[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]
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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: B Reader
Decertification and Autopsy Payment
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Notice of proposed rulemaking.
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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.
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\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).
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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\
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\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.
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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.
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\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.
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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.
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Average
Number of Responses per burden per Total burden
Section Title respondents respondent response (hr)
(min)
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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.
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Total..................... ................ .............. .............. .............. 5
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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