[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Proposed Rules]
[Pages 8521-8527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02705]


=======================================================================
-----------------------------------------------------------------------

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: B Reader 
Decertification and Autopsy Payment

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: HHS proposes to revise the National Institute for Occupational 
Safety and Health (NIOSH), Coal Workers' Health Surveillance Program 
(Program) regulations by adding a provision to allow NIOSH to suspend 
or revoke B Reader certification. Certification may be revoked for any 
B Reader found by NIOSH to have engaged in a pattern of providing 
unreasonably inaccurate chest radiograph classifications in practice--
those that are found by the Program to diverge substantially from a 
competent interpretation of the radiographs, as determined by a panel 
of practicing, certified B Readers selected by NIOSH. In addition to 
the B Reader provisions, HHS would also amend 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.

DATES: Comments must be received by May 14, 2020. Comments on the 
information collection approval request sought under the Paperwork 
Reduction Act must be received by April 14, 2020.

ADDRESSES: Written comments: Comments may be submitted by any of the 
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments to the docket.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226.
    Instructions: All submissions received must include the agency name 
(Centers for Disease Control and Prevention, HHS) and docket number 
(CDC-2019-0088; NIOSH-330) or Regulation Identifier Number (0920-AA68) 
for this rulemaking. All relevant comments, including any personal 
information provided, will be posted without change to http://www.regulations.gov. For detailed instructions on submitting public 
comments, see the ``Public Participation'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.

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

    Interested parties may participate in this rulemaking by submitting 
written views, opinions, recommendations, and data. Comments received, 
including attachments and other supporting materials, are part of the 
public record and subject to public disclosure. Do not include any 
information in your comment or supporting materials that you do not 
wish to be disclosed. You may submit comments on any topic related to 
this notice of proposed rulemaking.

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 specifically 
directs that medical examination of coal miners shall be given in 
accordance with specifications prescribed by the Secretary (30 U.S.C. 
843(a), 957). 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

    All mining work generates fine particles of dust in the air. Coal 
miners who inhale excessive dust are known to develop a group of 
diseases of the lungs and airways, including dust-induced fibrotic lung 
disease (pneumoconiosis) and chronic obstructive pulmonary disease, 
including chronic bronchitis and emphysema. To address such

[[Page 8522]]

threats to the U.S. coal mining workforce, the Mine Act was enacted in 
1969 and amended in 1977, authorizing the NIOSH Coal Workers' Health 
Surveillance Program, within the Respiratory Health Division, to detect 
pneumoconiosis and prevent its progression in individual miners, while 
at the same time providing information for evaluation of temporal and 
geographic trends in pneumoconiosis.
    To inform each miner of his or her health status, the Act requires 
that coal mine operators provide each miner who begins work at a coal 
mine for the first time a chest radiograph (X-ray) through an approved 
facility as soon as possible after employment starts. Three years later 
a miner must be offered a second chest radiograph. If this second 
examination reveals evidence of pneumoconiosis, the miner is entitled 
to a third chest radiograph 2 years after the second. Further, all 
miners working in a coal mine must be offered a chest radiograph 
approximately every 5 years.
    Under NIOSH supervision, chest radiographs are assessed and a 
summary report based on at least two independent classifications 
(readings) of each periodic chest radiograph is sent to each 
participating coal miner, who then has the opportunity to take action 
to reduce further dust exposure if early dust-induced lung disease is 
detected. The combined results of these radiographic examinations of 
miners also enable NIOSH to track rates and patterns of pneumoconiosis 
among the participating miners.

B Readers

    Pursuant to NIOSH Coal Workers' Health Surveillance Program 
regulations in 42 CFR 37.51 and 37.52, chest radiographs taken for the 
Program are assessed by qualified licensed physician B Readers. B 
Readers are physicians who have demonstrated proficiency in the use of 
the International Labour Office (ILO) Classification of Radiographs of 
Pneumoconioses \1\ by taking and passing a specially-designed 
proficiency examination offered by NIOSH, as specified in 42 CFR 37.52. 
The goal of the NIOSH B Reader Program is to ensure competency in the 
detection of pneumoconiosis by evaluating the ability of readers to 
classify a test set of radiographs, thereby creating and maintaining a 
pool of qualified readers having the skills and ability to provide 
accurate and precise classifications in accordance with ILO standards. 
The B Reader examination currently offered by NIOSH consists of the 
classification of 125 chest radiographs over the course of 6 hours; the 
test addresses proficiency in classification of small opacities, large 
opacities, pleural abnormalities, and certain other abnormalities that 
may appear in the lung radiographs. In order to maintain B Reader 
status, B Readers must take and pass the B Reader recertification exam 
every 5 years.
---------------------------------------------------------------------------

    \1\ International Labour Office [2011], Guidelines for the use 
of ILO International Classification of Pneumoconiosis, revised 
edition 2011, Geneva, Switzerland: International Labour Office. 
Occupational Safety and Health Series No. 22 (Rev. 2011).
---------------------------------------------------------------------------

    B Readers participate in the NIOSH Coal Workers' Health 
Surveillance Program, as well as other national and state programs 
addressing dust-related illnesses,\2\ and are also involved with 
epidemiologic evaluations, surveillance, and worker monitoring programs 
involving many types of pneumoconioses. In applying the ILO 
Classification, B Readers compare sets of standard images, which 
represent different types of abnormalities and levels of disease 
severity, with images of the individual being evaluated to identify 
parenchymal abnormalities (small and large opacities), pleural changes, 
and other features that can occur in chest radiographs of individuals 
with pneumoconiosis. In the current ILO Classification, the B Reader is 
first asked to grade film quality and then to categorize small 
opacities according to their presence, shape and size, location, and 
profusion. Large opacities are classified according to their presence 
and size. The B Reader also assesses the presence, location, width, 
extent, and degree of calcification of pleural abnormalities as well as 
provides a description of additional features related to dust exposure 
and other etiologies visible on the chest radiograph.\3\
---------------------------------------------------------------------------

    \2\ Other examples of national compensation programs that use B 
Readers include the Department of Labor, Office of Workers' 
Compensation Programs (OWCP), Division of Coal Mine Workers' 
Compensation, Black Lung Program; and the Asbestos Medical 
Surveillance Program, administered by the Navy and Marine Corps 
Public Health Center.
    \3\ NIOSH [2015], Chest Radiograph Classification, CDC/NIOSH 
form (M) 2.8, http://www.cdc.gov/niosh/topics/surveillance/ords/pdfs/CWHSP-ReadingForm-2.8.pdf.
---------------------------------------------------------------------------

    The classification of chest radiographs is semi-quantitative and 
relies on the B Reader's professional judgment, comparing case 
radiographs to the ILO standard classification radiographs. Skilled B 
Readers can disagree about the presence of disease, particularly in a 
radiograph with borderline findings, or differ somewhat in classifying 
the severity of disease. However, since the beginning of the Program in 
the 1970s, the NIOSH Respiratory Health Division has occasionally 
learned of B Readers found to provide unreasonably inaccurate 
radiograph classifications in formal litigation and compensation 
proceedings relative to the actual features of the chest radiographs in 
question. ``Unreasonably inaccurate'' classifications are those that 
diverge substantially from a competent interpretation of the 
radiographs and are unsupported by the chest radiographs in question, 
as determined by a panel of practicing, certified B Readers selected by 
NIOSH. For example, one B Reader was accused of ``under-reading'' chest 
radiographs, frequently not identifying severe cases of pneumoconiosis 
that may have been indicated by the radiographs; \4\ another was 
accused of ``over-reading,'' frequently identifying asbestosis where 
the radiographs were subsequently found not to support that 
determination.\5\ The Program regulations in 42 CFR part 37 do not 
currently provide a mechanism for NIOSH to take remedial action 
addressing such B Readers.
---------------------------------------------------------------------------

    \4\ The Center for Public Integrity [2013], Johns Hopkins 
Medical Unit Rarely Finds Black Lung, Helping Coal Industry Defeat 
Miners' Claims, https://publicintegrity.org/environment/johns-hopkins-medical-unit-rarely-finds-black-lung-helping-coal-industry-defeat-miners-claims/.
    \5\ Fisher D [2012], Law Firm Hit with $429,000 Verdict over 
Faked Asbestos Suits, Forbes, https://www.forbes.com/sites/danielfisher/2012/12/21/law-firm-hit-with-429000-verdict-over-faked-asbestos-suits/#14f1d2f92325.
---------------------------------------------------------------------------

Autopsies

    The Mine Act also authorizes HHS to provide for coal miner 
autopsies and to pay for their submission to NIOSH. Autopsies can be 
used for public health purposes such as studying the emerging issue of 
rapidly progressive and severe pneumoconiosis in coal miners by 
assessing its pathology and lung content of mineral particles relative 
to what was seen in the past. Also, autopsies are sometimes requested 
after mine disasters. The current regulatory language, promulgated over 
45 years ago, provides for payments to pathologists up to $200; today, 
autopsies generally cost between $2,000 and $3,000. As a result, very 
few autopsies of coal miners are provided to the Coal Workers' Health 
Surveillance Program and the Autopsy Program is rarely used. Increasing 
the compensation rate would make it possible 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 more thoroughly perform public health 
investigations, especially in the aftermath of mine disasters.

[[Page 8523]]

IV. Summary of Proposed Rule

    To promote administrative efficiency and ensure program integrity, 
HHS proposes to amend 42 CFR part 37 by adding a new paragraph (d) to 
Sec.  37.52, to allow NIOSH to take remedial action for any B Reader 
found by NIOSH to have engaged in a pattern of providing chest 
radiograph classifications in practice that are found by the Program to 
be unreasonably inaccurate, as determined by a panel of practicing, 
certified B Readers selected by NIOSH.
    Remedial actions may be taken at NIOSH's discretion or in response 
to a complaint from any interested party or at the discretion of the 
Coal Workers' Health Surveillance Program. To ensure that NIOSH can 
identify those B Readers who provide unreasonably inaccurate 
classifications to compensation programs, a valid complaint from any 
interested party must provide the chest radiograph(s) and ILO 
classification(s) being contested, as well as a letter from a medical 
professional supporting the complaint that the classification was 
unreasonable. A new Sec.  37.52(d)(1) would describe the complaint 
process. Paragraph (d)(1)(i) would define ``unreasonably inaccurate'' 
classifications as those that a panel of B Readers would unanimously 
determine are substantially divergent from a competent interpretation 
of the radiographs and are unsupported by the radiographs in question. 
Paragraph (d)(1)(ii) would describe the elements of a valid complaint; 
paragraph (d)(1)(iii) would describe an invalid complaint.
    A new Sec.  37.52(d)(2) would describe the procedures that would be 
used by NIOSH to determine whether an individual B Reader has engaged 
in a pattern of providing unreasonably inaccurate chest radiographs in 
practice. Complaint investigations would involve a panel of at least 
four B Readers who would independently review the information provided 
in each complaint. If at least one B Reader on the panel finds that the 
contested classification is reasonable, no further review will be 
conducted. If the B Readers on the panel independently and unanimously 
conclude that the classification is not reasonable, the actions 
described in paragraphs (d)(2)(ii)-(v) will be taken.
    In accordance with the new provisions in Sec.  37.52(d)(2), the 
certification of a B Reader who is under investigation will remain in 
good standing until the Program issues its final decision regarding 
remedial actions. If three independent complaint investigations 
conclude that an individual B Reader has engaged in a pattern of 
providing unreasonably inaccurate chest radiographs in practice, the B 
Reader's certification will be permanently revoked.
    A new paragraph (d)(3) would establish an appeal process for those 
B Readers whose certifications have been revoked by the Coal Workers' 
Health Surveillance Program.
    HHS is also considering permitting the revocation or suspension of 
B Reader certifications for demonstrated patterns of violating the B 
Reader's Code of Ethics. The Code of Ethics is available on the NIOSH 
website at https://www.cdc.gov/niosh/topics/chestradiography/breader-ethics.html, and would be included in part 37 as an appendix should 
this option be adopted. HHS encourages comments on this matter.
    In addition to the proposed regulatory language on remediating 
inaccurate B Readers, HHS would also amend 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) would be revised to clarify that pathologists must 
secure prior authorization from NIOSH and have legal consent to conduct 
an autopsy on a coal miner. New language in Sec.  37.202(a)(2)(i) and 
(ii) would clarify the types of chest radiographs accepted by the 
Program, and new language in Sec.  37.202(b) would specify that 
pathologists would be compensated in accordance with the ordinary, 
usual, or customary fee charged by other pathologists for the same 
services. Section 37.203 would be revised to update the reference for 
standard autopsy procedures. Finally, new language in Sec.  37.204(a) 
would detail the new requirement that the pathologist obtain written 
authorization from the NIOSH Respiratory Health Division prior to 
completion of the autopsy. Existing language specifying how claims for 
payment should be submitted to NIOSH would be reorganized.
    In existing Sec.  37.201(b), the definition of Miner would be 
revised to remove the word ``underground,'' to clarify that the autopsy 
provisions pertain to all coal miners. Section 37.201(d) would also be 
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 proposed rule has been determined not to be a ``significant 
regulatory action'' under section 3(f) of E.O. 12866. The revisions 
proposed in this notice would allow NIOSH to take remedial action 
addressing any B Readers who frequently provide chest radiograph 
classifications in practice that are determined by the Program to be 
unreasonably inaccurate. Part 37 would also be revised to allow NIOSH 
to compensate pathologists at a contemporary rate for autopsies 
submitted to the Coal Workers' Health Surveillance Program.
    The proposed revisions to Part 37 would not impose significant 
costs on the public and would benefit coal miners and coal mine 
operators. Depending on the types of unreasonably inaccurate 
classifications they provide, B Readers can compromise the health of 
and benefits owed to coal miners who have pneumoconiosis by under-
reading or cause unnecessary emotional distress to miners and 
unnecessary costs for mine operators by over-reading. Allowing the 
NIOSH Respiratory Health Division to take remedial actions addressing 
these B Readers through suspension or revocation of their B Reader 
certifications would ensure that these adverse outcomes were minimized 
or avoided. Allowing the NIOSH Respiratory Health Division to better 
compensate pathologists for autopsies submitted to the Program would 
also ensure that NIOSH is able to study pneumoconiosis in coal miners.
    The costs to the Federal government of administering these 
revisions would be minor and infrequent. NIOSH estimates that over a 5-
year period, it might conduct two evaluations of B Readers, costing 
NIOSH approximately $3,000. Over the same period, NIOSH estimates it 
might fund up to 20

[[Page 8524]]

autopsies, costing NIOSH approximately $60,000.
    The only costs potentially imposed on the public would be borne by 
B Readers whose certifications are suspended or revoked. NIOSH 
estimates that over a 5-year period it might suspend or revoke 
certifications for one B Reader. However, conducting B Reader medical 
examinations is generally infrequent within a physician's medical 
practice, and moreover, other medical procedures similarly compensated 
would likely substitute for conducting B Reader examinations. It is not 
possible to reasonably estimate whether such costs would arise and, if 
so, their level and frequency.

B. Executive Order 13771 (Reducing Regulation and Controlling 
Regulatory Costs)

    Executive Order 13771 requires executive departments and agencies 
to eliminate at least two existing regulations for every new 
significant regulation that imposes costs. HHS has determined that this 
rulemaking is cost-neutral because it does not require any new action 
by stakeholders. The rulemaking ensures that coal miners properly 
receive compensation for their occupational illness and that NIOSH can 
more thoroughly study the development of pneumoconiosis. Because OMB 
has determined that this rulemaking is not significant, pursuant to 
E.O. 12866, and because it does not impose costs, OMB has determined 
that this rulemaking is exempt from the requirements of E.O. 13771. 
Thus it has not been reviewed by OMB.

C. 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 proposed 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.).

D. 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 proposed amendments in this rulemaking would not 
impact the existing collection of data but would add two new items to 
the approval: B Reader challenge and appeal, and the pathologist prior 
authorization request. To request more information or to obtain a copy 
of the data collection plans and instruments, you may call 404-639-
5960; send comments to Kimberly S. Lane, 1600 Clifton Road, MS-D74, 
Atlanta, GA 30333; or send an email to [email protected].
    Comments are invited on the following: (a) Whether the proposed 
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; and (d) ways to minimize the burden of the collection of 
information on respondents. Written comments should be received within 
60 days of the publication of this notice. The addition of additional 
paperwork requirements resulting from this proposed rule will increase 
the burden associated with the following provisions:
    Section 37.52 Proficiency in the use of systems for classifying the 
pneumoconioses. This section establishes the process for certifying B 
Readers. Of the 167 B Readers currently certified and the approximately 
additional 200 who will be certified over the next 10 years, HHS 
anticipates that no more than three B Readers may be disciplined over 
time. Of those, HHS expects two B Readers to challenge or appeal the 
decision to take disciplinary action; if all decisions are challenged 
and the final decision to revoke certification is appealed, NIOSH would 
receive up to eight letters (for each of the four final disciplinary 
decisions). HHS estimates that the challenge or appeal letter will take 
no more than 30 minutes to complete, totaling 4 hours annually. There 
will be no form associated with this collection.
    Section 37.204 Procedure for obtaining payment. This section would 
establish 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 
that the number of requests will vary substantially from year-to-year. 
For example, more requests might be granted following a mine disaster. 
Over a period of years, 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 1 hour annually over a period of years.

----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of    Responses  per    burden per     Total burden
            Section                   Title         respondents      respondent      response          (hr)
                                                                                       (min)
----------------------------------------------------------------------------------------------------------------
37.52.........................  Challenge to                   2               4           30/60               4
                                 disciplinary
                                 action and
                                 appeal of
                                 decertification
                                 decision.
37.204........................  Autopsy prior                  4               1           15/60               1
                                 authorization.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............               5
----------------------------------------------------------------------------------------------------------------

E. 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.

F. 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

[[Page 8525]]

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 proposed 
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.

G. Executive Order 12988 (Civil Justice Reform)

    This proposed 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.

H. Executive Order 13132 (Federalism)

    HHS has reviewed this proposed 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.''

I. 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 proposed rule on 
children. HHS has determined that the rule would have no environmental 
health and safety effect on children.

J. 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 proposed rule on energy supply, distribution or use, 
and has determined that the rule will not have a significant adverse 
effect.

K. 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 proposed rule consistent with the Federal 
Plain Writing Act guidelines.

List of Subjects in 42 CFR Part 37

    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.

Proposed Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services proposes to amend 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.  37.52 by adding paragraph (d) to read as follows:


Sec.  37.52  Proficiency in the use of systems for classifying the 
pneumoconioses.

* * * * *
    (d) Remedial Actions. (1) Any interested party may make a complaint 
to the NIOSH Coal Workers' Health Surveillance Program against any B 
Reader who routinely provides chest radiograph classifications in 
practice that are believed to be unreasonably inaccurate.
    (i) Inaccurate classifications are those that fail to identify 
small or large opacities in lung fields, pleural changes, and other 
features indicating the presence of lung disease where they exist, or 
those that identify small or large opacities, pleural changes, and 
other features where they do not exist. Unreasonably inaccurate 
classifications are those that a panel of B Readers would unanimously 
determine are substantially divergent from a competent interpretation 
of the radiographs and are unsupported by the chest radiographs in 
question.
    (ii) A valid complaint must be submitted to the NIOSH Coal Workers' 
Health Surveillance Program, Respiratory Health Division, and include 
the chest radiographs and ILO classifications being contested as well 
as a letter of support from a medical professional. A complaint that 
demonstrates more than a reasonable difference of opinion will be 
considered valid.
    (iii) A complaint that fails to include any required element will 
be considered invalid, and the NIOSH Respiratory Health Division will 
notify the complainant that no further investigation will occur.
    (2) Investigations may be initiated at NIOSH's discretion or in 
response to a valid complaint, pursuant to paragraph (d)(1) of this 
section, to determine whether a B Reader has provided chest radiograph 
classifications in practice that are unreasonably inaccurate.
    (i) Investigations will include the following:
    (A) The NIOSH Respiratory Health Division will choose a panel of at 
least four B Readers who will independently review the information 
provided in each valid complaint.
    (B) If one or more of the B Readers on the panel independently 
determines that the classification being contested is reasonable, the 
NIOSH Respiratory Health Division will conclude that the classification 
being contested is reasonable. The complainant will be notified of the 
finding and no further action will be conducted.
    (C) If the B Readers on the panel independently and unanimously 
concur that the classification being contested is unreasonable, 
remedial actions will be taken by the NIOSH Respiratory Health Division 
pursuant to paragraphs (d)(2)(ii) through (v) of this section, 
accordingly.
    (ii) If, after an investigation, a panel of B Readers unanimously 
finds that the classification contested in a complaint is unreasonably 
inaccurate, the Program will issue an initial report to the B Reader 
under review. If the B Reader chooses not to challenge the initial 
report within 30 days, the initial report becomes a final 
determination. If the B Reader chooses to challenge the initial report, 
the Coal Workers' Health Surveillance Program will respond within 90 
days; the Program's decision is final. The first final report may be 
considered a warning that further misclassification of small or large 
opacities or other types of pleural abnormalities will result in 
suspension or revocation of the B Reader's certification.
    (iii) If, after an investigation, a panel of B Readers unanimously 
finds that the classification contested in a second complaint is 
unreasonably inaccurate, the Program will issue an initial report to 
the B Reader under review. If the B Reader chooses not to challenge the 
initial report within 30 days, the initial report becomes a final 
determination. If the B Reader chooses to challenge the initial report, 
the Coal Workers' Health Surveillance Program will respond

[[Page 8526]]

within 90 days, during which time the B Reader's certification will 
remain in good standing; the Program's decision is final and may result 
in the 1-year suspension of the B Reader's certification with the 1-
year period beginning on the date the Program issues the final decision 
letter. The suspended B Reader must take and pass the certification 
examination at the conclusion of the suspension period in order to be 
reinstated.
    (iv) If, after an investigation, a panel of B Readers unanimously 
finds that the classification contested in a third complaint is 
unreasonably inaccurate, the Program will issue an initial report to 
the B Reader under review. If the B Reader chooses not to challenge the 
initial report within 30 days, the initial report becomes a final 
determination. If the B Reader chooses to challenge the initial report, 
the Coal Workers' Health Surveillance Program will respond within 90 
days, during which time the B Reader's certification will remain in 
good standing; the Program's decision is final, unless the B Reader 
successfully appeals the decision pursuant to Sec.  37.52(d)(3), and 
will result in permanent revocation of the B Reader's certification 
beginning on the date the Program issues the final decision letter.
    (v) If the first complaint is found to be valid and to demonstrate 
a pattern of inaccurate chest radiograph classifications, the Program 
will issue an initial report to the B Reader under review and 
immediately apply the procedures in paragraph (d)(2)(iv) of this 
section. To demonstrate a pattern of inaccurate classifications, the 
valid complaint must provide radiographs from three or more patients 
conducted within a one-year period that are determined by the Program 
to be inaccurate.
    (3) A B Reader whose certification is revoked after three final 
adverse determinations is no longer a certified B Reader. Such B Reader 
may appeal the Coal Workers' Health Surveillance Program's decision to 
revoke the B Reader's certification.
    (i) An appeal request must be submitted in writing to the NIOSH 
Respiratory Health Division Director, signed and postmarked within 30 
calendar days of the date of the letter notifying the B Reader of the 
decertification decision. Electronic versions of the signed appeal 
request letter will also be accepted.
    (ii) The appeal request must state the reason(s) the B Reader 
believes the decertification decision is incorrect and should be 
reversed. The appeal request may include scientific or medical 
information correcting factual errors, any information demonstrating 
that the decertification decision was not reasonable, and/or relevant 
new information not previously considered by the Coal Workers' Health 
Surveillance Program.
    (iii) The appeal request must be sent to the NIOSH Respiratory 
Health Division Director at the address specified in the 
decertification letter.
    (iv) The NIOSH Respiratory Health Division Director will review the 
Coal Workers' Health Surveillance Program decision and any relevant 
information provided by the B Reader and make a final decision on the 
appeal. The Director will notify the B Reader of the following in 
writing:
    (A) The Director's final decision on the appeal;
    (B) An explanation of the reason(s) for the Director's final 
decision on the appeal; and
    (C) Any administrative actions taken by the Coal Workers' Health 
Surveillance Program.
0
3. 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 his/her 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 programmatic responsibility for the medical examination 
and surveillance program.
0
4. 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 from NIOSH pursuant to Sec.  37.204(a), 
and with legal consent:
    (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) Pathologists will be compensated in accordance with the 
ordinary, usual, or customary fee charged by other pathologists for the 
same services, at the discretion of NIOSH. 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 his/
her death together with copies of any interpretations made.
    (c) A pathologist who receives any other specific payment, fee, or 
reimbursement in connection with the autopsy from the miner's widow/
widower, his/her family, his/her estate, or any other Federal agency 
will not receive compensation from NIOSH.
0
5. 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

[[Page 8527]]

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 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 must be 
submitted.
    (c) Needle biopsy techniques will not be accepted.
0
6. 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 #0.1585).
    (1) NIOSH will maintain up-to-date information about the 
availability of payments on its website. If payments are not available, 
the online Authorization of Payment for Autopsy form will not be active 
and available for completion on the NIOSH 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 is not receiving any other 
specific compensation for the autopsy from the miner's widow/widower, 
his/her surviving 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.

    Dated: January 10, 2020.
Alex M. Azar II
Secretary, Department of Health and Human Services.
[FR Doc. 2020-02705 Filed 2-13-20; 8:45 am]
 BILLING CODE 4163-218-P