42 USC 300 - Clinical Centers of Excellence and Data Centers

Collapse to view only § 300mm-4. Clinical Centers of Excellence and Data Centers

§ 300mm. Establishment of World Trade Center Health Program
§ 300mm-1. WTC Health Program Scientific/Technical Advisory Committee; WTC Health Program Steering Committees
§ 300mm-2. Education and outreach
§ 300mm-3. Uniform data collection and analysis
§ 300mm-4. Clinical Centers of Excellence and Data Centers
§ 300mm-5. Definitions

§ 300mm. Establishment of World Trade Center Health Program

(a) In general

There is hereby established within the Department of Health and Human Services a program to be known as the World Trade Center Health Program, which shall be administered by the WTC Program Administrator, to provide beginning on July 1, 2011—

(1) medical monitoring and treatment benefits to eligible emergency responders and recovery and cleanup workers (including those who are Federal employees) who responded to the September 11, 2001, terrorist attacks; and

(2) initial health evaluation, monitoring, and treatment benefits to residents and other building occupants and area workers in New York City who were directly impacted and adversely affected by such attacks.

(b) Components of program

The WTC Program includes the following components:

(1) Medical monitoring for responders

(2) Initial health evaluation for survivors

(3) Followup monitoring and treatment for WTC-related health conditions for responders and survivors

(4) Outreach

(5) Clinical data collection and analysis

(6) Research on health conditions

(d) Preventing fraud and unreasonable administrative costs

(1) Fraud

(2) Unreasonable administrative costs

(e) Quality assurance

The WTC Program Administrator working with the Clinical Centers of Excellence shall develop and implement a quality assurance program for the monitoring and treatment delivered by such Centers of Excellence and any other participating health care providers. Such program shall include—

(1) adherence to monitoring and treatment protocols;

(2) appropriate diagnostic and treatment referrals for participants;

(3) prompt communication of test results to participants; and

(4) such other elements as the Administrator specifies in consultation with the Clinical Centers of Excellence.

(f) Annual program report

(1) In general

(2) Contents included in report

Each annual report under paragraph (1) shall include at least the following:

(A) Eligible individuals

Information for each clinical program described in paragraph (3)—

(i) on the number of individuals who applied for certification under part B and the number of such individuals who were so certified;

(ii) of the individuals who were certified, on the number who received monitoring under the program and the number of such individuals who received medical treatment under the program;

(iii) with respect to individuals so certified who received such treatment, on the WTC-related health conditions for which they were treated; and

(iv) on the projected number of individuals who will be certified under part B in the succeeding fiscal year and the succeeding 10-year period.

(B) Monitoring, initial health evaluation, and treatment costs

For each clinical program so described—

(i) information on the costs of monitoring and initial health evaluation and the costs of treatment and on the estimated costs of such monitoring, evaluation, and treatment in the succeeding fiscal year; and

(ii) an estimate of the cost of medical treatment for WTC-related health conditions that have been paid for or reimbursed by workers’ compensation, by public or private health plans, or by New York City under section 300mm–41 of this title.

(D) Administrative experience

Information on the administrative performance of the program, including—

(i) the performance of the program in providing timely evaluation of and treatment to eligible individuals; and

(ii) a list of the Clinical Centers of Excellence and other providers that are participating in the program.

(E) Scientific reports

(F) Advisory Committee recommendations

(3) Separate clinical programs described

In paragraph (2), each of the following shall be treated as a separate clinical program of the WTC Program:

(A) Firefighters and related personnel

(B) Other WTC responders

(g) Notification to Congress upon reaching 80 percent of eligibility numerical limits

The Secretary shall promptly notify the Congress of each of the following:

(1) When the number of enrollments of WTC responders subject to the limit established under section 300mm–21(a)(4) of this title has reached 80 percent of such limit.

(2) When the number of certifications for certified-eligible WTC survivors subject to the limit established under section 300mm–31(a)(3) of this title has reached 80 percent of such limit.

(h) Consultation

(i) GAO studies

(1) Report

Not later than 18 months after December 18, 2015, 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 that assesses, with respect to the WTC Program, the effectiveness of each of the following:

(A) The quality assurance program developed and implemented under subsection (e).

(B) The procedures for providing certifications of coverage of conditions as WTC-related health conditions for enrolled WTC responders under section 300mm–22(b)(2)(B)(iii) of this title and for screening-eligible WTC survivors and certified-eligible WTC survivors under such section as applied under section 300mm–32(a) of this title.

(C) Any action under the WTC Program to ensure appropriate payment (including the avoidance of improper payments), including determining the extent to which individuals enrolled in the WTC Program are eligible for workers compensation or sources of health coverage, ascertaining the liability of such compensation or sources of health coverage, and making recommendations for ensuring effective and efficient coordination of benefits for individuals enrolled in the WTC Program that does not place an undue burden on such individuals.

(2) Subsequent assessments

Not later than 6 years and 6 months after December 18, 2015, and every 5 years thereafter through fiscal year 2042, the Comptroller General of the United States shall—

(A) consult the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the objectives in assessing the WTC Program; and

(B) prepare and submit to such Committees a report that assesses the WTC Program for the applicable reporting period, including the objectives described in subparagraph (A).

(j) Regulations

(k) Termination

(July 1, 1944, ch. 373, title XXXIII, § 3301, as added Pub. L. 111–347, title I, § 101, Jan. 2, 2011, 124 Stat. 3624; amended Pub. L. 114–113, div. O, title III, § 302(b), Dec. 18, 2015, 129 Stat. 2998; Pub. L. 117–328, div. FF, title VII, § 7702(c), Dec. 29, 2022, 136 Stat. 5967.)

§ 300mm–1. WTC Health Program Scientific/Technical Advisory Committee; WTC Health Program Steering Committees

(a) Advisory Committee

(1) Establishment

(2) Composition

The WTC Program Administrator shall appoint the members of the Advisory Committee and shall include at least—

(A) 4 occupational physicians, at least 2 of whom have experience treating WTC rescue and recovery workers;

(B) 1 physician with expertise in pulmonary medicine;

(D) 2 representatives of WTC responders;

(E) 2 representatives of certified-eligible WTC survivors;

(F) an industrial hygienist;

(G) a toxicologist;

(H) an epidemiologist; and

(I) a mental health professional.

(3) Meetings

(4) Reports

(5) Duration

(6) Application of chapter 10 of title 5

(b) WTC Health Program Steering Committees

(1) Consultation

The WTC Program Administrator shall consult with 2 steering committees (each in this section referred to as a “Steering Committee”) that are established as follows:

(A) WTC Responders Steering Committee

(B) WTC Survivors Steering Committee

(2) Membership

(A) WTC Responders Steering Committee

(i) Representation

The WTC Responders Steering Committee shall include—

(I) representatives of the Centers of Excellence providing services to WTC responders;(II) representatives of labor organizations representing firefighters, police, other New York City employees, and recovery and cleanup workers who responded to the September 11, 2001, terrorist attacks; and(III) 3 representatives of New York City, 1 of whom will be selected by the police commissioner of New York City, 1 by the health commissioner of New York City, and 1 by the mayor of New York City.

(ii) Initial membership

(B) WTC Survivors Steering Committee

(i) Representation

The WTC Survivors Steering Committee shall include representatives of—

(I) the Centers of Excellence providing services to screening-eligible and certified-eligible WTC survivors;(II) the population of residents, students, and area and other workers affected by the September 11, 2001, terrorist attacks;(III) screening-eligible and certified-eligible survivors receiving initial health evaluations, monitoring, or treatment under subpart 2 of part B and organizations advocating on their behalf; and(IV) New York City.

(ii) Initial membership

(D) Vacancies

(July 1, 1944, ch. 373, title XXXIII, § 3302, as added Pub. L. 111–347, title I, § 101, Jan. 2, 2011, 124 Stat. 3627; amended Pub. L. 117–286, § 4(a)(247), Dec. 27, 2022, 136 Stat. 4333.)

§ 300mm–2. Education and outreachThe WTC Program Administrator shall institute a program that provides education and outreach on the existence and availability of services under the WTC Program. The outreach and education program—

(1) shall include—

(A) the establishment of a public Web site with information about the WTC Program;

(B) meetings with potentially eligible populations;

(D) the establishment of phone information services; and

(2) shall be conducted in a manner intended—

(A) to reach all affected populations; and

(B) to include materials for culturally and linguistically diverse populations.

(July 1, 1944, ch. 373, title XXXIII, § 3303, as added Pub. L. 111–347, title I, § 101, Jan. 2, 2011, 124 Stat. 3629.)

§ 300mm–3. Uniform data collection and analysis

(a) In general

(b) Coordinating through Centers of Excellence

(d) Privacy

(July 1, 1944, ch. 373, title XXXIII, § 3304, as added Pub. L. 111–347, title I, § 101, Jan. 2, 2011, 124 Stat. 3629.)

§ 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

1 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) Medical provider selection

(D) Transparency of data

(3) Authority for contracts to be class specific

(4) Use of cooperative agreements

(5) Review on feasibility of consolidating Data Centers

(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.

(2) Data Centers

(3) Corresponding centers

(1) In general

(2) Fixed infrastructure costs

(d) GAO analysis

(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.)

§ 300mm–5. DefinitionsIn this subchapter:

(1) The term “aggravating” means, with respect to a health condition, a health condition that existed on September 11, 2001, and that, as a result of exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, requires medical treatment that is (or will be) in addition to, more frequent than, or of longer duration than the medical treatment that would have been required for such condition in the absence of such exposure.

(2) The term “certified-eligible WTC survivor” has the meaning given such term in section 300mm–31(a)(2) of this title.

(3) The terms “Clinical Center of Excellence” and “Data Center” have the meanings given such terms in section 300mm–4 of this title.

(4) The term “enrolled WTC responder” means a WTC responder enrolled under section 300mm–21(a)(3) of this title.

(5) The term “Federal agency” means an agency, office, or other establishment in the executive, legislative, or judicial branch of the Federal Government.

(6) The term “initial health evaluation” includes, with respect to an individual, a medical and exposure history, a physical examination, and additional medical testing as needed to evaluate whether the individual has a WTC-related health condition and is eligible for treatment under the WTC Program.

(7) The term “list of WTC-related health conditions” means—

(A) for WTC responders, the health conditions listed in section 300mm–22(a)(3) of this title; and

(B) for screening-eligible and certified-eligible WTC survivors, the health conditions listed in section 300mm–32(b) of this title.

(8) The term “New York City disaster area” means the area within New York City that is—

(A) the area of Manhattan that is south of Houston Street; and

(B) any block in Brooklyn that is wholly or partially contained within a 1.5-mile radius of the former World Trade Center site.

(9) The term “New York metropolitan area” means an area, specified by the WTC Program Administrator, within which WTC responders and eligible WTC screening-eligible survivors who reside in such area are reasonably able to access monitoring and treatment benefits and initial health evaluation benefits under this subchapter through a Clinical Center of Excellence described in subparagraphs (A), (B), or (C) of section 300mm–4(b)(1) of this title.

(10) The term “screening-eligible WTC survivor” has the meaning given such term in section 300mm–31(a)(1) of this title.

(11) Any reference to “September 11, 2001” shall be deemed a reference to the period on such date subsequent to the terrorist attacks at the World Trade Center, Shanksville, Pennsylvania, or the Pentagon, as applicable, on such date.

(12) The term “September 11, 2001, terrorist attacks” means the terrorist attacks that occurred on September 11, 2001, in New York City, in Shanksville, Pennsylvania, and at the Pentagon, and includes the aftermath of such attacks.

(13) The term “uniformed services” has the meaning given the term in section 101(a) of title 10.

(14) The term “WTC Health Program Steering Committee” means such a Steering Committee established under section 300mm–1(b) of this title.

(15) The term “WTC Program” means the Word Trade Center Health Program established under section 300mm(a) of this title.

(16)

(A) The term “WTC Program Administrator” means—

(i) subject to subparagraph (B), with respect to paragraphs (3) and (4) of section 300mm–21(a) of this title (relating to enrollment of WTC responders), section 300mm–22(c) of this title and the corresponding provisions of section 300mm–32 of this title (relating to payment for initial health evaluation, monitoring, and treatment,1

1 So in original. A closing parenthesis probably should precede the comma.

paragraphs (1)(C), (2)(B), and (3) of section 300mm–31(a) of this title (relating to determination or certification of screening-eligible or certified-eligible WTC responders), and subpart 3 of part B (relating to payor provisions), an official in the Department of Health and Human Services, to be designated by the Secretary; and

(ii) with respect to any other provision of this subchapter, the Director of the National Institute for Occupational Safety and Health, or a designee of such Director.

(B) In no case may the Secretary designate under subparagraph (A)(i) the Director of the National Institute for Occupational Safety and Health or a designee of such Director with respect to section 300mm–32 of this title (relating to payment for initial health evaluation, monitoring, and treatment).

(17) The term “WTC-related health condition” is defined in section 300mm–22(a) of this title.

(18) The term “WTC responder” is defined in section 300mm–21(a) of this title.

(19) The term “WTC Scientific/Technical Advisory Committee” means such Committee established under section 300mm–1(a) of this title.

(July 1, 1944, ch. 373, title XXXIII, § 3306, as added Pub. L. 111–347, title I, § 101, Jan. 2, 2011, 124 Stat. 3633; amended Pub. L. 118–31, div. A, title XVIII, § 1851(a)(1), Dec. 22, 2023, 137 Stat. 706.)