[Federal Register Volume 86, Number 86 (Thursday, May 6, 2021)]
[Rules and Regulations]
[Pages 24336-24339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09499]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 37

[Docket No. CDC-2019-0088; NIOSH-330]
RIN 0920-AA68


Coal Workers' Health Surveillance Program: Autopsy Payment

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Final rule.

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SUMMARY: With this final rule, HHS amends existing regulatory text to 
allow compensation for pathologists who perform autopsies on coal 
miners at a market rate, on a discretionary basis as needed for public 
health purposes. HHS has determined that the agency needs additional 
time to consider the public comments received on the addition of 
procedures for suspending or revoking B Reader certification, as 
proposed in the notice of proposed rulemaking preceding this final 
rule; those procedures will be finalized at a later date.

DATES: This rule is effective on July 6, 2021. Comments on the 
information collection approval request sought under the Paperwork 
Reduction Act must be received by June 7, 2021.

ADDRESSES: Submit comments on the Paperwork Reduction Act information 
collection to CDC Desk Officer, Office of Management and Budget, 725 
17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst; 1090 
Tusculum Ave., MS: C-48, Cincinnati, OH 45226; telephone (855) 818-1629 
(this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION:

I. Public Participation

    HHS invited interested parties to participate in a proposed 
rulemaking published on February 14, 2020 (85 FR 8521) by submitting 
written views, opinions, recommendations, and data. HHS received 12 
submissions from 11 commenters, including unaffiliated individuals, 
professional societies, trade associations, a labor union, and a law 
firm. No submissions were received regarding the proposed Paperwork 
Reduction Act information collection.
    Within the February 14, 2020 rulemaking, HHS published a ``Proposed 
Data Collection Submitted for Public Comment and Recommendations'' to 
obtain comments from the public and affected agencies. HHS did not 
receive comments related to the previous notice. This notice serves to 
allow an additional 30 days for public and affected agency comments.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, email 
[email protected]. Comments and recommendations for the proposed information 
collection should be sent within 30 days of publication of this notice 
to www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under 30-day Review--Open for 
Public Comments'' or by using the search function. Direct written 
comments and/or suggestions regarding the items contained in this 
notice to the Attention: CDC Desk Officer, Office of Management and 
Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 
395-5806. Provide written comments within 30 days of notice 
publication.

II. Statutory Authority

    The Federal Mine Safety and Health Act of 1977 (Pub. L. 91-173, 30 
U.S.C. 801 et seq.) (Mine Act), authorizes the HHS Secretary 
(Secretary) to work with coal mine operators to make available to coal 
miners the opportunity to have regular and routine chest radiographs 
(X-rays) in order to detect coal workers' pneumoconiosis (i.e., black 
lung) and prevent its progression in individual miners. The Mine Act 
grants the Secretary general authority to issue regulations as is 
deemed appropriate to carry out provisions of the Act and authorizes 
the Coal Workers' Health Surveillance Program (Program), within the 
NIOSH Respiratory Health Division, to detect pneumoconiosis and prevent 
its progression in individual miners and to provide information to 
NIOSH for the evaluation of temporal and geographic trends in 
pneumoconiosis. The Mine Act also authorizes the Secretary to establish 
specifications for the reading of radiographs and to pay for autopsies 
submitted to the Program.

III. Background and Need for Rulemaking

    The NIOSH Respiratory Health Division uses coal miner autopsies to 
study important issues affecting coal miners, such as evaluating the 
cause of rapidly progressive and severe pneumoconiosis by assessing its 
pathology and determining the lung content of mineral particles 
relative to what was seen in the past. Also, autopsies are sometimes 
requested after mine disasters. With this final rule, regulatory 
language promulgated over 45 years ago is updated to reflect the

[[Page 24337]]

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 
Sec. Sec.  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 
Sec.  37.202(a) 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 
Sec.  37.202(a)(2)(i) and (ii) clarifies the types of chest 
radiographic images accepted by the Program.
    New language in Sec.  37.202(b) 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 miner's 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 Sec.  37.202(c) 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 the 
prohibition on double payment is extended to the pathologist's 
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 Sec.  37.203, 
NIOSH has added language to paragraph (b)(7) 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 Sec.  37.204(a) 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 Sec.  37.204(b)(1) to clarify 
that the claim for payment must include a statement that the 
pathologist or the pathologist's 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 Sec.  37.201(b), the definition of Miner is revised to remove 
the word ``underground,'' to clarify that the autopsy provisions 
pertain to all coal miners. Section 37.201(d) 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.
    This final rule has been determined not to be a ``significant 
regulatory action'' under section 3(f) 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 NIOSH's 
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-for-profit 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 3507(d) 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 0920-0020, 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 [email protected].
    Comments are invited on the following: (a) Whether the proposed

[[Page 24338]]

collection of information is necessary for the proper performance of 
the functions of the Agency, including whether the information shall 
have practical utility; (b) the accuracy of the Agency's estimate of 
the burden of the proposed collection of information; (c) ways to 
enhance the quality, utility, and clarity of the information to be 
collected; (d) ways to minimize the burden of the collection of 
information on respondents; and (e) information collection costs. 
Written comments must be received within 30 days of the publication of 
this notice. The addition of additional paperwork requirements 
resulting from this final rule will increase the burden associated with 
the following provision:
    Section 37.204 Procedure for obtaining payment. This section 
establishes that a pathologist who wants to submit an autopsy to the 
Coal Workers' Health Surveillance Program must first obtain written 
authorization from the NIOSH Respiratory Health Division. HHS expects 
an average of about four requests for prior authorization annually. HHS 
estimates that each request for prior authorization will take no more 
than 15 minutes to complete, averaging about one hour annually over a 
period of years.

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                                                                                  Average burden
            Section                   Title          Number of     Responses per   per response    Total burden
                                                    respondents     respondent         (min)           (hr)
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37.204........................  Authorization                  4               1           15/60               1
                                 for Payment of
                                 Autopsy.
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D. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS will 
report the promulgation of this rule to Congress prior to its effective 
date.

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of Federal regulatory 
actions on State, local, and Tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this final rule does not include any 
Federal mandate that may result in increased annual expenditures in 
excess of $100 million by State, local, or Tribal governments in the 
aggregate, or by the private sector.

F. Executive Order 12988 (Civil Justice Reform)

    This final rule has been drafted and reviewed in accordance with 
Executive Order 12988 and will not unduly burden the Federal court 
system. This rule has been reviewed carefully to eliminate drafting 
errors and ambiguities.

G. Executive Order 13132 (Federalism)

    HHS has reviewed this final rule in accordance with Executive Order 
13132 regarding federalism and has determined that it does not have 
``federalism implications.'' The rule does not ``have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''

H. Executive Order 13045 (Protection of Children From Environmental 
Health Risks and Safety Risks)

    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this final rule on children. 
HHS has determined that the rule will have no environmental health and 
safety effect on children.

I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)

    In accordance with Executive Order 13211, HHS has evaluated the 
effects of this final rule on energy supply, distribution, or use, and 
has determined that the rule will not have a significant adverse 
effect.

J. Plain Writing Act of 2010

    Under Public Law 111-274 (October 13, 2010), executive Departments 
and Agencies are required to use plain language in documents that 
explain to the public how to comply with a requirement the Federal 
government administers or enforces. HHS has attempted to use plain 
language in promulgating the final rule consistent with the Federal 
Plain Writing Act guidelines.

List of Subjects in 42 CFR Part 37

    Autopsy, Chronic Obstructive Pulmonary Disease, Coal Workers' 
Pneumoconiosis, Incorporation by reference, Lung diseases, Mine safety 
and health, Occupational safety and health, Part 90 miner, Part 90 
transfer rights, Pneumoconiosis, Respiratory and pulmonary diseases, 
Silicosis, Spirometry, Surface coal mining, Underground coal mining, X-
rays.

Final Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services amends 42 CFR part 37 as follows:

PART 37--SPECIFICATIONS FOR MEDICAL EXAMINATIONS OF COAL MINERS

0
1. The authority citation for part 37 continues to read as follows:

    Authority: Sec. 203, 83 Stat. 763, 30 U.S.C. 843, unless 
otherwise noted.

0
2. Revise Sec.  37.201 to read as follows:


 Sec.  37.201   Definitions.

    As used in this subpart:
    (a) Secretary means the Secretary of Health and Human Services.
    (b) Miner means any individual who during their life was employed 
in any coal mine.
    (c) Pathologist means:
    (1) A physician certified in anatomic pathology or pathology by the 
American Board of Pathology or the American Osteopathic Board of 
Pathology,
    (2) A physician who possesses qualifications which are considered 
board-eligible by the American Board of Pathology or American 
Osteopathic Board of Pathology, or
    (3) An intern, resident, or other physician in a training program 
in pathology who performs the autopsy under the supervision of a 
pathologist as defined in paragraph (c) (1) or (2) of this section.
    (d) NIOSH means the National Institute for Occupational Safety and 
Health, located within the Centers for Disease Control and Prevention 
(CDC). Within NIOSH, the Respiratory Health Division (formerly called 
the Division of Respiratory Disease Studies and the Appalachian 
Laboratory for Occupational Safety and Health) is the organizational 
unit that has

[[Page 24339]]

programmatic responsibility for the medical examination and 
surveillance program.

0
3. Revise Sec.  37.202 to read as follows:


Sec.  37.202  Payment for autopsy.

    (a) NIOSH may, at its discretion, pay any pathologist who has 
received prior authorization for payment from NIOSH pursuant to Sec.  
37.204(a). Payment will only be provided with proof that legal consent 
for an autopsy as required by applicable law from the next of kin or 
other authorized person has been obtained, or that consent is not 
required, such as for a forensic autopsy. Payment may be provided to a 
pathologist who:
    (1) Performs an autopsy on a miner in accordance with this subpart; 
and
    (2) Submits the findings and other materials to NIOSH in accordance 
with this subpart within 180 calendar days after having performed the 
autopsy.
    (i) Types of chest radiographic images accepted for submission 
include a digital chest image (posteroanterior view) provided in an 
electronic format consistent with the DICOM standards described in 
Sec.  37.42(c)(5), a chest computed tomography provided in an 
electronic format consistent with DICOM standards, or a good-quality 
copy or original of a film chest radiograph (posteroanterior view).
    (ii) More than one type of chest radiographic image may be 
submitted.
    (b) If payments are available, pathologists will be compensated in 
accordance with their ordinary, usual, or customary fees or at amounts 
determined through negotiation with NIOSH. To inform payment amounts, 
NIOSH may collect information about the fees charged by other 
pathologists with the same board certifications for the same services, 
in the same geographic area. NIOSH will additionally compensate a 
pathologist for the submission of chest radiographic images made of the 
subject of the autopsy within 5 years prior to their death together 
with copies of any interpretations made.
    (c) A pathologist (or the pathologist's employer, the organization 
in which the pathologist practices, or another entity receiving payment 
on behalf of or for services provided by the pathologist) who receives 
any other specific payment, fee, or reimbursement in connection with 
the autopsy from the miner's surviving spouse, family, estate, or any 
other Federal agency will not receive payment from NIOSH.

0
4. Revise Sec.  37.203 to read as follows:


Sec.  37.203   Autopsy specifications.

    (a) Each autopsy for which a claim for payment is submitted 
pursuant to this subpart must be performed in a manner consistent with 
standard autopsy procedures such as those, for example, set forth in 
Autopsy Performance & Reporting, third edition (Kim A. Collins, ed., 
College of American Pathologists, 2017). Copies of this document may be 
borrowed from NIOSH.
    (b) Each autopsy must include:
    (1) Gross and microscopic examination of the lungs, pulmonary 
pleura, and tracheobronchial lymph nodes;
    (2) Weights of the heart and each lung (these and all other 
measurements required under this subparagraph must be in the metric 
system);
    (3) Circumference of each cardiac valve when opened;
    (4) Thickness of right and left ventricles; these measurements must 
be made perpendicular to the ventricular surface and must not include 
trabeculations or pericardial fat. The right ventricle must be measured 
at a point midway between the tricuspid valve and the apex, and the 
left ventricle must be measured directly above the insertion of the 
anterior papillary muscle;
    (5) Size, number, consistency, location, description and other 
relevant details of all lesions of the lungs;
    (6) Level of the diaphragm;
    (7) From each type of suspected pneumoconiotic lesion, 
representative microscopic slides stained with hematoxylin eosin or 
other appropriate stain, and one formalin fixed, paraffin-impregnated 
block of tissue; a minimum of three stained slides and three blocks of 
tissue corresponding to the three stained slides must be submitted. 
When no such lesion is recognized, similar material must be submitted 
from three separate areas of the lungs selected at random; a minimum of 
three stained slides and three formalin fixed, paraffin-impregnated 
blocks of tissue corresponding to the three stained slides must be 
submitted.
    (c) Needle biopsy techniques will not be accepted.

0
5. Revise Sec.  37.204 to read as follows:


Sec.  37.204  Procedure for obtaining payment.

    (a) Prior to performing an autopsy, the pathologist must obtain 
written authorization from NIOSH and agreement regarding payment amount 
for services specified in Sec.  37.202(a) by submitting an 
Authorization for Payment of Autopsy (form CDC 2.19).
    (1) NIOSH will maintain up-to-date information about the 
availability of payments on its website.
    (2) After receiving a completed authorization request form, NIOSH 
will reply in writing with an authorization determination within 3 
working days.
    (b) After performance of an autopsy, each claim for payment under 
this subpart must be submitted to NIOSH and must include:
    (1) An invoice (in duplicate) on the pathologist's letterhead or 
billhead indicating the date of autopsy, the amount of the claim, and a 
signed statement that the pathologist (or the pathologist's employer, 
the organization in which the pathologist practices, or another entity 
receiving compensation on behalf of or for services provided by the 
pathologist) is not receiving any other specific compensation for the 
autopsy from the miner's surviving spouse or next-of-kin, the estate of 
the miner, or any other source.
    (2) Completed Consent, Release and History Form for Autopsy (CDC/
NIOSH (M)2.6). This form may be completed with the assistance of the 
pathologist, attending physician, family physician, or any other 
responsible person who can provide reliable information.
    (3) Report of autopsy:
    (i) The information, slides, and blocks of tissue required by this 
subpart.
    (ii) Clinical abstract of terminal illness and other data that the 
pathologist determines is relevant.
    (iii) Final summary, including final anatomical diagnoses, 
indicating presence or absence of simple and complicated 
pneumoconiosis, and correlation with clinical history if indicated.

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-09499 Filed 5-5-21; 8:45 am]
BILLING CODE 4163-18-P