USC Subpart 1

USC Subpart 1
in effect

42 U.S.C. § 300mm–21 Identification of WTC responders and provision of WTC-related monitoring services

(a) WTC responder defined(1) In generalFor purposes of this subchapter, the term “WTC responder” means any of the following individuals, subject to paragraph (4):(A) Currently identified responderAn individual who has been identified as eligible for monitoring under the arrangements as in effect on January 2, 2011, between the National Institute for Occupational Safety and Health and—(i) the consortium coordinated by Mt. Sinai Hospital in New York City that coordinates the monitoring and treatment for enrolled WTC responders other than with respect to those covered under the arrangement with the Fire Department of New York City; or (ii) the Fire Department of New York City. (B) Responder who meets current eligibility criteriaAn individual who meets the current eligibility criteria described in paragraph (2). (C) Responder who meets modified eligibility criteriaAn individual who—(i) performed rescue, recovery, demolition, debris cleanup, or other related services in the New York City disaster area in response to the September 11, 2001, terrorist attacks, regardless of whether such services were performed by a State or Federal employee or member of the National Guard or otherwise; and (ii) meets such eligibility criteria relating to exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 11, 2001, terrorist attacks as the WTC Program Administrator, after consultation with the WTC Scientific/Technical Advisory Committee, determines appropriate. The WTC Program Administrator shall not modify such eligibility criteria on or after the date that the number of enrollments of WTC responders has reached 80 percent of the limit described in paragraph (4) or on or after the date that the number of certifications for certified-eligible WTC survivors under section 300mm–31(a)(2)(B) of this title has reached 80 percent of the limit described in section 300mm–31(a)(3) of this title. (2) Current eligibility criteriaThe eligibility criteria described in this paragraph for an individual is that the individual is described in any of the following categories:(A) Firefighters and related personnelThe individual—(i) was a member of the Fire Department of New York City (whether fire or emergency personnel, active or retired) who participated at least one day in the rescue and recovery effort at any of the former World Trade Center sites (including Ground Zero, Staten Island Landfill, and the New York City Chief Medical Examiner’s Office) for any time during the period beginning on September 11, 2001, and ending on July 31, 2002; or (ii)(I) is a surviving immediate family member of an individual who was a member of the Fire Department of New York City (whether fire or emergency personnel, active or retired) and was killed at the World Trade site on September 11, 2001; and (II) received any treatment for a WTC-related health condition described in section 300mm–22(a)(1)(A)(ii) of this title (relating to mental health conditions) on or before September 1, 2008. (B) Law enforcement officers and WTC rescue, recovery, and cleanup workersThe individual—(i) worked or volunteered onsite in rescue, recovery, debris cleanup, or related support services in lower Manhattan (south of Canal St.), the Staten Island Landfill, or the barge loading piers, for at least 4 hours during the period beginning on September 11, 2001, and ending on September 14, 2001, for at least 24 hours during the period beginning on September 11, 2001, and ending on September 30, 2001, or for at least 80 hours during the period beginning on September 11, 2001, and ending on July 31, 2002; (ii)(I) was a member of the Police Department of New York City (whether active or retired) or a member of the Port Authority Police of the Port Authority of New York and New Jersey (whether active or retired) who participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal St.), including Ground Zero, the Staten Island Landfill, or the barge loading piers, for at least 4 hours during the period beginning September 11, 2001, and ending on September 14, 2001; (II) participated onsite in rescue, recovery, debris cleanup, or related services at Ground Zero, the Staten Island Landfill, or the barge loading piers, for at least one day during the period beginning on September 11, 2001, and ending on July 31, 2002; (III) participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal St.) for at least 24 hours during the period beginning on September 11, 2001, and ending on September 30, 2001; or (IV) participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal St.) for at least 80 hours during the period beginning on September 11, 2001, and ending on July 31, 2002; (iii) was an employee of the Office of the Chief Medical Examiner of New York City involved in the examination and handling of human remains from the World Trade Center attacks, or other morgue worker who performed similar post-September 11 functions for such Office staff, during the period beginning on September 11, 2001, and ending on July 31, 2002; (iv) was a worker in the Port Authority Trans-Hudson Corporation Tunnel for at least 24 hours during the period beginning on February 1, 2002, and ending on July 1, 2002; or (v) was a vehicle-maintenance worker who was exposed to debris from the former World Trade Center while retrieving, driving, cleaning, repairing, and maintaining vehicles contaminated by airborne toxins from the September 11, 2001, terrorist attacks during a duration and period described in subparagraph (A). (C) Responders to the September 11 attacks at the Pentagon and Shanksville, PennsylvaniaThe individual—(i)(I) was a member of a fire or police department (whether fire or emergency personnel, active or retired), worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, demolition, debris cleanup, or other related services at the Pentagon site of the terrorist-related aircraft crash of September 11, 2001, during the period beginning on September 11, 2001, and ending on the date on which the cleanup of the site was concluded, as determined by the WTC Program Administrator; (II) was a member of a fire or police department (whether fire or emergency personnel, active or retired), worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, demolition, debris cleanup, or other related services at the Shanksville, Pennsylvania, site of the terrorist-related aircraft crash of September 11, 2001, during the period beginning on September 11, 2001, and ending on the date on which the cleanup of the site was concluded, as determined by the WTC Program Administrator; (III) was an employee of the Department of Defense or any other Federal agency, worked during the period beginning on September 11, 2001, and ending on September 18, 2001, for a contractor of the Department of Defense or any other Federal agency, or was a member of a regular or reserve component of the uniformed services; and performed rescue, recovery, demolition, debris cleanup, or other related services at the Pentagon site of the terrorist-related aircraft crash of September 11, 2001, during the period beginning on September 11, 2001, and ending on the date on which the cleanup of the site was concluded, as determined by the WTC Program Administrator; or (IV) was an employee of the Department of Defense or any other Federal agency, worked during the period beginning on September 11, 2001, and ending on September 18, 2001, for a contractor of the Department of Defense or any other Federal agency, or was a member of a regular or reserve component of the uniformed services; and performed rescue, recovery, demolition, debris cleanup, or other related services at the Shanksville, Pennsylvania, site of the terrorist-related aircraft crash of September 11, 2001, during the period beginning on September 11, 2001, and ending on the date on which the cleanup of the site was concluded, as determined by the WTC Program Administrator; and (ii) is determined by the WTC Program Administrator to be at an increased risk of developing a WTC-related health condition as a result of exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 11, 2001, terrorist attacks, and meets such eligibility criteria related to such exposures, as the WTC Program Administrator determines are appropriate, after consultation with the WTC Scientific/Technical Advisory Committee. (3) Enrollment process(A) In generalThe WTC Program Administrator shall establish a process for enrolling WTC responders in the WTC Program. Under such process—(i) WTC responders described in paragraph (1)(A) shall be deemed to be enrolled in such Program; (ii) subject to clause (iii), the Administrator shall enroll in such program individuals who are determined to be WTC responders; (iii) the Administrator shall deny such enrollment to an individual if the Administrator determines that the numerical limitation in paragraph (4) on enrollment of WTC responders has been met; (iv) there shall be no fee charged to the applicant for making an application for such enrollment; (v) the Administrator shall make a determination on such an application not later than 60 days after the date of filing the application; and (vi) an individual who is denied enrollment in such Program shall have an opportunity to appeal such determination in a manner established under such process. (B) Timing(i) Currently identified respondersIn accordance with subparagraph (A)(i), the WTC Program Administrator shall enroll an individual described in paragraph (1)(A) in the WTC Program not later than July 1, 2011. (ii) Other respondersIn accordance with subparagraph (A)(ii) and consistent with paragraph (4), the WTC Program Administrator shall enroll any other individual who is determined to be a WTC responder in the WTC Program at the time of such determination. (4) Numerical limitation on eligible WTC responders(A) Limit(i) In generalThe total number of individuals not described in paragraph (1)(A) or (2)(A)(ii) or subclause (III) or (IV) of paragraph (2)(C)(i) who may be enrolled under paragraph (3)(A)(ii) shall not exceed 75,000 at any time, of which no more than 2,500 may be individuals enrolled based on modified eligibility criteria established under paragraph (1)(C). (ii) Certain responders to the September 11 attacks at the Pentagon and Shanksville, PennsylvaniaThe total number of individuals who may be enrolled under paragraph (3)(A)(ii) based on eligibility criteria described in subclause (III) or (IV) of paragraph (2)(C)(i) shall not exceed 500 at any time. (B) ProcessIn implementing subparagraph (A), the WTC Program Administrator shall—(i) limit the number of enrollments made under paragraph (3)—(I) in accordance with such subparagraph; and (II) to such number, as determined by the Administrator based on the best available information and subject to amounts available under this subchapter, that will ensure sufficient funds will be available to provide treatment and monitoring benefits under this subchapter, with respect to all individuals who are enrolled; and (ii) provide priority (subject to paragraph (3)(A)(i)) in such enrollments in the order in which individuals apply for enrollment under paragraph (3). (5) Disqualification of individuals on terrorist watch listNo individual who is on the terrorist watch list maintained by the Department of Homeland Security shall qualify as an eligible WTC responder. Before enrolling any individual as a WTC responder in the WTC Program under paragraph (3), the Administrator, in consultation with the Secretary of Homeland Security, shall determine whether the individual is on such list. (b) Monitoring benefits(1) In generalIn the case of an enrolled WTC responder (other than one described in subsection (a)(2)(A)(ii)), the WTC Program shall provide for monitoring benefits that include monitoring consistent with protocols approved by the WTC Program Administrator and including clinical examinations and long-term health monitoring and analysis. In the case of an enrolled WTC responder who is an active member of the Fire Department of New York City, the responder shall receive such benefits as part of the individual’s periodic company medical exams. (2) Provision of monitoring benefitsThe monitoring benefits under paragraph (1) shall be provided through the Clinical Center of Excellence for the type of individual involved or, in the case of an individual residing outside the New York metropolitan area, under an arrangement under section 300mm–23 of this title.

42 U.S.C. § 300mm–22 Treatment of enrolled WTC responders for WTC-related health conditions

(a) WTC-related health condition defined(1) In generalFor purposes of this subchapter, the term “WTC-related health condition” means a condition that—(A)(i) is an illness or health condition for which exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, based on an examination by a medical professional with experience in treating or diagnosing the health conditions included in the applicable list of WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition, as determined under paragraph (2); or (ii) is a mental health condition for which such attacks, based on an examination by a medical professional with experience in treating or diagnosing the health conditions included in the applicable list of WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to, or causing the condition, as determined under paragraph (2); and (B) is included in the applicable list of WTC-related health conditions or—(i) with respect to a WTC responder, is provided certification of coverage under subsection (b)(2)(B)(iii); or (ii) with respect to a screening-eligible WTC survivor or certified-eligible WTC survivor, is provided certification of coverage under subsection (b)(2)(B)(iii), as applied under section 300mm–32(a) of this title. In the case of a WTC responder described in section 300mm–21(a)(2)(A)(ii) of this title (relating to a surviving immediate family member of a firefighter), such term does not include an illness or health condition described in subparagraph (A)(i). (2) DeterminationThe determination under paragraph (1) or subsection (b) of whether the September 11, 2001, terrorist attacks were substantially likely to be a significant factor in aggravating, contributing to, or causing an individual’s illness or health condition shall be made based on an assessment of the following:(A) The individual’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the terrorist attacks. Such exposure shall be—(i) evaluated and characterized through the use of a standardized, population-appropriate questionnaire approved by the Director of the National Institute for Occupational Safety and Health; and (ii) assessed and documented by a medical professional with experience in treating or diagnosing health conditions included on the list of WTC-related health conditions. (B) The type of symptoms and temporal sequence of symptoms. Such symptoms shall be—(i) assessed through the use of a standardized, population-appropriate medical questionnaire approved by the Director of the National Institute for Occupational Safety and Health and a medical examination; and (ii) diagnosed and documented by a medical professional described in subparagraph (A)(ii). (3) List of health conditions for WTC respondersThe list of health conditions for WTC responders consists of the following:(A) Aerodigestive disorders(i) Interstitial lung diseases. (ii) Chronic respiratory disorder—fumes/vapors. (iii) Asthma. (iv) Reactive airways dysfunction syndrome (RADS). (v) WTC-exacerbated chronic obstructive pulmonary disease (COPD). (vi) Chronic cough syndrome. (vii) Upper airway hyperreactivity. (viii) Chronic rhinosinusitis. (ix) Chronic nasopharyngitis. (x) Chronic laryngitis. (xi) Gastroesophageal reflux disorder (GERD). (xii) Sleep apnea exacerbated by or related to a condition described in a previous clause. (B) Mental health conditions(i) Posttraumatic stress disorder (PTSD). (ii) Major depressive disorder. (iii) Panic disorder. (iv) Generalized anxiety disorder. (v) Anxiety disorder (not otherwise specified). (vi) Depression (not otherwise specified). (vii) Acute stress disorder. (viii) Dysthymic disorder. (ix) Adjustment disorder. (x) Substance abuse. (C) Musculoskeletal disorders for certain WTC respondersIn the case of a WTC responder described in paragraph (4), a condition described in such paragraph. (D) Additional conditionsAny cancer (or type of cancer) or other condition added, pursuant to paragraph (5) or (6), to the list under this paragraph. (4) Musculoskeletal disorders(A) In generalFor purposes of this subchapter, in the case of a WTC responder who received any treatment for a WTC-related musculoskeletal disorder on or before September 11, 2003, the list of health conditions in paragraph (3) shall include:(i) Low back pain. (ii) Carpal tunnel syndrome (CTS). (iii) Other musculoskeletal disorders. (B) DefinitionThe term “WTC-related musculoskeletal disorder” means a chronic or recurrent disorder of the musculoskeletal system caused by heavy lifting or repetitive strain on the joints or musculoskeletal system occurring during rescue or recovery efforts in the New York City disaster area in the aftermath of the September 11, 2001, terrorist attacks. (5) Cancer(A) In generalThe WTC Program Administrator shall periodically conduct a review of all available scientific and medical evidence, including findings and recommendations of Clinical Centers of Excellence, published in peer-reviewed journals to determine if, based on such evidence, cancer or a certain type of cancer should be added to the applicable list of WTC-related health conditions. The WTC Program Administrator shall conduct the first review under this subparagraph not later than 180 days after January 2, 2011. (B) Proposed regulations and rulemakingBased on the periodic reviews under subparagraph (A), if the WTC Program Administrator determines that cancer or a certain type of cancer should be added to such list of WTC-related health conditions, the WTC Program Administrator shall propose regulations, through rulemaking, to add cancer or the certain type of cancer to such list. (C) Final regulationsBased on all the available evidence in the rulemaking record, the WTC Program Administrator shall make a final determination of whether cancer or a certain type of cancer should be added to such list of WTC-related health conditions. If such a determination is made to make such an addition, the WTC Program Administrator shall by regulation add cancer or the certain type of cancer to such list. (D) Determinations not to add cancer or certain types of cancerIn the case that the WTC Program Administrator determines under subparagraph (B) or (C) that cancer or a certain type of cancer should not be added to such list of WTC-related health conditions, the WTC Program Administrator shall publish an explanation for such determination in the Federal Register. Any such determination to not make such an addition shall not preclude the addition of cancer or the certain type of cancer to such list at a later date. (6) Addition of health conditions to list for WTC responders(A) In generalWhenever the WTC Program Administrator determines that a proposed rule should be promulgated to add a health condition to the list of health conditions in paragraph (3), the Administrator may request a recommendation of the Advisory Committee or may publish such a proposed rule in the Federal Register in accordance with subparagraph (D). (B) Administrator’s options after receipt of petitionIn the case that the WTC Program Administrator receives a written petition by an interested party to add a health condition to the list of health conditions in paragraph (3), not later than 90 days after the date of receipt of such petition the Administrator shall—(i) request a recommendation of the Advisory Committee; (ii) publish a proposed rule in the Federal Register to add such health condition, in accordance with subparagraph (D); (iii) publish in the Federal Register the Administrator’s determination not to publish such a proposed rule and the basis for such determination; or (iv) publish in the Federal Register a determination that insufficient evidence exists to take action under clauses (i) through (iii). (C) Action by Advisory CommitteeIn the case that the Administrator requests a recommendation of the Advisory Committee under this paragraph, with respect to adding a health condition to the list in paragraph (3), the Advisory Committee shall submit to the Administrator such recommendation not later than 90 days after the date of such request or by such date (not to exceed 180 days after such date of request) as specified by the Administrator. Not later than 90 days after the date of receipt of such recommendation, the Administrator shall, in accordance with subparagraph (D), publish in the Federal Register a proposed rule with respect to such recommendation or a determination not to propose such a proposed rule and the basis for such determination. (D) PublicationThe WTC Program Administrator shall, with respect to any proposed rule under this paragraph—(i) publish such proposed rule in accordance with section 553 of title 5; and (ii) provide interested parties a period of 30 days after such publication to submit written comments on the proposed rule. The WTC Program Administrator may extend the period described in clause (ii) upon a finding of good cause. In the case of such an extension, the Administrator shall publish such extension in the Federal Register. (E) Interested party definedFor purposes of this paragraph, the term “interested party” includes a representative of any organization representing WTC responders, a nationally recognized medical association, a Clinical or Data Center, a State or political subdivision, or any other interested person. (F) Independent peer reviewsPrior to issuing a final rule to add a health condition to the list in paragraph (3), the WTC Program Administrator shall provide for an independent peer review of the scientific and technical evidence that would be the basis for issuing such final rule. (G) Additional advisory committee recommendations(i) Program policies(I) Existing policiesNot later than 1 year after December 18, 2015, the WTC Program Administrator shall request the Advisory Committee to review and evaluate the policies and procedures, in effect at the time of the review and evaluation, that are used to determine whether sufficient evidence exists to support adding a health condition to the list in paragraph (3). (II) Subsequent policiesPrior to establishing any substantive new policy or procedure used to make the determination described in subclause (I) or prior to making any substantive amendment to any policy or procedure described in such subclause, the WTC Program Administrator shall request the Advisory Committee to review and evaluate such substantive policy, procedure, or amendment. (ii) Identification of individuals conducting independent peer reviewsNot later than 1 year after December 18, 2015, and not less than every 2 years thereafter, the WTC Program Administrator shall seek recommendations from the Advisory Committee regarding the identification of individuals to conduct the independent peer reviews under subparagraph (F). (b) Coverage of treatment for WTC-related health conditions(1) Determination for enrolled WTC responders based on a WTC-related health condition(A) In generalIf a physician at a Clinical Center of Excellence that is providing monitoring benefits under section 300mm–21 of this title for an enrolled WTC responder makes a determination that the responder has a WTC-related health condition that is in the list in subsection (a)(3) and that exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 1, 2001, terrorist attacks is substantially likely to be a significant factor in aggravating, contributing to, or causing the condition—(i) the physician shall promptly transmit such determination to the WTC Program Administrator and provide the Administrator with the medical facts supporting such determination; and (ii) on and after the date of such transmittal and subject to subparagraph (B), the WTC Program shall provide for payment under subsection (c) for medically necessary treatment for such condition. (B) Review; certification; appeals(i) ReviewA Federal employee designated by the WTC Program Administrator shall review determinations made under subparagraph (A). (ii) CertificationThe Administrator shall provide a certification of such condition based upon reviews conducted under clause (i). Such a certification shall be provided unless the Administrator determines that the responder’s condition is not a WTC-related health condition in the list in subsection (a)(3) or that exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 1, 2001, terrorist attacks is not substantially likely to be a significant factor in aggravating, contributing to, or causing the condition. (iii) Appeal processThe Administrator shall establish, by rule, a process for the appeal of determinations under clause (ii). (2) Determination based on medically associated WTC-related health conditions(A) In generalIf a physician at a Clinical Center of Excellence determines pursuant to subsection (a) that the enrolled WTC responder has a health condition described in subsection (a)(1)(A) that is not in the list in subsection (a)(3) but which is medically associated with a WTC-related health condition—(i) the physician shall promptly transmit such determination to the WTC Program Administrator and provide the Administrator with the facts supporting such determination; and (ii) the Administrator shall make a determination under subparagraph (B) with respect to such physician’s determination. (B) Procedures for review, certification, and appealThe WTC Program Administrator shall, by rule, establish procedures for the review and certification of physician determinations under subparagraph (A). Such rule shall provide for—(i) the timely review of such a determination by a physician panel with appropriate expertise for the condition and recommendations to the WTC Program Administrator; (ii) not later than 60 days after the date of the transmittal under subparagraph (A)(i), a determination by the WTC Program Administrator on whether or not the condition involved is described in subsection (a)(1)(A) and is medically associated with a WTC-related health condition; (iii) certification in accordance with paragraph (1)(B)(ii) of coverage of such condition if determined to be described in subsection (a)(1)(A) and medically associated with a WTC-related health condition; and (iv) a process for appeals of determinations relating to such conditions. (C) Inclusion in list of health conditionsIf the WTC Program Administrator provides certification under subparagraph (B)(iii) for coverage of a condition, the Administrator may, pursuant to subsection (a)(6), add the condition to the list in subsection (a)(3). (D) Conditions already declined for inclusion in listIf the WTC Program Administrator publishes a determination under subsection (a)(6)(B) not to include a condition in the list in subsection (a)(3), the WTC Program Administrator shall not provide certification under subparagraph (B)(iii) for coverage of the condition. In the case of an individual who is certified under subparagraph (B)(iii) with respect to such condition before the date of the publication of such determination the previous sentence shall not apply. (3) Requirement of medical necessity(A) In generalIn providing treatment for a WTC-related health condition, a physician or other provider shall provide treatment that is medically necessary and in accordance with medical treatment protocols established under subsection (d). (B) Regulations relating to medical necessityFor the purpose of this subchapter, the WTC Program Administrator shall issue regulations specifying a standard for determining medical necessity with respect to health care services and prescription pharmaceuticals, a process for determining whether treatment furnished and pharmaceuticals prescribed under this subchapter meet such standard (including any prior authorization requirement), and a process for appeal of a determination under subsection (c)(3). (4) Scope of treatment covered(A) In generalThe scope of treatment covered under this subsection includes services of physicians and other health care providers, diagnostic and laboratory tests, prescription drugs, inpatient and outpatient hospital services, and other medically necessary treatment. (B) Pharmaceutical coverageWith respect to ensuring coverage of medically necessary outpatient prescription drugs, such drugs shall be provided, under arrangements made by the WTC Program Administrator, directly through participating Clinical Centers of Excellence or through one or more outside vendors. (C) Transportation expenses for nationwide networkThe WTC Program Administrator may provide for necessary and reasonable transportation and expenses incident to the securing of medically necessary treatment through the nationwide network under section 300mm–23 of this title involving travel of more than 250 miles and for which payment is made under this section in the same manner in which individuals may be furnished necessary and reasonable transportation and expenses incident to services involving travel of more than 250 miles under regulations implementing section 7384t(c) of this title. (5) Provision of treatment pending certificationWith respect to an enrolled WTC responder for whom a determination is made by an examining physician under paragraph (1) or (2), but for whom the WTC Program Administrator has not yet determined whether to certify the determination, the WTC Program Administrator may establish by rule a process through which the Administrator may approve the provision of medical treatment under this subsection (and payment under subsection (c)) with respect to such responder and such responder’s WTC-related health condition (under such terms and conditions as the Administrator may provide) until the Administrator makes a decision on whether to certify the determination. (c) Payment for initial health evaluation, monitoring, and treatment of WTC-related health conditions(1) Medical treatment(A) Use of FECA payment rates(i) In generalSubject to clause (ii):(I) Subject to subparagraphs (B) and (C), the WTC Program Administrator shall reimburse costs for medically necessary treatment under this subchapter for WTC-related health conditions according to the payment rates that would apply to the provision of such treatment and services by the facility under the Federal Employees Compensation Act. (II) For treatment not covered under subclause (i) or subparagraph (B), the WTC Program Administrator shall establish by regulation a reimbursement rate for such treatment. (ii) ExceptionIn no case shall payments for products or services under clause (i) be made at a rate higher than the Office of Worker’s Compensation Programs in the Department 11 So in original. The word “of” probably should appear. Labor would pay for such products or services rendered at the time such products or services were provided. (B) Pharmaceuticals(i) In generalThe WTC Program Administrator shall establish a program for paying for the medically necessary outpatient prescription pharmaceuticals prescribed under this subchapter for WTC-related health conditions through one or more contracts with outside vendors. (ii) Competitive biddingUnder such program the Administrator shall—(I) select one or more appropriate vendors through a Federal competitive bid process; and (II) select the lowest bidder (or bidders) meeting the requirements for providing pharmaceutical benefits for participants in the WTC Program. (iii) Treatment of FDNY participantsUnder such program the Administrator may enter into an agreement with a separate vendor to provide pharmaceutical benefits to enrolled WTC responders for whom the Clinical Center of Excellence is described in section 300mm—4 of this title if such an arrangement is deemed necessary and beneficial to the program by the WTC Program Administrator. (iv) PharmaceuticalsNot 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 whether existing Federal pharmaceutical purchasing programs can provide pharmaceutical benefits more efficiently and effectively than through the WTC program. (C) Improving quality and efficiency through modification of payment amounts and methodologiesThe WTC Program Administrator may modify the amounts and methodologies for making payments for initial health evaluations, monitoring, or treatment, if, taking into account utilization and quality data furnished by the Clinical Centers of Excellence under section 300mm–4(b)(1)(B)(iii) of this title, the Administrator determines that a bundling, capitation, pay for performance, or other payment methodology would better ensure high quality and efficient delivery of initial health evaluations, monitoring, or treatment to an enrolled WTC responder, screening-eligible WTC survivor, or certified-eligible WTC survivor. (2) Monitoring and initial health evaluationThe WTC Program Administrator shall reimburse the costs of monitoring and the costs of an initial health evaluation provided under this subchapter at a rate set by the Administrator by regulation. (3) Determination of medical necessity(A) Review of medical necessity and protocolsAs part of the process for reimbursement or payment under this subsection, the WTC Program Administrator shall provide for the review of claims for reimbursement or payment for the provision of medical treatment to determine if such treatment is medically necessary and in accordance with medical treatment protocols established under subsection (d). (B) Withholding of payment for medically unnecessary treatmentThe Administrator shall withhold such reimbursement or payment for treatment that the Administrator determines is not medically necessary or is not in accordance with such medical treatment protocols. (d) Medical treatment protocols(1) DevelopmentThe Data Centers shall develop medical treatment protocols for the treatment of enrolled WTC responders and certified-eligible WTC survivors for health conditions included in the applicable list of WTC-related health conditions. (2) ApprovalThe medical treatment protocols developed under paragraph (1) shall be subject to approval by the WTC Program Administrator.

42 U.S.C. § 300mm–23 National arrangement for benefits for eligible individuals outside New York

(a) In generalIn order to ensure reasonable access to benefits under this part for individuals who are enrolled WTC responders, screening-eligible WTC survivors, or certified-eligible WTC survivors and who reside in any State, as defined in section 201(f) of this title, outside the New York metropolitan area, the WTC Program Administrator shall establish a nationwide network of health care providers to provide monitoring and treatment benefits and initial health evaluations near such individuals’ areas of residence in such States. Nothing in this subsection shall be construed as preventing such individuals from being provided such monitoring and treatment benefits or initial health evaluation through any Clinical Center of Excellence. (b) Network requirementsAny health care provider participating in the network under subsection (a) shall—(1) meet criteria for credentialing established by the Data Centers; (2) follow the monitoring, initial health evaluation, and treatment protocols developed under section 300mm–4(a)(2)(A)(ii) of this title; (3) collect and report data in accordance with section 300mm–3 of this title; and (4) meet such fraud, quality assurance, and other requirements as the WTC Program Administrator establishes, including sections 1320a–7 through 1320a–7e of this title, as applied by section 300mm(d) of this title. (c) Training and technical assistanceThe WTC Program Administer 11 So in original. Probably should be “Administrator”. may provide, including through contract, for the provision of training and technical assistance to health care providers participating in the network under subsection (a). (d) Provision of services through the VA(1) In generalThe WTC Program Administrator may enter into an agreement with the Secretary of Veterans Affairs for the Secretary to provide services under this section through facilities of the Department of Veterans Affairs. (2) National programNot 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 whether the Department of Veterans Affairs can provide monitoring and treatment services to individuals under this section more efficiently and effectively than through the nationwide network to be established under subsection (a).

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