[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Rules and Regulations]
[Pages 21606-21615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08636]
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DEPARTMENT OF LABOR
Office of Workers' Compensation Programs
20 CFR Parts 718 and 725
RIN 1240-AA07
Black Lung Benefits Act: Standards for Chest Radiographs
AGENCY: Office of Workers' Compensation Programs, Labor.
ACTION: Final rule.
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SUMMARY: Physicians and adjudicators use chest radiographs (X-rays) as
a tool in evaluating whether a coal miner suffers from pneumoconiosis
(black lung disease). Accordingly, the Department's regulations
implementing the Black Lung Benefits Act allow the submission of
radiographs in connection with benefit claims and set out quality
standards for administering and interpreting film-based chest
radiographs. This final rule updates the Department's existing film-
radiograph standards and provides parallel standards for digital
radiographs. This rule also updates outdated terminology and removes
certain obsolete provisions.
DATES: This rule is effective May 19, 2014. The incorporation by
reference of certain publications listed in the rule is approved by the
Director of the Federal Register as of May 19, 2014.
FOR FURTHER INFORMATION CONTACT: Gerald Delo, Deputy Director, Division
of Coal Mine Workers' Compensation, Office of Workers' Compensation
Programs, U.S. Department of Labor, 200 Constitution Avenue NW., Suite
C-3520, Washington, DC 20210. Telephone: (202) 343-5907 (this is not a
toll-free number). TTY/TDD callers may dial toll-free 1-800-877-8339
for further information.
SUPPLEMENTARY INFORMATION:
I. Background of This Rulemaking
On June 13, 2013, the Office of Workers' Compensation Programs
(OWCP) published a direct final rule (78 FR 35549) and a companion
notice of proposed rulemaking (NPRM) (78 FR 35575) to update the
existing quality standards for administering and interpreting film-
based chest radiographs and to add parallel standards for digital
radiographs for claims under the Black Lung Benefits Act (BLBA), 30
U.S.C. 901-944. Both documents stated that if OWCP received significant
adverse comment, the direct final rule would be withdrawn. OWCP asked
for comments on all issues related to the rule, including economic or
other regulatory impacts on the regulated community. Because OWCP
received significant adverse comment, OWCP withdrew the direct final
rule on August 30, 2013, 78 FR 53645. This final rule completes the
process begun by the notice of proposed rulemaking.
As explained in the NPRM, OWCP proposed adding digital radiography
standards to the existing standards
[[Page 21607]]
because digital radiography systems are rapidly replacing traditional
analog film-based systems in medical facilities. 78 FR 35576-35577.
Because of this technology shift, claimants, coal mine operators, and
the Department had been experiencing increasing difficulty in obtaining
film chest X-rays of miners. Although interpretations of digital X-rays
were admissible as ``other medical evidence'' under the catch-all
provision at 20 CFR 718.107, the interpretation's proponent had to
establish to the adjudicator's satisfaction that digital X-rays are
medically acceptable and relevant to the claimant's entitlement to
benefits. See generally Webber v. Peabody Coal Co., 23 BLR 1-123 (2006)
(en banc) aff'd on recon., 24 BLR 1-1 (2007) (en banc); Harris v. Old
Ben Coal Co., 23 BLR 1-98 (2006) (en banc), aff'd on recon., 24 BLR 1-
13 (2007) (en banc). This led to mixed results from adjudicators, with
some admitting digitally based interpretations and others refusing to
consider them or affording them less weight based on the technology
employed.
This final rule fills the technological gap with regulatory quality
standards for digital radiographs. As it did when it first promulgated
quality standards for film-based chest X-rays, see 78 FR 35576-35577
(summarizing history of X-ray quality standards and Department's
authority to adopt them), the Department has based the standards
adopted in this final rule largely on those promulgated in 2012 by the
Department of Health and Human Services for use in the National
Institute for Occupational Safety and Health (NIOSH) Coal Workers'
Health Surveillance Program (CWHSP) (the NIOSH rules). See 42 CFR 37.1
et seq.; see also 77 FR 56718-56735 (September 13, 2012) (NIOSH final
rule); 77 FR 1360-1385 (January 9, 2012) (NIOSH proposed rule). Under
the CWHSP, NIOSH approves medical facilities for participation in
monitoring the health of the nation's coal miners through periodic
chest X-ray screening. See 42 CFR 37.44-37.45; see also 78 FR 35577
(discussing the CWHSP). Congress designated NIOSH as the Department's
statutory advisor for establishing standards for BLBA medical testing.
30 U.S.C. 902(f)(1)(D).
The standards adopted here will ensure that claim adjudications
continue to be based on high-quality, uniform radiographs. By adopting
quality standards for digitally acquired chest X-rays, the Department
intends that interpretations of film and digital X-rays--so long as
they are made and interpreted in accordance with the applicable quality
standards--will be put on equal footing both for admission into
evidence and for the weight accorded them. The final rule also retains
the current regulatory quality standards for film-based chest X-rays
with the minor terminology modifications explained in the NPRM. See 78
FR 35579. The final rule does not impose any new requirements on the
parties in BLBA claims; instead, it merely provides the parties another
option for developing medical evidence in claim proceedings.
II. Statutory Authority
Section 426(a) of the BLBA, 30 U.S.C. 936(a), authorizes the
Secretary of Labor to prescribe all rules and regulations necessary for
the administration and enforcement of the Act. The BLBA also authorizes
the Secretary of Labor, in consultation with NIOSH, to ``establish
criteria for all appropriate medical tests'' administered in connection
with a benefits claim, 30 U.S.C. 902(f)(1)(D), and to ``establish
specific requirements for the techniques used to take [X-rays] of the
chest'' to ensure their quality. 30 U.S.C. 923(b).
III. Discussion of Comments
The Department received comments from only three sources: The
American College of Radiology (ACR), a coal mine operator, and an
insurance company that insures coal mine operators for BLBA
liabilities. The latter two submissions (industry comments) were
identical in all substantive respects. While the commenters commend the
Department for moving forward with digital radiograph standards, they
also criticize the proposed rules. Their comments pertain primarily to
very limited portions of Sec. 718.102 and Part 718, Appendix A. The
Department had proposed substantially revising these regulations to
allow parties the option of submitting X-rays that are produced either
by film or digital radiography systems. The Department explained in
detail each of the proposed revisions, deletions, and additions in the
NPRM. See 78 FR 35577-79.
The Department has considered the comments received but declines to
revise the proposed rule for the reasons set forth in this section. In
reaching this conclusion, the Department consulted extensively with
NIOSH, and NIOSH has reviewed this final rule. The Department's
response to cost-related comments is set forth below in the section on
Executive Orders 12866 and 13563.
20 CFR 718.102(c) and Part 718 Appendix A, Paragraph (d)(16): Converted
Radiographs
Section 718.102(c) and paragraph (d)(16) of Appendix A, as
proposed, prohibit the use of interpretations of X-rays that have been
converted from digital to film, or vice-versa. The Department proposed
the limitation because NIOSH had determined that these ``converted''
radiographs do not assure similar results to that obtained from film
under the existing standards. See 78 FR 35578.
The ACR and the industry comments ask the Department to remove this
provision from the regulation. Acknowledging that converted images are
not ideal, the ACR states that they nevertheless can be adequate for
interpretation. The industry comments claim that using converted images
is a common practice and that disallowing their use is inconsistent
with the Guidelines for the Use of ILO International Classification of
Radiographs of Pneumoconiosis, 2011 edition. Both the ACR and the
industry argue that determining whether any particular converted image
is of sufficient quality and suitable for classification under the ILO
Guidelines should be left to a qualified B-reader's discretion.
All parties recognize the importance of valid, accurate medical
evidence in claims adjudications. In promulgating these rules, the
Department is expanding accessibility to medical providers by
permitting the use of digitally acquired images. But it must still
assure that decisions regarding a miner's physical condition do not
vary depending on the radiographic technology used for evaluations.
A primary difficulty with using converted images is that, at the
current time, the Department is unaware of specifications for
equipment, procedures, and methods that can assure the accuracy and
precision of converted images when used for ILO classification
purposes. In fact, the available scientific evidence casts doubt on the
accuracy of some converted images. Studies of digital images converted
to film showed that the apparent profusion of small opacities was
greater on printed hard copies of digital images than on either
digitally acquired radiographs displayed on a monitor or analog film-
based radiographs obtained at the same time. Franzblau A, Kazerooni EA,
Sen A, Goodsitt MM, Lee SY, Rosenman KD, Lockey JE, Meyer CA, Gillespie
BW, Petsonk EL, Wang ML [2009], Comparison of digital radiographs with
[[Page 21608]]
film radiographs for the classification of pneumoconiosis, Acad Radiol
16(6):669-677. See also 78 FR 35578 citing 77 FR 1366 (NIOSH discussion
of scientific studies). Moreover, there is no standardized approach to
the process of creating the hard copy or for the equipment used to do
so.
The Department also lacks data about the accuracy of scanned,
digitized images obtained from analog chest radiographs when used for
ILO classification purposes. Theoretically, available image receptors
for digital radiography systems can detect a depth of gray scale that
is considerably greater than for analog photographic film, and the
additional gray scale is not available when analog images are scanned
to digital. Signal processing after digital image acquisition also
generally improves the visualization of structures that might not be
visible on an analog film image, for example those overlying the
mediastinum and heart. This post-processing cannot generally be done
when analog images are digitized. Another barrier to using scanned,
digitized versions of analog images is the absence of an industry-wide
standard for the digitizing process that is documented to provide image
characteristics that are relatively uniform and acceptable for
pneumoconiosis classification. Specifications, operation, and
maintenance of the scanning equipment used to digitize images can all
affect the quality of the resulting image.
The industry comments state that disallowing converted radiographs
is contrary to the ILO Guidelines and that the ILO itself converted its
standard film radiographs to create standardized digital images for use
with the ILO classification system. While the ILO Guidelines do not
prohibit application of the classification system to converted
radiographs, the Guidelines are necessarily broad because they are used
worldwide, including countries where the industry has strict standards
for conversion processes and the associated hardware (e.g., printers
and scanners). In fact, the ILO's experience in digitizing its standard
analog films highlights the problems with the digital conversion
process and the difficulty of preserving the integrity of
pneumoconiotic findings during that process. It is a highly subjective
process that is not easily routinized; multiple iterations and software
manipulations were required to provide images with characteristics that
the ILO experts felt adequately reflected their original standard
films. These labor-intensive efforts are simply not a normal part of
current clinical practice in the United States, and it is unlikely a
clinician would go to such extraordinary lengths to ensure accurate
conversion of an individual miner's radiographs. Although the ACR
comment asserts that existing technology can display excellent analog
images converted from digitally-acquired images, it does not include
any details or other information on that technology for the Department
to consider.
The Department also does not agree that detection of quality
problems in the conversion process should be left to certified B
readers for several reasons. First, even assuming a B-reader could
detect quality problems, parties are not required to submit
interpretations made by B-readers or physicians who specialize in
radiology. Readings made by the miner's treating physician or
pulmonologist are often offered as evidence, even when these physicians
are not certified B-readers. Thus, it is important that the radiographs
themselves are consistently high-quality for all interpreting
physicians. Second, the Department is not confident that a B-reader
could reliably detect quality deficiencies such as data loss from the
converted image alone, and the Department is unaware of any scientific
studies suggesting otherwise. Finally, leaving the validity of
converted radiographs to resolution on a claim-by-claim, radiograph-by-
radiograph basis would generate additional litigation in BLBA claims.
The quality standards are designed to avoid such a result.
In sum, the Department is unaware of any scientific evidence
supporting the use of converted radiographs for pneumoconiosis
classification, and the comments point to none. The Department intends
to monitor the scientific literature, and will consider further
modification of the rule if additional evidence becomes available
regarding specific methods of converting images between analog and
digital formats, and the equivalence of ILO classifications of such
converted images.
The commenters suggest two alternatives to banning converted
radiographs. First, they ask the Department to allow interpretations of
converted images to be submitted under Sec. 718.107, which permits
submission of ``any medically acceptable test or procedure reported by
a physician and not addressed in this subpart[.]'' 20 CFR 718.107(a)
(emphasis added). The submitting party must demonstrate the medical
acceptability of the test or procedure and its relevance to the claim's
adjudication. 20 CFR 718.107(b). Section 718.107 is a flexible catch-
all provision for admitting existing or future types of testing not
specifically addressed by the regulatory quality standards at 20 CFR
718.101-718.106 (standards for chest X-rays, pulmonary function tests,
reports of physical examinations, arterial blood gas studies, and
autopsy and biopsy evidence). For instance, parties may submit chest
computed tomography (CT) scan results under Sec. 718.107 if the
submitter satisfies the adjudicator as to its reliability and relevance
because the Department has not established quality standards for that
particular test. Likewise, prior to this final rule's promulgation,
parties could submit interpretations based on digital chest radiographs
under Sec. 718.107 because the Department had not addressed that
particular technology. See, e.g., Harris v. Old Ben Coal Co., 23 BLR 1-
98 (2006) (en banc), aff'd on recon., 24 BLR 1-13 (2007) (en banc).
Because the final rule now provides standards for digital radiographs,
Sec. 718.107's catch-all provision, by its plain language, no longer
applies. Instead, the new rule embodies the Department's determination
of what digital radiographs (and their interpretations) are medically
acceptable for purposes of adjudicating BLBA claims. This relieves
parties of the burden of proving medical acceptability in each case and
sets a quality threshold for digital radiographic evidence used for
entitlement determinations. To accept the commenter's suggestion and
allow submission of digital radiographs under Sec. 718.107 that do not
meet the new criteria would effectively create a loophole that negates
the very purpose of those criteria.
Second, the commenters ask the Department to delay the effective
date of Sec. 718.102(c) and Appendix A, paragraph (d)(16) for 2 to 3
years so that medical facilities and state regulatory bodies have time
to comply with the rule. In support, the ACR states that some
facilities may not have a system that allows for digital image
transmission and that they should be allowed time to modernize their
equipment to comply with the new standards. The ACR also notes at least
one state requires film radiographs for workers' compensation
evaluations and that it is unclear whether legal entities involved in
state workers' compensation claims have the ability to display digital
images on medical-grade monitors.
The Department does not agree that delaying the effective date of
Sec. 718.102(c) is necessary. While some facilities may not yet have
acquired the equipment necessary to meet the final rule's requirements,
many have. In 2011, prior to NIOSH's promulgation of
[[Page 21609]]
its digital radiography regulations, approximately sixty-one analog
film facilities were approved to participate in the CWHSP. After NIOSH
adopted digital radiography standards in 2012, the total number of
NIOSH-approved facilities rose to ninety in 2013, with forty-two of
these facilities approved to perform digital radiographs. This dramatic
growth in the number of NIOSH-approved facilities would not have
occurred so quickly if facilities either did not already have the
capacity or could not easily acquire it to perform digital radiographs
in compliance with the standards adopted in this final rule. More
importantly, the regulations do not force any party to use digital
radiography systems; the traditional analog film option remains
available. Thus, if a state requires film radiographs, interpretations
of those films will also be admissible in BLBA claims, provided the X-
rays were administered and interpreted in compliance with the analog-
film standards set forth in Sec. 718.102 and Appendix A.
Part 718 Appendix A, Paragraph (d)(14): Software Availability for
Interpreting Digital Radiographs
The industry comments state that no commercial picture archiving
and communications system (PACS) vendors provide software that allows
side-by-side display of the miner's radiograph with the ILO standard
digital images. This method of interpreting digital radiographs is set
forth in proposed Part 718 Appendix A, paragraph (d)(14). Although
software availability is limited, facilities seeking to provide this
service are not without options. Facilities can use the NIOSH BViewer
software, which is offered free to the public and available on NIOSH's
Web site. Facilities can also work with their PACS vendor to adapt
existing software, utilize the BViewer software, or develop other
innovative solutions. Indeed, at least one PACS provider has given
NIOSH a software supplement that permits chest image classifications to
be performed side-by-side with the ILO standard digital images on its
commercially available system. The Department believes the availability
of chest image classification software will increase as more of the
industry utilizes digital systems. Moreover, limited software
availability should not forestall the Department from adopting a rule
for classifying digital radiographs for use by those facilities that
currently have the capacity to meet the quality standards. Accordingly,
no change has been made in response to this comment.
Remaining Provisions
No comments were received on several proposed provisions--Sec.
718.5 (incorporations by reference), Sec. 718.202 (determining the
existence of pneumoconiosis), and Sec. 718.304 (Irrebuttable
presumption of total disability or death due to pneumoconiosis). These
regulations are therefore promulgated in this final rule as proposed
with one technical revision to Sec. 718.202(a)(3). As proposed,
section 718.202(a)(3) included a cross-reference to Sec. 718.306. 78
FR 35582. After the proposal was published, however, the Department
promulgated a final rule revising Sec. 718.202(a)(3) to remove the
cross-reference because the Department had ceased publication of Sec.
718.306. 78 FR 39114 (September 25, 2013). This final rule conforms
Sec. 718.202(a)(3) to the intervening September 25, 2013 final rule.
IV. Administrative Law Considerations
A. Information Collection Requirements (Subject to the Paperwork
Reduction Act)
In the NPRM, the Department stated that the proposed rules did not
impose any new information collections under the Paperwork Reduction
Act, 44 U.S.C. 3501 et seq. 78 FR 35579. The final rule at Sec.
718.102(f) requires physicians obtaining radiographs of miners on
digital radiography systems to submit the radiograph in electronic
format, rather than analog film format. The Department is incorporating
this format change into an existing approved information collection
titled ``Claim Adjudication Process for Alleged Presence of
Pneumoconiosis,'' OMB Control Number 1240-0023. Although the Department
does not believe this is a new information collection, changes the
actual data collected, or alters the estimated information collection
(paperwork) burdens imposed on the public, the additional electronic
format option could be considered a change to an existing information
collection currently approved under the PRA.
Accordingly, the Department published a notice in the Federal
Register on November 19, 2013, 78 FR 69449, requesting comments from
the public on revising the collection to include information in
electronic format. The notice directed the public to submit comments to
the Office of Management and Budget (OMB) on or before December 19,
2013. No comments were received. The Department also submitted a
revised information collection request to OMB. OMB preapproved the
revisions to the information collection on December 27, 2013. See
http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1240-0023 (last visited Feb. 24, 2014).
B. Executive Orders 12866 and 13563 (Regulatory Planning and 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). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. The Department has considered this rule with these
principles in mind and has concluded that the regulated community will
greatly benefit from this regulation.
The Department fully explained this conclusion in the NPRM (78 FR
35579-80). The rule will increase access to radiographic technology,
which in turn will increase the number of medical providers available
to OWCP and reduce delays in processing miners' benefits claims;
increase access for claimants and coal mine operators (and their
insurers) to additional radiographic facilities; and relieve parties of
the demanding evidentiary burden of proving medical acceptability of
digital X-rays under Sec. 718.107. The Department also considered
whether the parties will realize any monetary benefits or incur any
additional costs in light of this rule, and concluded that it is a
cost-neutral rule. The rule expands opportunities for claimants and
coal mine employers to obtain X-ray evidence, but does not require any
party to use digital X-ray systems; medical facilities generally charge
the same fee for film and digital radiographs; and miners' reimbursable
travel costs may decrease if miners have access to a digital facility
in their locality.
The industry comments state that the Department has underestimated
the cost impact of the rule. They note that to comply with the
requirements set forth in Part 718, Appendix A, medical facilities will
need to obtain physics support, conduct annual testing of monitors, and
purchase additional medical-grade monitors so that the X-ray
interpreter can display the miner's digital radiograph side-by-side
with the standard ILO-approved digital images when reading the
radiograph. They believe these requirements will impose additional
costs on medical facilities.
[[Page 21610]]
In the context of this rulemaking, the Department's primary concern
is the direct financial impact on parties to BLBA claims. Cf. Mid-Tex
Elec. Coop., Inc. v. Fed. Energy Regulatory Comm'n, 773 F.2d 327, 343
(D.C. Cir. 1985) (recognizing that ``Congress did not intend to require
that every agency consider every indirect effect that any regulation
might have on small businesses in any stratum of the national
economy''). The comments neither suggest that the parties will incur
higher costs to obtain digital radiographs than analog film radiographs
nor disagree with the Department's analysis of that cost as set out in
the NPRM. Thus, the Department continues to believe that the rule is
cost-neutral for the parties in claim proceedings.
Looking further downstream at potential costs imposed on medical
facilities, the Department notes that any costs incurred for purchasing
and maintaining digital radiography systems is at the facilities'
option and is not required by these rules. The final rule continues to
allow submission of traditional analog film radiographs. Thus,
facilities may proceed as they have in the past with no change in cost
burden.
Facilities that choose to transition to a digital environment are
already investing in the core hardware, software, and maintenance
needed to perform digital radiography and evaluate digital images. As
both the Department and NIOSH have noted, the burden imposed by these
standards is low because they reflect standard industry practice and
technology that digital-radiography facilities already follow. See 78
FR 35579; 77 FR 56724 (September 13, 2012); 77 FR 1372 (January 9,
2012). Although a particular facility might incur an added cost for
purchasing an additional medical-grade monitor or computer processing
unit so that images may be displayed side-by-side with the ILO standard
images when interpreting them for pneumoconiosis--a requirement in both
the NIOSH regulations and this final rule--the Department believes that
many, if not most, radiography facilities already have this capacity.
Notably, no member of the medical community commented on this
requirement or raised cost-related concerns in response to either the
NPRM or NIOSH's proposed rule.
Executive Order 13563 also instructs agencies to review ``rules
that may be outmoded, ineffective, insufficient, or excessively
burdensome, and to modify, streamline, expand, or repeal them.'' As
explained in the NPRM, this rule revises obsolete terms (e.g.,
replacing ``roentgenogram'' with ``radiograph'' or ``X-ray''),
discontinues publication of obsolete provisions (e.g., the X-ray
rereading prohibition provisions), and replaces the imprecise term
``shall.'' 78 FR 35577-35578. Because the Department received no
comment on these revisions, the affected regulations have been
promulgated as proposed.
Finally, because this is not a ``significant'' rule within the
meaning of Executive Order 12866, the Office of Management and Budget
has not reviewed it prior to publication.
C. 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.'' 2 U.S.C. 1531. For
purposes of the Unfunded Mandates Reform Act, this rule does not
include any Federal mandate that may result in increased expenditures
by State, local, tribal governments, or increased expenditures by the
private sector of more than $100,000,000.
D. Regulatory Flexibility Act and Executive Order 13272 (Proper
Consideration of Small Entities in Agency Rulemaking)
The Regulatory Flexibility Act of 1980, as amended, 5 U.S.C. 601 et
seq. (RFA), requires agencies to evaluate the potential impacts of
their proposed and final rules on small businesses, small
organizations, and small governmental jurisdictions and to prepare an
analysis (called a ``regulatory flexibility analysis'') describing
those impacts. See 5 U.S.C. 601, 603-604. But if the rule is not
expected to ``have a significant economic impact on a substantial
number of small entities[,]'' the RFA allows an agency to so certify in
lieu of preparing the analysis. See 5 U.S.C. 605.
For the reasons set forth in the NPRM, the Department determined
that a complete regulatory flexibility analysis was not necessary, and
certified that the proposed rules would not have a significant economic
impact on a substantial number of small entities. 78 FR 35580. The
Department invited public comment on the certification and delivered a
copy of the certification to the Chief Counsel for Advocacy of the
Small Business Administration. See generally 5 U.S.C. 605.
The Chief Counsel for Advocacy has not filed comments on the
certification. Although the industry comments state generally that
medical facilities could incur additional costs under the new rule,
these comments do not challenge the Department's stated factual basis
for the certification: (1) Using digital radiography (and incurring
associated additional costs, if any) is optional; (2) the costs for a
party to obtain a film or digital radiograph are equivalent; and (3)
the rule will benefit all parties by providing access to additional
medical facilities. These comments also were not couched in terms of
small business and made no allegation that the parties in claim
proceedings would incur additional costs. See, e.g., United Distrb.
Companies v. Fed. Energy Regulatory Comm'n, 88 F.3d 1105, 1170 (D.C.
Cir. 1996) (holding that agency has ``no obligation to conduct a small
entity impact analysis of effects on entities which it does not
regulate''); Mid-Tex Elec. Coop., Inc., 773 F.2d at 343; see also White
Eagle Coop. Ass'n v. Conner, 553 F.3d 467, 480 (7th Cir. 2009) (holding
that milk producers did not have standing to bring challenge to
regulation of milk market under the RFA where the regulation reached
the producers only indirectly).
Because the comments provide no basis for departing from its prior
conclusion, the Department again certifies that this rule will not have
a significant economic impact on a substantial number of small
entities. As a result, no regulatory impact analysis is required.
E. Executive Order 13132 (Federalism)
The Department has reviewed this rule in accordance with Executive
Order 13132 regarding federalism, and has determined that it does not
have ``federalism implications.'' E.O. 13132, 64 FR 43255 (Aug. 4,
1999). The final rule will 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.'' Id.
F. Executive Order 12988 (Civil Justice Reform)
This rule meets the applicable standards in Sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden. 61 FR 4729 (Feb. 5,
1996).
G. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must
[[Page 21611]]
submit a report, which includes a copy of the rule, to each House of
the Congress and to the Comptroller General of the United States. OWCP
will report this rule's promulgation to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
simultaneously with publication of the rule in the Federal Register.
The report will state that the rule is not a ``major rule'' as defined
by 5 U.S.C. 804(2).
List of Subjects in 20 CFR Parts 718 and 725
Black lung benefits, Claims, Coal miners' entitlement to benefits,
Incorporation by reference, Survivors' entitlement to benefits, Total
disability due to pneumoconiosis, Workers' compensation, X-rays.
For the reasons set forth in the preamble, the Department of Labor
amends 20 CFR parts 718 and 725 as follows:
PART 718--STANDARDS FOR DETERMINING COAL MINERS' TOTAL DISABILITY
OR DEATH DUE TO PNEUMOCONIOSIS
0
1. The authority citation for part 718 is revised to read as follows:
Authority: 5 U.S.C. 301; Reorganization Plan No. 6 of 1950, 15
FR 3174; 30 U.S.C. 901 et seq., 902(f), 934, 936; 33 U.S.C. 901 et
seq.; 42 U.S.C. 405; Secretary's Order 10-2009, 74 FR 58834.
0
2. Add Sec. 718.5 to Subpart A to read as follows:
Sec. 718.5 Incorporations by reference.
(a) The materials listed in paragraphs (b) through (f) of this
section are incorporated by reference in this part. The Director of the
Federal Register has approved these incorporations by reference under 5
U.S.C. 522(a) and 1 CFR part 51. To enforce any edition other than that
specified in these regulations, OWCP must publish notice of change in
the Federal Register. All approved material is available from the
sources listed below. You may inspect a copy of the approved material
at the Division of Coal Mine Workers' Compensation, OWCP, U.S.
Department of Labor, Washington, DC. To arrange for an inspection at
OWCP, call 202-693-0046. These materials are also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030 or go to http://www.archives.gov/federalregister/codeoffederalregulations/ibrlocations.html.
(b) American Association of Physicists in Medicine, Order
Department, Medical Physics Publishing, 4513 Vernon Blvd., Madison, WI
53705, http://www.aapm.org/pubs/reports:
(1) AAPM On-Line Report No. 03, Assessment of Display Performance
for Medical Imaging Systems, April 2005, IBR approved for Appendix A to
part 718, paragraph (d).
(2) AAPM Report No. 93, Acceptance Testing and Quality Control of
Photostimulable Storage Phosphor Imaging Systems, October 2006, IBR
approved for Appendix A to part 718, paragraph (d).
(c) American College of Radiology, 1891 Preston White Dr., Reston,
VA 20191, http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/
Reference--Levels.pdf:
(1) ACR Practice Guideline for Diagnostic Reference Levels in
Medical X-Ray Imaging, Revised 2008 (Resolution 3), IBR approved for
Appendix A to part 718, paragraph (d).
(2) [Reserved]
(d) International Labour Office, CH-1211 Geneva 22, Switzerland,
http://www.ilo.org/publns: (1) Occupational Safety and Health Series
No. 22, Guidelines for the Use of the ILO International Classification
of Radiographs of Pneumoconioses, Revised edition 2011, IBR approved
for Sec. 718.102(d) and Appendix A to part 718, paragraph (d).
(2) Occupational Safety and Health Series No. 22 (Rev. 2000),
Guidelines for the Use of the ILO International Classification of
Radiographs of Pneumoconioses, Revised edition 2000, IBR approved for
Sec. 718.102(d).
(3) Occupational Safety and Health Series No. 22 (Rev. 80),
Guidelines for the Use of ILO International Classification of
Radiographs of Pneumoconioses, Revised edition 1980, IBR approved for
Sec. 718.102(d).
(e) National Council on Radiation Protection and Measurements, NCRP
Publications, 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3095,
Telephone (800) 229-2652, http://www.ncrppublications.org:
(1) NCRP Report No. 102, Medical X-Ray, Electron Beam, and Gamma-
Ray Protection for Energies Up to 50 MeV (Equipment Design,
Performance, and Use), issued June 30, 1989, IBR approved for Appendix
A to part 718, paragraph (b).
(2) NCRP Report No. 105, Radiation Protection for Medical and
Allied Health Personnel, issued October 30, 1989, IBR approved for
Appendix A to part 718, paragraph (b).
(3) NCRP Report No. 147, Structural Shielding Design for Medical X-
Ray Imaging Facilities, revised March 18, 2005, IBR approved for
Appendix A to part 718, paragraph (b).
(f) National Electrical Manufacturers Association, 1300 N. 17th
Street, Rosslyn, VA 22209, http://medical.nema.org:
(1) DICOM Standard PS 3.3-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 3: Information Object Definitions,
copyright 2011, IBR approved for Appendix A to part 718, paragraph (d).
(2) DICOM Standard PS 3.4-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 4: Service Class Specifications,
copyright 2011, IBR approved for Appendix A to part 718, paragraph (d).
(3) DICOM Standard PS 3.10-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 10: Media Storage and File Format
for Media Interchange, copyright 2011, IBR approved for Appendix A to
part 718, paragraph (d).
(4) DICOM Standard PS 3.11-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 11: Media Storage Application
Profiles, copyright 2011, IBR approved for Appendix A to part 718,
paragraph (d).
(5) DICOM Standard PS 3.12-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 12: Media Formats and Physical Media
for Media Interchange, copyright 2011, IBR approved for Appendix A to
part 718, paragraph (d).
(6) DICOM Standard PS 3.14-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 14: Grayscale Standard Display
Function, copyright 2011, IBR approved for Appendix A to part 718,
paragraph (d).
(7) DICOM Standard PS 3.16-2011, Digital Imaging and Communications
in Medicine (DICOM) standard, Part 16: Content Mapping Resource,
copyright 2011, IBR approved for Appendix A to part 718, paragraph (d).
0
3. Revise Sec. 718.101(a) to read as follows:
Sec. 718.101 General.
(a) The Office of Workers' Compensation Programs (hereinafter OWCP
or the Office) must develop the medical evidence necessary to determine
each claimant's entitlement to benefits. Each miner who files a claim
for benefits under the Act must be provided an opportunity to
substantiate his or her claim by means of a complete pulmonary
evaluation including, but not limited to, a chest radiograph (X-
[[Page 21612]]
ray), physical examination, pulmonary function tests, and a blood-gas
study.
* * * * *
0
4. Revise Sec. 718.102 to read as follows:
Sec. 718.102 Chest radiographs (X-rays).
(a) A chest radiograph (X-ray) must be of suitable quality for
proper classification of pneumoconiosis and must conform to the
standards for administration and interpretation of chest X-rays as
described in Appendix A.
(b) Chest X-rays may be produced by either film or digital
radiography systems as defined in Appendix A to this part.
(c) The images described in paragraphs (c)(1) and (2) of this
section will not be considered of suitable quality for proper
classification of pneumoconiosis under this section:
(1) Digital images derived from film screen chest X-rays (e.g., by
scanning or digital photography); and
(2) Images that were acquired using digital systems and then
printed on transparencies for back-lighted display (e.g., using
traditional view boxes).
(d) Standards for classifying radiographs:
(1) To establish the existence of pneumoconiosis, a film chest X-
ray must be classified as Category 1, 2, 3, A, B, or C, in accordance
with the International Labour Organization (ILO) classification system
established in one of the following:
(i) Guidelines for the Use of the ILO International Classification
of Radiographs of Pneumoconioses, revised edition 2011 (incorporated by
reference, see Sec. 718.5).
(ii) Guidelines for the Use of the ILO International Classification
of Radiographs of Pneumoconioses, revised edition 2000 (incorporated by
reference, see Sec. 718.5).
(iii) Guidelines for the Use of ILO International Classification of
Radiographs of Pneumoconioses, revised edition 1980 (incorporated by
reference, see Sec. 718.5).
(2) To establish the existence of pneumoconiosis, a digital chest
radiograph must be classified as Category 1, 2, 3, A, B, or C, in
accordance with the ILO classification system established in Guidelines
for the Use of the ILO International Classification of Radiographs of
Pneumoconioses, revised edition 2011.
(3) A chest radiograph classified under any of the foregoing ILO
classification systems as Category 0, including subcategories 0-, 0/0,
or 0/1, does not constitute evidence of pneumoconiosis.
(e) An X-ray report must include the following:
(1) The name and qualifications of the person who took the X-ray.
(2) The name and qualifications of the physician who interpreted
the X-ray. The interpreting physician must indicate whether he or she
was a Board-certified radiologist, a Board-eligible radiologist, or a
Certified B Reader as defined below on the date the interpretation was
made.
(i) Board-certified radiologist means that the physician is
certified in radiology or diagnostic radiology by the American Board of
Radiology, Inc., or the American Osteopathic Association.
(ii) Board-eligible radiologist means that the physician has
successfully completed a formal accredited residency program in
radiology or diagnostic radiology.
(iii) Certified B Reader means that the physician has demonstrated
ongoing proficiency in evaluating chest radiographs for radiographic
quality and in the use of the ILO classification for interpreting chest
radiographs for pneumoconiosis and other diseases by taking and passing
a specially designed proficiency examination given on behalf of or by
the National Institute for Occupational Safety and Health (NIOSH), and
has maintained that certification through the date the interpretation
is made. See 42 CFR 37.52(b).
(3) A description and interpretation of the findings in terms of
the ILO classification described in paragraph (d) of this section.
(4) A statement that the X-ray was interpreted in compliance with
this section.
(f) Radiograph Submission: For film X-rays, the original film on
which the X-ray report is based must be supplied to OWCP. For digital
X-rays, a copy of the original digital object upon which the X-ray
report is based, formatted to meet the standards for transmission of
diagnostic chest images set forth in Appendix A, paragraph (d), must be
provided to OWCP on a DVD or other media specified by OWCP. In cases
where the law prohibits the parties or a physician from supplying the
original film or a copy of the digital image, the report will be
considered as evidence only if the original film or digital image is
otherwise available to OWCP and the other parties.
(g) Where the chest X-ray of a deceased miner has been lost or
destroyed, or is otherwise unavailable, a report of the chest X-ray
submitted by any party may be considered in connection with the claim.
(h) Except as provided in this paragraph (h), no chest X-ray may
constitute evidence of the presence or absence of pneumoconiosis unless
it is conducted and reported in accordance with the requirements of
this section and Appendix A. In the absence of evidence to the
contrary, compliance with the requirements of Appendix A must be
presumed. In the case of a deceased miner where the only available X-
ray does not substantially comply with paragraphs (a) through (e) of
this section, the X-ray may form the basis for a finding of the
presence or absence of pneumoconiosis if it is of sufficient quality
for determining whether pneumoconiosis is present and it was
interpreted by a Board-certified radiologist, Board-eligible
radiologist, or Certified B Reader.
0
5. Revise Sec. 718.202 to read as follows:
Sec. 718.202 Determining the existence of pneumoconiosis.
(a) A finding of the existence of pneumoconiosis may be made as
follows in paragraphs (a)(1) through (4) of this section:
(1) A chest X-ray conducted and classified in accordance with Sec.
718.102 may form the basis for a finding of the existence of
pneumoconiosis. Except as otherwise provided in this section, where two
or more X-ray reports are in conflict, in evaluating such X-ray reports
consideration must be given to the radiological qualifications of the
physicians interpreting such X-rays (see Sec. 718.102(d)).
(2) A biopsy or autopsy conducted and reported in compliance with
Sec. 718.106 may be the basis for a finding of the existence of
pneumoconiosis. A finding in an autopsy or biopsy of anthracotic
pigmentation, however, must not be considered sufficient, by itself, to
establish the existence of pneumoconiosis. A report of autopsy must be
accepted unless there is evidence that the report is not accurate or
that the claim has been fraudulently represented.
(3) If the presumptions described in Sec. 718.304 or Sec. 718.305
are applicable, it must be presumed that the miner is or was suffering
from pneumoconiosis.
(4) A determination of the existence of pneumoconiosis may also be
made if a physician, exercising sound medical judgment, notwithstanding
a negative X-ray, finds that the miner suffers or suffered from
pneumoconiosis as defined in Sec. 718.201. Any such finding must be
based on objective medical evidence such as blood-gas studies,
electrocardiograms, pulmonary function studies, physical performance
tests, physical examination, and medical and
[[Page 21613]]
work histories. Such a finding must be supported by a reasoned medical
opinion.
(b) A claim for benefits must not be denied solely on the basis of
a negative chest X-ray.
(c) A determination of the existence of pneumoconiosis must not be
made--
(1) Solely on the basis of a living miner's statements or
testimony; or
(2) In a claim involving a deceased miner, solely on the basis of
the affidavit(s) (or equivalent testimony) of the claimant and/or his
or her dependents who would be eligible for augmentation of the
claimant's benefits if the claim were approved.
0
6. Revise Sec. 718.304 to read as follows:
Sec. 718.304 Irrebuttable presumption of total disability or death
due to pneumoconiosis.
There is an irrebuttable presumption that a miner is totally
disabled due to pneumoconiosis, that a miner's death was due to
pneumoconiosis or that a miner was totally disabled due to
pneumoconiosis at the time of death, if such miner is suffering or
suffered from a chronic dust disease of the lung which:
(a) When diagnosed by chest X-ray (see Sec. 718.202 concerning the
standards for X-rays and the effect of interpretations of X-rays by
physicians) yields one or more large opacities (greater than one
centimeter in diameter) and would be classified in Category A, B, or C
in accordance with the classification system established in Guidelines
for the Use of the ILO International Classification of Radiographs of
Pneumoconioses as provided in Sec. 718.102(d); or
(b) When diagnosed by biopsy or autopsy, yields massive lesions in
the lung; or
(c) When diagnosed by means other than those specified in
paragraphs (a) and (b) of this section, would be a condition which
could reasonably be expected to yield the results described in
paragraph (a) or (b) of this section had diagnosis been made as therein
described: Provided, however, that any diagnosis made under this
paragraph must accord with acceptable medical procedures.
0
7. Revise Appendix A to Part 718 to read as follows:
Appendix A to Part 718--Standards for Administration and Interpretation
of Chest Radiographs (X-rays)
The following standards are established in accordance with
sections 402(f)(1)(D) and 413(b) of the Act. They were developed in
consultation with the National Institute for Occupational Safety and
Health (NIOSH) of the Centers for Disease Control and Prevention in
the Department of Health and Human Services. These standards are
promulgated for the guidance of physicians and medical technicians
to ensure that uniform procedures are used in administering and
interpreting X-rays and that the best available medical evidence
will be submitted in connection with a claim for black lung
benefits. If it is established that one or more standards have not
been met, the claims adjudicator may consider such fact in
determining the evidentiary weight to be assigned to the physician's
report of an X-ray.
(a) Definitions.
(1) Digital radiography systems, as used in this context,
include both digital radiography (DR) and computed radiography (CR).
Digital radiography is the term used for digital X-ray image
acquisition systems in which the X-ray signals received by the image
detector are converted nearly instantaneously to electronic signals
without moveable cassettes. Computed radiography is the term for
digital X-ray image acquisition systems that detect X-ray signals
using a cassette-based photostimulable storage phosphor.
Subsequently, the cassette is processed using a stimulating laser
beam to convert the latent radiographic image to electronic signals
which are then processed and stored so they can be displayed.
(2) Qualified medical physicist means an individual who is
trained in evaluating the performance of radiographic equipment
including radiation controls and facility quality assurance
programs, and has the relevant current certification by a competent
U.S. national board, or unrestricted license or approval from a U.S.
State or Territory.
(3) Radiographic technique chart means a table that specifies
the types of cassette, intensifying screen, film or digital
detector, grid, filter, and lists X-ray machine settings (timing,
kVp, mA) that enables the radiographer to select the correct
settings based on the body habitus or the thickness of the chest
tissue.
(4) Radiologic technologist means an individual who has met the
requirements for privileges to perform general radiographic
procedures and for competence in using the equipment and software
employed by the examining facility to obtain chest images as
specified by the State or Territory and examining facility in which
such services are provided. Optimally, such an individual will have
completed a formal training program in radiography leading to a
certificate, an associate's degree, or a bachelor's degree and
participated in the voluntary initial certification and annual
renewal of registration for radiologic technologists offered by the
American Registry of Radiologic Technologists.
(5) Soft copy means the image of a coal miner's chest radiograph
acquired using a digital radiography system, viewed at the full
resolution of the image acquisition system using an electronic
medical image display device.
(b) General provisions.
(1) Facilities must maintain ongoing licensure and certification
under relevant local, State, and Federal laws and regulations for
all digital equipment and related processes covered by this
Appendix. Radiographic equipment, its use and the facilities
(including mobile facilities) in which such equipment is used must
conform to applicable State or Territorial and Federal regulations.
Where no applicable regulations exist regarding reducing the risk
from ionizing radiation exposure in the clinical setting,
radiographic equipment, its use and the facilities (including mobile
facilities) in which such equipment is used should conform to the
recommendations in NCRP Report No. 102, NCRP Report No. 105, and
NCRP Report No. 147 (incorporated by reference, see Sec. 718.5).
(2) Chest radiographs of miners must be performed:
(i) By or under the supervision of a physician who makes chest
radiographs in the normal course of practice and who has
demonstrated ability to make chest radiographs of a quality to best
ascertain the presence of pneumoconiosis; or
(ii) By a radiologic technologist.
(3) Miners must be disrobed from the waist up at the time the
radiograph is given. The facility must provide a dressing area and
for those miners who wish to use one, the facility will provide a
clean gown. Facilities must be heated to a comfortable temperature.
(4) Before the miner is advised that the examination is
concluded, the radiograph must be processed and inspected and
accepted for quality standards by the physician, or if the physician
is not available, acceptance may be made by the radiologic
technologist. In a case of a substandard radiograph, another must be
made immediately.
(c) Chest radiograph specifications--film.
(1) Every chest radiograph must be a single posteroanterior
projection at full inspiration on a film being no less than 14 by 17
inch film. Additional chest films or views must be obtained if they
are necessary for clarification and classification. The film and
cassette must be capable of being positioned both vertically and
horizontally so that the chest radiograph will include both apices
and costophrenic angles. If a miner is too large to permit the above
requirements, then a projection with minimum loss of costophrenic
angle must be made.
(2) Radiographs must be made with a diagnostic X-ray machine
having a rotating anode tube with a maximum of a 2 mm source (focal
spot).
(3) Except as provided in paragraph (c)(4) of this appendix,
radiographs must be made with units having generators that comply
with the following:
(i) Generators of existing radiographic units acquired by the
examining facility prior to July 27, 1973, must have a minimum
rating of 200 mA at 100 kVp;
(ii) Generators of units acquired subsequent to that date must
have a minimum rating of 300 mA at 125 kVp. A generator with a
rating of 150 kVp is recommended.
(4) Radiographs made with battery-powered mobile or portable
equipment must be made with units having a minimum rating of 100 mA
at 110 kVp at 500 Hz, or 200 mA at 110 kVp at 60 Hz.
(5) Capacitor discharge and field emission units may be used.
[[Page 21614]]
(6) Radiographs must be given only with equipment having a beam-
limiting device that does not cause large unexposed boundaries. The
use of such a device must be discernible from an examination of the
radiograph.
(7) To ensure high quality chest radiographs:
(i) The maximum exposure time must not exceed 50 milliseconds
except that with single phase units with a rating less than 300 mA
at 125 kVp and subjects with chests over 28 cm postero-anterior, the
exposure may be increased to not more than 100 milliseconds;
(ii) The source or focal spot to film distance must be at least
6 feet.
(iii) Medium-speed film and medium-speed intensifying screens
are recommended. However, any film-screen combination, the rated
``speed'' of which is at least 100 and does not exceed 300, which
produces radiographs with spatial resolution, contrast, latitude and
quantum mottle similar to those of systems designated as ``medium
speed'' may be employed;
(iv) Film-screen contact must be maintained and verified at 6-
month or shorter intervals.
(v) Intensifying screens must be inspected at least once a month
and cleaned when necessary by the method recommended by the
manufacturer;
(vi) All intensifying screens in a cassette must be of the same
type and made by the same manufacturer;
(vii) When using over 90 kV, a suitable grid or other means of
reducing scattered radiation must be used;
(viii) The geometry of the radiographic system must ensure that
the central axis (ray) of the primary beam is perpendicular to the
plane of the film surface and impinges on the center of the film.
(8) Radiographic processing:
(i) Either automatic or manual film processing is acceptable. A
constant time-temperature technique must be meticulously employed
for manual processing.
(ii) If mineral or other impurities in the processing water
introduce difficulty in obtaining a high-quality radiograph, a
suitable filter or purification system must be used.
(9) An electric power supply must be used that complies with the
voltage, current, and regulation specified by the manufacturer of
the machine.
(10) A test object may be required on each radiograph for an
objective evaluation of film quality at the discretion of the
Department of Labor.
(11) Each radiograph made under this Appendix must be
permanently and legibly marked with the name and address of the
facility at which it is made, the miner's DOL claim number, the date
of the radiograph, and left and right side of the film. No other
identifying markings may be recorded on the radiograph.
(d) Chest radiograph specifications--digital radiography
systems.
(1) Every digital chest radiograph must be a single
posteroanterior projection at full inspiration on a digital detector
with sensor area being no less than 1505 square centimeters with a
minimum width of 35 cm. The imaging plate must have a maximum pixel
pitch of 200 [mu]m, with a minimum bit depth of 10. Spatial
resolution must be at least 2.5 line pairs per millimeter. The
storage phosphor cassette or digital image detector must be
positioned either vertically or horizontally so that the image
includes the apices and costophrenic angles of both right and left
lungs. If the detector cannot include the apices and costophrenic
angles of both lungs as described, then the two side-by-side images
can be obtained that together include the apices and costophrenic
angles of both right and left lungs.
(2) Radiographs must be made with a diagnostic X-ray machine
with a maximum actual (not nominal) source (focal spot) of 2 mm, as
measured in two orthogonal directions.
(3) Radiographs must be made with units having generators which
have a minimum rating of 300 mA at 125 kVp. Exposure kilovoltage
must be at least the minimum as recommended by the manufacturer for
chest radiography.
(4) An electric power supply must be used that complies with the
voltage, current, and regulation specified by the manufacturer of
the machine. If the manufacturer or installer of the radiographic
equipment recommends equipment for control of electrical power
fluctuations, such equipment must be used as recommended.
(5) Radiographs must be obtained only with equipment having a
beam-limiting device that does not cause large unexposed boundaries.
The beam limiting device must provide rectangular collimation.
Electronic post-image acquisition ``shutters'' available on some CR
or DR systems that limit the size of the final image and that
simulate collimator limits must not be used. The use and effect of
the beam limiting device must be discernible on the resulting image.
(6) Radiographic technique charts must be used that are
developed specifically for the X-ray system and detector
combinations used, indicating exposure parameters by anatomic
measurements.
(7) To ensure high quality chest radiographs:
(i) The maximum exposure time must not exceed 50 milliseconds
except for subjects with chests over 28 cm posteroanterior, for whom
the exposure time must not exceed 100 milliseconds.
(ii) The distance from source or focal spot to detector must be
at least 70 inches (or 180 centimeters if measured in centimeters).
(iii) The exposure setting for chest images must be within the
range of 100-300 equivalent exposure speeds and must comply with ACR
Practice Guidelines for Diagnostic Reference Levels in Medical X-ray
Imaging, Section V--Diagnostic Reference Levels for Imaging with
Ionizing Radiation and Section VII-Radiation Safety in Imaging
(incorporated by reference, see Sec. 718.5). Radiation exposures
should be periodically measured and patient radiation doses
estimated by the medical physicist to assure doses are as low as
reasonably achievable.
(iv) Digital radiography system performance, including
resolution, modulation transfer function (MTF), image signal-to-
noise and detective quantum efficiency must be evaluated and judged
acceptable by a qualified medical physicist using the specifications
in AAPM Report No. 93, pages 1-68 (incorporated by reference, see
Sec. 718.5). Image management software and settings for routine
chest imaging must be used, including routine amplification of
digital detector signal as well as standard image post-processing
functions. Image or edge enhancement software functions must not be
employed unless they are integral to the digital radiography system
(not elective); in such cases, only the minimum image enhancement
permitted by the system may be employed.
(v)(A) The image object, transmission and associated data
storage, film format, and transmissions of associated information
must conform to the following components of the Digital Imaging and
Communications in Medicine (DICOM) standard (incorporated by
reference, see Sec. 718.5):
(1) DICOM Standard PS 3.3-2011, Annex A--Composite Information
Object Definitions, sections: Computed Radiographic Image
Information Object Definition; Digital X-Ray Image Information
Object Definition; X-Ray Radiation Dose SR Information Object
Definition; and Grayscale Softcopy Presentation State Information
Object Definition.
(2) DICOM Standard PS 3.4-2011: Annex B--Storage Service Class;
Annex N--Softcopy Presentation State Storage SOP Classes; Annex O--
Structured Reporting Storage SOP Classes.
(3) DICOM Standard PS 3.10-2011.
(4) DICOM Standard PS 3.11-2011.
(5) DICOM Standard PS 3.12-2011.
(6) DICOM Standard PS 13.14-2011.
(7) DICOM Standard PS 3.16-2011.
(B) Identification of each miner, chest image, facility, date
and time of the examination must be encoded within the image
information object, according to DICOM Standard PS 3.3-2011,
Information Object Definitions, for the DICOM ``DX'' object. If data
compression is performed, it must be lossless. Exposure parameters
(kVp, mA, time, beam filtration, scatter reduction, radiation
exposure) must be stored in the DX information object.
(C) Exposure parameters as defined in the DICOM Standard PS
3.16-2011 must additionally be provided when such parameters are
available from the facility digital image acquisition system or
recorded in a written report or electronic file and transmitted to
OWCP.
(8) A specific test object may be required on each radiograph
for an objective evaluation of image quality at the Department of
Labor's discretion.
(9) CR imaging plates must be inspected at least once a month
and cleaned when necessary by the method recommended by the
manufacturer.
(10) A grid or air gap for reducing scattered radiation must be
used; grids must not be used that cause Moir[eacute] interference
patterns in either horizontal or vertical images.
(11) The geometry of the radiographic system must ensure that
the central axis (ray) of the primary beam is perpendicular to the
plane of the CR imaging plate or DR detector and is correctly
aligned to the grid.
[[Page 21615]]
(12) Radiographs must not be made when the environmental
temperatures and humidity in the facility are outside the
manufacturer's recommended range of the CR and DR equipment to be
used.
(13) All interpreters, whenever classifying digitally acquired
chest radiographs, must have immediately available for reference a
complete set of ILO standard digital chest radiographic images
provided for use with the Guidelines for the Use of the ILO
International Classification of Radiographs of Pneumoconioses (2011
Revision) (incorporated by reference, see Sec. 718.5). Modification
of the appearance of the standard images using software tools is not
permitted.
(14) Viewing systems should enable readers to display the coal
miner's chest image at the full resolution of the image acquisition
system, side-by-side with the selected ILO standard images for
comparison.
(i)(A) Image display devices must be flat panel monitors
displaying at least 3 MP at 10 bit depth. Image displays and
associated graphics cards must meet the calibration and other
specifications of the Digital Imaging and Communications in Medicine
(DICOM) standard PS 3.14-2011 (incorporated by reference, see Sec.
718.5).
(B) Image displays and associated graphics cards must not
deviate by more than 10 percent from the grayscale standard display
function (GSDF) when assessed according to the AAPM On-Line Report
No. 03, pages 1-146 (incorporated by reference, see Sec. 718.5).
(ii) Display system luminance (maximum and ratio), relative
noise, linearity, modulation transfer function (MTF), frequency, and
glare should meet or exceed recommendations listed in AAPM On-Line
Report No. 03, pages 1-146 (incorporated by reference, see Sec.
718.5). Viewing displays must have a maximum luminance of at least
171 cd/m\2\, a ratio of maximum luminance to minimum luminance of at
least 250, and a glare ratio greater than 400. The contribution of
ambient light reflected from the display surface, after light
sources have been minimized, must be included in luminance
measurements.
(iii) Displays must be situated so as to minimize front surface
glare. Readers must minimize reflected light from ambient sources
during the performance of classifications.
(iv) Measurements of the width and length of pleural shadows and
the diameter of opacities must be taken using calibrated software
measuring tools. If permitted by the viewing software, a record must
be made of the presentation state(s), including any noise reduction
and edge enhancement or restoration functions that were used in
performing the classification, including any annotations and
measurements.
(15) Quality control procedures for devices used to display
chest images for classification must comply with the recommendations
of the American Association of Physicists in Medicine AAPM On-Line
Report No. 03, pages 1-146 (incorporated by reference, see Sec.
718.5). If automatic quality assurance systems are used, visual
inspection must be performed using one or more test patterns
recommended by the medical physicist every 6 months, or more
frequently, to check for defects that automatic systems may not
detect.
(16) Classification of CR and DR digitally-acquired chest
radiographs under this Part must be performed based on the viewing
images displayed as soft copies using the viewing workstations
specified in this section. Classification of radiographs must not be
based on the viewing of hard copy printed transparencies of images
that were digitally-acquired.
(17) The classification of chest radiographs based on digitized
copies of chest radiographs that were originally acquired using
film-screen techniques is not permissible.
PART 725--CLAIMS FOR BENEFITS UNDER PART C OF TITLE IV OF THE
FEDERAL MINE SAFETY AND HEALTH ACT, AS AMENDED
0
8. The authority citation for part 725 is revised to read as follows:
Authority: 5 U.S.C. 301; Reorganization Plan No. 6 of 1950, 15
FR 3174; 30 U.S.C. 901 et seq., 902(f), 921, 932, 936; 33 U.S.C. 901
et seq.; 42 U.S.C. 405; Secretary's Order 10-2009, 74 FR 58834.
0
9. In Sec. 725.406, revise paragraphs (a), (b), (c) and (e) to read as
follows:
Sec. 725.406 Medical examinations and tests.
(a) The Act requires the Department to provide each miner who
applies for benefits with the opportunity to undergo a complete
pulmonary evaluation at no expense to the miner. A complete pulmonary
evaluation includes a report of physical examination, a pulmonary
function study, a chest radiograph, and, unless medically
contraindicated, a blood gas study.
(b) As soon as possible after a miner files an application for
benefits, the district director will provide the miner with a list of
medical facilities and physicians in the state of the miner's residence
and states contiguous to the state of the miner's residence that the
Office has authorized to perform complete pulmonary evaluations. The
miner must select one of the facilities or physicians on the list,
provided that the miner may not select any physician to whom the miner
or the miner's spouse is related to the fourth degree of consanguinity,
and the miner may not select any physician who has examined or provided
medical treatment to the miner within the twelve months preceding the
date of the miner's application. The district director will make
arrangements for the miner to be given a complete pulmonary evaluation
by that facility or physician. The results of the complete pulmonary
evaluation must not be counted as evidence submitted by the miner under
Sec. 725.414.
(c) If any medical examination or test conducted under paragraph
(a) of this section is not administered or reported in substantial
compliance with the provisions of part 718 of this subchapter, or does
not provide sufficient information to allow the district director to
decide whether the miner is eligible for benefits, the district
director must schedule the miner for further examination and testing.
Where the deficiencies in the report are the result of a lack of effort
on the part of the miner, the miner will be afforded one additional
opportunity to produce a satisfactory result. In order to determine
whether any medical examination or test was administered and reported
in substantial compliance with the provisions of part 718 of this
subchapter, the district director may have any component of such
examination or test reviewed by a physician selected by the district
director.
* * * * *
(e) The cost of any medical examination or test authorized under
this section, including the cost of travel to and from the examination,
must be paid by the fund. Reimbursement for overnight accommodations
must not be authorized unless the district director determines that an
adequate testing facility is unavailable within one day's round trip
travel by automobile from the miner's residence. The fund must be
reimbursed for such payments by an operator, if any, found liable for
the payment of benefits to the claimant. If an operator fails to repay
such expenses, with interest, upon request of the Office, the entire
amount may be collected in an action brought under section 424 of the
Act and Sec. 725.603.
Gary A. Steinberg,
Acting Director, Office of Workers' Compensation Programs.
[FR Doc. 2014-08636 Filed 4-16-14; 8:45 am]
BILLING CODE 4510-CR-P