42 U.S.C. § 300mm–4 — Clinical Centers of Excellence and Data Centers

(a) In general: (1) Contracts with Clinical Centers of Excellence — the Administrator must contract with Clinical Centers of Excellence (defined in (b)(1)(A)) to provide: (A) monitoring, treatment, and initial health evaluation benefits; (B) outreach, retention, and followup for eligible and enrolled individuals; (C) counseling on WTC-related health condition benefits; (D) counseling on other benefits that might be available — workers' compensation, health or disability insurance, or public or private social services — and help applying for them; (E) translation and interpretation for people who aren't proficient in English; and (F) collecting and reporting data, including claims data, under section 300mm–3. (2) Contracts with Data Centers — (A) the Administrator must contract with one or more Data Centers (defined in (b)(2)) to (i) receive, analyze, and report data collected by their matching Clinical Centers; (ii) develop monitoring, evaluation, and treatment protocols; (iii) coordinate outreach and retention work across matching Clinical Centers; (iv) set credentialing criteria for providers in the nationwide network under section 300mm–23; (v) coordinate and run the WTC Health Program Steering Committees; and (vi) meet regularly with matching Clinical Centers for input on data analysis and protocol development. (B) The Administrator picks network medical providers under (A)(iv) based on their experience with WTC-related conditions. (C) A Data Center must hold clinical discussions across the Program to guide treatment approaches. (D) A Data Center's contract must require it to share collected data with health researchers and others, following the CDC/ATSDR data-sharing policy. (3) Class-specific contracts — a contract with a Clinical Center or Data Center can cover just one or more categories of responders or survivors. (4) Cooperative agreements — any contract under this subchapter can instead take the form of a cooperative agreement. (5) Review on consolidating Data Centers — by July 1, 2011, the Comptroller General had to report to Congress on whether it made sense to combine the Data Centers into one. (b) Centers of Excellence: (1) Clinical Centers of Excellence — (A) a Center qualifies if it satisfies the Administrator that it (i) uses one coordinated approach to give a full, accessible range of health services; (ii) has experience caring for responders and survivors, or uses providers trained under section 300mm–23(c); (iii) employs staff with expertise in occupational medicine, environmental medicine, trauma-related psychiatry and psychology, and social-services counseling; and (iv) meets any other requirements the Administrator sets. (B) Before contracting, a Center must agree to (i) formally consult with people who use its services; (ii) coordinate WTC-related care with a patient's routine medical care; (iii) collect and report data to its Data Center; (iv) have anti-fraud safeguards acceptable to the Administrator and the HHS Inspector General; (v) treat or refer anyone eligible who shows up for treatment of a WTC-related condition; (vi) protect the confidentiality of health information, including never disclosing it to a patient's employer without the patient's permission; (vii) spend payments received under (c)(1) only on the activities in subsection (a), other than actual monitoring or treatment; (viii) use occupational and environmental medicine providers to run physical and mental health assessments; (ix) communicate in appropriate languages and do outreach with relevant community and worker groups; and (x) meet every other applicable requirement, including any regulations. (C) The Administrator must, as much as reasonably possible, keep care continuous when a responder or survivor moves from one provider to a Clinical Center of Excellence or a nationwide-network provider. (2) Data Centers — a Center qualifies as a Data Center if the Administrator decides it can handle a Data Center's responsibilities under (a)(2). (3) Corresponding centers — a Clinical Center and a Data Center "correspond" to each other when they serve the same population group. (c) Payment for infrastructure costs: (1) The Administrator must reimburse a Clinical Center's fixed infrastructure costs at a fair rate negotiated between the Administrator and the Center, taking into account how many enrolled responders the Center serves. (2) "Fixed infrastructure costs" means costs the Center isn't already reimbursed for under section 300mm–22(c) for actual patient evaluation, monitoring, or treatment, but that it still needs to run the WTC program — such as outreach, recruiting participants, data collection and analysis, counseling patients on other outside assistance, and developing treatment protocols. This does not include new construction or other capital costs. (d) GAO analysis: By July 1, 2011, the Comptroller General had to analyze and report to Congress on whether the contracted Clinical Centers of Excellence have financial systems good enough to submit claims data on time, as required by section 300mm–3 and subsections (a)(1)(F) and (b)(1)(B)(iii).