Sec. 109. Establishment of pilot program to provide impartial classifications of chest radiographs
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Part C of the Black Lung Benefits Act ( 30 U.S.C. 931 et seq. ), as amended by section 108, is further amended by adding at the end the following: In this section: The term B Reader means an individual who— has a valid license to practice medicine in not less than one State, territory, commonwealth, or possession of the United States; and has demonstrated a proficiency, through an examination administered by the National Institute for Occupational Safety and Health, in classifying chest radiographs for findings consistent with pneumoconiosis using the International Classification of Radiographs of Pneumoconioses by the International Labor Organization (referred to in this section as the ILO ).
The term B Reader Panel means a panel of not less than 3 B Readers selected by the Director exclusively from the B Reader Panel Pool. The term B Reader Panel Pool means the group of physicians included in the pool described in subsection (c). The term complicated pneumoconiosis or progressive massive fibrosis means pneumoconiosis with the formation of large opacities greater than or equal to category A of the ILO classification. The term Director means the Director of the National Institute for Occupational Safety and Health.
The term ILO classification means the standardized categorization of chest radiographs for findings consistent with pneumoconiosis using the International Classification of Radiographs of Pneumoconioses by the ILO. The term ILO Standard Radiographs means the set of standard radiographs used in the ILO International Classification of Radiographs of Pneumoconioses by the ILO. The Director shall establish, in the National Institute for Occupational Safety and Health, a pilot program to be known as the B Reader Panel Program .
The B Reader Panel Program shall establish B Reader Panels that— are operated in a manner to assure accurate ILO classifications, which may be used for claims for benefits described in subparagraph (C); only classify chest radiographs; and classify all appearances— described in the International Classification of Radiographs of Pneumoconiosis by the ILO; or illustrated by the ILO Standard Radiographs. The B Reader Panel Program established under this section shall be conducted for a duration of one year, beginning after the issuance of necessary protocols and interim final rules under subsection (h).
A chest radiograph classification may only be requested under this section for a claim for benefits under this title where the presence or absence of complicated pneumoconiosis or progressive massive fibrosis is in fact at issue. The Director may hire such personnel as are necessary to establish, manage, and evaluate the B Reader Panel Program, including a B Reader Program Director described in subparagraph (B). The B Reader Program Director shall be a physician who is a B Reader and has documented expertise in ILO classifications.
In procuring the services of B Readers for this section, the Director may hire Federal personnel, contract for services, or both. The Director shall establish compensation rates for B Readers who are hired under contract. In order to maximize the quality, objectivity, and confidence in ILO classifications under this section, the Director shall establish a binding code of ethics to which all B Readers in the B Reader Panel Pool shall agree to in writing and adhere. The code of ethics shall include— definitions and stipulations of procedures dealing with actual and apparent conflicts of interest and the appearance of bias or lack of sufficient impartiality; a requirement that each such B Reader submits a conflict of interest disclosure statement to the Director and annually updates such statement; and requirements for the content of the conflict of interest disclosure statements required under subclause (II).
The Director shall designate an employee of the National Institute for Occupational Safety and Health as the B Reader Ethics Officer whose responsibilities shall include— reviewing all conflict of interest disclosures of B Readers on the B Reader Panel Pool; investigating the validity of such disclosures; maintaining a list of such B Readers who fail to disclose a conflict of interest; addressing complaints about incomplete or inaccurate conflict of interest disclosures; assessing whether any such B Reader has been improperly assigned to a panel due to a conflict of interest; and assuring full transparency of conflict of interest disclosures to the public.
The Director shall establish a quality assurance program consisting of protocols to ensure that the results produced by B Reader Panels meet or exceed standards of performance required for accuracy and consistency. The protocols under this subparagraph shall include protocols— for each B Reader to prepare an individual ILO classification report for each chest radiograph; and for the preparation of a final ILO classification report for the chest radiograph. If individual ILO classifications reported by each B Reader of a B Reader Panel diverge from each other by more than an acceptable variance, as determined by protocols established under subsection (h), the Director shall assign additional B Readers to the applicable B Reader Panel or convene an additional B Reader Panel, as the Director determines necessary, to assure that the ILO classification report of the initial B Reader Panel is accurate and scientifically valid.
The quality assurance program under this paragraph shall use pre-read radiographs, for which ILO classifications have been previously established as external standards, with sufficient frequency in order to assure that B Readers on B Reader Panels read radiographs that are borderline positive or negative for complicated pneumoconiosis or progressive massive fibrosis with accuracy and consistency. In reading a radiograph to make an ILO classification, a B Reader shall be blinded from the origin of the radiograph.
The Director shall establish a process for providing feedback to B Readers in the B Reader Pool with respect to their performance in providing ILO classifications and provide suggestions for improvement. The Director shall establish a B Reader Panel Pool to be used for the B Reader Panel Program under this section. The Director shall solicit and select physicians who are B Readers for inclusion in the B Reader Panel Pool. The Director shall establish and disclose criteria by which B Readers are selected and retained within the B Reader Panel Pool, including minimum standards of performance described in subparagraph (B).
The minimum standards of performance for inclusion in the B Reader Panel Pool shall include requiring the B Reader to make radiograph classifications consistent with ILO classification criteria that are consistently within acceptable norms, as established by the Director. In selecting a B Reader to be included in the B Reader Panel Pool, the Director shall— assess, to the maximum extent practicable, the prior performance of the B Reader in making ILO classifications; consult the National Practitioner Data Bank of the Department of Health and Human Services for information on physician suitability; and assess reports of adverse licensure, certifications, hospital privilege, and professional society actions involving the B Reader.
The Director shall monitor ILO classifications conducted under this section to determine if any B Reader included in the B Reader Panel Pool demonstrates a pattern of providing ILO classifications that are erroneous or not consistently within the acceptable norms, as established by the Director. The Director shall be authorized to suspend or remove any B Reader from the B Reader Panel Pool for— consistently failing to meet the minimum standards of performance under paragraph (2)(B); breaching the code of ethics under subsection (b)(3)(A); or other disqualifying conduct, as established by rule or policy.
The Director shall provide a process for a B Reader who is aggrieved by a decision of the Director under subparagraph
(A)to seek review by the Secretary of Health and Human Services. The review by such Secretary shall not stay the suspension of the B Reader during the pendency of the review. The Director shall make publicly accessible— the names and qualifications of the B Readers included in the B Reader Panel Pool; the names of B Readers who have been suspended or removed from the B Reader Panel Pool and the reasons for such suspension or removal; the conflict of interest disclosure statements required under subsection (b)(3)(A)(ii)(II); and any pertinent information which the Director determines necessary to assure transparency and program integrity. Each of the following individuals may request an ILO classification under this section: Claimants or operators, or their authorized representatives, in a claim for benefits that meets the requirements of subsection (b)(1)(C). Individuals defined as adjudication officers by regulations of the Secretary. Following the receipt of a written request for the classification of a chest radiograph, the Director shall provide a report conducted by a B Reader Panel— for digital chest radiographic images, within 45 days; and for film-based chest radiographs, within 90 days. The Director, or a designee of the Director, shall be available to respond to interrogatories or appear and testify about a B Reader Panel's conclusions or the process by which B Reader Panels classify radiographs in a case under subsection (b)(1)(C), upon the request of a party to such case. To the extent that additional information is reasonably necessary for the full development of evidence pertaining to a B Reader Panel Report in a case under subsection (b)(1)(C), a B Reader of a B Reader Panel— may be required to respond to interrogatories with respect to the ILO classification provided by the B Reader in the case, only if so ordered by an administrative law judge; and may not be required to appear and testify under subpoena, unless the party making such request demonstrates to an administrative law judge that— the B Reader Panel Report is incomplete or lacks information that is reasonably necessary for such full development; and if responses to interrogatories were ordered, the responses are unclear or incomplete; or there is an extraordinary circumstance in which additional information that is reasonably necessary for such full development is otherwise unavailable from the Director and can only be provided by such B Reader. Funds necessary to establish and operate the B Reader Panel Program under this section shall be paid as an administrative cost from the fund. The Director shall consult with the Secretary on allocations of funds in establishing such program. The Director shall establish a fee for a B Reader Panel Report in accordance with clause (ii). Such fee shall be payable by the party requesting such report. No fee shall be charged if the request for such ILO classification is made by an individual defined as an adjudication officer by regulations of the Secretary. The amount of a fee under clause
(i)shall not exceed the direct cost of hiring the B Readers of the B Reader Panel that made the ILO classification. The National Institute for Occupational Safety and Health shall use amounts in the fund to pay for all costs related to the appearance and responses to interrogatories of the Director or a designee of the Director, or a B Reader of a B Reader Panel, in a proceeding under this section. The General Counsel of the Department of Health and Human Services shall, in consultation with the Solicitor of Labor, represent the National Institute for Occupational Safety and Health in any proceeding under this section, which costs shall be payable from the fund. Not later than 180 days after the date of enactment of the Black Lung Benefits Improvement Act of 2014 , the Secretary of Health and Human Services shall issue protocols and promulgate interim final rules, as necessary, to commence the implementation of this section. Not later than 30 days after the completion of the pilot program under this section, the Director shall, in consultation with the Secretary of Labor, prepare and submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Education and the Workforce of the House of Representatives that includes the information in paragraph (2). The report under this subsection shall include— the number of B Reader Panels established under this section; the number of B Readers participating in the pilot program under this section; the effectiveness of the quality assurance program under subsection (b)(4); the accuracy of the ILO classifications conducted by B Readers under this section; challenges in the administration and implementation of such pilot program; the costs and revenues of such pilot program; the impact of the pilot program on the claims adjudication process; a recommendation on whether the pilot program under this section should extend beyond the one-year duration under subsection (b)(1)(B); and recommendations for any necessary modifications to such pilot program, if the Director recommends such an extension. .
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Sec. 109
Establishment of pilot program to provide impartial classifications of chest radiographs
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