ health conditions are related to their 9/11 exposures.

Appendices

Chapter 11—Financial Management Quality Assurance Standards

1. Introduction

The financial management quality assurance standards plan is designed to create the framework for achieving and maintaining financial management control and performance standards in the World Trade Center (WTC) Health Program. A well-executed quality assurance standards program creates awareness of performance standards and emphasizes policies and procedures, controls, performance management, performance measurement, efficiency, and guidance measures to prevent waste, fraud, and abuse. In addition, good quality assurance standards provide reasonable assurance that a program’s goals and objectives will be achieved.

2. Purpose

The purpose of this guidance is to create a framework for WTC Health Program financial controls, performance management, and performance measurement. This framework includes five focus areas relevant to financial controls, performance management, and performance measurement. The five focus areas are as follows:

3. Policy Guidance

The WTC Health Program financial controls and policy and procedures guidance was developed to assist Program and financial management in accomplishing fiscal year fund control objectives. This guidance provides fund control procedures and contract clauses for applicable activities for each fiscal year.

The WTC Health Program works with its contractors, the CCEs and the NPN, to provide quality care to WTC Health Program members. As the Federal entity, the WTC Health Program’s governing role is to ensure that the resources dedicated are properly managed and performance is measured against the Program’s goals and mission to improve financial efficiency.

Procedural Guidance

1. Statutory Authority

   Title I of the Zadroga Act amended the Public Health Service Act to add Title XXXIII and established the WTC Health Program within the HHS. In December 2015, Title XXXIII of the Public Health Act was amended by the Reauthorization. The Reauthorization authorized the WTC Health Program through FY 2090.

2. Fiscal Year Spend Plan/Apportionment

   Each Fiscal Year’s Spend plan requires the approval of the OMB before execution.

   Responsibility: Centers for Disease Control and Prevention (CDC)/National Institute for Occupational Safety and Health (NIOSH)/WTC Health Program

3. Awards

   Once the Spend Plan is approved by OMB, the Grants Management Officer (GMO) and Contracting Officer (CO) can begin the process of issuing awards.

   Responsibility: OFR/WTC Health Program

4. Personnel

   Personnel projections are based on program priorities and are also subject to the availability of funds.

   Responsibility: NIOSH/WTC Health Program

5. Governance

   NIOSH is the responsible Federal entity and must exercise sound stewardship of appropriated funds.

   Responsibility: NIOSH/WTC Health Program/OFR

6. Performance

   The WTC Health Program’s overall performance is measured by how effectively and efficiently the Zadroga Act’s and Reauthorization’s requirements were executed.

   Responsibility: NIOSH/WTC Health Program

7. Reports

   The Zadroga Act requires the WTC Health Program to submit annual reports to Congress. OMB requires monthly report submissions.

   Responsibility: NIOSH/WTC Health Program

8. Close out

   All awards must be closed out at the end of their performance period.

   Responsibility: NIOSH/WTC Health Program

Chapter 12—Pharmacy Benefits

Note:
The World Trade Center Health Program has a new Pharmacy Benefit Manager (PBM), Express Scripts, as of June 1, 2022, and some of the PBM policies have updated with this change. This section is currently being updated. In the meantime, please visit the Program Pharmacy Page, the Coordination of Benefits page, and our FAQ page for current information about WTC Health Program pharmacy benefits. For more detailed questions, please call our help line at 1-888-982-4748.