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

#### (a) In general

#### (1) Contracts with Clinical Centers of Excellence

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) Contracts with Data Centers

#### (A) In general

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) 1 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) Medical provider selection

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) Clinical discussions

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) Transparency of data

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) Authority for contracts to be class specific

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) Use of cooperative agreements

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) Review on feasibility of consolidating Data Centers

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) Centers of Excellence

#### (1) Clinical Centers of Excellence

#### (A) Definition

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) Contract requirements

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) Transition rule to ensure continuity of care

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) Data Centers

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) Corresponding centers

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) Payment for infrastructure costs

#### (1) In general

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) Fixed infrastructure costs

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) GAO analysis

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).

(July 1, 1944, ch. 373, title XXXIII, §3305, as added Pub. L. 111–347, title I, §101, Jan. 2, 2011, 124 Stat. 3630; amended Pub. L. 114–113, div. O, title III, §302(c), Dec. 18, 2015, 129 Stat. 2998.)

#### **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)".

1 See References in Text note below.