2024-04901. Reorganization of the National Institute for Occupational Safety and Health

AGENCY:

Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

CDC has modified its structure. This notice announces the reorganization of the World Trade Center (WTC) Health Program within the National Institute for Occupational Safety and Health (NIOSH). The WTC Health Program has established three branches.

DATES:

This reorganization was approved by the HHS Secretary on March 4, 2024, and became effective.

FOR FURTHER INFORMATION CONTACT:

D'Artonya Graham, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Office of the Director, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS TW–2, Atlanta, GA 30329; Telephone [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772–76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at Vol. 88, No. 132, pg. 44359–44363, dated July 12, 2023) is amended to reflect the reorganization of the World Trade Center (WTC) Health Program, National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Specifically, the changes are as follows:

I. Under Part C, Section C–B, Organization and Functions, insert the following:

• Office of the Director (CCP1)
• Healthcare Benefits Branch (CCPB)
• Research and Evaluation Branch (CCPC)
• Business Operations Branch (CCPD)

II. Under Part C, Section C–B, Organization and Functions, after the World Trade Center Health Program (CCP) insert the following:

Office of the Director (CCP1). Conducts the legislatively mandated World Trade Center (WTC) Health Program established by the James Zadroga 9/11 Health and Compensation Act of 2010, as amended. (1) Provides management, strategic planning and oversight, budget formulation and execution, science and medical policy oversight and development, industry expertise, and contract transition oversight; (2) consults with stakeholders in carrying out the WTC Health Program mission, develops and disseminates all WTC Health Program communications, and provides oversight for public relations and media strategy; and (3) oversees all program statutory directives in the Zadroga Act to provide medical monitoring and treatment to eligible responders and survivors who were affected by the September 11, 2001, terrorist attacks.

Healthcare Benefits Branch (CCPB). The Healthcare Benefits Branch confirms eligibility for Program benefits and implements a limited health benefits model to provide quality and compassionate medically necessary treatment and monitoring of WTC-related health conditions to eligible members in the WTC Health Program. Specifically, the branch: (1) develops recommendations for the Administrator of the WTC Health Program for medical coverage determinations including medically necessary diagnostic, cancer screening, and treatment services allowed under the WTC Health Program; (2) establishes and maintains the pharmaceutical formulary and conducts compliance as well as outlier audits with the Pharmacy Benefit Manager, Clinical Centers of Excellence, and the Nationwide Provider Network vendors; (3) provides subject matter expertise to contracting officer representatives for contracts such as the Clinical Centers of Excellence, Nationwide Provider Network, Cost Avoidance, and Pharmacy Benefit Manager contract statements of work; (4) provides enrollment recommendations to the Administrator of the WTC Health Program for of WTC responders and survivors and Pentagon and Shanksville responders and follows statutory and regulatory requirements and approved process and procedures to enroll members into the WTC Health Program; (5) processes certification of member's WTC-related health conditions eligible for treatment coverage in the WTC Health Program and follows statutory and regulatory requirements and approved processes and procedures to issue certification decisions on behalf of the Administrator of the WTC Health Program; (6) develops medical and pharmacy benefit coverage determinations and issues coverage decisions on prior authorization requests for medical services, durable medical equipment, supplies, and pharmaceuticals; (7) coordinates working groups, such as the Pharmaceutical and Therapeutics Working Group, with stakeholder clinicians for continuing education and alignment with program formulary changes; (8) provides oversight and expertise to Clinical Centers of Excellence and Nationwide Provider Network on case management, care coordination, and utilization management; (9) designs and manages the medical diagnosis and procedural services codebook, which supports benefit access for covered conditions and approved services with utilization limitations; (10) supports members through customer support and by coordinating and managing call centers, issues written member correspondence, and supports member transfers; (11) coordinates, on behalf of the Administrator of the WTC Health Program, certification, enrollment, and treatment appeals following statutory and regulatory requirements and approved processes and procedures; (12) serves as subject matter experts for vendors, particularly for outreach and education vendors on program eligibility and available services; and (13) works with vendors, primarily the Health Program Support/Third Party Administrator vendor and the Centers for Medicare & Medicaid Services (CMS), to ensure providers receive appropriate reimbursement for initial health evaluations, annual medical monitoring, cancer screening, diagnostic services, and treatment of covered health conditions.

Research and Evaluation Branch (CCPC). The Research and Evaluation Branch establishes and manages a research agenda and research translation program to increase understanding of 9/11 health effects as well as to improve WTC Health Program member health and well-being. Specifically, the branch: (1) establishes an evaluation program for quality management and program integrity and improvement; (2) establishes a research agenda to address existing knowledge gaps, investigate the emergence of health conditions linked to 9/11 exposures, and build upon current knowledge for research translation; (3) designs the competitive funding opportunity announcements in coordination with the NIOSH Office of Extramural Programs; (4) establishes a process to obtain insight from community members, patients, and other stakeholders that helps shape the evolving research agenda over time; (5) conducts reviews—through assessing and integrating data sources—to identify research gaps, using the Program's logic model on research translation; (6) reviews and assesses information on potential emerging conditions that should be further evaluated and utilizes research solicitations in doing so; (7) conducts scientific reviews of the literature to determine if new health conditions, including those petitioned by interested parties, should be recommended to the Administrator of the WTC Health Program for addition to the List of WTC-Related Health Conditions; (8) ensures that the WTC database of research publications is maintained and current; (9) aids in administering the statutorily-established WTC Health Program Scientific/Technical Advisory Committee; (10) supports, develops, and implements research products, such as research seminars, science blogs, and a research summary database, to disseminate information about research findings and assist in the translation of those findings to the member healthcare component of the Program; (11) ensures uniform data collection and scientific data integration; supports collaboration between the Data Centers and the WTC Health Registry; and oversees the transfer of member data from the Nationwide Provider Network to the cohort-specific Data Center(s) for inclusion in health surveillance analyses and program-funded research; (12) coordinates and evaluates administrative quality control and enterprise risk management for the WTC Health Program; (13) implements the WTC Health Program's approved processes and procedures to identify and address fraud, waste, and abuse; (14) provides subject matter expertise for administrative and clinical quality metrics for the Clinical Centers of Excellence, the Nationwide Provider Network, and the Pharmacy Benefit Manager contract statements of work; (15) ensures the 9/11 exposure-based WTC Health Registry is maintained in accordance with statutory requirements and that appropriate analysis plans are implemented; and (16) provides subject matter expertise for the WTC Health Program annual report to Congress and government audits of the WTC Health Program.

Business Operations Branch (CCPD). The Business Operations Branch leads strategic acquisition planning as well as the development and dissemination of technical documentation to support the division. Specifically, the branch: (1) improves the WTC Health Program's efficiency through process improvement and solution development and workforce management and development; (2) oversees training, project management, and travel; (3) develops and oversees acquisition and procurement strategy, the acquisition plan and performance work statements for contract awards—for the Clinical Centers of Excellence, Data Centers, Nationwide Provider Network, Pharmacy Benefit Manager, Health Program Support/Third Party Administrator, and for other support contracts—to carry out the mission of the WTC Health Program in coordination with the CDC Office of Acquisitions; (4) manages the reimbursement of the Clinical Centers of Excellence and the Nationwide Provider Network for infrastructure costs, the Data Centers, Pharmacy Benefit Manager, Health Program Support/Third Party Administrator, and other support contracts; (5) implements agreement with New York City for purposes of collecting 10% of specified Program expenses, in accordance with the authorizing legislation; (6) administers and/or collects recoupments from private insurance and workers compensation; (7) enters into agreement(s) with CMS for provider reimbursements; (8) ensures all requirements pursuant to the Health Information Portability and Accountability Act (HIPAA) and implementing regulations are followed and coordinates implementation of approved processes and procedures to ensure member information is securely transmitted and used in alignment with both HIPAA and the Privacy Act; (9) ensures compliance with all records management requirements and that WTC Health Program data and records are maintained in alignment with agency and National Archives and Records Administration requirements; and (10) provides expertise to the division on process improvement and use of technology and business solutions to meet the division's missions.

Delegations of Authority

All delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegation, provided they are consistent with this reorganization.

(Authority: 44 U.S.C. 3101)

Xavier Becerra,

Secretary, Department of Health and Human Services.