[Federal Register Volume 84, Number 188 (Friday, September 27, 2019)]
[Proposed Rules]
[Pages 51073-51075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20851]
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DEPARTMENT OF LABOR
Office of Workers' Compensation Programs
20 CFR Part 718
RIN 1240-AA12
Black Lung Benefits Act: Quality Standards for Medical Testing
AGENCY: Office of Workers' Compensation Programs, Labor.
ACTION: Request for information.
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SUMMARY: The Black Lung Benefits Act provides benefits to miners who
are totally disabled due to pneumoconiosis arising out of coal mine
employment and to certain miners' survivors. Determining benefits
entitlement necessarily entails evaluating the miner's physical
condition, particularly his or her respiratory system. These
evaluations usually involve medical tests that assess the miner's
respiratory capacity. To promote accuracy when tests are conducted in
connection with a claim, the program regulations set out quality
standards for administering and interpreting two commonly used tests:
pulmonary function tests and arterial blood gas studies. The Office of
Workers' Compensation Programs (OWCP) is considering updating the
quality standards, which were last amended in 2000, to better reflect
current medical technology and practice. This request for information
seeks the public's input on current standards for administering
pulmonary function tests and arterial blood gas studies; criteria used
to evaluate the results of these tests; whether OWCP should adopt
quality standards for additional testing methods; and the economic
impact of any changes to the quality standards.
DATES: The Department invites written comments on the request for
information from interested parties. Written comments must be received
by January 27, 2020.
ADDRESSES: You may submit written comments by any of the following
methods. To facilitate receipt and processing of comments, OWCP
encourages interested parties to submit their comments electronically.
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions on the website for submitting comments.
Facsimile: (202) 693-1395 (this is not a toll-free
number). Only comments of ten or fewer pages, including a Fax cover
sheet and attachments, if any, will be accepted by Fax.
Regular Mail/Hand Delivery/Courier: Submit comments on
paper to the Division of Coal Mine Workers' Compensation Programs,
Office of Workers' Compensation Programs, U.S. Department of Labor,
Room C-3520, 200 Constitution Avenue NW, Washington, DC 20210. The
Department's receipt of U.S. mail may be significantly delayed due to
security procedures. You must take this into consideration when
preparing to meet the deadline for submitting comments.
Instructions: You must include the agency name and the Regulatory
Information Number (RIN) for this rulemaking in your submission.
Caution: All comments received will be posted without change to http://www.regulations.gov. Please do not include any personally identifiable
or confidential business information you do not want publicly
disclosed.
Docket: For access to the rulemaking docket and to read background
documents or comments received, go to http://www.regulations.gov.
Although some information (e.g., copyrighted material) will not be
available through the website, the entire rulemaking record, including
copyrighted material, will be available for inspection at OWCP. Please
contact the individual named below if you would like to inspect the
record.
FOR FURTHER INFORMATION CONTACT: Michael Chance, Director, Division of
Coal Mine Workers' Compensation, Office of Workers' Compensation
Programs, U.S. Department of Labor, 200 Constitution Avenue NW, Suite
N-3520, Washington, DC 20210. Telephone: 1-800-347-2502. This is 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
The Black Lung Benefits Act (BLBA), 30 U.S.C. 901-944, provides for
the payment of benefits to coal miners and certain of their dependent
survivors for total disability or death due to coal workers'
pneumoconiosis arising from coal mine employment. See 30 U.S.C. 901(a);
Usery v. Turner Elkhorn Mining Co., 428 U.S. 1, 5 (1976). Medical
testing evidence is used to evaluate benefits entitlement in virtually
every claim filed by miners and in many claims filed by survivors. For
this reason, the BLBA gives the Secretary of Labor authority to
develop, in consultation with the National Institute for Occupational
Safety and Health (NIOSH), ``criteria for all appropriate medical tests
. . . which accurately reflect total disability in coal miners.'' 30
U.S.C. 902(f)(1)(D).
The Department of Labor first published ``Criteria for the
Development of Medical Evidence,'' commonly referred to as the
``quality standards,'' on February 29, 1980. 45 FR 13679-85; 13694-712.
Originally published at 20 CFR 718.102-718.103, 718.105 and appendices
A-C (1981), these standards set out detailed requirements for
administering chest radiographs, pulmonary function tests (PFTs), and
arterial blood gas studies (ABGs). The Department based the
requirements on then-current medical industry practices, standards, and
equipment. See, e.g., 45 FR 13697. The quality standards were intended
to ensure that claims determinations were based on the best available
medical evidence.
Simultaneously, the Department adopted criteria to establish total
disability based on these tests. 45 FR 13687-90, 13699-13711, 20 CFR
718.204 and appendices B-C (1981). PFT and ABG results that met the
criteria in part 718, appendices B or C (commonly referred to as
``qualifying'' results) were sufficient, absent ``contrary probative
evidence,'' to establish total respiratory disability. 45 FR 13688, 20
CFR 718.204(c) (1981). For PFTs, the criteria addressed the forced
expiratory volume in 1 second (FEV1), the forced
[[Page 51074]]
vital capacity (FVC), and the maximum voluntary ventilation (MVV)
maneuvers.
The quality standards and the disability criteria remained the same
until 2000 when, in addition to a few revisions to the existing PFT
standards, the Department required that a ``flow-volume loop'' be
included in each PFT. The Department adopted this requirement to
increase the reliability of the testing results. See 65 FR 79929-30
(Dec. 20, 2000), 20 CFR 718.103(a) (2001).
In the 2000 rulemaking, the Department also added two additional
points related to all of the quality standards. First, the Department
clarified that the standards for test administration applied only to
tests conducted ``in connection with a claim'' for benefits after the
date the regulations went into effect (i.e., after January 19, 2001).
65 FR 79927-29, 20 CFR 718.101(b) (2001). Second, the Department
required that any test subject to the quality standards had to be in
``substantial compliance'' with the applicable standard to be valid
evidence. Id. Before then, the regulations imposed this requirement
only on PFTs. See 20 CFR 718.103(c) (1999).
In 2014, OWCP, in consultation with NIOSH, comprehensively revised
the standards applicable to chest radiographs and added new standards
addressing digital imaging methods. 79 FR 21606-15 (April 17, 2014), 20
CFR 718.101 and appendix A (2015). OWCP also updated the criteria for
establishing pneumoconiosis by chest radiograph. 79 FR 21612, 20 CFR
718.102 (2015).
OWCP is now considering, again in consultation with NIOSH, updating
the standards for administering PFTs and ABGs and the criteria for
establishing total disability based on these tests. OWCP's goal is to
adopt regulations that reflect current medical technology and practice.
II. Information Request
OWCP requests input from medical professionals, medical
associations, black lung clinics, miners, employers, insurance
carriers, trade associations, and other interested parties on current
techniques, equipment, and best practices for administering PFTs and
ABGs to ensure accurate and reliable results. OWCP also seeks input on
PFT- and ABG-related criteria for establishing total respiratory
disability under the BLBA. Finally, OWCP requests information regarding
whether test administration standards or qualifying disability criteria
should be developed for other tests (for example, pulse oximetry) and,
if so, what those standards or criteria should be.
When responding, please:
Address your comments to the topic and question number
whenever possible. For example, you would identify your response to
questions regarding administration of PFTs, Question 1, as ``A.1.''
Provide your rationale for your views.
Provide sufficient detail in your responses to enable
proper agency review and consideration. OWCP wants to fully understand
your answers and any recommendations you make.
Identify the information on which you rely. Please provide
specific examples. Include applicable data, studies, or articles
regarding standard professional practices, availability of technology,
and costs.
OWCP invites comment in response to the specific questions posed
below and encourages commenters to include any related cost and benefit
data. OWCP is especially interested in issues related to the economic
impact on small entities as defined by the Regulatory Flexibility Act,
5 U.S.C. 601(6).
Please note that as used in the questions below: (1)
``Administration'' refers to the methods, equipment, and techniques
used to conduct the test and interpret the results; and (2)
``criteria'' refers to the values set to define total respiratory
disability (i.e., ``qualifying'' test results) in coal miners absent
contrary probative evidence.
A. Pulmonary Function Tests--Test Administration
OWCP is considering aligning the black lung program's PFT
administration standards, currently codified at 20 CFR 718.103 and part
718, appendix B, with NIOSH's requirements for NIOSH-approved
spirometry facilities and the Social Security Administration's (SSA's)
medical testing standards for evaluating respiratory disorders, both of
which were updated in 2016. See 81 FR 37138-53 (June 9, 2016), 20 CFR
part 404, subpart P, appendix 1, part A, Listing 3.00 et seq. (SSA); 81
FR 73274-77, 73286-90 (Oct. 24, 2016), 42 CFR part 37, subpart--
Spirometry Testing (NIOSH). OWCP seeks information on the following
issues:
1. Should OWCP require PFTs to be administered according to the
procedures in pages 323-326 of M.R. Miller, et al., ATS/ERS Task Force:
Standardisation of Lung Function Testing, Standardisation of
Spirometry, 26 Eur. Respir. J. 319 (2005) (``2005 ATS/ERS
Standardisation of Spirometry''), including M.R. Miller, et al.,
Standardisation of Lung Function Testing: the Authors' Replies to
Readers' Comments, 36 Euro. Respir. J. 1496 (2010). See 42 CFR
37.95(c)(5). Are there alternative standards OWCP should consider?
2. Should OWCP require spirometers to undergo calibration checks
according to the procedures on pages 322-323 in 2005 ATS/ERS
Standardisation of Spirometry? See 42 CFR 37.93(b)(1). Are there
alternative standards OWCP should consider?
3. Should OWCP require spirometers to meet the specifications for
spirometer accuracy, precision, and real-time display size and content
listed on pages 322 (Table 2), 325, and 331-333 in 2005 ATS/ERS
Standardisation of Spirometry? 42 CFR 37.93(b)(2), 37.95(b). Are there
alternative standards OWCP should consider?
4. Should OWCP require each person administering a spirometry test
to complete NIOSH-approved training and maintain a valid NIOSH
certificate by periodically completing NIOSH-approved refresher
courses? See 42 CFR 37.95(a).
5. Currently, appendix B to part 718 provides that PFTs ``shall not
be performed during or soon after an acute respiratory illness.''
Should OWCP further define this requirement? If so, how should it be
defined?
6. Are there any other standards OWCP should consider regarding the
validity of PFTs?
7. Should OWCP consider removing MVV test administration standards
(and criteria) from the regulations given its limited usefulness? See,
e.g., R. Pellegrino, et al., ATS/ERS Task Force: Standardisation of
Lung Function Testing, Interpretive Strategies for Lung Function Tests,
26 Eur. Respir. J. 957 (2005) (MVV ``is not generally included in the
set of lung function parameters needed for diagnosis or follow-up of
the pulmonary abnormalities[;]'' MVV ``may be of some help'' in upper
airway obstruction and ``may be of limited value in mild-to-moderate
COPD''). Please explain your view.
8. What are the costs, benefits, and the technological and economic
feasibility of these potential changes to PFT administration standards?
B. Pulmonary Function Tests--Qualifying Disability Criteria
The current FEV1 and FVC Tables in appendix B, which
specify the FEV1 and FVC values that qualify as totally
disabling (in the absence of contrary probative evidence) for purposes
of the black lung program, are based on reference values in Ronald J.
Knudson, et al., The Maximal Expiratory Flow-
[[Page 51075]]
Volume Curve Normal Standards, Variability, and Effects of Age, 113 Am.
Rev. of Respir. Disease 587 (1976) (``Knudson 1976''). See 45 FR 13711.
OWCP is considering developing new tables based on reference values in
one of two more recent studies: (1) John L. Hankinson, et al.,
Spirometric Reference Values from a Sample of the General U.S.
Population, 159 Am. J. of Respir. & Critical Care Med. 179 (1999)
(``NHANES III''); or (2) Philip H. Quanjer, et al., Multi-Ethnic
Reference Values for Spirometry for the 3-95-Year Age Range: The Global
Lung Function 2012 Equations, 40 Eur. Respir. J. 1324 (2012) (``GLI
2012'').
9. Is either (or both) of these sets of reference values superior
to the Knudson 1976 values? Why?
10. Which of these two sets of reference values is better suited to
evaluating respiratory disability in coal miners? Why?
11. Are there other sets of reference values OWCP should consider?
C. Arterial Blood Gas Studies--Test Administration
12. Should OWCP require facilities administering ABG studies and
analyzing samples to either have a Clinical Laboratory Improvement
Amendments of 1988 (CLIA) certificate or be CLIA-exempt? See 42 CFR
493.2.
13. Should OWCP require the use of plastic syringes instead of
glass syringes? If plastic syringes are used, should OWCP prohibit
icing blood samples prior to analysis? See, e.g., Thomas P. Knowles, et
al., Effects of Syringe Material, Sample Storage Time, and Temperature
on Blood Gases and Oxygen Saturation in Arterialized Human Blood
Samples, 51 Resp. Care 732 (2006); Gregg L. Ruppel, Of Time and
Temperature, Plastic and Glass: Specimen Handling in the Blood-Gas
Laboratory, 51 Resp. Care 717 (2006).
14. Should OWCP require that a blood sample be analyzed within a
certain time period of the sample being drawn for the result to be
considered valid, and if so, what should that time period be? See id.
15. Currently, Sec. 718.105(b) provides that if an exercise ABG
study is conducted, ``blood shall be drawn during exercise.'' Should
OWCP allow pulse oximetry measurements (SpO2) to
be used in lieu of a blood draw during exercise? See, e.g., 20 CFR part
404, subpart P, appendix 1, part A, Listing 3.02C (allowing chronic
impairment of gas exchange to be demonstrated through ABG test or pulse
oximetry results).
16. Currently, appendix C to part 718 provides that ABG tests
``must not be performed during or soon after an acute respiratory or
cardiac illness.'' Should OWCP further define this requirement? If so,
how should it be defined?
17. What are the costs, benefits, and the technological and
economic feasibility of these suggested changes to ABG administration
standards?
D. Arterial Blood Gas Studies--Qualifying Disability Criteria
18. Do the Tables in Appendix C need to be revised? If so, what
criteria should OWCP consider and why?
E. Pulse Oximetry (SpO2)
19. Should OWCP adopt test administration standards for pulse
oximetry? If so, what standards should OWCP consider adopting and why?
See, e.g., 20 CFR part 404, subpart P, appendix 1, part A, Listing
3.00H1-2.
20. Are there SpO2 values that would
establish total respiratory disability in a coal miner under the BLBA
absent contrary probative evidence? If so, what values should OWCP
consider and why?
21. Should OWCP require a threshold measurement of a miner's oxygen
saturation level through pulse oximetry before determining whether more
invasive testing such as an ABG is necessary? If so, what should the
threshold be? What are the advantages and disadvantages (including
potential costs or benefits) of adopting such a threshold measurement?
F. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
22. Should OWCP adopt test administration standards for DLCO
testing? If so, what standards should OWCP consider adopting and why?
See, e.g., Brian L. Graham, et al., 2017 ERS/ATS Standards for Single-
Breath Carbon Monoxide Uptake in the Lung (2017); 20 CFR part 404,
subpart P, appendix 1, part A, Listing 3.00F1-3.
23. Are there DLCO values that would establish total respiratory
disability in a coal miner under the BLBA absent contrary probative
evidence? If so, what values should OWCP consider and why?
G. Other Information
24. Please provide any other data or information that may be useful
to OWCP in evaluating its quality standards and related disability
criteria, including whether there are other tests of respiratory
disability for which quality standards or qualifying disability
criteria should be developed.
Dated: September 18, 2019.
Julia K. Hearthway,
Director, Office of Workers' Compensation Programs.
[FR Doc. 2019-20851 Filed 9-26-19; 8:45 am]
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