§300mm–4 — Title 42 The Public Health and Welfare | U.S. Code

Summary

The WTC Program Administrator must hire Clinical Centers of Excellence and one or more Data Centers to run the WTC Health Program. Clinical Centers must provide monitoring, treatment, and initial health exams; do outreach and keep people in care; give counseling about program benefits and other benefits like workers’ compensation or insurance; offer translation and interpretation; and collect and report data under the rules in section 300mm–3. They must consult with patients, coordinate WTC care with regular medical care, have fraud safeguards reviewed with the HHS Inspector General, protect patients’ private health information (including not giving it to an employer without permission), treat or refer enrolled responders or certified survivors, use trained occupational and environmental medicine providers for exams, communicate in the right languages, and meet other program rules. Contracts can cover different classes of responders or survivors and may be cooperative agreements. The Administrator must also hire Data Centers to gather, analyze, and report clinical data, develop clinical protocols, coordinate outreach and credentialing, run steering committee work, meet regularly with Clinical Centers, and make data available under the CDC/ATSDR Policy on Releasing and Sharing Data. Medical providers for credentialing must be chosen for their experience treating the listed WTC-related conditions. A Clinical Center of Excellence is a health center that provides a coordinated set of WTC services and has staff experienced with WTC patients. A Data Center is a center that can do the data work the Administrator assigns. The Administrator must pay Clinical Centers a negotiated, fair rate for fixed infrastructure costs (like outreach, data work, social services, and protocol development, but not new construction). By July 1, 2011, the Comptroller General had to report on whether Data Centers should be merged and whether Clinical Centers’ financial systems can submit claims data on time.

Title 42, §300mm–4

The Public Health and Welfare — Source: USLM XML via OLRC

(a)(1)The WTC Program Administrator shall, subject to subsection (b)(1)(B), enter into contracts with Clinical Centers of Excellence (as defined in subsection (b)(1)(A))—

(A)for the provision of monitoring and treatment benefits and initial health evaluation benefits under part B;

(B)for the provision of outreach and retention activities to individuals eligible for such monitoring and treatment benefits, for initial health evaluation benefits, and for followup to individuals who are enrolled in the monitoring program;

(C)for the provision of counseling for benefits under part B, with respect to WTC-related health conditions, for individuals eligible for such benefits;

(D)for the provision of counseling for benefits for WTC-related health conditions that may be available under workers’ compensation or other benefit programs for work-related injuries or illnesses, health insurance, disability insurance, or other insurance plans or through public or private social service agencies and assisting eligible individuals in applying for such benefits;

(E)for the provision of translational and interpretive services for program participants who are not English language proficient; and

(F)for the collection and reporting of data, including claims data, in accordance with section 300mm–3 of this title.

(2)(A)The WTC Program Administrator shall enter into contracts with one or more Data Centers (as defined in subsection (b)(2))—

(i)for receiving, analyzing, and reporting to the WTC Program Administrator on data, in accordance with section 300mm–3 of this title, that have been collected and reported to such Data Centers by the corresponding Clinical Centers of Excellence under subsection (b)(1)(B)(iii);

(ii)for the development of monitoring, initial health evaluation, and treatment protocols, with respect to WTC-related health conditions;

(iii)for coordinating the outreach and retention activities conducted under paragraph (1)(B) by each corresponding Clinical Center of Excellence;

(iv)for establishing criteria for the credentialing of medical providers participating in the nationwide network under section 300mm–23 of this title;

(v)for coordinating and administering the activities of the WTC Health Program Steering Committees established under section 300mm–1(b) 11 See References in Text note below. of this title; and

(vi)for meeting periodically with the corresponding Clinical Centers of Excellence to obtain input on the analysis and reporting of data collected under clause (i) and on the development of monitoring, initial health evaluation, and treatment protocols under clause (ii).

(B)The medical providers under subparagraph (A)(iv) shall be selected by the WTC Program Administrator on the basis of their experience treating or diagnosing the health conditions included in the list of WTC-related health conditions.

(C)In carrying out subparagraph (A)(ii), a Data Center shall engage in clinical discussions across the WTC Program to guide treatment approaches for individuals with a WTC-related health condition.

(D)A contract entered into under this subsection with a Data Center shall require the Data Center to make any data collected and reported to such Center under subsection (b)(1)(B)(iii) available to health researchers and others as provided in the CDC/ATSDR Policy on Releasing and Sharing Data.

(3)A contract entered into under this subsection with a Clinical Center of Excellence or a Data Center may be with respect to one or more class of enrolled WTC responders, screening-eligible WTC survivors, or certified-eligible WTC survivors.

(4)Any contract under this subchapter between the WTC Program Administrator and a Data Center or a Clinical Center of Excellence may be in the form of a cooperative agreement.

(5)Not later than July 1, 2011, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the feasibility of consolidating Data Centers into a single Data Center.

(b)(1)(A)For purposes of this subchapter, the term “Clinical Center of Excellence” means a Center that demonstrates to the satisfaction of the Administrator that the Center—

(i)uses an integrated, centralized health care provider approach to create a comprehensive suite of health services under this subchapter that are accessible to enrolled WTC responders, screening-eligible WTC survivors, or certified-eligible WTC survivors;

(ii)has experience in caring for WTC responders and screening-eligible WTC survivors or includes health care providers who have been trained pursuant to section 300mm–23(c) of this title;

(iii)employs 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

(iv)meets such other requirements as specified by the Administrator.

(B)The WTC Program Administrator shall not enter into a contract with a Clinical Center of Excellence under subsection (a)(1) unless the Center agrees to do each of the following:

(i)Establish a formal mechanism for consulting with and receiving input from representatives of eligible populations receiving monitoring and treatment benefits under part B from such Center.

(ii)Coordinate monitoring and treatment benefits under part B with routine medical care provided for the treatment of conditions other than WTC-related health conditions.

(iii)Collect and report to the corresponding Data Center data, including claims data, in accordance with section 300mm–3(b) of this title.

(iv)Have in place safeguards against fraud that are satisfactory to the Administrator, in consultation with the Inspector General of the Department of Health and Human Services.

(v)Treat or refer for treatment all individuals who are enrolled WTC responders or certified-eligible WTC survivors with respect to such Center who present themselves for treatment of a WTC-related health condition.

(vi)Have in place safeguards, consistent with section 300mm–3(d) of this title, to ensure the confidentiality of an individual’s individually identifiable health information, including requiring that such information not be disclosed to the individual’s employer without the authorization of the individual.

(vii)Use amounts paid under subsection (c)(1) only for costs incurred in carrying out the activities described in subsection (a), other than those described in subsection (a)(1)(A).

(viii)Utilize health care providers with occupational and environmental medicine expertise to conduct physical and mental health assessments, in accordance with protocols developed under subsection (a)(2)(A)(ii).

(ix)Communicate with WTC responders and screening-eligible and certified-eligible WTC survivors in appropriate languages and conduct outreach activities with relevant stakeholder worker or community associations.

(x)Meet all the other applicable requirements of this subchapter, including regulations implementing such requirements.

(C)The WTC Program Administrator shall to the maximum extent feasible ensure continuity of care in any period of transition from monitoring and treatment of an enrolled WTC responder or certified-eligible WTC survivor by a provider to a Clinical Center of Excellence or a health care provider participating in the nationwide network under section 300mm–23 of this title.

(2)For purposes of this subchapter, the term “Data Center” means a Center that the WTC Program Administrator determines has the capacity to carry out the responsibilities for a Data Center under subsection (a)(2).

(3)For purposes of this subchapter, a Clinical Center of Excellence and a Data Center shall be treated as “corresponding” to the extent that such Clinical Center and Data Center serve the same population group.

(c)(1)The WTC Program Administrator shall reimburse a Clinical Center of Excellence for the fixed infrastructure costs of such Center in carrying out the activities described in part B at a rate negotiated by the Administrator and such Centers. Such negotiated rate shall be fair and appropriate and take into account the number of enrolled WTC responders receiving services from such Center under this subchapter.

(2)For purposes of paragraph (1), the term “fixed infrastructure costs” means, with respect to a Clinical Center of Excellence, the costs incurred by such Center that are not otherwise reimbursable by the WTC Program Administrator under section 300mm–22(c) of this title for patient evaluation, monitoring, or treatment but which are needed to operate the WTC program such as the costs involved in outreach to participants or recruiting participants, data collection and analysis, social services for counseling patients on other available assistance outside the WTC program, and the development of treatment protocols. Such term does not include costs for new construction or other capital costs.

(d)Not later than July 1, 2011, the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate an analysis on whether Clinical Centers of Excellence with which the WTC Program Administrator enters into a contract under this section have financial systems that will allow for the timely submission of claims data for purposes of section 300mm–3 of this title and subsections (a)(1)(F) and (b)(1)(B)(iii).

Notes & Related Subsidiaries

Editorial Notes

References in Text

section 300mm–1(b) of this title, referred to in subsec. (a)(2)(A)(v), was in the original “section 3002(b)” and was translated as meaning section 3302(b) of act July 1, 1944, to reflect the probable intent of Congress.

Amendments

2015—Subsec. (a)(1)(B). Pub. L. 114–113, § 302(c)(1)(A), inserted “and retention” after “outreach”. Subsec. (a)(2)(A)(iii). Pub. L. 114–113, § 302(c)(1)(B), inserted “and retention” after “outreach”. Subsec. (b)(1)(B)(vi). Pub. L. 114–113, § 302(c)(2), substituted “section 300mm–3(d)” for “section 300mm–3(c)”.

§300mm–4 Clinical Centers of Excellence and Data Centers