[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]
 BILLING CODE 4510-CR-P