Black Lung Benefits Act: Quality Standards for Medical Testing

Published date27 September 2019
Citation84 FR 51073
Record Number2019-20851
SectionProposed rules
CourtWorkers' Compensation Programs Office
Federal Register, Volume 84 Issue 188 (Friday, September 27, 2019)
[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
                

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