ESA Final Rule

Regulations Implementing the Federal Coal Mine Health and Safety Act of 1969, as Amended [12/20/2000]

Due to the large file size, this document has been divided into four parts:

Volume 65, Number 245, Page 79919-79968

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Part II





Department of Labor





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Employment Standards Administration



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20 CFR Part 718 et al.



Regulations Implementing the Federal Coal Mine Health and Safety Act of 
1969, as Amended; Final Rule


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DEPARTMENT OF LABOR

Employment Standards Administration

20 CFR Parts 718, 722, 725, 726, 727

RIN 1215-AA99

 
Regulations Implementing the Federal Coal Mine Health and Safety 
Act of 1969, as Amended

AGENCY: Employment Standards Administration, Labor.

ACTION: Final rule.

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SUMMARY: On January 22, 1997, the Department issued a proposed rule to 
amend the regulations implementing the Black Lung Benefits Act. 62 FR 
3338-3435 (Jan. 22, 1997). When the comment period closed on August 21, 
1997, the Department had received written submissions from almost 200 
interested persons, including coal miners, coal mine operators, 
insurers, physicians, and attorneys. The Department also held hearings 
in Charleston, West Virginia, and Washington, D.C. at which over 50 
people testified. The Department carefully reviewed the testimony and 
the comments and, on October 8, 1999, issued a second notice of 
proposed rulemaking. 64 FR 54966-55072 (Oct. 8, 1999). In its second 
notice, the Department proposed changing several of the most important 
provisions in its initial proposal. The Department also explained its 
decision not to alter the original proposal with respect to other key 
regulations based on the comments received to date. Finally, the 
Department prepared an initial regulatory flexibility analysis. In 
order to ensure that small businesses that could be affected by the 
Department's proposal received appropriate notice of the Department's 
proposed changes, the Department mailed a copy of the second notice of 
proposed rulemaking to all coal mine operators contained in the 
databases maintained by the Mine Safety and Health Administration.
    The Department initially allowed interested parties until December 
7, 1999 to file comments to its second proposal, but extended that 
period until January 6, 2000. The Department received 37 written 
submissions before the close of the comment period, from groups 
representing both coal miners and coal mine operators. The Department 
also received comments from individual miners, various coal mining and 
insurance companies, as well as from claims processing organizations, 
attorneys, and various professional organizations. The Department has 
carefully reviewed all of the comments, and is issuing its final rule. 
The rule contains a final regulatory flexibility analysis as required 
by the Regulatory Flexibility Act.

EFFECTIVE DATE: January 19, 2001.

FOR FURTHER INFORMATION CONTACT: James L. DeMarce, (202) 693-0046.

SUPPLEMENTARY INFORMATION: The Department's final rule reprints 20 CFR 
Parts 718 (except Tables B1 through B6 in Appendix B), 722, 725, and 
726 in their entirety. The Department has not revised all of the 
regulations in these parts. A detailed list of the regulations to which 
the Department has made substantive revisions follows the Summary of 
Noteworthy Regulations below, accompanied by a list of regulations to 
which the Department has made technical revisions, a list of 
regulations that the Department has deleted, and a list of regulations 
that the Department has not changed in any manner.

Summary of Noteworthy Provisions

District Director Claims Processing

    These final regulations implementing the Black Lung Benefits Act 
provide simplified administrative procedures for the adjudication of 
claims pending before the Office of Workers' Compensation Programs 
(OWCP). The new streamlined procedures are less formal and should be 
easier for claims participants to understand. They require the district 
director to issue fewer documents and therefore involve fewer 
procedural steps and deadlines. They also require fewer responses from 
the parties. These changes are in response to the many comments the 
Department has received asking that OWCP's procedures be simplified and 
made less formal and adversarial.
    In its initial notice of proposed rulemaking, the Department 
announced its intent to amend these regulations with the goal of 
helping to improve services, streamline the adjudication process and 
simplify the regulations' language. The Department noted OWCP's many 
years of experience administering the program and the variety of ideas 
for change which had resulted from it. 62 FR 3338 (Jan. 22, 1997). In 
the second notice of proposed rulemaking, the Department emphasized its 
commitment to improve the quality of the information it provides the 
parties to a black lung claim. As part of this commitment, the 
Department noted its intent to substantially rewrite the documents used 
by district directors to notify parties of the ``initial findings'' on 
their claims. The Department stated its goal was to help make claim 
processing by district offices easier to understand and to give 
claimants a clear picture of the medical evidence developed in 
connection with their claims so that they were able to make more 
informed decisions as to how to proceed. The Department also noted that 
it had attempted to ``eliminat[e] the hierarchy of response times'' at 
the district director level. 64 FR 54992 (Oct. 8, 1999). After the 
receipt of many comments addressing its proposals, the Department has 
determined that a more comprehensive streamlining of district director 
procedures is warranted.
    The Department has therefore eliminated the use of initial findings 
and the required responses to them, as well as the district director's 
initial adjudication as proposed in Secs. 725.410-725.413. Similarly, 
the Department has altered the rules governing informal conferences, 
Sec. 725.416. If a conference is held, no memorandum of conference will 
result, Sec. 725.417(c). Instead, OWCP will issue only one decisional 
document at the conclusion of the district director's processing of a 
claim: in most cases a proposed decision and order, Sec. 725.418. The 
proposed decision and order will give rise to the thirty-day period for 
requesting a hearing before the Office of Administrative Law Judges 
and, if no such hearing is requested, to the one-year period for filing 
a request for modification, Sec. 725.419. The proposed decision and 
order will also contain the district director's final designation of 
the responsible operator liable for the payment of benefits, and the 
dismissal of all other potentially liable operators that had previously 
received notice of the claim.
    The Department hopes that the absence of documents with titles such 
as ``initial findings'' and ``memorandum of conference'' will encourage 
a less adversarial and less formal development of the necessary 
evidence and will promote more timely evidentiary development. As 
previously proposed, the district director will engage in a preliminary 
gathering of the relevant evidence. He will develop medical evidence, 
including the complete pulmonary evaluation, Secs. 725.405-725.406. He 
will identify and notify those coal mine operators among the claimant's 
former employers which he deems to be potentially liable operators, 
Sec. 725.407, and gather evidence from them regarding their employment 
of the miner and their status as operators, Sec. 725.408. At the 
conclusion of this evidence-gathering, however, rather than issue an 
initial finding (a document with the appearance of a preliminary 
adjudication of the claim), the district director will issue a schedule 
for the submission of additional evidence, Sec. 725.410. This

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document will contain a summary of the results of the complete 
pulmonary evaluation and the district director's preliminary analysis 
of that evidence. The analysis will include a discussion of any of the 
elements of entitlement that appear not to have been established and 
why. The schedule will also contain the district director's designation 
of a responsible operator liable for the payment of claimant's 
benefits. If the designated responsible operator is not the miner's 
last employer, the district director will include with the schedule the 
statements necessary to comply with Sec. 725.495(d).
    The schedule will allow the claimant and the designated responsible 
operator not less than 60 days to submit additional evidence, including 
evidence relevant to the claimant's entitlement to benefits and the 
employer's liability for them. The schedule will also allow at least an 
additional 30 days within which to respond to evidence the other party 
submits, Sec. 725.410(b). These time periods may be extended for good 
cause shown, Sec. 725.423. The district director will serve the 
schedule by certified mail on all parties and will include with it 
copies of all relevant evidence, Sec. 725.410(c). The schedule will 
also inform the claimant and the designated responsible operator of 
their rights, including the right to submit additional evidence and the 
right to further adjudication of the claim, Sec. 725.410(a)(4). 
Finally, the schedule will notify the claimant that he has the right to 
obtain representation and that, if the designated responsible operator 
fails to accept the claimant's entitlement within the specified time 
and the claimant establishes his entitlement to benefits payable by 
that operator, the responsible operator will be liable for a reasonable 
attorney's fee.
    The new procedure requires a responsible operator to respond within 
30 days as to the liability designation in the schedule, 
Sec. 725.412(a)(1). Silence on the responsible operator's part will be 
deemed an acceptance of the district director's designation as to its 
liability. Silence on the operator's part with respect to claimant's 
entitlement, however, will be deemed a controversion. If the operator 
wishes to accept a claimant's entitlement to benefits, it must file a 
statement indicating this intent within 30 days of issuance of the 
district director's schedule, Sec. 725.412(b). Thus, this schedule 
requires a less comprehensive operator response than the initial 
findings would have. The responsible operator must file a response only 
to contest its liability and/or to accept a claimant's entitlement to 
benefits. In addition, fewer parties are required to respond to the 
schedule since the claimant need not respond at all.
    By contrast, if the district director concludes that there is no 
operator responsible for the payment of benefits and that the results 
of the complete pulmonary evaluation support a finding of eligibility, 
the district director shall issue a proposed decision and order 
awarding the claimant benefits, Sec. 725.411. In such a case, no 
schedule for the submission of additional evidence is necessary, and no 
claimant response to the proposed decision and order is required.
    At the conclusion of the time scheduled for the submission of 
additional evidence, Sec. 725.415(b), the district director may either 
notify additional operators of their potential liability for benefits 
under Sec. 725.407, issue another schedule for the submission of 
additional evidence identifying another potentially liable operator as 
the responsible operator liable for the payment of benefits, 
Sec. 725.410, schedule a case for an informal conference, Sec. 725.416, 
or issue a proposed decision and order, Sec. 725.418. In the event the 
district director issues another schedule for the submission of 
additional evidence pursuant to Sec. 725.410, the district director 
shall not permit the development or submission of any additional 
medical evidence until after he has determined the responsible operator 
liable for the payment of benefits. If the operator determined to be 
the responsible operator has not had the opportunity to submit medical 
evidence, the district director shall afford that operator the 
opportunity outlined in Sec. 725.410. The designated responsible 
operator may elect to adopt any medical evidence previously submitted 
by another operator as its own, subject to the Sec. 725.414 
limitations.
    The regulations also contain significant modifications to the 
informal conference procedure in order to reduce delay and to ensure 
that conferences are held only in appropriate cases. Thus, if an 
informal conference is scheduled, it must be held within 90 days of the 
conclusion of the evidentiary development period unless a party 
requests that it be postponed for good cause, Sec. 725.416(a). A 
district director may schedule a conference only if all the parties to 
a claim are represented or deemed represented, although lay 
representation is sufficient, Sec. 725.416(b). If all the pertinent 
requirements are met, however, and an informal conference is scheduled, 
the unexcused failure of a party to appear constitutes grounds for the 
imposition of sanctions, Sec. 725.416(c). These sanctions may include 
denial of the claim by reason of abandonment, Sec. 725.409(a)(4). In 
the event an ALJ ultimately reviews the denial by reason of abandonment 
and concludes that it was improper, he may proceed to address the 
merits of the claim, but only with the written agreement of the 
Director, Sec. 725.409(c).
    In most cases, however, at the conclusion of either the evidentiary 
development period or informal conference proceedings, the district 
director will issue a proposed decision and order setting forth his 
findings and conclusions with respect to the claim. In order to reduce 
the delay caused by informal conferences, the regulations require 
issuance of a proposed decision and order within 20 days after the 
conclusion of all informal conference proceedings, Sec. 725.418(a). The 
proposed decision and order will contain the district director's final 
designation of the responsible operator liable for the payment of 
benefits, and will dismiss, as parties to the claim, all other 
potentially liable operators that received notification pursuant to 
Sec. 725.407. Any party may request a hearing within 30 days of 
issuance of the decision and order, Sec. 725.419(a). If no party 
responds to the proposed decision, it shall become final and effective 
upon the expiration of the 30-day period and no further proceedings 
with respect to the claim shall be possible, except for the filing of a 
request for modification, Sec. 725.419(d).
    The Department hopes that this simplified procedure will reduce, if 
not eliminate, hearing requests filed before the conclusion of a 
district director's claims processing. In the event a hearing request 
is filed before a district director has concluded his adjudication of 
the claim, however, OWCP will honor the request at the conclusion of 
processing in the absence of a party's affirmative statement that it no 
longer desires a hearing. Thus, if a claimant has previously requested 
a hearing and has been denied benefits in a proposed decision and 
order, the case will be forwarded to the Office of Administrative Law 
Judges for hearing in the absence of a statement that a hearing is no 
longer desired. Similarly, if an operator has previously requested a 
hearing, and the proposed decision and order awards the claimant 
benefits, OWCP will forward the claim for hearing absent a statement 
from the operator that it no longer desires a hearing, Sec. 725.418(c).

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Evidentiary Development

Documentary Evidence

    With one substantive addition and several deletions, these final 
rules implement the Department's second proposal with respect to the 
development of both documentary medical evidence and evidence 
pertaining to operator liability. The designated responsible operator 
may submit documentary medical evidence either to the district director 
or to the administrative law judge (ALJ) up to 20 days before an ALJ 
hearing, or even thereafter, if good cause is shown. Documentary 
medical evidence may only be submitted up to the numerical limitations 
outlined in Secs. 725.414(a), however, absent a showing of good cause, 
Sec. 725.456(b). Thus, each side in a claim may submit two chest x-ray 
interpretations, the results of two pulmonary function tests, two 
arterial blood gas studies and two medical reports as its affirmative 
case. In addition, each party may submit one piece of evidence in 
rebuttal of each piece of evidence submitted by the opposing party. 
Finally, in a case in which rebuttal evidence has been submitted, the 
party that originally proferred the evidence which has been the subject 
of rebuttal may submit one additional statement to rehabilitate its 
evidence.
    By contrast, documentary evidence as to operator liability must be 
submitted to the district director, absent a showing of exceptional 
circumstances, Secs. 725.408(b)(2), 725.414(d), 725.456(b). There is no 
limit on the amount of such evidence that may be submitted, however.
    At the urging of commenters representing both industry and 
claimants, the Department has made one addition to Sec. 725.414(a). The 
Department has added a specific limitation on the amount of autopsy and 
biopsy evidence which may be submitted in a claim. Each side may submit 
one autopsy report and one report of each biopsy as part of an 
affirmative case. Each side may submit one autopsy report and one 
report of each biopsy in rebuttal of the opponent's case. Finally, 
where the original autopsy or biopsy evidence has been the subject of 
rebuttal, the party that submitted the original report may submit an 
additional statement from the physician who authored that report.
    The Department has deleted language throughout Sec. 725.414 
referring to potentially liable operators since only the designated 
responsible operator and/or the Trust Fund will have the authority to 
develop documentary medical evidence in a claim. The Department has 
also deleted one provision of proposed Sec. 725.414, Sec. 725.414(e), 
as well as the comparable provision proposed as Sec. 725.456(c). These 
subsections would have provided that any evidence obtained by a party 
while a claim was pending before a district director but withheld from 
the district director or any other party shall not be admitted into the 
record in any later proceedings in the absence of extraordinary 
circumstances unless its admission is requested by another party. 
Commenters opposed these provisions, and the Department has agreed to 
delete them. The Department believes they are no longer necessary, 
given the significant alteration in the district director's methods for 
gathering evidence under the new regulations, see preamble to 
Sec. 725.456. In addition, these rules would have posed a danger to 
parties who are unrepresented before the district director and might 
have run afoul of the rules unintentionally.

Complete Pulmonary Evaluation

    With one exception, these final rules implement the Department's 
second proposal with respect to the administration of the complete 
pulmonary evaluation required by 30 U.S.C. 923(b). The Department will 
allow each claimant to select the physician or facility to perform his 
evaluation from a list of authorized providers maintained by the 
Department. The list in each case will include all authorized 
physicians and facilities in the state of the miner's residence and 
contiguous states, Sec. 725.406(b). The Department will also make 
available to the claimant's treating physician, at the claimant's 
request, the results of the objective testing administered as part of 
the complete pulmonary evaluation and will inform the claimant that any 
opinion submitted by his treating physician will count as one of the 
two medical reports that the miner may submit, Sec. 725.406(d).
    The Department has not included in the final regulation at 
Sec. 725.406, however, the provision proposed as subsection (e) which 
would have allowed the district director to require the claimant to be 
reexamined after the completion of the complete pulmonary evaluation if 
the district director believed that unresolved medical questions 
remained. Commenters from both industry and claimants' groups opposed 
this provision, and the Department has concluded it is no longer 
necessary. The complete pulmonary evaluation will now be performed by a 
highly qualified physician who may be asked by the district director to 
clarify and/or supplement an initial report if unresolved medical 
questions remain. In addition, the components of the complete pulmonary 
evaluation are to be in substantial compliance with the applicable 
quality standards and the district director retains authority elsewhere 
in Sec. 725.406 to schedule the miner for further examination or 
testing to ensure compliance with these standards.
    In the second notice of proposed rulemaking, the Department also 
announced its intent to perform the best possible respiratory and 
pulmonary evaluation of miners applying for benefits. The Department 
promised a thorough examination, performed in compliance with the 
quality standards, in order to provide each claimant with a realistic 
appraisal of his condition and the district director with a sound 
evidentiary basis for a preliminary evaluation of the claim. The 
Department also announced its intent to develop more rigorous standards 
for physicians who perform complete pulmonary evaluations. The 
Department invited the interested public to comment on the possible 
standards that might be used to select physicians and facilities, 64 FR 
54988-54989 (Oct. 8, 1999).
    The comments the Department received are discussed in detail in the 
preamble to Sec. 725.406. It is the Department's intent, however, to 
include in its Black Lung Program Manual the requirements for a 
physician's or medical facility's inclusion on the list. The Manual is 
available to the public in every district office of OWCP. Thus, the 
requirements for participation in OWCP's program and the manner in 
which the Department has used those requirements to select physicians 
for inclusion on the approved list will be public information. The 
Department does not intend to screen the contents of physicians' prior 
reports and testimony before including them on the list. The Department 
intends only to ascertain that the required professional credentials 
are present.

Witnesses

    These final rules adopt the provisions governing witness testimony 
proposed in the Department's second notice of proposed rulemaking. No 
person shall be permitted to testify as a witness at a hearing, 
pursuant to deposition or by interrogatory unless that person meets the 
requirements of Sec. 725.414(c). Thus, in the case of a witness 
offering testimony relevant to the liability of a potentially liable 
operator or the identification of a responsible operator,

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the witness must have been identified while the claim was pending 
before the district director in the absence of extraordinary 
circumstances, Sec. 725.457(c)(1). In the case of a physician offering 
testimony relevant to the physical condition of the miner, the 
physician must have prepared a medical report submitted into evidence. 
Alternatively, the party offering the physician's testimony must have 
submitted fewer than two medical reports into evidence in which case 
the physician's testimony shall be considered a medical report for the 
purpose of the evidentiary limitations in Sec. 725.414(c). A party may 
offer the testimony of more than two physicians only upon a finding of 
good cause, Sec. 725.457(c)(2).

Treating Physicians' Opinions

    The Department has adopted a rule governing the weighing of 
treating physicians' opinions similar to the one proposed in its second 
notice of proposed rulemaking, Sec. 718.104(d). The rule is discussed 
in detail in the preamble to Sec. 718.104. The language of 
Sec. 718.104(d) has been altered to provide that, in appropriate cases, 
the relationship between the miner and his treating physician may 
constitute substantial evidence in support of the adjudication 
officer's decision to give that physician's opinion controlling weight. 
See Sec. 718.104(d)(5). The rule's purpose is to recognize that a 
physician's professional relationship with the miner may enhance his 
insight into the miner's pulmonary condition. A treating physician may 
develop a more in-depth knowledge and understanding of the miner's 
respiratory and pulmonary condition than a physician who examines the 
miner only once or who reviews others' examination reports. Section 
718.104(d) is not an outcome-determinative evidentiary rule, however. 
It does not preclude consideration of other relevant evidence of 
record. Rather, it provides criteria for evaluating the quality of the 
doctor-patient relationship. The criteria at Sec. 718.104(d)(1)-(4) are 
indicia of the potential insight the physician may have gained from on-
going treatment of the miner. The rule is designed to force a careful 
and thorough assessment of the treatment relationship. If the 
adjudicator concludes the treating physician has a special 
understanding of the miner's pulmonary health, that opinion may receive 
``controlling weight'' over contrary opinions. That determination may 
be made, however, only after the adjudicator considers the credibility 
of the physician's opinion in light of its documentation and reasoning 
and the relative merits of the other relevant medical evidence of 
record.

Definition of Pneumoconiosis and Establishing Total Disability Due to 
Pneumoconiosis

    The Department has adopted the proposed definition of 
pneumoconiosis without alteration. In the preamble to Sec. 718.201, the 
Department explains that the term ``legal pneumoconiosis'' does not 
create a new medical diagnosis, but rather reflects the statute's 
definition of the disease as ``a chronic dust disease of the lung and 
its sequelae, including respiratory and pulmonary impairments, arising 
out of coal mine employment.'' 30 U.S.C. 902(b). The preamble also 
explains in detail the Department's decision to include chronic 
obstructive pulmonary disease in the definition of pneumoconiosis to 
the extent it is shown to have arisen from coal mine employment. The 
Department attempts to clarify that not all obstructive lung disease is 
pneumoconiosis. It remains the claimant's burden of persuasion to 
demonstrate that his obstructive lung disease arose out of his coal 
mine employment and therefore falls within the statutory definition of 
pneumoconiosis. The Department has concluded, however, that the 
prevailing view of the medical community and the substantial weight of 
the medical and scientific literature supports the conclusion that 
exposure to coal mine dust may cause chronic obstructive pulmonary 
disease. Each miner must therefore be given the opportunity to prove 
that his obstructive lung disease arose out of his coal mine employment 
and constitutes ``legal'' pneumoconiosis.
    The Department has also adopted the proposed regulation defining 
total disability and disability due to pneumoconiosis with one 
alteration, Sec. 718.204. To clarify its original intent concerning the 
extent to which pneumoconiosis must contribute to a miner's total 
disability, the Department has amended the language of 
Secs. 718.204(c)(1)(i) and 718.204(c)(1)(ii) by adding the words 
``material'' and ``materially.'' Thus, a miner has established that his 
pneumoconiosis is a substantially contributing cause of his disability 
if it either has a material adverse effect on his respiratory or 
pulmonary condition or materially worsens a totally disabling 
respiratory or pulmonary impairment caused by a disease or exposure 
unrelated to coal mine dust. Evidence that pneumoconiosis made only a 
negligible, inconsequential or insignificant contribution to the 
miner's disability is insufficient to establish total disability due to 
pneumoconiosis. This change is discussed in detail in the preamble at 
Sec. 718.204. The Department has also adopted one important proposed 
change with respect to the clinical evidence which may be used to 
establish total disability, see preamble to Sec. 718.103. The 
Department has concluded that the claims adjudication process would 
benefit by making mandatory the use of the flow-volume loop in 
pulmonary function testing (spirometry testing). The Department has 
previously noted that the test, conducted in this manner, provides a 
``more reliable method of ensuring valid, verifiable results * * *.'' 
64 FR 54975 (Oct. 8, 1999). In the second notice of proposed 
rulemaking, the Department announced its intent to conduct a survey of 
physicians, clinics and facilities which perform pulmonary function 
testing to evaluate the prevalence of spirometers capable of producing 
a flow-volume loop. The Department has now evaluated the results of its 
survey and has concluded that the prevalence of the necessary equipment 
and the willingness of those physicians who do not currently have it to 
buy it, warrant the mandatory usage of such equipment.

Subsequent Claims

    These final rules adopt the regulation governing subsequent claims 
that was proposed in the Department's second notice of proposed 
rulemaking. A subsequent claim is an application for benefits filed 
more than one year after the denial of a previous claim. It may be 
adjudicated on its merits only if the claimant demonstrates that an 
applicable condition of entitlement has changed in the interim. In the 
second proposal, the Department justified the rule by noting that 
``allowing the filing of a subsequent claim for benefits which alleges 
a worsening of the miner's condition, * * * merely recognizes the 
progressive nature of pneumoconiosis.'' 64 FR 54968 (Oct. 8, 1999). In 
the preamble to Sec. 725.309, the Department responds in detail to 
those commenters who oppose the regulation. They argue, in part, that 
the Department's recognition of pneumoconiosis as a latent and 
progressive disease is scientifically unsound. The Department has 
summarized the scientific and medical evidence supporting its view that 
pneumoconiosis is both latent and progressive and has responded to the 
criticism leveled at that evidence. It is the Department's conclusion 
that the record contains abundant evidence to justify the regulation 
governing subsequent claims.

[[Page 79924]]

Attorneys' Fees

    With minor changes, these final rules promulgate the regulation 
governing the payment of a claimant's attorney's fee as it was proposed 
in the Department's second notice of proposed rulemaking, Sec. 725.367. 
The Department wishes to encourage attorneys to represent claimants 
early in the administrative process, given the important decisions 
which may be made by a claimant while a claim is pending before the 
district director. For example, the rules now limit the quantity of 
medical evidence that a claimant may submit in support of his 
entitlement. A claimant may request that the Department send the 
objective test results from his complete pulmonary evaluation to his 
treating physician. Any treating physician's opinion which is submitted 
to the district director, however, may become one of the claimant's two 
medical reports. The Department's rule governing attorney's fees, 
therefore, seeks to encourage early attorney involvement by providing a 
different starting point for employer and Fund attorney fee liability. 
Although the creation of an adversarial relationship and the ultimately 
successful prosecution of a claim are still necessary to trigger 
employer or Fund liability, once that liability is triggered, a 
reasonable fee will be awarded for all necessary work performed, even 
if it was performed before the creation of the adversarial 
relationship.
    The text of the regulation has been altered in minor ways. The 
language describing the fee to which an attorney is entitled has been 
amended to conform with Sec. 725.366. Section 725.367 therefore 
provides for the payment of a ``reasonable fee[] for necessary services 
performed. * * *'' In addition, the regulation has been amended to 
conform with the revised district director claims procedure. Thus, 
Sec. 725.367(a)(1) now provides that if the responsible operator 
designated by the district director pursuant to Sec. 725.410(a)(3) 
fails to accept the claimant's entitlement to benefits within the 30 
day period provided by Sec. 725.412(b) and is ultimately determined to 
be liable for benefits, the operator shall also be liable for a 
reasonable attorney's fee. Similarly, if there is no operator that may 
be held liable for the payment of benefits, the district director 
issues a schedule for the submission of additional evidence under 
Sec. 725.410, and the claimant successfully prosecutes his application 
for benefits, the Fund will be liable for a reasonable attorney's fee, 
Sec. 725.367(a)(2). Finally, if the district director issues more than 
one schedule for the submission of additional evidence in order to 
designate a different operator as the responsible operator, and that 
operator is ultimately determined to be liable for the payment of 
benefits, that operator will be liable for the payment of claimant's 
attorney's fee if it fails to accept the claimant's entitlement within 
30 days of the date upon which it is notified of its designation as 
responsible operator.

True Doubt

    The Department has not adopted a ``true doubt'' rule in these 
regulations. The ``true doubt'' rule was an evidentiary weighing 
principle under which an issue was resolved in favor of the claimant if 
the probative evidence for and against the claimant was in equipoise. 
The Department believes that evaluation of conflicting medical evidence 
requires careful consideration of a wide variety of disparate factors 
affecting the credibility of that evidence. The presence of these 
factors makes it unlikely that a factfinder will be able to conclude 
that conflicting evidence is truly in equipoise. See preamble to 
Sec. 718.3.

Criteria for Determining a Responsible Operator

    The Department has made two changes to the regulation governing the 
identification of a responsible operator, Sec. 725.495. That regulation 
now provides that if the miner's most recent employer was a self-
insured operator which no longer possesses sufficient assets to secure 
the payment of benefits when the miner files his claim, the Department 
will not name a previous employer as responsible operator. Rather, the 
claim will be the responsibility of the Black Lung Disability Trust 
Fund. The Department has made this change in response to a comment that 
stated that it is unfair to name a prior employer as liable for a claim 
when the financial inability of the later employer to pay the claim is 
the fault of the Department. Because the Department has the authority 
to accept or reject applications for self-insurance and to set minimum 
standards for qualifying as a self-insurer, the Department agrees with 
the commenter. Thus, to the extent the security deposited by a self-
insured coal mine operator pursuant to Sec. 726.104 proves insufficient 
to pay individual claims, liability will not be placed on previous 
employers, but rather on the Trust Fund. The Department has also 
altered the language of Sec. 725.495(d) to reflect the changes made in 
the regulations governing district director claims processing, 
Secs. 725.410-725.413. The district director will no longer issue an 
initial finding naming a responsible operator but rather will finally 
designate in a proposed decision and order one operator as the 
responsible operator liable for a claim, Sec. 725.418(d).

Insurance Endorsement

    In the second notice of proposed rulemaking, the Department opened 
Sec. 726.203 for comment, noting that representatives of the insurance 
industry had told the Department that a different version of the 
insurance endorsement than the one contained in Sec. 726.203(a) had 
been in use since 1984 with the Department's consent. The Department 
invited the submission of any document the insurance industry might 
possess from the Department authorizing use of the different 
endorsement. 64 FR 54969-70, 55005-06 (Oct. 8, 1999). The Department 
has carefully considered the comments submitted in response to the 
second notice of proposed rulemaking and declines to amend 
Sec. 726.203. The revised black lung endorsement offered by the 
commenters would materially alter the obligations and coverage provided 
by the insurance industry, thereby increasing the potential exposure of 
coal mine operators and the Black Lung Disability Trust Fund, see 
preamble to Sec. 726.203.

Explanation of Changes

Complete List of Substantive Revisions

    The Department has made substantive revisions to the following 
regulations: Sec. 718.3, Sec. 718.101, Sec. 718.102, Sec. 718.103, 
Sec. 718.104, Sec. 718.105, Sec. 718.106, Sec. 718.107, Sec. 718.201, 
Sec. 718.202, Sec. 718.204, Sec. 718.205, Sec. 718.301, Appendix B to 
part 718, Appendix C to Part 718, part 722 (entire), Sec. 725.1, 
Sec. 725.2, Sec. 725.4, Sec. 725.101, Sec. 725.103, Sec. 725.202, 
Sec. 725.203, Sec. 725.204, Sec. 725.209, Sec. 725.212, Sec. 725.213, 
Sec. 725.214, Sec. 725.215, Sec. 725.219, Sec. 725.221, Sec. 725.222, 
Sec. 725.223, Sec. 725.306, Sec. 725.309, Sec. 725.310, Sec. 725.311, 
Sec. 725.351, Sec. 725.362, Sec. 725.367, Sec. 725.403, Sec. 725.405, 
Sec. 725.406, Sec. 725.407, Sec. 725.408, Sec. 725.409, Sec. 725.410, 
Sec. 725.411, Sec. 725.412, Sec. 725.413, Sec. 725.414, Sec. 725.415, 
Sec. 725.416, Sec. 725.417, Sec. 725.418, Sec. 725.421, Sec. 725.423, 
Sec. 725.452, Sec. 725.454, Sec. 725.456, Sec. 725.457, Sec. 725.458, 
Sec. 725.459, Sec. 725.465, Sec. 725.478, Sec. 725.479, Sec. 725.490, 
Sec. 725.491, Sec. 725.492, Sec. 725.493, Sec. 725.494, Sec. 725.495, 
Sec. 725.502, Sec. 725.503, Sec. 725.515, Sec. 725.522, Sec. 725.530, 
Sec. 725.533, Sec. 725.537, Sec. 725.543, Sec. 725.544, Sec. 725.547, 
Sec. 725.548, Sec. 725.606,

[[Page 79925]]

Sec. 725.608, Sec. 725.609, Sec. 725.620, Sec. 725.621, Sec. 725.701, 
Sec. 725.706, Sec. 726.2, Sec. 726.3, Sec. 726.8, Sec. 726.101, 
Sec. 726.104, Sec. 726.105, Sec. 726.106, Sec. 726.109, Sec. 726.110, 
Sec. 726.111, Sec. 726.114, Sec. 726.300, Sec. 726.301, Sec. 726.302, 
Sec. 726.303, Sec. 726.304, Sec. 726.305, Sec. 726.306, Sec. 726.307, 
Sec. 726.308, Sec. 726.309, Sec. 726.310, Sec. 726.311, Sec. 726.312, 
Sec. 726.313, Sec. 726.314, Sec. 726.315, Sec. 726.316, Sec. 726.317, 
Sec. 726.318, Sec. 726.319, and Sec. 726.320. Detailed explanations of 
the reasons for the Department's revisions may be found in the 
discussion of individual regulations below.

Complete List of Technical Revisions

    The Department has made only technical changes to the following 
regulations: Sec. 718.1, Sec. 718.2, Sec. 718.4, 718.303, Appendix A to 
Part 718, Sec. 725.3, Sec. 725.102, Sec. 725.201, Sec. 725.206, 
Sec. 725.207, Sec. 725.216, Sec. 725.217, Sec. 725.218, Sec. 725.220, 
Sec. 725.301, Sec. 725.302, Sec. 725.350, Sec. 725.360, Sec. 725.366, 
Sec. 725.401, Sec. 725.402, Sec. 725.404, Sec. 725.419, Sec. 725.420, 
Sec. 725.450, Sec. 725.451, Sec. 725.455, Sec. 725.462, Sec. 725.463, 
Sec. 725.466, Sec. 725.480, Sec. 725.496, Sec. 725.497, Sec. 725.501, 
Sec. 725.504, Sec. 725.505, Sec. 725.506, Sec. 725.507, Sec. 725.510, 
Sec. 725.513, Sec. 725.514, Sec. 725.521, Sec. 725.531, Sec. 725.532, 
Sec. 725.536, Sec. 725.540, Sec. 725.601, Sec. 725.603, Sec. 725.604, 
Sec. 725.605, Sec. 725.607, Sec. 725.702, Sec. 725.703, Sec. 725.704, 
Sec. 725.705, Sec. 725.707, Sec. 725.708, Sec. 725.711, Sec. 726.1, 
Sec. 726.4, Sec. 726.103, Sec. 726.203, Sec. 726.207, Sec. 726.208, 
Sec. 726.209, Sec. 726.210, Sec. 726.211, Sec. 726.212, and 
Sec. 726.213. In its first notice of proposed rulemaking, the 
Department revised Sec. 725.3 to create a new subpart E in part 725, 
and to recognize the relabeling of the remaining subparts. The 
Department inadvertently omitted the regulation from the list of 
technical revisions, however. Accordingly, Sec. 725.3 now appears in 
the complete list of technical revisions. The Department also 
inadvertently omitted Secs. 725.206 and 725.540 from the list of 
technical revisions. The Department added a reference to Sec. 725.4(d) 
to each regulation, see 62 FR 3340-41 (Jan. 22, 1997). The Department 
also inadvertently omitted Sec. 725.207 from the list of technical 
revisions. The Department replaced commas in subsections (b) and (c) 
with the word ``and.'' The Department also inadvertently omitted 
Sec. 725.497 from the list of technical revisions. The Department 
replaced references to the ``Trust Fund'' with references to the 
``fund,'' the term defined in Sec. 725.101(a)(8), and capitalized the 
word ``section'' in subsections (a) and (b). Finally, the Department 
inadvertently omitted Sec. 725.601 from the list of technical 
revisions. The Department replaced references to ``deputy 
commissioner'' with references to ``district director,'' see 62 FR 3340 
(Jan. 22, 1997), and replaced a reference to the ``Trust Fund'' with a 
reference to the ``fund.'' The Department explained the other technical 
changes that it was making to the regulations in its first and second 
notices of proposed rulemaking. See 62 FR 3340-41 (Jan. 22, 1997); 64 
FR 54970 (Oct. 8, 1999). With the exception of Sec. 726.203, none of 
the regulations listed above were open for comment. The Department's 
decision not to revise Sec. 726.203, other than the technical revisions 
discussed in the Department's first notice of proposed rulemaking, is 
explained in the preamble to Sec. 726.203.

Complete List of Deleted Regulations

    The following regulations have been deleted: Sec. 718.307, 
Sec. 718.401, Sec. 718.402, Sec. 718.403, Sec. 718.404, Sec. 725.453A, 
Sec. 725.459A, Sec. 725.503A, Sec. 725.701A, and part 727 (entire). The 
Department explained its decision to incorporate the text of sections 
725.453A, 725.459A, 725.503A, and 725.701A into other regulations in 
its first notice of proposed rulemaking. See list of Technical 
revisions, 62 FR 3341 (Jan. 22, 1997). Detailed explanations of the 
Department's decision to delete the remaining regulations in this list 
may be found in the discussion of individual regulations below.

Complete List of Unchanged Regulations

    The following regulations have not been revised: Sec. 718.203, 
Sec. 718.206, Sec. 718.302, Sec. 718.304, Sec. 718.305, Sec. 718.306, 
Sec. 725.205, Sec. 725.208, Sec. 725.210, Sec. 725.211, Sec. 725.224, 
Sec. 725.225, Sec. 725.226, Sec. 725.227, Sec. 725.228, Sec. 725.229, 
Sec. 725.230, Sec. 725.231, Sec. 725.232, Sec. 725.233, Sec. 725.303, 
Sec. 725.304, Sec. 725.305, Sec. 725.307, Sec. 725.308, Sec. 725.352, 
Sec. 725.361, Sec. 725.363, Sec. 725.364, Sec. 725.365, Sec. 725.422, 
Sec. 725.453, Sec. 725.460, Sec. 725.461, Sec. 725.464, Sec. 725.475, 
Sec. 725.476, Sec. 725.477, Sec. 725.481, Sec. 725.482, Sec. 725.483, 
Sec. 725.511, Sec. 725.512, Sec. 725.520, Sec. 725.534, Sec. 725.535, 
Sec. 725.538, Sec. 725.539, Sec. 725.541, Sec. 725.542, Sec. 725.545, 
Sec. 725.546, Sec. 725.602, Sec. 725.710, Sec. 726.5, Sec. 726.6, 
Sec. 726.7, Sec. 726.102, Sec. 726.107, Sec. 726.108, Sec. 726.112, 
Sec. 726.113, Sec. 726.115, Sec. 726.201, Sec. 726.202, Sec. 726.204, 
Sec. 726.205, and Sec. 726.206. The Department did not accept comments 
on these regulations, and is re-promulgating the regulations for the 
convenience of readers.
    For purposes of this preamble, ``he'', ``his'', and ``him'' shall 
include ``she'', ``hers'', and ``her''.

20 CFR Part 718--Standards for Determining Coal Miners' Total 
Disability or Death Due to Pneumoconiosis

Subpart A--General

20 CFR 718.3

    (a)(i) In the initial notice of proposed rulemaking, the Department 
invited public comment on the continued use of the ``true doubt'' rule, 
and specifically on the language contained in Sec. 718.3(c), which had 
been cited to the Supreme Court in support of the rule. 62 FR 3341 
(Jan. 22, 1997). The ``true doubt'' rule is an evidentiary principle 
which requires the adjudicator to find in favor of the claimant on a 
factual issue if the evidence for and against the claimant is evenly 
balanced. The Supreme Court invalidated the ``true doubt'' rule in 
Director, OWCP v. Greenwich Collieries, 512 U.S. 267 (1994). The Court 
held Sec. 718.3(c) failed to define the rule effectively, and that the 
rule, as applied by the Benefits Review Board, violated the 
Administrative Procedure Act (APA), 5 U.S.C. 551 et seq., by relieving 
the claimant of the burden of proving his or her claim by a 
preponderance of the evidence (the ``burden of persuasion''). The 
Department therefore proposed deleting Sec. 718.3(c) and moving the 
existing 20 CFR 718.403 (1999) (``Burden of proof'') to proposed 
Sec. 725.103. (ii) In the second notice of proposed rulemaking, the 
Department addressed the comments responding to the proposed deletion 
of paragraph (c). 64 FR 54974 (Oct. 8, 1999). Some comments urged the 
Department to promulgate a version of the ``true doubt'' rule which 
would comply with Greenwich Collieries. Other comments suggested 
retaining paragraph (c) as a statement of general principle and a 
reminder to adjudicators of the purpose of the Black Lung Benefits Act 
(BLBA). The Department rejected both suggestions. The Department 
concluded a ``true doubt'' evidentiary rule would not improve claims 
adjudication. Rather, the factfinder must conduct an in-depth analysis 
of the medical evidence in each case, and resolve credibility issues. 
The Department also noted that evidence is rarely in equipoise because 
a factfinder must consider such a wide variety of factors in weighing 
it: Physicians' qualifications, clinical documentation,

[[Page 79926]]

reasoning, relationship to other medical evidence, etc. With respect to 
paragraph (c) as a statement of principle, the Department considered 
the provision unnecessary because it would be unenforceable, and 
because the principles appear in the legislative history of the BLBA 
which may be cited by a party in litigation. Moreover, the Department 
noted it had addressed the difficulties confronted by claimants in 
proving their claims in other regulations, e.g., by requiring 
substantial compliance rather than strict compliance with the quality 
standards for medical evidence. (iii) The Department has received four 
additional comments concerning the ``true doubt'' rule.
    (b) Two comments observe that the Department has the regulatory 
authority to promulgate a ``true doubt'' rule which will comply with 
Greenwich Collieries, and three comments urge the need for such a rule 
to implement Congressional intent that all reasonable doubt be resolved 
in the claimant's favor. The Department recognizes that it has the 
statutory authority to depart from the requirements of the APA and 
allocate burdens of production and persuasion among the parties. The 
Department, however, does not believe codification of the ``true 
doubt'' rule is necessary to afford claimants the protections Congress 
intended in directing resolution of reasonable doubts in their favor. 
Rather than a statement of general principle, the Department has 
provided assistance to claimants in other ways. As noted in the second 
notice of proposed rulemaking, the Department eased the level of 
compliance with the quality standards for clinical tests and medical 
reports from strict adherence to ``substantial compliance.'' 64 FR 
54974 (Oct. 8, 1999). The reduced standard allows the adjudicator more 
leeway to determine in each particular case whether any defects in 
compliance undermine the credibility of the test or report. Another 
example is the ``treating physician'' rule in Sec. 718.104(d). The 
regulation enhances the weight an adjudicator may give to a miner's 
treating physician's opinion provided the opinion meets certain 
standards. In addition, Sec. 725.406(d) provides each claimant with the 
opportunity to have his or her treating physician receive objective 
test results (such as a chest x-ray reading and pulmonary function 
study results), in substantial compliance with the regulations' quality 
standards. This provision ensures that the claimant's treating 
physician's opinion may be based on complying evidence. Finally, the 
Department has adopted burden-shifting presumptions such as the default 
onset date for the commencement of benefits, Sec. 725.503(b), (d), and 
the presumption of coverage for pulmonary-related medical benefits, 
Sec. 725.701(e), which assist claimants on medical treatment issues. 
These provisions significantly reduce the need for a ``true doubt'' 
rule.
    (c) Three comments contend a ``true doubt'' rule is necessary 
because the limitations on the quantity of medical evidence imposed by 
the regulations will result in increased instances in which the 
evidence for and against entitlement is in equipoise despite scrupulous 
consideration of all relevant factors affecting credibility. The 
Department disagrees. The adjudicator must examine several variables in 
weighing the credibility of each item of medical evidence, especially 
physicians' opinions. Age of the opinion, reasoning, underlying 
clinical data, the physician's level of expertise, reliability of 
employment, social and medical histories, etc., are all factors to be 
considered in each report. As for clinical studies, the quality 
standards establish criteria to measure the reliability of the clinical 
results, and physicians' reviews of the results provide additional 
information on the studies' validity. When all available information is 
assembled, the Department believes few medical records for and against 
entitlement will be in equipoise. Furthermore, the limitations on 
evidence should prompt each party to bolster the credibility of its 
medical evidence and challenge the credibility of its opponent's case.
    (d) One comment states the ``true doubt'' rule is especially needed 
for weighing chest x-rays because that type of evidence involves very 
few variables (film quality, readers' expertise) which can affect the 
credibility of the evidence. The Department believes no need exists to 
adopt a specialized ``true doubt'' rule for use in weighing only x-
rays. Such a rule would place undue importance on one type of evidence, 
and would overemphasize the role of x-rays in determining whether the 
miner has pneumoconiosis. Chest x-rays are used to determine whether 
the miner has ``clinical'' pneumoconiosis, i.e., ``the lung disease 
caused by fibrotic reaction of the lung tissue to inhaled dust, which 
is generally visible on chest x-rays as opacities.'' Hobbs v. 
Clinchfield Coal Co., 917 F.2d 790, 791 n. 1 (4th Cir. 1990) (citation 
omitted). The BLBA explicitly prohibits the denial of a claim based 
solely on negative x-rays. 30 U.S.C. 923(b). The reason for this 
prohibition is Congress' reservations about the reliability of negative 
x-rays as trustworthy evidence that the miner does not have 
pneumoconiosis. Usery v. Turner Elkhorn Mining Co., 428 U.S. 1, 31-34 
(1976). Consequently, Congress has limited the use of negative x-rays 
in evaluating a miner's entitlement to benefits. Even if the x-ray 
readings in a particular claim appear to be truly balanced and 
therefore insufficient to meet the preponderance standard, however, the 
claimant may nevertheless establish the existence of clinical 
pneumoconiosis. For example, a factfinder might find one x-ray reading 
more credible than another based on a radiologist's explanation, 
contained in a supplemental report or deposition testimony, of the 
reasons for his x-ray diagnosis. Such reasons may include consideration 
of the miner's complete occupational history, including the length of 
his or her coal mine employment, and the absence of other injurious 
exposures, see 45 FR 13687, Discussion and changes, Sec. 718.202 (Feb. 
29, 1980). In addition, a claimant may prove the existence of ``legal'' 
pneumoconiosis. This broader category of compensable disease comprises 
``all lung diseases which * * * [are] significantly related to, or 
substantially aggravated by, dust exposure in coal mine employment.'' 
Hobbs, 917 F.2d 4 791 n. 1; see also Barber v. Director, OWCP, 43 F.3d 
899, 901 (4th Cir. 1995). In weighing medical evidence relevant to 
``legal'' pneumoconiosis, the adjudicator may consider a variety of 
factors which affect the weight of the medical evidence, e.g., the 
physicians' expertise, the reasoning and documentation in the medical 
reports, the comparative consistency or inconsistency of the opinions 
with other medical evidence such as hospital reports, etc. A claimant 
has ample opportunity to establish that (s)he has a lung disease caused 
by coal mine employment in addition to the narrow type of disease 
discoverable by x-rays. The Department therefore rejects the position 
that a ``true doubt'' rule should be available for the purpose of 
resolving conflicts in x-ray evidence.
    (e) One comment suggests a ``true doubt'' rule would be useful in 
resolving conflicts between qualifying and nonqualifying pulmonary 
function and blood gas studies. The commenter acknowledges that more 
factors exist to determine the credibility of these types of clinical 
evidence than exist when chest x-ray evidence is in conflict, but 
nevertheless recommends making the rule applicable in the event the 
evidence is in equipoise. Both pulmonary function (Sec. 718.103) and

[[Page 79927]]

blood gas studies (Sec. 718.105) must comply with far more detailed 
quality standards than x-rays. Although only ``substantial compliance'' 
is required under the regulations, the more detailed standards 
necessarily provide more points of comparison between studies and more 
bases for preferring one study to another. A party may challenge 
another party's study by submitting expert opinion evidence 
demonstrating the study is unreliable or invalid. Given the numerous 
means of challenging or bolstering a study, the Department does not 
believe a ``true doubt'' rule would play a significant role in weighing 
pulmonary function studies and blood gas studies. No change in the 
regulation is appropriate.
    (f) No other comments have been received concerning this section, 
and no changes have been made in it.

Subpart B

20 CFR 718.101

    (a) In the initial notice of proposed rulemaking, the Department 
added subsection (b) to emphasize that the part 718 quality standards 
apply to all evidence developed by any party in connection with a claim 
filed after March 31, 1980, and to claims governed by part 727 if the 
evidence was developed after that date. 62 FR 3341 (Jan. 22, 1997). 
Paragraph (b) also established a single standard of compliance for all 
clinical tests and medical reports, in place of the varying standards 
contained in the former individual regulations. The Department revised 
paragraph (b) in the second notice of proposed rulemaking to clarify 
that the quality standards will apply only prospectively to evidence 
developed in connection with a claim, after promulgation of these 
regulations. The Department noted it wished to avoid invalidating 
evidence already submitted in pending claims based on the parties' 
settled expectations. 64 FR 54974-75 (Oct. 8, 1999). The Department 
also responded to numerous comments received after the initial notice 
of proposed rulemaking. It rejected comments opposing the general 
applicability of the quality standards to medical evidence and 
advocating consideration of noncomplying evidence, citing the need for 
technically accurate and reliable evidence for the adjudication of 
entitlement issues. For the same reason, the Department rejected 
comments disputing its authority to impose quality standards on medical 
evidence as inconsistent with the Black Lung Benefits Act's (BLBA) 
requirement that ``all relevant evidence'' be considered. See 30 U.S.C. 
923(b). The Department concluded quality standards are consistent with 
the mandated consideration of all relevant evidence because 
noncomplying evidence is inherently unreliable, and therefore not 
relevant to the adjudication of a claim. The Department rejected the 
suggestion that the criteria enumerated in the quality standards should 
provide the only grounds for invalidating medical evidence; rather, 
parties may develop any evidence which addresses the validity of the 
evidence. The Department explained there was no need to add an 
exemption from the quality standards for hospitalization and treatment 
records because Sec. 718.101 is clear that it applies quality standards 
only to evidence developed ``in connection with a claim'' for black 
lung benefits. Finally, the Department rejected as unnecessary a 
requirement that the Department notify a party if its evidence is 
noncomplying and allow it to rehabilitate the evidence because the 
responsibility for submitting complying evidence rests with the party 
submitting it. The district director is already responsible for 
ensuring the complete pulmonary examination required by 30 U.S.C. 
923(b) complies with all applicable quality standards. In addition, if 
an opposing party challenges evidence as noncomplying, the party 
originally submitting it may rehabilitate the evidence by submitting an 
additional report from the author of the original report.
    (b) Two comments reiterate the general argument that 30 U.S.C. 
923(b) and the Administrative Procedure Act (APA), 5 U.S.C. 556(d), 
require consideration of ``all relevant evidence,'' and the Department 
therefore cannot exclude from the adjudicator's consideration 
noncomplying medical evidence. The Department previously addressed, and 
rejected, this argument in the second notice of proposed rulemaking. 64 
FR 54974 (Oct. 8, 1999). The Department stated that noncomplying 
evidence is not ``relevant evidence'' because it is inherently 
unreliable, and cannot form the basis for awarding or denying a claim. 
Upon further consideration, the Department concludes this statement, 
while accurate in the majority of cases, should be qualified. Evidence 
which does not substantially comply with the applicable standard 
generally is not very reliable. Noncomplying evidence should only form 
the basis for awarding or denying a claim in limited circumstances. All 
three of the following requirements must be met: no evidence exists 
which does comply with the applicable standards; the defect(s) cannot 
be cured by a supplementary opinion or other evidence; and the death of 
the miner precludes developing evidence which would be in substantial 
compliance. In order for such evidence to support an award or denial, 
the adjudicator must find the evidence sufficiently reliable to 
establish the fact(s) for which it is offered despite its failure to 
meet the threshold ``substantial compliance'' standard. The Department 
therefore rejects the commenters' general position that noncomplying 
evidence cannot be excluded under 30 U.S.C. 923(b), although the 
Department recognizes a limited exception to the standards' gatekeeping 
function for some claims involving deceased miners.
    (c) Two comments cite specific examples of circumstances in which 
allegedly probative physicians' opinions could be disregarded on 
compliance grounds. (i) In one example, the commenter cites as 
potentially noncomplying a medical opinion diagnosing ``legal'' 
pneumoconiosis based on valid pulmonary function and arterial blood gas 
testing, but omitting any chest x-ray testing. The Department has 
previously considered the position that a medical report should not 
automatically be found noncomplying based on the absence of an x-ray. 
64 FR 54977 (Oct. 8, 1999). In rejecting the comment that the quality 
standard applicable to reports of physical examination (Sec. 718.104) 
should not make a chest x-ray a standard requirement, the Department 
noted that an x-ray is an integral part of any examination for 
pneumoconiosis. The Department further noted, however, that medical 
evidence must only be in ``substantial compliance'' with the applicable 
quality standards; the party proffering the evidence may demonstrate 
that the evidence is reliable despite its failure to comply with every 
criterion in the standard. The Department reiterates that position. 
Whether any particular piece of evidence is in ``substantial 
compliance'' with the standards, and therefore reliable, is a matter 
for the adjudicator to determine taking into consideration all relevant 
circumstances. One important factor is the element(s) of entitlement 
for which the evidence is offered. In the example cited above, the lack 
of an x-ray is not necessarily fatal. The report may contain: valid and 
pertinent other tests and information upon which the physician can make 
a diagnosis; accurate medical, smoking and employment histories; 
results of a physical examination confirming the

[[Page 79928]]

presence of pulmonary symptoms or impairment; and pulmonary function 
study and/or blood gas studies demonstrating impairment. Based on this 
documentation, the physician may provide a documented and reasoned 
diagnosis of ``legal pneumoconiosis'' which the adjudicator considers 
reliable, i.e., in ``substantial compliance'' with the quality 
standards. See 45 FR 13687 (Feb. 29, 1980), Sec. 718.202, Discussion 
and changes (h). (ii) In another example, the commenter posits a 
``positive'' medical opinion based on an invalid pulmonary function 
test, valid arterial blood gas testing, physical examination and other 
data. The lack of a valid pulmonary function study is not necessarily a 
reason to reject the entire report. The hypothetical assumes a valid 
blood gas test, physical examination, etc. As in the first example, 
this testing and information may support a documented and reasoned 
diagnosis depending on the purpose for which the report is offered. If 
the physical examination and clinical tests other than the pulmonary 
function study substantiate the presence of a pulmonary/respiratory 
impairment, the factfinder may deem the physician's diagnosis a 
reliable assessment of the miner's extent of impairment. If the 
employment, smoking and other personal information is accurate, the 
adjudicator may accept the physician's conclusions about the cause of 
the miner's pulmonary or respiratory impairment. If, however, the 
physician clearly relied on the invalid pulmonary function study (or 
other inaccurate data or information), the adjudicator may find the 
opinion unreliable in one or more respects. (iii) The Department 
emphasizes that the ``substantial compliance'' standard is a rule of 
reason. In each case in which an issue of noncompliance is raised, the 
factfinder must identify any failure to comply strictly with the 
applicable quality standard. The factfinder must then determine whether 
the test or report is reliable despite its failure to comply with every 
criterion in the standard. This finding is necessarily dependent to an 
extent on the element(s) of entitlement for which the test or report 
may be relevant. The significance of the particular defect must 
therefore be ascertained by considering whether it is critical to the 
physician's conclusions. In the first example, the lack of an x-ray may 
be excused if the physician has offered a documented and reasoned 
diagnosis of ``legal'' pneumoconiosis. In the second example, the 
invalid pulmonary function study may or may not affect an otherwise 
documented and reasoned evaluation of the miner's respiratory/pulmonary 
condition. No categorical response, however, can be given to the 
hypotheticals since the reliability, and therefore the probative value, 
of the reports can only be evaluated in the context of an actual claim. 
No change in the regulation is warranted.
    (d) One comment urges the Department to include a provision 
specifically exempting those medical tests and reports generated 
outside the black lung benefits claim context from the quality 
standards. Specifically, the commenter requests that the text of the 
regulation make clear that chest x-rays, pulmonary function tests and 
blood gas studies administered in the hospital or as part of the 
miner's routine care be exempted from quality standards applicability. 
The Department previously addressed this concern in the second notice 
of proposed rulemaking. 64 FR 54975 (Oct. 8, 1999). The Department 
noted that Sec. 718.101 limits the applicability of the quality 
standards to evidence ``developed * * * in connection with a claim for 
benefits'' governed by 20 CFR parts 718, 725 or 727. Despite the 
inapplicability of the quality standards to certain categories of 
evidence, the adjudicator still must be persuaded that the evidence is 
reliable in order for it to form the basis for a finding of fact on an 
entitlement issue. Additional exclusionary language in the regulation 
is therefore unnecessary.
    (e) One comment contends all medical evidence involving a deceased 
miner should be considered without regard to the quality standards 
because the miner is no longer available for further testing. The 
Department disagrees. The regulations provide that a deceased miner's 
noncomplying chest x-rays, pulmonary function studies and medical 
reports may form the basis of an award or denial of benefits under 
certain circumstances provided no complying study or report is 
available. See Secs. 718.102(e) (x-rays), 718.103(c) (pulmonary 
function studies), 718.104(c) (medical reports). The Department has 
added a similar provision to Sec. 718.105 (arterial blood gas studies). 
With respect to each category of evidence, the availability of tests or 
reports in substantial compliance with the applicable quality standards 
makes reliance on the noncomplying tests or reports unnecessary; the 
record already contains reliable evidence addressing the deceased 
miner's pulmonary condition, and reliable evidence is the fundamental 
purpose of the quality standards. Furthermore, excusing noncompliance 
for all evidence involving a deceased miner ignores the fact that 
existing evidence may be brought into substantial compliance despite 
the unavailability of the miner. The party offering the evidence may 
obtain a supplementary opinion from the physician who conducted the 
noncomplying test or authored the report, and cure the defect(s). 
Finally, the party may submit the noncomplying evidence in any event, 
ecognizing that it may be considered but cannot establish any fact for 
which complying evidence is in the record.
    (f) One comment suggests that applying the quality standards only 
prospectively will sanction the acceptance of inferior evidence if the 
evidence was developed before the effective date of these regulations. 
The commenter also contends the Department's rationale for prospective 
application implies the former quality standards will not apply to 
evidence developed before the effective date of these regulations, 
especially for unrepresented claimants. The Department disagrees. In 
the initial notice of proposed rulemaking, proposed Sec. 718.101(b) 
required all evidence developed in conjunction with a black lung 
benefits claim to comply with the applicable quality standards. 62 FR 
3374 (Jan. 22, 1997). The Department stated that the purpose of 
Sec. 718.101(b) was to make clear the Department's disagreement with 
Benefits Review Board precedent holding the former 20 CFR part 718 
quality standards applied only to evidence developed by the Director. 
62 FR 3341 (January 22, 1997). One comment, in response to the first 
proposal, noted that, as written, Sec. 718.101(b) would invalidate 
evidence in claims pending before the Department which was valid under 
prevailing Board precedent at the time the evidence was generated. The 
Department responded to this concern in the second notice of proposed 
rulemaking by revising Sec. 718.101 to apply the quality standards only 
to evidence developed after the effective date of the regulations. 64 
FR 55010 (Oct. 8, 1999). In explaining the revision, the Department 
acknowledged the ``substantial hardship'' which might occur, especially 
for unrepresented claimants, if medical evidence which complied with 
the law when submitted into evidence became invalid after the 
regulations become effective. This explanation, however, is not a 
concession as to the correctness of the Board's decisions. Since 1980, 
the Department has consistently taken the position that the 20 CFR part 
718 quality standards apply to all evidence

[[Page 79929]]

developed by any party in black lung benefits claim litigation. 
Although the Board has rejected the Department's position, Gorzalka v. 
Big Horn Coal Co., 16 Black Lung Rep. 1-48, 1-51 (1990) (and cases 
collected), the only court of appeals to consider the issue has agreed 
with the Department. Director, OWCP v. Mangifest, 826 F.2d 1318 (3d 
Cir. 1987). The Department adheres to this view with respect to any 
evidence developed in conjunction with a claim by any party before the 
effective date of the proposed regulations.
    (g) Two comments approve of the prospective application of the 
quality standards. One comment approves of the ``substantial 
compliance'' standard.
    (h) No other comments have been received concerning this section, 
and no changes have been made in it.

20 CFR 718.102

    (a) In the initial notice of proposed rulemaking, the Department 
proposed three minor changes to Sec. 718.102: eliminating the reference 
to the compliance standard in light of the substantial compliance 
language of general applicability in Sec. 718.101(b); adding language 
presuming compliance with the technical criteria for chest x-rays in 
Appendix A; and correcting a typographical error in subsection (e) 
which cited to a nonexistent regulation. 62 FR 3342 (Jan. 22, 1997). 
The Department did not propose any additional changes in the second 
notice of proposed rulemaking. 64 FR 54971 (Oct. 8, 1999). In the final 
rule, the Department has changed subsection (e) to clarify the 
probative value of noncomplying x-rays in the case of a deceased miner. 
Specifically, this provision states that an x-ray, which is not in 
substantial compliance with the quality standard, may still establish 
the presence or absence of pneumoconiosis if the x-ray is of sufficient 
quality for a board-eligible radiologist, board-certified radiologist, 
or ``B'' reader to interpret the film. The Department has also added a 
sentence to subsection (b) to inform interested parties where they may 
obtain a copy of the ILO classification.
    (b) One comment argues that Sec. 718.102(b) should state that an x-
ray cannot establish the absence of pneumoconiosis unless it complies 
with the quality standards and is classified according to a recognized 
scheme. The commenter further argues that Sec. 718.102(b) and (e), in 
conjunction with Sec. 718.101(b), are insufficient to impose this 
requirement. Section 718.102(b) identifies the classification systems 
which are acceptable for black lung claims. Subsection (e) states that 
no x-ray may demonstrate either the presence or absence of 
pneumoconiosis unless it complies with reporting requirements, i.e., 
paragraph (b). Section 718.101(b) reinforces this requirement by 
stating that ``any evidence'' which is not in substantial compliance 
with the applicable quality standard cannot ``establish the fact for 
which it is proffered.'' For purposes of the quality standards, 
``substantial compliance'' may mean less than strict compliance with 
each and every requirement of the applicable quality standard if the 
evidence is nevertheless deemed reliable by the factfinder. The 
adjudicator must determine whether the x-ray reading is, or is not, in 
substantial compliance if one or more items of required information 
have been omitted, including classification of x-ray findings according 
to any of the reporting schemes in Sec. 718.102(b). In some 
circumstances, the adjudicator may determine that the x-ray 
interpretation provides sufficient information to make a factual 
finding on the presence or absence of pneumoconiosis. For example, the 
physician may describe the film findings in terms of ``no 
pneumoconiosis,'' rather than classifying the film as ``0/-, 0/0 or 0/
1.'' Such a reading may be considered sufficiently detailed to be in 
``substantial compliance'' notwithstanding the lack of classification. 
Conversely, the physician's description or reporting of x-ray film 
findings may indicate (s)he read the film for reasons unrelated to 
diagnosing the existence of pneumoconiosis, e.g., lung cancer or 
cardiac surgery. The adjudicator may consider that evidence not in 
substantial compliance because it does not reliably address the 
presence or absence of pneumoconiosis. Accordingly, the Department 
disagrees with the commenter's position that any unclassified x-ray is 
not in ``substantial compliance'' with Sec. 718.102.
    (c) Four comments suggest adding the phrase ``in and of itself'' to 
the subsection (e) prohibition on using unclassified x-rays to 
demonstrate the presence or absence of pneumoconiosis. The comments 
contend that the change would make clear that x-ray evidence of some 
disease process, in conjunction with other evidence, could be used to 
prove the miner has a lung disease caused by coal dust exposure, i.e., 
``legal'' pneumoconiosis. The recommended change is unnecessary. An 
unclassified x-ray which yields positive indications of lung disease 
cannot establish the presence of pneumoconiosis under 
Sec. 718.202(a)(1), which is intended as a means of proving only the 
existence of clinical pneumoconiosis. An x-ray report, however, may 
also be part of a medical report which must be considered under 
Sec. 718.202(a)(4). Even an unclassified x-ray may therefore provide 
some clinical basis for a diagnosis of a respiratory disease arising 
out of coal mine employment under that section. Consequently, provision 
is already made for consideration of the results of an unclassified x-
ray in the context of a medical report. In this context, it may be used 
to support a diagnosis of legal pneumoconiosis.
    (d) No other comments were received concerning this section, and no 
other changes have been made in it.

20 CFR 718.103

    (a)(i) The Department proposed amending Sec. 718.103 in the initial 
notice of proposed rulemaking to take into account proposed 
Sec. 718.101(b), which would establish a single standard of 
``substantial compliance'' for all of the quality standards. 62 FR 3342 
(Jan. 22, 1997). The Department also proposed changes to 
Sec. 718.103(c) to harmonize it with Sec. 718.102(e) (X-rays). Both 
provisions operate in the same manner and for the same purposes: to 
presume compliance with technical requirements in the applicable 
appendices to part 718; to permit rebuttal of the presumed compliance 
with relevant evidence; and to permit exceptions to the quality 
standards for a deceased miner if the claim presents limited evidence. 
(ii) In response to comments received concerning the initial notice of 
proposed rulemaking, the Department recommended several additional 
changes to Sec. 718.103 in the second notice of proposed rulemaking. 64 
FR 54975-76 (Oct. 8, 1999). One physician testified at the Washington, 
D.C., hearing that a flow-volume loop provided a more acceptable basis 
for obtaining verifiable test results than the proposed prohibition on 
an initial inspiration from room air. The Department agreed, and 
proposed changing both Sec. 718.103 and Appendix B to require flow-
volume loops for every pulmonary function test obtained after the 
effective date of the final regulation. The Department invited 
additional comment on this proposal. The Department also announced its 
intention to survey clinics and facilities which specialize in the 
treatment of pulmonary conditions to ascertain the extent to which they 
already used spirometers capable of producing flow-volume loops. The 
same physician observed that 20 CFR 718.103(a) (1999) required that 
pulmonary function

[[Page 79930]]

testing produce either a Forced Vital Capacity (FVC) or a Maximum 
Voluntary Ventilation (MVV) result, yet also required a one-second 
Forced Expiratory Volume (FEV1) which must be derived from the FVC. The 
Department agreed the regulation was inconsistent, and proposed a 
revision to Sec. 718.103(a) making the FVC a required result along with 
the FEV1 and the MVV optional. The Department also proposed increasing 
the allowable difference between the two largest MVV values from 5 
percent to 10 percent in Sec. 718.103(b) to harmonize the regulation 
with Appendix B. The former and initially proposed Sec. 718.103(b) 
required submission of three tracings of the MVV maneuver unless the 
two largest MVV results were within 5 percent of each other, in which 
case only two tracings were necessary. By contrast, Appendix B has 
consistently stated that the variation between the two largest MVV 
shall not exceed 10 percent. The Department chose the more liberal 
variation. The Department agreed that the validity of the MVV and FEVl/
FVC values must be assessed independently, and that the MVV maneuver is 
optional for compliance purposes. The Department, however, rejected the 
suggestion to remove certain technical requirements from the quality 
standards to avoid invalidating a pulmonary function test for less than 
strict compliance; the Department responded that the ``substantial 
compliance'' standard would allow a party to establish the credibility 
of the study, notwithstanding the absence of one or more of the 
Sec. 718.103 requirements. Finally, the Department proposed revisions 
to Secs. 718.104(a)(6) and 718.204(b)(2)(iv) to recognize that a 
medical report cannot be rejected for lack of a pulmonary function 
study if the performance of the test was medically contraindicated. 
(iii) For the final rule, the Department has changed the word 
``submitted'' in Sec. 718.103(b) to ``developed'' to conform the 
regulation to similar usage in Sec. 718.101(b). The Department also 
changed the opening phrase of the first sentence in Sec. 718.103(c) to 
clarify that paragraph (c) is an exception to the remainder of 
Sec. 718.103. Finally, the Department amended the final sentence in 
subsection (c) to make clear that a noncomplying pulmonary function 
test involving a deceased miner may be used to establish the presence 
or absence of a respiratory or pulmonary impairment under limited 
circumstances. If no complying test is in the record and, in the 
adjudicator's opinion, the noncomplying test yielded technically valid 
results and the miner provided good cooperation, the party submitting 
the noncomplying test may rely on it.
    (b) The Department announced its intention in the second notice of 
proposed rulemaking to conduct a survey of the physicians, clinics and 
facilities which perform pulmonary function testing (spirometry 
testing) to evaluate the prevalence of spirometers capable of producing 
a flow-volume loop. The Department considered the survey necessary in 
light of its conclusion that the flow-volume loop may provide a ``more 
reliable method of ensuring valid, verifiable results in pulmonary 
function testing.'' 64 FR 54975 (Oct. 8, 1999). The Department also 
cited the relatively inexpensive cost (approximately $2000) for a 
spirometer capable of producing the flow-volume loop. The Department 
sent out the survey, dated March 7, 2000, to approximately 1800 
pulmonary clinics, facilities and physicians board-certified in 
internal medicine with a subspecialty in pulmonary disease (Rulemaking 
Record Ex. 107), and received 225 responses (Rulemaking Record Ex. 
109). Of those responses, only nine indicated they did not perform 
pulmonary function testing on equipment producing a flow-volume loop. 
Of those nine, five indicated they would consider obtaining the 
necessary equipment. An additional 19 surveys did not respond to the 
questions concerning spirometric testing. The remaining respondents, 
197 in all, unanimously used the flow-volume loop. Based on these 
survey results, the Department concludes the benefit to the claims 
adjudication process in obtaining reliable pulmonary function data 
warrants revising Sec. 718.103(a) and Appendix B to make the flow-
volume loop a mandatory requirement for any pulmonary function test 
conducted after the effective date of these regulations in connection 
with a claim for benefits under the Black Lung Benefits Act (BLBA).
    (c) One comment opposes the flow-volume loop requirement because 
spirometric equipment which records this data may not be universally 
available. The Department disagrees. In the second notice of proposed 
rulemaking, the Department proposed using the flow-volume loop because 
it provides a reliable and relatively inexpensive means of producing 
valid, verifiable pulmonary function test results. 64 FR 54975 (Oct. 8, 
1999). The Department's survey of physicians, clinics and facilities 
which perform pulmonary function testing confirmed the widespread use 
of spirometers capable of producing flow-volume loops. Although some 
clinics and individual physicians may not utilize such machines, the 
Department has concluded that the overall benefit to the claims 
adjudication process warrants required use of this technology. In any 
event, the claimant should always have access to one set of testing 
which complies with the quality standards, including the flow-volume 
loop requirement, as a result of the pulmonary examination authorized 
by 30 U.S.C. 923(b). This provision of the BLBA requires the Black Lung 
Disability Trust Fund to afford each miner-claimant the opportunity to 
substantiate his or her claim by means of a complete pulmonary 
examination at no expense to the claimant. See also Sec. 725.406(a). 
Under Sec. 725.406(c), the district director is responsible for 
ensuring that the examination authorized by 30 U.S.C. 923(b) is in 
``substantial compliance'' with the requirements of part 718, including 
the quality standards. Section 725.406(d) requires the Department to 
make available to the claimant's physician, on the claimant's request, 
the clinical test results obtained in conjunction with the pulmonary 
examination. Thus, contrary to the commenter's concern, the claimant's 
physician should routinely be able to consider substantially complying 
clinical testing of the miner in formulating an opinion, despite the 
lack of capable technology in his or her own practice.
    (d) One comment approves of the Sec. 718.103 revisions generally, 
and particularly approves of the language making clear that the Maximum 
Voluntary Ventilation maneuver is optional. One comment supports the 
use of flow-volume loops and changes to Sec. 718.103(a) which eliminate 
internal inconsistencies and clarify that the Maximum Voluntary 
Ventilation maneuver is optional. One comment approves of requiring 
pulmonary function test results using flow-volume loops and the 
increase from 5 percent to 10 percent in the maximum variation between 
the two largest MVV values.
    (e) No other comments were received concerning this section, and no 
other changes have been made in it.

20 CFR 718.104

    (a)(i) The Department proposed several changes to Sec. 718.104 in 
the initial notice of proposed rulemaking. 62 FR 3342-43, 3375 (Jan. 
22, 1997). One change required that each medical opinion developed in 
connection with a claim be based on specified tests and information, 
including a chest x-ray and pulmonary function study which comply with 
the applicable quality standards. Another change proposed

[[Page 79931]]

guidelines for the adjudicator to determine whether to afford special 
weight to an opinion from the miner's treating physician. The 
Department considered codification of the treating physician's special 
status appropriate, given its longstanding judicial recognition in the 
caselaw. In order to ensure a critical analysis of the physician-
patient relationship, the guidelines described four basic factors the 
adjudicator must consider: whether the physician provided pulmonary or 
non-pulmonary treatment; how long the physician treated the miner; how 
often the physician treated the miner; and what types of tests and 
examinations the physician conducted. Finally, the Department 
emphasized that the adjudicator must consider not only the quality of 
the physician's relationship with the miner, but also the reasoning and 
documentation in the opinion itself, and in the context of the 
remainder of the record, before crediting that opinion. (ii) In the 
second notice of proposed rulemaking, the Department responded to the 
extensive comments which the proposed regulation had elicited. 64 FR 
54976-77 (Oct. 8, 1999). The Department revised the regulation to 
excuse mandatory pulmonary function testing if it was medically 
contraindicated and the physician conducted other types of medically 
accepted diagnostic tests; to make explicit that a treating physician's 
opinion could be used to establish all elements of a miner's 
entitlement; and to accept the physician's statement as to subsection 
(d)'s treating relationship criteria, absent contrary evidence from 
another party. The Department rejected comments which advocated the 
automatic acceptance of a treating physician's opinion if it satisfied 
the criteria of subsections (d)(1) through (5) and was documented and 
reasoned, regardless of the remaining medical evidence. The Department 
also rejected one comment which contended the regulation already 
mandated the automatic acceptance of a treating physician's opinion in 
violation of 30 U.S.C. 923(b) (requiring consideration of all relevant 
evidence). In response, the Department emphasized that Sec. 718.104(d) 
only required the adjudicator to consider the possible enhanced value 
of a treating physician's opinion, and did not require a mechanistic 
acceptance of that opinion. The Department responded in similar fashion 
to several comments which contended that all medical opinions, 
including a treating physician's opinion, should be evaluated only on 
the strength of their documentation and reasoning and each physician's 
professional qualifications. With respect to a comment recommending 
placement of the treating physician rule in a separate regulation, the 
Department concluded no change was warranted; subsection (d)'s position 
in the quality standards governing reports of physician examinations 
underscored that a treating physician's opinion was required to satisfy 
the same quality standards as any other physician examination report 
developed in connection with a claim for benefits. The Department 
acknowledged some commenters' concern that unrepresented claimants 
would likely submit noncomplying reports from their treating 
physicians. The Department, however, rejected the suggestion that 
treating physicians' opinions should be exempted from the evidentiary 
limitations for that reason. Instead, the Department noted its own 
obligation to inform claimants in an understandable manner about the 
evidentiary limitations, and to provide any claimant's treating 
physician with the results of the Sec. 725.406 objective testing upon 
the claimant's request. The Department denied one comment's suggestion 
that language in the initial notice of proposed rulemaking (see 62 FR 
3339 (Jan. 22, 1997)) made an adjudicator's failure to consider a 
physician's training and specialization reversible error. In the 
Department's view, a physician's qualifications were an issue only when 
raised by a party. The Department also rejected the suggestion that a 
chest x-ray, administered and read in accordance with Sec. 718.102, not 
be mandatory documentation for a complying report of physical 
examination. The Department cited the importance of such a diagnostic 
test and the flexibility of the ``substantial compliance'' standard in 
excusing noncompliance depending on the particular circumstances of the 
case. In response to two comments, the Department declined to remove a 
limitation on the use of noncomplying medical opinions. The regulation 
therefore allowed consideration of reports of physical examination not 
in substantial compliance with Sec. 718.104 only if the miner was 
deceased, the physician was unavailable to cure the defects in the 
report, and there was no complying report in the record. In 
explanation, the Department emphasized that entitlement decisions must 
be based on the best available evidence. Finally, the Department 
invited additional public comment on alternative means of determining 
when a treating physician's opinion should receive ``controlling 
weight,'' including whether the Department should adopt the Social 
Security Administration's rule. (iii) For purposes of the final rule, 
the Department has altered subsection (c) to conform this provision to 
the general ``substantial compliance'' standard in Sec. 718.101(b). As 
amended, Sec. 718.104(c) makes clear that a noncomplying report of 
physical examination may nevertheless provide evidence for a factual 
finding in certain limited circumstances involving a deceased miner and 
the lack of any complying report of physical examination in the record. 
The report must have been prepared by a physician who is 
``unavailable,'' e.g., deceased, whose whereabouts are unknown, etc. 
The report must also be found to possess sufficient indicia of 
reliability that the adjudicator may reasonably rely on it for factual 
findings.
    (b) Several comments oppose granting special weight to the opinion 
of a miner's treating physician, contending the rule either intrudes on 
the adjudicator's role in evaluating evidence or compels the acceptance 
of an opinion from the treating physician regardless of contrary 
opinions from physicians with greater expertise in pulmonary medicine. 
The Department responded to a similar criticism in the second notice of 
proposed rulemaking. 64 FR 54976 (Oct. 8, 1999). In rejecting a 
commenter's view that Sec. 718.104(d) effectively precluded 
consideration of all relevant evidence in favor of the opinion of the 
miner's treating physician, the Department emphasized the real purpose 
of the rule: to recognize that a physician's professional relationship 
with the miner may enhance his or her insight into the miner's 
pulmonary condition. The Department does not believe that, as proposed, 
section 718.104(d) contained an outcome-determinative evidentiary rule. 
See 64 FR 54977 (Oct. 8, 1999). The Department has revised the language 
of section 718.104(d), however, in light of several commenters' 
continued confusion as to the role of Sec. 718.104(d) in weighing 
reports of physical examinations. The Department hopes to clarify its 
original intent with this revision. Like the previously proposed 
version, subsection (d) acknowledges the special weight which the 
opinion of a miner's treating physician may receive from the 
adjudicator. Section 718.104(d)(1)-(4) provide criteria for evaluating 
the quality of that doctor-patient relationship as indicia of the 
potential insight the physician may have gained from on-going treatment 
of the miner.

[[Page 79932]]

Instead of compelling the automatic acceptance of the treating 
physician's opinion, section 718.104(d) is designed to force a careful 
and thorough assessment of the treatment relationship. The adjudicator 
may conclude that no additional weight is due the physician's opinion 
because one or more of the criteria establish facts which make such 
weight inappropriate. For example, the physician may have provided only 
a short-term course of treatment, or have actually examined the miner 
only infrequently. The adjudicator should consider giving additional 
weight to the treating physician's opinion only when review of the 
regulatory criteria establishes the physician's thorough understanding 
of the miner's pulmonary condition. Subsection (d)(5) describes the 
next step in the adjudicator's inquiry: the adjudicator must consider 
whether the treating physician's opinion is supported by sufficient 
documentation and reasoning, and must weigh it with all other reasoned 
and documented medical opinions in the record. In addition, the fact 
finder must consider all other relevant evidence of record. The 
regulation provides that only after the adjudicator finishes this 
weighing may he, in appropriate cases, base his decision to give 
``controlling weight'' to the opinion of the miner's treating physician 
on that physician's superior understanding of the miner's pulmonary 
condition. The Department recognizes that each case will present 
different issues regarding both the extent to which the treating 
physician meets the four criteria in subsection (d)(1)-(4), the 
documentation and reasoning of that physician's opinion, and the 
relative merits of the other relevant medical evidence of record. As a 
result, the regulation does not attempt to dictate the outcome of any 
particular case. The Department therefore rejects the position that 
Sec. 718.104(d) intrudes on the fact-finding responsibilities of the 
adjudicator.
    (c) One comment opposes requiring each physician's opinion to 
include an x-ray or pulmonary function study conducted according to the 
applicable quality standards. The commenter suggests these tests are 
not always necessary for a relevant and credible opinion, and cites 
three examples: (i) A physician diagnoses an obstructive lung 
impairment based on valid pulmonary function testing, examination, 
etc., but does not obtain an x-ray. With respect to the mandatory x-ray 
requirement, the Department has previously addressed this argument in 
the second notice of proposed rulemaking, 64 FR 54977 (Oct. 8, 1999), 
and reiterates its position in responding to comments under 
Sec. 718.101 of this rule. X-rays are an integral part of any informed 
and complete pulmonary evaluation of a miner; a general requirement for 
inclusion of this test is therefore appropriate. The Department also 
notes, however, that the quality standards require only ``substantial 
compliance'' with the various criteria, not technical compliance with 
every criterion in every quality standard in every case. A factfinder 
may conclude the omission of an x-ray does not undermine the overall 
credibility of the opinion, but this determination must be made on a 
case-by-case basis. The same commenter poses this example in the 
context of Sec. 718.101. The Department's response to that hypothetical 
makes certain critical assumptions in concluding the physician's 
opinion may be found in ``substantial compliance'' with the quality 
standards: the valid pulmonary function study demonstrates the presence 
of a pulmonary/respiratory impairment; the physician's examination of 
the miner identifies signs or symptoms of a pulmonary condition; and 
the physician has an accurate understanding of the miner's employment, 
smoking and personal histories. If the clinical tests and other 
information provide a documented basis for a reasoned and reliable 
opinion, the factfinder may find the diagnosis of ``legal 
pneumoconiosis'' in ``substantial compliance'' with Sec. 718.104 
despite the absence of the x-ray. (ii) A physician finds complicated 
pneumoconiosis on an x-ray, but does not conduct a pulmonary function 
test. One means of diagnosing complicated pneumoconiosis is by x-ray. 
30 U.S.C. 921(c)(3)(A). The x-ray evidence is relevant to 
Secs. 718.202(a)(3) and 718.304(a); accordingly, Sec. 718.102 provides 
the applicable quality standards, and not Sec. 718.104. The lack of a 
pulmonary function study does not affect the probative value of the x-
ray reading(s) as evidence of complicated pneumoconiosis under 30 
U.S.C. 921(c)(3)(A), because a pulmonary function study is not relevant 
to that means of invoking the irrebuttable presumption. Although all 
relevant evidence must be weighed in determining whether the miner has 
complicated pneumoconiosis, Melnick v. Consolidation Coal Co., 16 Black 
Lung Rep. 1-31, 1-33 (1991), the evidence must pertain to the means of 
diagnosing or refuting the existence of complicated pneumoconiosis as 
provided by 30 U.S.C. 921(c)(3)(B) and (C). Cf. Double B Mining v. 
Blankenship, 177 F.3d 240, 243 (4th Cir. 1999) (holding factfinder must 
determine whether evidence relevant to each method of invoking 
irrebuttable presumption is ``equivalent,'' and establishes same 
underlying condition). The physician's report may provide additional 
valuable insight into his or her reasons for interpreting the x-ray as 
positive for complicated pneumoconiosis rather than some other 
condition detectable by x-ray; to that extent, the report may be 
relevant to weighing the credibility of the x-ray evidence. As a report 
of physical examination, however, the hypothetical report does not 
satisfy the ``substantial compliance'' standard. (iii) In his report of 
physical examination, a physician relies in part on a noncomplying 
pulmonary function test, but another complying test yields comparable 
results. Again, ``substantial compliance'' is a test of evidentiary 
reliability based on all relevant circumstances of the particular case. 
The factfinder must evaluate those circumstances and determine whether 
the specific omission undermines the credibility of the evidence. In 
the hypothetical, the factfinder must consider not only the defects in 
the physician's pulmonary function study, but also the remaining 
documentation in the report (other clinical studies, the miner's 
employment, smoking and personal information, etc.). If the report 
otherwise complies with Sec. 718.104, the invalid pulmonary function 
study may be mitigated by the presence of a complying study which 
confirms the physician's interpretation of the invalid study.
    (d) One comment supports the revision of Sec. 718.104(a)(6) in the 
second notice of proposed rulemaking, which exempts a miner from 
mandatory pulmonary function testing if the test is medically 
contraindicated, and allows a physician preparing a report of physical 
examination to substitute other medically acceptable clinical and 
laboratory diagnostic techniques in support of his conclusions. 64 FR 
54976, 55011 (Oct. 8, 1999).
    (e) One comment recommends the Department delete the conditions in 
Sec. 718.104(c) that, in the case of a deceased miner, limit the 
consideration of a report from a physician who is not available if the 
report is not in substantial compliance with the quality standards. 
This provision permits the adjudicator to base a finding on such 
evidence only if the record does not contain any physician's report 
which is in substantial compliance. No change in the regulation is 
necessary. Although ``substantial compliance'' is a flexible

[[Page 79933]]

concept, it is also necessary to ensure that claims are adjudicated 
using the most reliable evidence available. Consequently, the 
Department has incorporated limitations throughout the quality 
standards on the use of noncomplying evidence in claims involving 
deceased miners in which there is no complying evidence of record. The 
fact that a miner is deceased is not necessarily a bar to 
rehabilitating noncomplying evidence. With respect to reports of 
physical examination, the physician who is available to review and 
further comment on his or her own report may cure the defect and bring 
the report into substantial compliance. If, however, the physician is 
unavailable, Sec. 718.104(c) permits noncomplying evidence to be 
considered if there is no complying evidence of record. The Department 
believes noncomplying evidence should be used to establish facts about 
a deceased miner's condition only when no practical alternative is 
available. As long as complying evidence or the means of achieving 
compliance exist, noncomplying evidence should not be the basis for 
determining the validity of a claim.
    (f) One comment objects to the retroactive application of the 
changes made to Sec. 718.104. None of these changes, however, apply 
retroactively. Section 718.101(b) provides that the ``standards for the 
administration of clinical tests and examinations'' will govern all 
evidence developed in connection with benefits claims after the 
effective date of the final rule. Section 718.104 contains the quality 
standards for any ``[r]eport of physical examinations,'' including 
reports prepared by a miner's treating physician. Physicians' medical 
reports are expressly included in the terms of Sec. 718.101(b). 
Consequently, the changes to Sec. 718.104 apply only to evidence 
developed after the effective date of the final rule. With respect to 
treating physicians' opinions developed and submitted before the 
effective date of the final rule, the judicial precedent summarized in 
the Department's initial notice of proposed rulemaking continues to 
apply. See 62 FR 3342 (Jan. 22, 1997). These decisions recognize that 
special weight may be afforded the opinion of a miner's treating 
physician based on the physician's opportunity to observe the miner 
over a period of time.
    (g) Two comments state the ``treating physician'' rule has no 
scientific basis because a treating physician is in no better position 
than any other physician to assess a miner's pulmonary status. The 
commenters note that a primary care physician will often, as a matter 
of medical practice, refer an individual to a physician with particular 
training for specialized care; the primary care provider may therefore 
have little, if any, qualified understanding of the patient's health 
problems. The commenters also state that the essential basis for a 
reasoned diagnosis is valid objective testing and sound interpretation 
of the data rather than patient complaints and physical examinations. 
Finally, the commenters conclude that frequency of contact alone does 
not provide any advantage for a physician in developing a comprehensive 
understanding of the patient's condition. The commenters' concerns do 
not provide a basis for abandoning the rule. First, the miner's 
``treating physician'' is not necessarily the physician with whom the 
miner has a long-standing generalized relationship if another physician 
actually provides specialized treatment for respiratory or pulmonary 
problems. If the miner's primary care provider refers the miner to a 
pulmonary specialist for treatment, then that specialist may be 
considered the miner's ``treating physician'' for purposes of his or 
her pulmonary condition. If, however, the specialist provides an 
opinion to the primary care physician which forms the basis for the 
miner's treatment by the latter, the primary care physician's opinion 
is strengthened by reliance on the specialist's expertise. Second, the 
Department agrees that valid clinical testing and a reasoned medical 
report are necessary prerequisites for a credible medical opinion. A 
treating physician's opinion is subject to the Department's quality 
standards, which require the report to be based on specific clinical 
tests, findings and other data and information. See Sec. 718.104(a)(l)-
(6). A treating physician's report must be reasoned as well as 
documented (Sec. 718.104(d)(5)). In this regard, a treating physician's 
opinion is no different than any other physician's opinion developed in 
connection with a claim for benefits. The Department does not intend to 
displace the long-standing judicial precedent that sanctions the 
rejection of a treating physician's report if it fails the basic 
requirements for credible evidence. See, e.g., Sterling Smokeless Coal 
Co. v. Akers, 131 F.3d 43 8, 441 (4th Cir. 1997); Lango v. Director, 
OWCP, 104 F.3d 573, 577 (3d Cir. 1997); Peabody Coal Co. v. Helms, 901 
F.2d 571, 573-74 (7th Cir. 1990); see generally Halsey v. Richardson, 
441 F.2d 1230, 1236 (6th Cir. 1971) (rejecting ``a mechanical rule 
insulating a treating doctor's opinion from attack, no matter how 
respectable and persuasive may be opposing opinions by doctors who 
examined a claimant on only one occasion''). As for the commenters' 
statement that the frequency of patient contact provides no advantage 
to a physician, this view is too simplistic. Frequency of treatment is 
only one of the regulatory criteria (Sec. 718.104(d)(3)) the 
adjudicator must consider in assessing the treating physician 
relationship. The number of visits must be viewed in the context of the 
other criteria (nature of relationship, duration of relationship, type 
and extent of treatment). The totality of the information demanded by 
the criteria establishes the overall quality of the doctor-patient 
relationship, which guides the adjudicator in determining whether to 
accord the treating physician's opinion controlling weight. The 
comments do not state a basis for changing or eliminating the 
``treating physician'' rule.
    (h) Two comments contend the ``treating physician'' rule creates an 
``evidentiary preference'' which violates section 7 of the 
Administrative Procedure Act (APA), 5 U.S.C. 556. Although the Social 
Security Administration (SSA) has also promulgated a regulation, 20 CFR 
404.1527(d) (1999), addressing the weight to be given a treating 
physician's opinion, the commenters argue there is no adverse party in 
SSA claims, and the APA does not apply to SSA claims adjudication. By 
implication, the commenters suggest the Department cannot adopt a 
``treating physician'' rule comparable to the SSA model, or any rule 
which affords special weight to a treating physician's opinion. The 
Department disagrees. As an initial matter, whether the APA does or 
does not apply to SSA claims adjudications is irrelevant to evaluating 
the validity of Sec. 718.104(d). The Supreme Court has expressly 
refused to resolve the issue because ``the social security 
administrative procedure does not vary from that prescribed by the APA. 
Indeed, the latter is modeled upon the Social Security Act.'' 
Richardson v. Perales, 402 U.S. 389, 409 (1971). In any event, the 
commenters misapprehend both the nature of Sec. 718.104(d) and the 
critical differences between that regulation and the SSA version. The 
commenters describe the ``treating physician'' rule as an ``evidentiary 
preference.'' The Department interprets this phrase to characterize the 
rule as a burden-shifting presumption which imposes on the party 
opposing the claim the burden to overcome the ``preference'' for the 
treating physician's opinion. The Department, however, has repeatedly 
emphasized in the second

[[Page 79934]]

notice of proposed rulemaking and its responses to comments in this 
rule that Sec. 718.104(d) does not create a presumption in favor of the 
treating physician's opinion. See 64 FR 54976-77 (Oct. 8, 1999). The 
regulation provides a set of criteria to guide the adjudicator's 
evaluation of the treating physician's professional relationship with 
the miner, and ensure a critical and thorough factual determination 
whether that opinion should ultimately be given ``controlling weight.'' 
Aside from assessing the strength or weakness of the treating 
physician's report, the adjudicator must also weigh that report against 
all other relevant evidence in the record. Consequently, 
Sec. 718.104(d) is not a strict, outcome-determinative rule like more 
traditional evidentiary presumptions. These characteristics also 
distinguish Sec. 718.104(d) from SSA's version in 20 CFR 404.1527(d). 
Both regulations state that ``controlling weight'' may be given to a 
treating physician's report. Section 404.1527(d), however, provides 
that ``[g]enerally, we give more weight to opinions from your treating 
sources, * * *.'' 20 CFR 404.1527(d)(2) (1999). This language 
demonstrates an affirmative preference for reports from treating 
physicians; Sec. 718.104(d) is more qualified in permitting 
``controlling weight'' only if the regulatory criteria warrant it. 
Another significant difference between the regulations is the role the 
criteria play in determining the weight given the medical evidence. 
Section 404.1527(d) makes the criteria relevant only after the 
adjudicator refuses to give the treating physician ``controlling 
weight:'' ``Unless we give a treating source's opinion controlling 
weight * * * we consider all of the following factors in deciding the 
weight we give to any medical opinion.'' The regulation lists several 
criteria which are similar to those listed in Sec. 718.104(d)(l)-(4). 
Section 718.104(d) makes the same criteria the basis for determining in 
the first place whether to give the treating physician controlling 
weight. To the extent 20 CFR 404.1527(d) operates like an evidentiary 
presumption, it does not affect the validity of Sec. 718.104(d) because 
Sec. 718.104(d) clearly is not a presumption in favor of the treating 
physician's opinions. Accordingly, the Department rejects the 
commenters' position that the rule violates the APA.
    (i) Three comments oppose the requirement in Sec. 718.104(d)(5) 
that the adjudicator must weigh a treating physician's opinion against 
the contrary relevant evidence in the record. One comment states that 
affording a treating physician's opinion ``controlling weight'' is 
meaningless unless the adjudicator may accept the opinion despite a 
reasoned and documented contrary opinion by a pulmonary specialist 
submitted by another party; otherwise, according to the commenter, a 
treating physician's opinion will prevail only when it echoes similar 
opinions from other physicians. Another comment interprets subsection 
(d) as a burden-shifting device which affords the treating physician's 
opinion presumptive controlling weight unless the opposing party 
overcomes that opinion by a preponderance of the evidence. The 
Department has previously responded to comments contending that a 
treating physician's opinion should receive conclusive weight once the 
adjudicator reviews the opinion in light of the criteria enumerated in 
subsection (d)(1)-(4). 64 FR 54976 (Oct. 8, 1999). The Department 
rejected this position because it artificially limits the adjudicator's 
consideration of the evidence, and may promote a mechanistic and 
uncritical acceptance of the treating physician's opinion at the 
expense of more credible contrary evidence. No basis for departing from 
this position is established by the new comments. The Department 
emphasizes that the ``treating physician'' rule guides the adjudicator 
in determining whether the physician's doctor-patient relationship 
warrants special consideration of the doctor's conclusions. The rule 
does not require the adjudicator to defer to those conclusions 
regardless of the other evidence in the record. The adjudicator must 
have the latitude to determine which, among the conflicting opinions, 
presents the most comprehensive and credible assessment of the miner's 
pulmonary health. For the same reasons, the Department does not 
consider subsection (d) to be an evidentiary presumption which shifts 
the burden of production or persuasion to the party opposing 
entitlement upon the submission of an opinion from a miner's treating 
physician. Accordingly, the Department declines to eliminate the 
requirement in subsection (d)(5) that a treating physician's opinion 
must be considered in light of all relevant evidence in the record.
    (j) One comment objects to comparing a treating physician's 
qualifications to those of any other physician in the record. The 
commenter suggests comparative qualifications may provide a basis for 
refusing controlling weight to the treating physician's opinion if 
another physician has superior credentials. The Department responded to 
a similar comment in the second notice of proposed rulemaking, and 
noted that professional credentials are only one factor the adjudicator 
may consider in weighing medical opinions. 64 FR 54977 (Oct. 8, 1999). 
No basis exists, however, for insulating the treating physician from a 
consideration of his or her qualifications, or prohibiting giving 
additional weight to the opinion of a physician with specialized 
training in a relevant area of medicine. Although expertise is only one 
of several potentially relevant factors to consider, it is nonetheless 
a significant consideration. See, e.g., Milburn Colliery Co. v. Hicks, 
138 F.3d 524, 536 (4th Cir. 1998). Furthermore, the commenter's concern 
over comparative qualifications overlooks an important consideration 
underlying the ``treating physician'' rule. In black lung benefits 
claims, the principal issue ordinarily is the miner's pulmonary 
condition. The treating physician may develop a more in-depth knowledge 
and understanding of that issue than a physician with greater academic 
credentials and minimal, or nonexistent, contact with the miner. The 
purpose of the Sec. 718.104(d) criteria is to enable the adjudicator to 
determine whether the treating physician has such informed knowledge 
that his or her opinion merits special weight.
    (k) One comment suggests a consultative physician's opinion should 
receive the same weight accorded a treating physician if the consultant 
relies on the treating physician's report, the results of clinical 
tests, medical records, etc., and the consulting report satisfies the 
Sec. 718.104(d) criteria. The Department rejects this suggestion. If 
any physician (other than the treating physician) could receive 
enhanced weight by incorporating consideration of the treating 
physician's opinion into his or her consulting opinion, the 
consultative physician(s) for each party would stand on equal footing 
based on access to the treating physician's report. No reason would 
therefore exist for the rule. In any event, a consultative physician's 
reliance on the treating physician's report does not necessarily confer 
the same benefit the treating physician may derive from the nature, 
duration, frequency and extent of treatment during the physician-
patient relationship with the miner.
    (l) Two comments oppose making the quality standards applicable to 
the report of physical examination prepared by a miner's treating 
physician. The commenters suggest removing subsection (d) from 
Sec. 718.104 and making it a separate regulation. The Department 
rejected the identical

[[Page 79935]]

argument in the second notice of proposed rulemaking. 64 FR 54976-77 
(Oct. 8, 1999). The Department intends the quality standards to apply 
to any physician's report developed in connection with a claim for 
benefits, including any report prepared by a treating physician. 
Although a treating physician may have a superior perspective on the 
miner's health in certain circumstances, status alone does not 
guarantee the validity of the physician's opinion.
    (m) Two comments recommend allowing a miner or a miner's family 
members to attest to the nature of the miner's relationship with his or 
her treating physician. The Department disagrees. Although persons 
other than the physician may have some direct knowledge of the miner's 
treatment, only the physician can provide a complete picture of the 
doctor-patient relationship, as well as documentary evidence of the 
specific clinical tests conducted. In addition, if representations as 
to the criteria in (d)(1) through (4) are challenged, it is the 
physician's records, including treatment notes, etc., which will enable 
the adjudicator to evaluate the quality of the relationship. Evidence 
from persons other than the physician may supplement the physician's 
characterization of the miner's treatment, but the physician (or the 
physician's records) remains the best primary source for depicting the 
miner's treatment.
    (n) In the second notice of proposed rulemaking, the Department 
invited comment on alternatives to the revised ``treating physician'' 
rule, including whether to adopt a version of the rule comparable to 
the Social Security Administration's (SSA) regulation, 20 CFR 
404.1527(d) (1999). 64 FR 54976 (Oct. 8, 1999). (i) Two comments oppose 
in general terms using the SSA regulation to evaluate the treating 
physician's opinion. (ii) One comment recommends incorporating language 
from the SSA regulation that more weight should ``generally'' be given 
a miner's treating physician. See 20 CFR 404.1527(d)(2) (1999). The 
commenter opposes any other use of the SSA regulation. The additional 
language is inappropriate. See paragraph (h), above. Section 718.104(d) 
outlines the circumstances in which a treating physician may be 
afforded ``controlling weight'' on entitlement issues. Although the 
regulation recognizes the special value which may attach to a treating 
physician's report in certain circumstances, the Department does not 
intend to deflect attention from the necessity for critical examination 
of the physician's reasoning and documentation. The Department has 
previously explained the intended limits of section 718.104(d) as an 
evidentiary rule which guides consideration of a treating physician's 
opinion but does not impose a strict outcome. 64 FR 54977 (Oct. 8, 
1999). The recommended additional language does not further this 
purpose. Accordingly, the recommendation is rejected. (iii) No comment 
recommended adopting the SSA regulation in place of the regulation as 
proposed by the Department.
    (o) Several comments approve generally of the ``treating 
physician'' rule.
    (p) No other comments were received concerning this section, and no 
other changes have been made in it.

20 CFR 718.105

    (a)(i) In the initial notice of proposed rulemaking, the Department 
proposed amending Sec. 718.105 to address arterial blood gas studies 
which are administered during a miner's terminal hospitalization, i.e., 
``deathbed'' studies. 62 FR 3342-43 (Jan. 22, 1997). Specifically, the 
Department expressed concern that such studies may produce qualifying 
values for reasons unrelated to chronic pulmonary disease. The 
Department therefore suggested a new requirement that a claimant must 
submit a physician's report linking the blood gas study results to a 
chronic pulmonary condition caused by exposure to coal mine dust in 
order to rely on the qualifying results as evidence of total 
disability. 62 FR 3375 (Jan. 22, 1997). (ii) In response to comments 
received, the Department deleted the requirement that, in the case of 
blood gas studies administered during a hospitalization that ends in 
the miner's death, the chronic pulmonary condition must be shown to be 
related to the miner's exposure to coal mine dust; the Department 
agreed the causation requirement was inappropriate because Sec. 718.105 
addresses the existence of a chronic pulmonary impairment, and not its 
source. 64 FR 54977-78 (Oct. 8, 1999). The Department also agreed to a 
minor change in technical nomenclature by changing ``p'' to ``P'' to 
denote partial pressure. Finally, the Department rejected those 
comments which opposed requiring the claimant to establish a link 
between a miner's ``deathbed'' blood gas study and a chronic pulmonary 
condition. The Department concluded the proposed requirement was 
necessary because the miner's qualifying test results during a terminal 
hospitalization may be related to an acute non-pulmonary condition 
rather than a chronic pulmonary impairment. 64 FR 54977 (Oct. 8, 1999).
    (b) One comment recommends the Department afford consideration to 
noncomplying blood gas studies in the case of a deceased miner since 
such consideration is given elsewhere in the regulations for x-rays 
(Sec. 718.102(e)) and pulmonary function studies (Sec. 718.103(c)). The 
regulations also outline specific circumstances under which a report of 
physical examination of a miner now deceased may be considered by an 
adjudication officer notwithstanding its failure to substantially 
comply with Sec. 718.104(a) and (b). See Sec. 718.104(c), above. The 
Department agrees, and has revised Sec. 718.105 accordingly by adding 
subsection (e). This provision is comparable to Sec. 718.103(c), and 
permits the adjudicator to consider a deceased miner's blood gas 
studies not in substantial compliance with subsections (a), (b) and (c) 
if they are the only available tests and, in the adjudicator's opinion, 
are technically valid. Subsection (e) also requires any such test to 
meet the requirements of subsection (d) if the test was obtained during 
a miner's hospitalization ending in death and yielded qualifying 
values. The claimant must submit a physician's opinion establishing 
that the qualifying values reflect a chronic pulmonary impairment and 
not some acute condition unrelated to a chronic pulmonary impairment.
    (c) Two comments oppose requiring the claimant to prove a miner's 
chronic respiratory or pulmonary impairment caused his qualifying 
``deathbed'' blood gas results. The commenters argue that the party 
opposing entitlement should bear the burden of proving a non-
respiratory or non-pulmonary condition caused the qualifying results 
since that party has equal access to the miner's hospital records and 
physicians. The Department disagrees. The claimant bears the general 
burden of persuasion to establish entitlement to benefits by a 
preponderance of the evidence, except to the extent a presumption eases 
that burden. See generally Director, OWCP v. Greenwich Collieries, 512 
U.S. 267 (1994). One facet of the claimant's burden is the 
responsibility to ensure that the clinical tests such as blood gas 
studies su