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Federal Register / Vol. 86, No. 86 / Thursday, May 6, 2021 / Rules and Regulations
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contemporary costs associated with autopsies. HHS anticipates that increasing the compensation rate will make it economically feasible for pathologists to conduct autopsies of coal miners, thereby allowing the NIOSH
Respiratory Health Division to better study pneumoconiosis in contemporary coal miners and to perform public health investigations more thoroughly, especially in the aftermath of mine disasters.
IV. Summary of Final Rule Of the 12 submissions to the docket for this activity, only one addressed the autopsy payment provisions. The commenter agreed that the proposed increase in payment for pathologists who provide autopsies to the NIOSH
Coal Workers Health Surveillance Program is essential to assure that autopsies can and will be conducted when indicated, and should be incorporated.
To promote administrative efficiency and ensure program integrity, HHS
amends 42 CFR part 37 by updating existing regulatory text in 37.202
through 37.204 to allow NIOSH, on a discretionary basis as needed for public health purposes, to better compensate pathologists who perform autopsies on coal miners. Existing text in 37.202a is revised to clarify that pathologists must secure prior authorization for payment from NIOSH and provide proof that legal consent to conduct an autopsy on a coal miner was either obtained or not required, as in the case of a forensic autopsy. New language in 37.202a2i and ii clarifies the types of chest radiographic images accepted by the Program.
New language in 37.202b specifies that pathologists will be compensated in accordance with their ordinary, usual, or customary fees or at amounts agreed upon through negotiation with NIOSH.
NIOSH may survey other board-certified pathologists who provide the same services in the same geographic area to inform payment amounts. Existing language in paragraph b is revised to clarify that NIOSH will provide additional payment for the submission of chest radiographs of the autopsy subject made within 5 years of the miners death. Compensation for chest radiographs is offered to the pathologist because NIOSH has found that asking families or estates to provide radiographs is often cumbersome, difficult, and emotionally painful.
Language in 37.202c states that NIOSH will not pay a pathologist for their services if that pathologist has already received payment from another party. The text is revised to clarify that
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the prohibition on double payment is extended to the pathologists employer, the organization in which the pathologist practices, or another entity receiving payment on behalf of or for services provided by the pathologist.
Section 37.203 is revised to update the reference for standard autopsy procedures. Although no public comments addressed 37.203, NIOSH
has added language to paragraph b7
to clarify that the three microscopic slides required for each autopsy must be accompanied by three blocks of tissue that correspond to those slides. The slides and tissue blocks must correspond so that NIOSH can make additional slides if needed.
Finally, new language in 37.204a details the new requirement that the pathologist obtain written authorization from the NIOSH Respiratory Health Division prior to completion of the autopsy. Language specifying how claims for payment should be submitted to NIOSH is reorganized. New language is added to 37.204b1 to clarify that the claim for payment must include a statement that the pathologist or the pathologists employer, the organization in which the pathologist practices, or another entity receiving payment on behalf of or for services provided by the pathologist has not been paid for performing the specific autopsy by another party.
In 37.201b, the definition of Miner is revised to remove the word underground, to clarify that the autopsy provisions pertain to all coal miners. Section 37.201d is also revised to update the definition of NIOSH, clarifying that the name of the NIOSH
division responsible for administering the Coal Workers Health Surveillance Program is now the Respiratory Health Division.
V. Regulatory Assessment Requirements A. Executive Order 12866 Regulatory Planning and Review and Executive Order 13563 Improving Regulation and Regulatory Review Executive Orders 12866 and 13563
direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety effects, distributive impacts, and equity. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

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This final rule has been determined not to be a significant regulatory action under section 3f of E.O. 12866.
The revisions finalized in this notice allow NIOSH to compensate pathologists at a contemporary rate for autopsies submitted to the Coal Workers Health Surveillance Program.
The revisions to Part 37 do not impose significant costs on the public and will benefit coal miners and coal mine operators. Allowing the NIOSH
Respiratory Health Division to better compensate pathologists for autopsies submitted to the Program would also enhance NIOSHs ability to study pneumoconiosis in coal miners.
The costs to the Federal government of administering these revisions would be minor and infrequent. In addition to the administrative costs, NIOSH
estimates that over a 5-year period, it might fund up to 20 autopsies, costing NIOSH approximately $60,000.
B. Regulatory Flexibility Act The Regulatory Flexibility Act RFA, 5 U.S.C. 601 et seq., requires each agency to consider the potential impact of its regulations on small entities including small businesses, small governmental units, and small not-forprofit organizations. HHS certifies that this final rule has no significant economic impact upon a substantial number of small entities within the meaning of the Regulatory Flexibility Act 5 U.S.C. 601 et seq..
C. Paperwork Reduction Act The Paperwork Reduction Act PRA, 44 U.S.C. 3501 et seq., requires an agency to invite public comment on, and to obtain Office of Management and Budget OMB approval of, any regulation that requires 10 or more people to report information to the agency or to keep certain records. In accordance with section 3507d of the PRA, HHS has determined that the PRA
does apply to information collection and recordkeeping requirements included in this rule. OMB has already approved the information collection and recordkeeping requirements under OMB
Control Number 09200020, National Coal Workers Health Surveillance Program CWHSP expiration date 9/
30/2021. HHS has determined that the amendments in this final rulemaking will not impact the existing collection of data but would add one new item to the approval: The pathologist prior authorization request. To request more information or to obtain a copy of the data collection plan and instrument send an email to omb@cdc.gov.
Comments are invited on the following: a Whether the proposed
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