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

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## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** December 20, 2000
- **Citation:** 65 FR 79920

## Text

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.

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 §§ 725.410-725.413. Similarly, the Department has altered the rules governing informal conferences, § 725.416. If a conference is held, no memorandum of conference will result, § 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, § 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, § 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, §§ 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, § 725.407, and gather evidence from them regarding their employment of the miner and their status as operators, § 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, § 725.410. This

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 § 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, § 725.410(b). These time periods may be extended for good cause shown, § 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, § 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, § 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, § 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, § 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, § 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, § 725.415(b), the district director may either notify additional operators of their potential liability for benefits under § 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, § 725.410, schedule a case for an informal conference, § 725.416, or issue a proposed decision and order, § 725.418. In the event the district director issues another schedule for the submission of additional evidence pursuant to § 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 § 725.410. The designated responsible operator may elect to adopt any medical evidence previously submitted by another operator as its own, subject to the § 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, § 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, § 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, § 725.416(c). These sanctions may include denial of the claim by reason of abandonment, § 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, § 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, § 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 § 725.407. Any party may request a hearing within 30 days of issuance of the decision and order, § 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, § 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, § 725.418(c).

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 §§ 725.414(a), however, absent a showing of good cause, § 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, §§ 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 § 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 § 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 § 725.414, § 725.414(e), as well as the comparable provision proposed as § 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 § 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, § 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, § 725.406(d).

The Department has not included in the final regulation at § 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 § 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 § 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 § 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,

the witness must have been identified while the claim was pending before the district director in the absence of extraordinary circumstances, § 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 § 725.414(c). A party may offer the testimony of more than two physicians only upon a finding of good cause, § 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, § 718.104(d). The rule is discussed in detail in the preamble to § 718.104. The language of § 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
§ 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 § 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 § 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, § 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 §§ 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 § 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 § 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 § 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.

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, § 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 § 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, § 725.367(a)(1) now provides that if the responsible operator designated by the district director pursuant to § 725.410(a)(3) fails to accept the claimant's entitlement to benefits within the 30 day period provided by § 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 § 725.410, and the claimant successfully prosecutes his application for benefits, the Fund will be liable for a reasonable attorney's fee, § 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 § 718.3.

Criteria for Determining a Responsible Operator

The Department has made two changes to the regulation governing the identification of a responsible operator, § 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 § 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 § 725.495(d) to reflect the changes made in the regulations governing district director claims processing, §§ 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, § 725.418(d).

Insurance Endorsement

In the second notice of proposed rulemaking, the Department opened § 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 § 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 § 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 § 726.203.

Explanation of Changes

Complete List of Substantive Revisions

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

§ 725.608, § 725.609, § 725.620, § 725.621, § 725.701, § 725.706, § 726.2, § 726.3, § 726.8, § 726.101, § 726.104, § 726.105, § 726.106, § 726.109, § 726.110, § 726.111, § 726.114, § 726.300, § 726.301, § 726.302, § 726.303, § 726.304, § 726.305, § 726.306, § 726.307, § 726.308, § 726.309, § 726.310, § 726.311, § 726.312, § 726.313, § 726.314, § 726.315, § 726.316, § 726.317, § 726.318, § 726.319, and § 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: § 718.1, § 718.2, § 718.4, 718.303, Appendix A to Part 718, § 725.3, § 725.102, § 725.201, § 725.206, § 725.207, § 725.216, § 725.217, § 725.218, § 725.220, § 725.301, § 725.302, § 725.350, § 725.360, § 725.366, § 725.401, § 725.402, § 725.404, § 725.419, § 725.420, § 725.450, § 725.451, § 725.455, § 725.462, § 725.463, § 725.466, § 725.480, § 725.496, § 725.497, § 725.501, § 725.504, § 725.505, § 725.506, § 725.507, § 725.510, § 725.513, § 725.514, § 725.521, § 725.531, § 725.532, § 725.536, § 725.540, § 725.601, § 725.603, § 725.604, § 725.605, § 725.607, § 725.702, § 725.703, § 725.704, § 725.705, § 725.707, § 725.708, § 725.711, § 726.1, § 726.4, § 726.103, § 726.203, § 726.207, § 726.208, § 726.209, § 726.210, § 726.211, § 726.212, and § 726.213. In its first notice of proposed rulemaking, the Department revised § 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, § 725.3 now appears in the complete list of technical revisions. The Department also inadvertently omitted §§ 725.206 and 725.540 from the list of technical revisions. The Department added a reference to § 725.4(d) to each regulation,
see
62 FR 3340-41 (Jan. 22, 1997). The Department also inadvertently omitted § 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 § 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 § 725.101(a)(8), and capitalized the word “section” in subsections (a) and (b). Finally, the Department inadvertently omitted § 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 § 726.203, none of the regulations listed above were open for comment. The Department's decision not to revise § 726.203, other than the technical revisions discussed in the Department's first notice of proposed rulemaking, is explained in the preamble to § 726.203.

Complete List of Deleted Regulations

The following regulations have been deleted: § 718.307, § 718.401, § 718.402, § 718.403, § 718.404, § 725.453A, § 725.459A, § 725.503A, § 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: § 718.203, § 718.206, § 718.302, § 718.304, § 718.305, § 718.306, § 725.205, § 725.208, § 725.210, § 725.211, § 725.224, § 725.225, § 725.226, § 725.227, § 725.228, § 725.229, § 725.230, § 725.231, § 725.232, § 725.233, § 725.303, § 725.304, § 725.305, § 725.307, § 725.308, § 725.352, § 725.361, § 725.363, § 725.364, § 725.365, § 725.422, § 725.453, § 725.460, § 725.461, § 725.464, § 725.475, § 725.476, § 725.477, § 725.481, § 725.482, § 725.483, § 725.511, § 725.512, § 725.520, § 725.534, § 725.535, § 725.538, § 725.539, § 725.541, § 725.542, § 725.545, § 725.546, § 725.602, § 725.710, § 726.5, § 726.6, § 726.7, § 726.102, § 726.107, § 726.108, § 726.112, § 726.113, § 726.115, § 726.201, § 726.202, § 726.204, § 726.205, and § 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 § 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 § 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 § 718.3(c) and moving the existing 20 CFR 718.403 (1999) (“Burden of proof”) to proposed § 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,

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 § 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, § 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, § 725.503(b), (d), and the presumption of coverage for pulmonary-related medical benefits, § 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, § 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 (§ 718.103) and

blood gas studies (§ 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 § 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 (§ 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

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), § 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 § 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
§§ 718.102(e) (x-rays), 718.103(c) (pulmonary function studies), 718.104(c) (medical reports). The Department has added a similar provision to § 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 § 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 § 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, § 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 § 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

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 § 718.102: eliminating the reference to the compliance standard in light of the substantial compliance language of general applicability in § 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 § 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 § 718.102(b) and (e), in conjunction with § 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 § 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 § 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 § 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 § 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 § 718.103 in the initial notice of proposed rulemaking to take into account proposed § 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 § 718.103(c) to harmonize it with § 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 § 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 § 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

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 § 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 § 718.103(b) to harmonize the regulation with Appendix B. The former and initially proposed § 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 § 718.103 requirements. Finally, the Department proposed revisions to §§ 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 § 718.103(b) to “developed” to conform the regulation to similar usage in § 718.101(b). The Department also changed the opening phrase of the first sentence in § 718.103(c) to clarify that paragraph (c) is an exception to the remainder of § 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 § 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 § 725.406(a). Under § 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 § 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 § 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 § 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

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 § 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 § 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 § 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 § 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 § 718.101(b). As amended, § 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 § 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 § 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.

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 § 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 § 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 § 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 § 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 §§ 718.202(a)(3) and 718.304(a); accordingly, § 718.102 provides the applicable quality standards, and not § 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 § 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 § 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 § 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

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, § 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 § 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 § 718.101(b). Consequently, the changes to § 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 § 718.104(a)(l)-(6). A treating physician's report must be reasoned as well as documented (§ 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 (§ 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 § 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 § 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

notice of proposed rulemaking and its responses to comments in this rule that § 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, § 718.104(d) is not a strict, outcome-determinative rule like more traditional evidentiary presumptions. These characteristics also distinguish § 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; § 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 § 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 § 718.104(d) because § 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 § 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 § 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 § 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 § 718.104 and making it a separate regulation. The Department rejected the identical

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 § 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 § 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 (§ 718.102(e)) and pulmonary function studies (§ 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 § 718.104(a) and (b).
See
§ 718.104(c), above. The Department agrees, and has revised § 718.105 accordingly by adding subsection (e). This provision is comparable to § 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 substantially comply with the quality standard. The quality standard provides some assurance to the adjudicator that the clinical test is valid, accurate and reliable evidence of the factual proposition for which it is proffered. The Department considers a physician's opinion necessary to establish a nexus between “deathbed”

blood gas studies and a chronic pulmonary disease; raw clinical test results under these circumstances are not sufficiently instructive for a lay adjudicator to make such a determination. The fact that the party opposing entitlement may have equal access to relevant information about the circumstances and interpretation of the blood gas testing is not determinative in allocating the burden of persuasion. The Department does not perceive any basis for shifting the overall burden of proof from the claimant to the opposing party in the case of qualifying “deathbed” blood gas studies. The comments do not address the Department's explanation in the second notice of proposed rulemaking, 64 FR 54977-78 (Oct. 8, 1999), for imposing this requirement, beyond noting continued opposition. The Department therefore rejects the comments' position.

(d) No other comments were received concerning this section, and no other changes have been made in it.

20 CFR 718.106

(a) The Department proposed minor changes to § 718.106 in the initial notice of proposed rulemaking to account for the adoption of a general standard of substantial compliance with the quality standards (§ 718.101), and to adopt consistent terminology for evidence which is not in substantial compliance with the applicable standard. 62 FR 3343 (Jan. 22, 1997). The Department responded to several comments in the second notice of proposed rulemaking. 64 FR 54978 (Oct. 8, 1999). At the urging of several commenters, the Department restored subsection (c) to § 718.106,

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A00-31166. Public record. Not legal advice.