II-4-1-2.Standards for Consultative Examinations and Existing Medical Evidence (Final Rules; 56 FR 36932, August 1, 1991)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Social Security Administration

20 CFR Parts 404 and 416 (56 FR 36932)

RIN 0960-AB22

[Regulations Nos. 4 and 16]

Standards for Consultative Examinations and Existing Medical Evidence

AGENCY: Social Security Administration, HHS.

ACTION: Final Rules.

SUMMARY: Section 9 of Pub. L. 98-460 requires that the Secretary issue regulations to establish standards for consultative examinations. These regulations must include standards for determining when to obtain a consultative examination, the type of consultative examination to be purchased, and monitoring procedures for both the purchase process and the consultative examination reports. Every reasonable effort must be made to obtain from the claimant's medical sources the medical evidence necessary to make a determination of disability before evaluating medical evidence obtained from another source on a consultative basis. Section 9 also requires consideration of all evidence available in a claimant's case record and development of a complete medical history covering at least the preceding 12 months in any case where a decision is made that the individual is not under a disability. We have interpreted this provision to refer to the 12 months prior to the date of application, the date the claimant was last insured for disability benefit or period-of-disability purposes, the end of the prescribed period for widow's or widower's benefits based on disability, or attainment of age 22 for child's benefits based on disability, as appropriate. We also understand this provision to mean that a 12-month medical history is generally not required if the disability is alleged to have begun less than 12 months before application. In such cases, we will develop a complete medical history beginning with the alleged onset date.

We published proposed rules in a Notice of Proposed Rulemaking in the Federal Register on April 20, 1987 (52 FR 13014). These final rules respond to comments, reflect and implement the statutory requirements, and clarify our policy on the weight to be given treating source opinions.

DATES: These rules are effective August 1, 1991.

FOR FURTHER INFORMATION CONTACT: William J. Ziegler, Legal Assistant, Office of Regulations, Social Security Administration, 6401 Security Boulevard, Baltimore, MD 21235, telephone 301-965-1759.

SUPPLEMENTARY INFORMATION

What We Mean by Evidence

We have explained in these final rules, at §§ 404.1512(b) and 416.912(b), what we mean by "evidence" in the disability evaluation process in order to place the rules on evaluating medical opinions in the broader context of all medical evidence in the case record. We have added a paragraph which describes the types of evidence we need from medical sources and the types of evidence we may need from others.

Evidence from Medical Sources

One of the factors required to establish that an individual is disabled is a medically determinable severe impairment. We must have medical evidence when we determine impairment severity and the individual's residual functional capacity. Objective and complete medical evidence results in quality determinations and prompt decisions. We consider all of the evidence in the individual's record to determine whether the individual is disabled.

We make every reasonable effort to obtain medical evidence from the sources who have treated the individual for the impairment(s) he or she alleges since the alleged disability onset date when the individual is applying for benefits, and during the preceding 12 months when the case of an individual receiving benefits is undergoing review.

The quality of medical examinations has a major effect on the quality of our decision making. We try to make decisions based on evidence from treating sources because of the presumed continuing relationship between the claimant and physician. When the evidence in the individual's case file is insufficient for making a disability decision, a consultative examination is purchased, at Government expense, from the treating source whenever possible. Because basing a decision on evidence from a treating or other medical source is not always possible for various reasons, it is sometimes necessary to purchase a consultative examination from an independent source at Government expense. For example, if the information provided by a treating source or other medical source appears not to be supported by medical findings and the source is unable or unwilling to provide the additional medical evidence we need, we may purchase a consultative examination from another source. We may also obtain a consultative examination from another source when highly technical or specialized evidence which is needed is not available from the treating source or other medical source. In some instances, we may order a consultative examination from an independent source while awaiting receipt of treating or other medical source evidence, but the report will not be evaluated until that evidence is received or every reasonable effort has been made to obtain it.

Program Integrity

Since the enactment of the Medicare/Medicaid anti-fraud and abuse amendments of 1977, an escalation in the prosecution of medical service providers for fraud and abuses in those programs has raised the issue of the propriety of the Social Security Administration (SSA) using these and other offenders in the disability programs administered under titles II and XVI of the Social Security Act (the Act). We are, therefore, providing rules in §§ 404.1503a and 416.903a barring our use of any individual or entity who is currently excluded, suspended, or otherwise barred from participation in the Medicare or Medicaid programs, or by any other Federal or Federally-assisted program or whose license is currently revoked or suspended by any State licensing authority pursuant to adequate due process procedures, except to provide existing medical evidence. The final rules reflect a change from the proposed rules to conform our policy to the policies of other agencies responsible for health care delivery programs. We believe it would be unreasonable and confusing to medical providers for us to administer a significantly different policy than these other agencies. For clarity, we are defining an individual or entity as a medical or psychological consultant, consultative examination provider, or diagnostic test facility.

Consultative Examinations

Consultative examinations are medical examinations we purchase from physicians, including pediatricians when appropriate, and other qualified health professionals outside the agency;

If an individual's treating or other medical sources cannot provide us with sufficient medical evidence about his or her impairment(s) to enable us to determine whether the individual is disabled or blind, we may ask the individual to have one or more physical or mental examinations or tests. We will pay for those examinations that we arrange in accordance with our rules at §§ 404.1624 and 416.1024 on payment for medical and other purchased services. When we arrange an examination or test, we will give the individual reasonable notice of the date, time, and place that the examination or test will be given, indicate the type of examination or test that will be given, and provide the name of the person or facility who will do it. We will also give the examiner any necessary background information about the individual's condition unless the examiner already has the background information because he or she is a treating source.

If an individual is applying for benefits and does not have a good reason for failing or refusing to take part in a consultative examination or test that we arrange to obtain information to determine disability or blindness, we may find that the individual is not disabled or blind. If the individual is already receiving benefits and does not have a good reason for failing or refusing to take part in a consultative examination or test that we have arranged, we may determine that the disability or blindness has ceased.

Standards for Consultative Examinations

Consultative examinations may be obtained to secure additional information necessary to make a disability determination or to resolve conflicting information. Evidence obtained through a consultative examination is considered with all other medical and nonmedical evidence submitted in connection with a disability claim. Sections 404.1519m and 416.919m have been revised to state that a State agency medical consultant must approve the ordering of any diagnostic test or procedure when there is a chance that it may entail significant risk;

Until enactment of section 9 of Pub. L. 98-460, there was no statutory requirement for regulatory standards specifying particular cases in which consultative examinations would be purchased, identifying the types of consultative examinations to be purchased, or requiring any standard procedures to be followed in establishing and monitoring purchase policies. Because consultative examinations are purchased at government expense, we have had guidelines that cover the standards to be used in purchasing and monitoring such examinations. For some time, we have had in place in our operating manuals these guidelines for managing every aspect of the consultative examination process from deciding when to purchase an examination, to providing guidance to the person performing the consultative examination, to monitoring the actual consultative examination delivery process and the reports which it produces. Congress, in passing section 9 of Pub. L. 98-460, expressed satisfaction over our success in better management of the consultative examination process, but stated that our standards should appear in regulations. See H. Rep. No. 98-618, 98th Cong., 2d Sess. 19-20 (1984). These regulations are being issued to comply with the law.

In addition to incorporating our existing operating procedures into this regulation, we are adding further provisions in three areas. First, we have identified certain time periods that we believe can serve as a frame of reference for scheduling a consultative examination. These minimum scheduling times are intended to emphasize our intentions that sufficient time be made available for thoroughly examining the claimant. They are meant to ensure sufficient time for a full consultative examination including development of the claimant's case history. They are not meant as inflexible rules to be applied mechanically or to impede appropriate judgment on the part of the State and professional individuals. Second, standards are included to ensure that laboratory fees paid to consultative examination providers for services are reasonable and do not permit excessive charges by the source. Third, we emphasize that State rules must be followed regarding minimum qualification levels for physicians' and psychologists' assistants.

The minimum scheduling times for consultative examinations were developed by a panel of regional office and State agency physicians and administrators that was convened to assist us in the preparation of these regulations. Many State agencies already had such standards, including some based on the duration of the examination and others on the numbers of patients who can be scheduled for consultative examinations per hour. These final rules establish national norms.

We have deleted the last two sentences of §§ 404.1519k(a) and 416.919k(a) that were included in the Notice of Proposed Rulemaking. Those sentences dealt with the State determining the rate of payment for the purchase of medical examinations, laboratory tests, and other services and were an overstatement of our policy on the State's authority to set the fees for such services.

The final rules on consultative examinations fall under the categories mandated by law. Those categories are:

1. Standards to be used by State and Federal personnel in determining when a consultative examination should be obtained in connection with disability determinations.

2. Standards for the type of referral to be made.

3. Procedures to monitor the referral process used.

4. Procedures to monitor the product of health professionals to whom cases are referred.

These standards are being included in Subpart P of Part 404 and Subpart I of Part 416. We are adding new §§ 404.1519 through 404.1519t and new §§ 416.919 through 416.919t. We are also updating the Table of Contents for Subpart P and Subpart I.

Definitions

We are revising §§ 404.1502 and 416.902 to define what we mean by "medical source," "treating source," and "source of record."

Evidence of Impairment

We have reorganized and expanded §§ 404.1512 and 416.912 to clarify our existing regulations, to provide greater detail about the rules on development of existing evidence, and to refine and consolidate some of the language in §§ 404.1519 and 416.919, 404.1519a and 416.919a, and 404.1519b and 416.919b. The final rule defines what we mean by "evidence" and clearly delineates the responsibilities of the individual and SSA. We explain these and other changes below.

The 12-Month Medical History

We are making changes in paragraph (b) of §§ 404.1512 and 416.912, and §§ 404.1593 and 416.993, to indicate that we will develop a complete medical history covering at least the preceding 12 months in any case in which an unfavorable determination is made, unless the disability is alleged to have begun less than 12 months before application. See S. Rep. No. 98?466S. Rep. No. 98-466, 98th Cong., 2d Sess., 26 (1984). In addition, we have made changes to indicate that, if applicable, we will develop a complete medical history for at least the 12-month period prior to the month the individual was last insured for disability benefits, the month ending the 7-year period to establish the individual's disability if the individual filed an application for widow's or widower's benefits, or the month of attainment of age 22 if the individual filed an application for child's insurance benefits based on disability. We are also stating that we will make every reasonable effort to obtain from the individual's treating and other medical sources the evidence necessary to make a determination before we evaluate medical evidence obtained from another source on a consultative basis. "Every reasonable effort" is defined to mean an initial request and, at any point between 10 and 20 calendar days after the initial request, if the evidence has not been received, one followup request to the medical source for the medical evidence. The source will have a minimum of 10 calendar days from the date of our followup request to reply, unless our experience with that source indicates a longer period is advisable in a particular case, before we evaluate the evidence that we may obtain on a consultative basis. In some instances, we may order a consultative examination while awaiting receipt of treating or other medical source evidence.

In addition, we are amending paragraph (a) of §§ 404.1520 and 416.920 to state more clearly that we consider all evidence in the individual's case record when we make a determination. We are also revising §§ 404.1593 and 416.993 to recognize that development of medical evidence in continuing disability review cases will be guided by the special requirements of the medical improvement review standard and to reaffirm that consultative examinations are purchased with only one purpose, to provide information necessary to reach a decision in a case.

Medical Assessment Requirement

We are also revising §§ 404.1513(b)(6) and (c), 404.1545(a) and 404.1546, as well as §§ 416.913(b)(6) and (c), 416.945(a) and 416.946 to delete references to medical assessments and to refer instead to medical source statements about what a person can still do despite his or her impairment(s). These revisions accomplish two things: They remove all reference to the term "medical assessment," which was not clearly defined and was thus open to various interpretations; and they indicate that we will consider all of the medical and other evidence in determining whether a person is disabled, including statements from medical sources about what a person can still do despite an impairment, and that medical source statements alone are not determinative of whether or not the person is disabled;

We believe these are important changes. There has been confusion among adjudicators as to what constitutes a "medical assessment." This has resulted in special requests being made to elicit information which was already at hand but not labeled "medical assessment." We have also revised §§ 404.1513(b)(6) and 416.913(b)(6) to make clear that we will request medical source statements from treating sources, although the absence of a medical source's statement in a report of existing medical evidence does not make the report incomplete. Also, §§ 404.1519n and 416.919n ensure that although medical source statements should ordinarily be requested as part of the consultative examination process, the absence of a medical source's statement in a consultative examination report does not make the report incomplete.

Evaluating Medical Opinions

In the preamble to the Notice of Proposed Rulemaking, we noted that the Senate Finance Committee had indicated in its report on Pub. L. 98-460 (S. Rep. No. 98-466, 98th Cong., 2d Sess., 26 (1984)), that it did not intend to alter in any way the relative weight that the Secretary places on reports received from treating physicians and from physicians who perform consultative examinations. We also noted that judicial decisions in several circuits pointed to a need for a clear policy statement that would encourage uniformity of adjudication and provide the public and the courts with a definitive explanation of our policy on weighing treating source opinions. Accordingly, we proposed to replace existing regulations §§ 404.1527 and 416.927 with longer and more detailed provisions that would prescribe rules stating how we would consider and weigh medical opinions.

Some public comments concerning the way we evaluate medical opinions were critical. The comments demonstrated to us that our proposed regulation was not as clear and comprehensive as we had hoped and that it could be misinterpreted. We have, therefore, revised and expanded §§ 404.1527 and 416.927 to state our policy more clearly and in more detail and to respond to the public's concerns.

Although the circuit courts vary somewhat in their formulation of the rule on how treating source evidence is to be considered, the majority of the circuit courts generally agree on two basic principles. First, they agree that treating source evidence tends to have a special intrinsic value by virtue of the treating source's relationship with the claimant. Second, they agree that if the Secretary decides to reject such an opinion, he should provide the claimant with good reasons for doing so. We have been guided by these principles in our development of the final rule.

We were guided in the development of these final rules by the general principles articulated by the various circuit courts. None of the circuit courts of appeals has held that its treating physician rule is required by the Act or the Constitution. Rather, the courts of appeals have articulated their treating physician precedent in the absence of a definitive regulation by the Secretary and in the context of reviewing individual decisions by the Secretary under section 205(g) of the Act to determine whether those individual decisions, given the facts of the particular case, were supported by "substantial evidence." Indeed, the Second Circuit in the Schisler case recently expressly invited the Secretary to use the "customary administrative process" to promulgate a treating physician policy. The Secretary has the authority and responsibility under sections 205(a), 223(d)(5) and 1102 of the Act to prescribe regulations for determining the amount and kind of evidence an individual must furnish in order to establish that he or she is under a disability. In these final rules we are exercising that authority to prescribe the standards that we will use to evaluate treating source opinions when those opinions are furnished as evidence in connection with a claim for disability benefits. The Secretary will be applying these final rules as the appropriate legal standard for evaluating treating physician opinion evidence in claims before the Agency.

Under the Act, a claimant is required to prove to us that he or she is disabled by providing medical and other evidence of disability. We consider medical opinions, including treating source opinions, to be evidence that must be evaluated together with all of the other evidence in a person's case record. Sometimes, medical opinions may be entitled to so much weight that they control the issues they address; other times, opinions may be entitled to less weight.

The final rule addresses the problems of weighing opinion evidence in several ways. It recognizes that, because opinions always have a subjective component, because the effects of medical conditions on individuals vary so widely, and because no two cases are ever exactly alike, it is not possible to create rules that prescribe the weight to be given to each piece of evidence that we may take into consideration in every case. It also recognizes that the weighing of any evidence, including opinions, is a process of comparing the intrinsic value, persuasiveness, and internal consistency of each piece of evidence and then evaluating all of the evidence together to determine which findings of fact are best supported by all of the evidence. The final rule places medical opinions in the context of the entire case record by first stating general principles of weighing evidence and then the specific rules for weighing opinion evidence. The final regulation provides more detail than the Notice of Proposed Rulemaking on how we will weigh all types of evidence, and contains some substantive changes in our policy made in response to public comment. We believe the level of detail in these final rules is necessary in order to explain our policy fully and to provide sufficient guidance to our adjudicators.

The regulation also recognizes that we may receive medical opinions from three kinds of medical sources: treating sources, other examining sources who are not treating sources (for example, consulting physicians and psychologists), and nonexamining sources. It describes the factors we will consider when we weigh each kind of opinion. It also provides special rules for weighing treating source opinions, and differentiates between the standards for weighing treating source opinions and opinions from other sources. We have included a discussion of evaluation of nontreating source opinions in these final rules because it was clear to us that we could not fully describe the rules to be used in weighing treating source opinions without also describing how those opinions were to be evaluated in relation to opinions from other sources.

The following discussion describes the structure of §§ 404.1527 and 416.927 in detail and why we revised the regulation as we did.

The final regulation contains six paragraphs that do not correspond directly to the paragraphs of the regulation proposed in the Notice of Proposed Rulemaking. Instead, we have reorganized and rewritten the provisions that were originally proposed.

1. Paragraph (a) of the final rule is a new provision that defines the kinds of medical evidence we may consider to be medical opinions.

2. Paragraph (b) states our policy that we always consider relevant medical opinion evidence together with other relevant evidence when we make our determinations and decisions.

3. Paragraph (c) describes generally how we consider evidence, including opinions, in making disability determinations. It also explains the weighing of evidence and describes the steps we will take before we make our determinations and decisions.

   The evaluation of evidence is a complex process that requires careful analysis of the value of each piece of evidence and the interrelationship of and consistency among the various pieces of evidence. When the evidence is consistent and sufficient for us to decide a case, decision making is relatively straightforward since we can simply make our findings consistent with the evidence as a whole. However, if there are any inconsistencies in the evidence, including any individual reports that may be internally inconsistent (for example, when a report provides detailed medical findings that suggest greater or lesser severity of impairment than is expressed in an opinion at the end of the report), we weigh all of the evidence to determine what findings are best supported and whether there is sufficient evidence for us to make a final determination or decision.

   Regardless of whether the evidence in the case record is consistent, if there is insufficient evidence for us to decide the case, we will try to remedy any evidentiary deficiencies, as provided elsewhere in these regulations. If we are successful, we will have a case record that is either wholly consistent and sufficient to decide the case, or which retains inconsistencies but contains sufficient evidence for us to resolve the inconsistencies. If we cannot get the evidence we need, we will have no alternative but to make a determination or decision by weighing all of the evidence we have and making judgments about what findings can be best supported.

4. Paragraph (d) contains the principal provisions of the regulation section and is intended to replace paragraphs (b) through (d) of the regulation section proposed in the Notice of Proposed Rulemaking. It recognizes that medical opinions are particularly difficult to assess since they always reflect judgments or beliefs of the person offering the opinion that we may not be able to verify or that we may find questionable based on our understanding of all of the evidence. We cannot decide a case solely in reliance on a medical opinion when there is not some reasonable support for the opinion, nor can we find an opinion to be controlling simply by virtue of the fact that it may come from a treating source if there is other substantial evidence which casts doubt on the opinion.

   We recognize that medical conditions affect individuals in widely different ways and that medical opinions—especially those from treating sources—can provide evidence of the nature and severity of an individual's impairment(s) that cannot be obtained by any other means. Accordingly, paragraph (d) reaffirms that we will never ignore any medical opinion in the case record. Then, it describes the factors we consider when we determine the amount of deference to give to a medical source's opinion, with particular attention to a treating source's opinion;

   In a trial-type or adversarial situation, the facts or grounds on which an opinion is based can be brought out by cross-examination. Such cross-examination can strengthen or weaken the probity of the medical opinion. The Social Security disability programs provide for the adjudication of disability claims in a nonadversarial context without the cross-examination safeguard. We believe that the use of the factors specified in paragraph (d) is a reasonable substitute for the scrutiny that any opinion would be subjected to if it were placed before a court in an adversarial context;

   When we cannot give controlling weight to a treating source's opinion about the nature and severity of a claimant's impairment(s), we consider all the following factors when we decide how much weight to give to the opinion.

   1. The examining relationship—A medical opinion of a source who has examined the individual will generally be given more weight than a medical opinion of a nonexamining source.

   2. The treatment relationship—We give treating source medical opinions special deference because treating sources usually have the most knowledge about their patients' conditions. When we weigh a treating source's medical opinion, we consider several factors that indicate the extent of this knowledge. Considering these factors allows us to determine whether the treating source is in fact an individual to whom we should give deference and the amount of deference to give to the source's medical opinion. We will consider the length, frequency, nature, and extent of the relationship between the treating source and the claimant. Generally, the longer a treating source has known an individual, the greater the number of times the source has seen the individual for treatment, and the greater the extent of examinations and testing the source has provided or ordered, the more weight we will give to the source's opinion on any medical issue;

   3. Supportability—The more relevant the supporting evidence of an opinion and the better an explanation a medical source provides, the more weight we will give that opinion.

   4. Consistency—The more consistent a medical opinion is with the record as a whole, the more weight we will give that opinion.

   5. Specialization—We generally give more weight to the opinion of a specialist about medical issues related to his or her area of specialty than to the opinion of a source who is not a specialist in that area.

   6. Other factors—We have included a provision to cover situations that may arise in rare cases that may not be covered by the foregoing provisions. For example, information that a particular physician or psychologist has been submitting identical medical reports for different individuals would clearly affect the weight we would give to any opinions expressed in those reports.

   Even though we will consider all of the foregoing factors each time we weigh an opinion, not every factor will apply in every case. Also, certain factors (for example, treatment relationship) will sometimes take precedence over other factors; at other times, certain combinations of factors will result in a finding that one opinion is entitled to more weight than another, or that a single opinion is entitled to great weight while another might not be. As we have explained above, there are simply too many variables to permit a formulaic description of how we will apply the factors in every case, but we believe that the factors in paragraph (d) represent a fair, logical, and comprehensive description of the considerations we should take into account when weighing medical opinions.

   Paragraph (d)(2) also states special rules for evaluating medical opinions from treating sources. It provides that we must give controlling weight to any treating source medical opinion on the issues of the nature and severity of the impairment when the opinion is well-supported by medically acceptable clinical and laboratory diagnostic techniques and is not inconsistent with other substantial evidence in the record. The final rule was drafted to clarify language in the Notice of Proposed Rulemaking, §§ 404.1527(b) and 416.927(b), which contained the provision most criticized in the public comments. The provision recognizes the deference to which a treating source's medical opinion should be entitled. It does not permit us to substitute our own judgment for the opinion of a treating source on the issues of the nature and severity of an impairment when the treating source has offered a medical opinion that is well-supported by medically acceptable clinical and laboratory diagnostic techniques and is not inconsistent with other substantial evidence.

   We substituted the word "controlling" for the word "conclusive" in those situations where treating source opinions are such that they should be accorded great deference. We believe the word "controlling" more clearly reflects the process we use, but do not believe any substantive difference in the standard results from the substitution of "controlling" for "conclusive." We changed the term "fully supported" to "well-supported" because we agreed with commenters who pointed out that "fully supported" was unclear and that, more important, it was an impractically high standard which, even if it were attainable, would essentially make any opinion superfluous. We believe that the new term, "well-supported," is more practicable and more reasonable; it should make clear that we will adopt opinions that are well-supported by medically acceptable clinical and laboratory diagnostic techniques unless they are inconsistent with substantial evidence in the record.

   Whether an opinion is well-supported will depend on the facts of each case; however, as we explain below, when a treating source's opinion is not accorded controlling weight, good reasons for such a decision are required in the notice of determination or decision.

   We also deleted the word "medical" from the phrase "substantial medical evidence" in order to avoid the possibility of an improper result being reached in some cases. Although we would expect it to be an extremely rare occurrence, it is possible that a treating source's opinion about the nature or severity of a claimant's impairment(s), even one that is well-supported by medically acceptable clinical and laboratory findings, may nevertheless be contradicted, and even outweighed, by substantial nonmedical evidence. For example, an opinion from a treating source about what a claimant can still do which would seem to be well-supported by the objective findings would not be entitled to controlling weight if there was other substantial evidence that the claimant engaged in activities that were inconsistent with the opinion.

   In addition to the rule requiring us to give controlling weight to certain treating source opinions, we have provided two rules in paragraph (d)(2) for weighing treating source opinions that are not entitled to controlling weight, in recognition of the special kind of knowledge about the nature and severity of their patients' impairments that only treating sources can have. These rules replace the provisions that were in the proposed regulation's paragraph (d), including the term "some extra weight" which was also identified in the public comments as a source of confusion. All things being equal, when a treating source has seen a claimant long enough to have obtained a detailed longitudinal picture of the claimant's impairment(s), we will always give greater weight to the treating source's opinion than to the opinions of nontreating sources even if the other opinions are also reasonable or even if the treating source's opinion is inconsistent with other substantial evidence of record. The rule also provides that, even if the treating source's opinion is not such that we can give it controlling weight, we will still give the opinion more weight than we would have given it if it came from a nontreating source.

   We combined the rule on according controlling weight to some treating source medical opinions with the other special rules addressing treating source medical opinions to emphasize that we will still carefully evaluate such opinions, and that we may still accord them special deference or determine that they are entitled to great weight when we do not give them controlling weight. Subsequent provisions in paragraph (d)(2) provide that, as long as the treating source is someone entitled to special deference, and all other factors are equal, we will always give more weight to treating source medical opinions than to opinions from other sources.

   Finally, paragraph (d) provides that, when we do not give a treating source's medical opinion controlling weight, we will always provide good reasons why we have not done so in our notices of determination and decision.

   Paragraph (d) provides that many of the factors we use for weighing opinions from treating sources are also used in weighing opinions from sources who have examined claimants but who have no treatment relationship (such as consulting physicians and psychologists or physicians or psychologists who may have performed individual consultations during the course of a hospitalization) and from nonexamining medical sources. Thus, the weight to which the opinion of a nontreating source will be entitled depends on such factors as the consistency of the opinion with other evidence, the qualifications of the source, and the degree to which the source offers supporting explanations for the opinion. Even though we may ultimately find the opinion of a nontreating medical source entitled to greater weight than that of a treating source, the opinions of nontreating sources are not entitled to the special deference that we give to treating source opinions;

   Essentially, once we have determined that an opinion is from a treating source, it is entitled to special deference. The final rules provide that treating source opinions are generally entitled to greater weight than opinions from nontreating sources unless there are clear and specific reasons why they are outweighed;

5. Paragraph (e) addresses the consideration of opinions on issues reserved to the Secretary. Except for editorial changes, paragraph (e)(1) is intended to be identical in meaning to the rule that was in the existing regulations §§ 404.1527 and 416.927. Paragraph (e)(2) replaces the paragraph (e) of the Notice of Proposed Rulemaking, which was another source of serious concern and misunderstanding in the public comments.

   Medical sources often offer opinions about whether their patients are "disabled" or "unable to work." Sometimes, medical sources offer opinions about whether their patients have impairments that meet or equal the requirements for an impairment listed in Appendix 1 to Subpart P of Part 404. Medical sources may also offer opinions about a claimant's "residual functional capacity" under §§ 404.1545 and 416.945 (as distinct from the "statements about what you can still do" described in §§ 404.1513 and 416.913), or about their patient's ability to perform past relevant work or any other type of work considering residual functional capacity, age, education, and work experience.

   The new paragraph (e) provides that we will not disregard these opinions, even though they may generally be beyond the expertise of most medical sources. In fact, if a treating source provides an opinion on a nonmedical issue and the basis for the opinion is not clear from the evidence in the case record, we will make every reasonable effort to recontact the source to obtain an explanation of the medical basis for that opinion. The intent of the paragraph, however, is to reiterate the principle previously stated in §§ 404.1527 and 416.927 that determinations on these issues, as described in those sections, are strictly the responsibility of the Secretary and that opinions which address these issues can only be given weight proportionate to the extent to which we can find that they are supported by the remainder of the record. The Act requires such determinations to be made by a State agency or the Secretary. To give a treating source's opinion on such an issue controlling weight would, in actuality, confer upon the treating source the authority to make the determination, and would not, in our view, be consistent with the statute. This was what we intended with the language in proposed paragraph (e). We did not mean to require medical sources to use proper terminology, as some commenters inferred. However, we did mean to reserve the ultimate determination of disability to the Secretary.

6. Paragraph (f) is a new provision that addresses evidence from nonexamining physicians and psychologists. We use physicians and psychologists in several capacities. At the State agency, physicians and psychologists are members of the teams that make disability determinations. We also employ physicians and psychologists to perform quality reviews and to provide expert opinions to State agencies, disability hearing officers, administrative law judges, and the Appeals Council. Administrative law judges may also call upon medical advisors to provide expert testimony at hearings. Even though the provisions of the introductory paragraph of paragraph (f) will normally apply to such physicians and psychologists, they are applicable to opinions received from any nonexamining source, including the rare nonexamining medical source opinion submitted by a claimant.

   Paragraphs (f)(1) and (f)(2) are new provisions which clarify the complex role of the State agency medical and psychological consultant. Paragraph (f)(1) explains that when State agency medical or psychological consultants make findings of fact about medical issues in their decision making capacities, the findings are not opinions which are to be weighed against opinions in the case record. Rather, they are findings based on the pertinent medical and other evidence, including medical opinions. When State agency medical or psychological consultants assess medical opinions in the case record, they apply the principles set forth in §§ 404.1527 and 416.927.

   At the hearing level, administrative law judges consider the issues before them de novo. Therefore, when administrative law judges consider issues of disability, they are not bound by any findings made at the State agency in connection with the initial and reconsidered determinations. However, State agency medical and psychological consultants are highly qualified physicians and psychologists who are also experts in Social Security disability evaluation. Therefore, it has been our longstanding policy that administrative law judges will consider the findings of State agency medical and psychological consultants with regard to the nature and severity of a claimant's impairment as opinions of nonexamining physicians and psychologists. We have incorporated this policy into the regulations in §§ 404.1512(b)(6) and 416.912(b)(6) and in §§ 404.1527(f)(2) and 416.927(f)(2);

   Administrative law judges will not give the opinions of State agency medical or psychological consultants any special weight as such; they will apply the principles of §§ 404.1527(a) through (e) and 416.927(a) through (e) when they weigh such opinions, always considering that the opinions come from sources who have never examined the individual whose case is being decided. Paragraph (f)(3) provides that the same policy applies to the Appeals Council when the Appeals Council issues a decision.

Public Comments

We published proposed rules to establish standards for consultative examinations in a Notice of Proposed Rulemaking in the Federal Register on April 20, 1987 (52 FR 13014). Interested persons, organizations, Government agencies, and other groups were given 60 days to comment. The comment period closed on June 19, 1987.

We received comments from individuals, organizations, and Government agencies, both State and Federal, whose responsibilities and interests require them to have some expertise in the evaluation of medical evidence used in making disability determinations under titles II and XVI of the Act. We received no comments from disabled persons individually, but we did receive them from six legal services organizations that represent the interests of disabled individuals. We also received comments from medical associations, physicians, and other medical professionals.

We have carefully considered all of the comments and have adopted many of the recommendations. These changes are identified in the following discussion of issues which were raised in the comments.

Many of the written comments, by necessity, had to be condensed, summarized or paraphrased. In doing this, we believe we have expressed everyone's views adequately and responded to the issues raised.

Some of the comments raised details about how the regulations would be implemented. We believe these comments are not substantive public comments that must be addressed in the regulations.

Many of the explanations and discussions of issues as published in the Notice of Rulemaking have been expanded and clarified. We believe the result is an improvement over the rules as published in the Notice of Proposed Rulemaking which will enhance the uniformity and equity with which the rules are applied.

We have refined and consolidated some of the language previously proposed in §§ 404.1519 and 416.919, 404.1519a and 416.919a and 404.1519b and 416.919b and moved it into §§ 404.1512 and 416.912. We believe this is appropriate as it makes clearer the process of obtaining existing medical evidence from medical sources, including recontacting the medical source, before evaluating a consultative examination. We revised §§ 404.1512 and 416.912 to clarify that the 12-month medical history means 12 months prior to the application, the date the claimant was last insured for disability benefit or period of disability purposes, the end of the prescribed period for widow's or widower's benefits based on disability, or attainment of age 22 for child's benefits based on disability, as appropriate.

We have reorganized the sections on consultative examinations issues into what we believe is a more logical order when read in the context of current regulations.

Although we did not include §§ 404.1517 and 416.917 of the existing regulations in the Notice of Proposed Rulemaking because we did not initially recognize the need for changes in those sections, we later realized that they should have been revised to avoid redundancy. We have therefore revised the last sentence of §§ 404.1517(a) and 416.917(a) by inserting a period after the words "about your condition." In addition, we have deleted §§ 404.1517(b) and 416.917(b) since situations requiring a consultative examination are now described in §§ 404.1519(a) and 416.919(a). Therefore, §§ 404.1517(a) and 416.917(a) have been redesignated to §§ 404.1517 and 416.917. We have deleted §§ 404.1519e and 416.919e and §§ 404.1519f and 416.919f as set out in the Notice of Proposed Rulemaking since the procedures for development of evidence and obtaining consultative examinations followed at the initial level are also applicable at the reconsideration and hearings level of review; we have added a statement to this effect in §§ 404.1519 and 416.919.

We reorganized the language previously proposed in §§ 404.1519s and 416.919s and §§ 404.1519t and 416.919t as follows:

1. The content of the first paragraph of §§ 404.1519s and 416.919s was moved to §§ 404.1519t(a) and 416.919t(a).

2. The language in §§ 404.1519t and 416.919t, with the exception of the language in §§ 404.1519t(9)(d) and 416.919t(9)(d), is now located in §§ 404.1519s and 416.919s.

We clarified § 416.920 to indicate that it does not apply to children under title XVI.

In proposing these regulations, we had certain objectives in mind in addition to implementing section 9 of Pub. L. 98-460:

• To ensure that accurate disability determinations are made as early in the process as possible;

• To improve the uniformity of disability determinations;

• To improve the management of the disability programs both at the State and Federal levels; and,

• To preserve the basic Federal/State relationship.

These objectives also guided us as we evaluated the comments received from the public.

For ease of comprehension, we have organized comments according to the issues raised. The issues and our responses are presented in the order in which the regulations are now organized and not in the order in which the issues appeared in the Notice of Proposed Rulemaking, except for the sections which we have deleted from the final regulations. The reference to sections in the headings regarding the comments and in the comments refer to sections as numbered in the Notice of Proposed Rulemaking.

§§ 404.1502/416.902 General definitions and terms for this subpart.

Comment:

Several commenters believed that the definition of "treating source" was too restrictive and should include physicians who have treated the claimant in the past as well as those currently treating the claimant. One commenter believed that "treating source" should be defined as "the one who provides medical treatment for alleged impairment(s)."

Response:

We have modified the language in the definition of "treating source" to include those physicians who had treated the claimant on an ongoing basis in the past. We did not limit the definition to "one who provides treatment for the alleged impairment," since pertinent evidence may be available in the records of a treating source who has or had an ongoing treatment relationship with the claimant for a condition other than the alleged impairment.

Comment:

Some commenters expressed concern about the distinction between "treating source" and "source of record." The commenters suggested clarification or deletion of the phrase "ongoing treatment relationship." One commenter suggested cross-referring this section to §§ 404.1513 and 416.913 to clearly define the term "your own physician," to avoid controversy over evidence from chiropractors, naturopaths, and other practitioners not licensed to practice medicine and surgery.

Response:

record" has been made to differentiate a source who has examined the claimant but did not have an ongoing relationship with the claimant from one who has such a relationship. Additionally, we have stated what we mean by "ongoing treatment relationship." We have cross-referred §§ 404.1502 and 416.902 to §§ 404.1513 and 416.913 to distinguish acceptable medical sources from other sources.

§§ 404.1503a/416.903a Program integrity.

Comment:

Some commenters stated there was not enough detail with regard to the issue of revocation and suspension of license by the State and asked, when revocation or suspension occurs, whether the individual involved is permanently barred from participation in the program or barred only for the duration of the revocation or suspension. One commenter wanted to know SSA's position regarding use of evidence from an individual whose license to practice is restored after (1) passage of penalty time or (2) after investigation.

Response:

We will not use in our program except to provide existing medical evidence, any medical or psychological consultant, consultative examination provider, or diagnostic test facility currently excluded, suspended, or otherwise barred from participation in the Medicare or Medicaid programs, or any other Federal or Federally-assisted program. The regulations have been revised to reflect this policy. Participation in the Social Security programs is permitted after revocation or suspension, once the license to practice has been restored by the State which revoked or suspended it and the bar from participation in the Medicare or Medicaid programs is removed.

We believe a physician's/provider's professional conduct, reputation, and dealings within the community and with all Government agencies must be such as to avoid any unfavorable reflection upon the Government and erosion of public confidence in the administration of the program.

Comment:

One commenter suggested we clarify whether the filing of an appeal on a bar from participation in the Medicare or Medicaid program by physicians would result in a suspension of the debarment by SSA.

Response:

The filing of an appeal would not result in a suspension of the debarment by SSA.

Comment:

Several commenters indicated the need for SSA to maintain a listing of individuals and entities found guilty of professional misconduct in order to keep the State agencies informed.

Response:

We agree and are looking into the possibility of obtaining such information through the use of a data bank service which maintains data on a wide variety of professional disciplinary actions taken against individuals and entities in the country.

Comment:

Several commenters suggested that we list additional reasons for exclusions since congressional hearings and the General Accounting Office reports on the consultative examination issue, particularly with regard to "key" or "volume providers," suggested the need to list further abuses in this section to avoid future problems.

Response:

We have not adopted the suggestion that we need to list additional reasons for exclusion. We believe the regulations cover a broad base of reasons for not using sanctioned physicians. The list of sanctioned physicians SSA receives from the Office of the Inspector General, which we regularly forward to the States, together with information the State agencies receive and maintain through their monitoring systems on volume providers and other medical sources are designed to ensure the integrity of the program.

Comment:

Two commenters believed that prohibitions against "using" physicians in the program and the type of participation that is precluded needed additional clarification. For example, the commenters asked if we would apply this regulation in situations in which the sanctioned individual or entity was involved in our program prior to the legal sanction, and whether we would apply the rule to laboratories used by treating physicians. The commenters believed the regulation could preclude use of a report from such a source in his or her role as a treating source or source of record.

Response:

We believe that evidence submitted by sanctioned physicians who are medical sources cannot be summarily disregarded in reviewing disability claims. Similarly, if we have knowledge that the treating source has used the services of a laboratory that has been sanctioned, such evidence will also be considered. Section 223(d)(5)(B) of the Act states, in part, that "in making any determination with respect to whether an individual is under a disability or continues to be under a disability, the Secretary shall consider all evidence available in such individual's case record."

Comment:

Several commenters questioned whether we would accept existing medical evidence from sanctioned individuals and entities, and, if so, what the probative value of such evidence would be. Another commenter wanted it specified that the State agencies will not base their disability determinations on any evidence presented by attending physicians who have been sanctioned by the Office of the Inspector General for Medicare or Medicaid program violations.

Response:

As we indicated earlier, evidence submitted by sanctioned physicians who are medical sources cannot be summarily disregarded because this would be unfair to the claimant. However, if the examiner has reason to doubt the reliability of a report from a sanctioned physician, then the evidence may have less probative value. Similarly, the particular action which has caused a physician to be excluded from the program will be considered in evaluating medical evidence of record submitted by that physician.

Comment:

With regard to the concept of using the treating physician as the preferred source for consultative examinations, one commenter wanted to know if such disciplinary action would bar consideration of those physicians. Another commenter wanted it clearly specified that the State agencies will not purchase consultative examinations from attending physicians who have been sanctioned by the Office of the Inspector General for Medicare or Medicaid program violations.

Response:

We will not use a treating source to perform a consultative examination if we have knowledge that the treating source is currently under sanction by the Office of the Inspector General for Medicare or Medicaid program violations or by the State licensing authority.

§§ 404.1512/416.912 Responsibility for evidence of your impairment.

Comment:

One commenter stated that it would be advantageous to ensure that all claimants fulfill their responsibility to submit evidence of disability. Two commenters indicated that a step-by-step procedure should be implemented for capable claimants to follow to secure medical evidence in support of their claims. Three commenters believed that requiring the claimant to contact medical sources to help obtain medical reports may result in unfair denials. Several commenters stated that severely disabled individuals cannot be expected to assume responsibility to get evidence, and that SSA must assume responsibility in those cases.

Response:

We have made clear in §§ 404.1512 and 416.912 of these final regulations the claimant's responsibility to submit evidence of disability and SSA's responsibility to assist the claimant in obtaining evidence of the claimant's impairment. We believe these provisions prevent unfair denials to claimants who must assist us in contacting medical sources to help obtain the medical reports. Additionally, SSA assists those claimants who may be physically or mentally unable to provide evidence.

Comment:

One commenter believed that the regulations should honor the statutory directive of developing a complete 12-month history in all cases regardless of the alleged onset date. Other commenters also believed that in cases involving mental impairments the claimant's statement or recall of disability onset should not necessarily be the sole determining factor in developing the preceding 12 months' evidence.

Response:

We do not believe that the statute requires 12 months' development in every case. We have revised the regulations to indicate that if the alleged onset date is less than 12 months before the application filing date, we will develop a complete medical history beginning with the month of alleged onset date. In mental impairment cases, as in any other case, evidence can be requested with respect to periods before the alleged onset date. The criteria of this provision are meant to be minimum standards. Judgment and selectivity should be used based on the facts of a particular case;

Comment:

Several commenters saw no purpose in rigid timeframes for followup for obtaining existing medical evidence. Some stated that the total 30-day timeframe is unreasonable and should be longer. Others stated that the timeframe should be less than 30 days. Some commenters stated that additional efforts should be made in securing existing medical evidence such as a second followup by telephone, or that a carbon copy of the followup should be sent to the claimant so the claimant can request the source to respond promptly. One commenter suggested waiting 28 days after the initial request for existing medical evidence before purchasing a consultative examination, except when a source is known to be uncooperative in providing such medical evidence. Several commenters stated that a consultative examination should not be ordered while awaiting existing medical evidence.

Response:

We have revised the language for "every reasonable effort," the effort which we must expend to help a claimant get medical evidence from his or her own medical source, to permit a period of 30 calendar days between the date of the initial request for existing medical evidence and the response to the followup. Within this 30-day period, the followup can be made at any point between 10 and 20 calendar days after the initial request. This allows a reasonable period of at least 10 calendar days after the followup for response. Current operating instructions provide that the disability determination services may contact the claimant to assist in obtaining needed evidence from a source who has not responded to the initial request. The final regulations provide that a consultative examination may be ordered while awaiting existing medical evidence when a source is known to be unable to provide certain tests or procedures or is known to be nonproductive or uncooperative.

Comment:

One commenter questioned whether the treating source should be used for a consultative examination when that source has been uncooperative in furnishing existing medical evidence.

Response:

A provision has been included in §§ 404.1519i and 416.919i of these final regulations for ordering a consultative examination from a source other than the treating source when the treating source is known to be uncooperative in furnishing existing medical evidence. The example included in the provision illustrates that when the treating source has consistently failed to furnish existing medical evidence, we should not then use the source to perform the consultative examination.

§§ 404.1513/416.913 Medical evidence of your impairment.

Comment:

Several commenters objected to use of the new phrase "medical source statement . . ." instead of the term "medical assessment." They believed that the change from "medical assessment" was made to allow consideration of observations by nonmedical personnel. One commenter stated that the new phrase is a reversal of longstanding SSA policy and is essentially a request for a residual functional capacity finding. Many commenters were concerned that the request to a treating physician for the statement of what the individual can still do despite impairment(s) will result in frequent conflict with the State agency staff medical or psychological consultant's residual functional capacity assessment which is based on the full medical record. These commenters thought that, generally, since the physician would not have access to the claimant's full record, the opinion of the treating source may be substantially different from the residual functional capacity assessment provided by the State agency physician, resulting in increased State agency time required to rebut the solicited opinion.

Response:

The new phrase "medical source statement" does not include observations by non-medical personnel. We clearly indicated in §§ 404.1513(b)(6) and 416.913(b)(6) that the "statement as to what a person can still do despite impairments" should be provided by a medical source. The request for a statement from a medical source about what a person can still do is not a reversal of SSA policy. It has always been our policy to request "medical assessments" from treating sources because these statements can provide important evidence about the actual functional effect of an individual's impairment(s). However, because the term "medical assessment" was open to various interpretations, we decided that the clarification of our policy was necessary. The final rules clarify that we will request each treating source and consultative source to provide a statement of what the claimant can still do despite impairments. Each opinion received will be considered along with all of the medical and other evidence in arriving at the residual functional capacity assessment. We agree that the State agency examiner or medical or psychological consultant may be required to spend additional time resolving differences between these opinions and the medical consultant's residual functional capacity assessment, but we believe this is necessary in our decision making process in order to properly weigh these opinions;

Comment:

One commenter believed the list of work-related activities should be complete rather than a partial list of activities. Two commenters believed that the statement of the medical source's opinion about a claimant's mental impairment should include "to concentrate" and "to persevere," since these are more often the abilities lost in chronic mental illness. Another commenter stated that the information to be included in a medical report does not address complaints of pain and limitations.

Response:

We have made clear in the regulations that the list of work- related activities is not all-inclusive and is not limited to the physical and mental capabilities as listed. However, even though the Notice of Proposed Rulemaking at §§ 404.1513(c)(2) and 416.913(c)(2) referred to the ability to reason or make occupational, personal, or social adjustments, §§ 404.1545(c) and 416.945(c) refer instead to the ability to understand, to carry out and remember instructions, and to respond appropriately to supervision, coworkers, and work pressures in a work setting. We believe that the language of the final regulations should be consistent throughout. We have, therefore, revised the language of these final regulations at §§ 404.1513(c)(2) and 416.913(c)(2) and §§ 404.1519n(c)(6) and 416.919n(c)(6) about mental capabilities to be consistent with the language in §§ 404.1545(c) and 416.945(c).

Comment:

Two commenters believed that excluding disabled widows or widowers from the requirement that a medical report should include a statement about what the claimant can still do despite his or her impairment will result in the exclusion of evidence needed in order to determine the eligibility of a claimant seeking widow's benefits based on disability.

Response:

As a result of the enactment of section 5103 of Pub. L. 101-508, the Omnibus Budget Reconciliation Act of 1990, on November 5, 1990, we will no longer exclude disabled widows or widowers from the requirement that a medical report should include a statement about what the claimant can still do despite his or her impairment;

Standards To Be Used in Determining When a Consultative Examination Will Be Obtained in Connection With Disability Determinations

§§ 404.1519/416.919 The consultative examination.

Comment:

One commenter suggested adding a provision that a consultative examination may be obtained at the claimant's request.

Response:

The claimant or the claimant's representative may request a consultative examination. However, §§ 404.1517 and 416.917 state that we will not pay for any medical examination arranged by the claimant or his representative without our advance approval.

Comment:

One commenter suggested rewording of the language that a consultative examination "must be obtained" to "should be obtained" since "must" is too directive and rigid. Several commenters indicated that in obtaining additional information readily available from a medical source, trained disability examiners or other professionals are just as effective as doctor-to-doctor contact. One commenter asked if the purchase of a consultative examination should be approved if a telephone contact to the treating source has not first been made. One commenter stated that there should be no instance of recording conversations with a medical source unless that source affirms the substance of any conversation with us by his or her signature.

Response:

As explained above, we have reorganized paragraphs on recontacting medical sources. Paragraphs 404.1519(b) and 416.919(b) as set out in the Notice of Proposed Rulemaking are now §§ 404.1512(e) and 416.912(e), respectively. We believe this reorganization better describes the process of the efforts of requesting existing medical evidence before obtaining a consultative examination. In rewording the new §§ 404.1512(e) and 416.912(e), we deleted the phrase "must be obtained." Reference to doctor-to-doctor contact was also deleted since existing operating instructions indicate that routine requests for needed information can be made by trained disability adjudicators. We have made clear in these final regulations at §§ 404.1512(e) and (f) and 416.912(e) and (f), that before we request a consultative examination we will first recontact the treating source or other medical source to determine whether the information we need is readily available. The decision to purchase a consultative examination will be made after we have given full consideration to whether or not the additional information is readily available from the records of the claimant's medical sources. Such full consideration includes making a telephone contact with the treating source. We agree that the substance of the conversation with a medical source must be affirmed by the source's signature. We cover this in our operating instructions, and we have added this requirement to the final regulations at §§ 404.1512(e)(1) and 416.912(e)(1). Every reasonable effort will be made to obtain the additional information or to obtain the source's signature when medical evidence is obtained over the telephone.

§§ 404.1519a/416.919a When we will purchase a consultative examination and how we will use it.

Comment:

One commenter indicated that the regulations reflect using a medical source other than the treating source to resolve conflicts, perform specialized tests, and to evaluate changes in a claimant's condition. Two commenters stated that there is no basis to seek a consultative examination when there is an indication of a change in the claimant's condition unless the treating source has first been contacted for the information and cannot provide it. Two commenters stated that unless the treating source is first contacted, SSA will not be able to determine that the source cannot reconcile an inconsistency or ambiguity. One commenter stated that the regulations should make clear that "conflict" involves solely a conflict within the medical data already submitted and not between the opinion of nonexamining physicians and the other medical evidence in the case. Two commenters believed that the provisions appear to indicate that a consultative examination will be required regardless of the quality of the evidence in file from a treating source. These two commenters believed that the language in §§ 404.1519a(b)(7) and 416.919a(b)(7) was unnecessarily broad and should be refined or deleted.

Response:

The regulations state that when the evidence we receive is inadequate to allow us to determine whether the individual is disabled, or when the treating source's report or other medical source's report contains a conflict or an ambiguity, we will give every consideration to whether the additional information we need is readily available from the records of the claimant's medical source. Recontact should be made with the treating source or other medical source to determine whether the additional information we need is readily available. We try to make decisions based on the evidence from treating sources because they are often in the best position to provide detailed longitudinal information about a claimant's condition. However, when the source cannot provide the necessary information, we will purchase a consultative examination from the treating source whenever possible, subject to the exceptions noted in §§ 404.1519i and 416.919i of these final regulations. We have made clear in the regulations that when a report from a treating source contains a conflict or an ambiguity, we will give every consideration to first recontacting the treating source for the additional evidence or clarification. The conflict may exist within the medical data or between opinions of the physicians involved in the claimant's case. We will, however, make every reasonable effort to recontact the treating source to resolve the conflict. We agree with the commenter that paragraph (7) of §§ 404.1519a(b) and 416.919a(b), as set out in the Notice of Proposed Rulemaking, should be deleted from these final regulations and have done so.

Comment:

One commenter said that consideration of vocational evidence, as mentioned in the Notice of Proposed Rulemaking, is usually not a factor in deciding whether or not to purchase a consultative examination unless there is evidence of work activity. One commenter stated that considering the vocational background from the background report before purchasing a consultative examination may delay the case and may ultimately be unnecessary.

Response:

We agree with these commenters and have deleted reference to the vocational background report.

§§ 404.1519b/416.919b When we will not purchase a consultative examination.

Comment:

Several commenters believed that the situations given in this section to illustrate when a consultative examination will not be purchased are vague and will result in the improper denial of benefits. Three commenters indicated that clarification is needed regarding issues involving work activity. Three commenters believed that these standards may have a significant negative impact on persons with mental impairments. Several commenters said that the intent and usage of situations (f) and (g) of § 404.1519b need particular clarification on how these situations will be applied.

Response:

These situations are provided as guidelines for us to use in exercising our judgment about obtaining a consultative examination based on the facts of a particular case. We make special efforts to ensure against denial of benefits to all individuals who may be severely impaired and unable to assist us in obtaining evidence, especially those who may be mentally impaired. The SSA field offices are responsible for resolving issues of work activity. Because resolution of the medical issues may be unnecessary, a consultative examination should not be ordered when the State agency recognizes that specific issues concerning evaluation and consideration of substantial gainful activity have not been resolved. We believe our regulations already safeguard against the denial of benefits to the mentally impaired. We have deleted situations (f) and (g), as set out in the Notice of Proposed Rulemaking, from these final regulations because those situations could be subject to misinterpretation.

§§ 416.919c Purchase of title XVI slight impairment examination.

Comment:

Many commenters expressed concern that this section appears to be designed to allow "quick and easy" determinations of nondisability under title XVI. Several commenters disagreed with letting the claimant make the arrangements for his or her own consultative examination. They believed that it is far more important that SSA do "usual development" of these cases in order to document and properly assess them. The commenters noted that this section presumes that if a person applies for Supplemental Security Income benefits because another agency requires a title XVI determination, then the individual suffers from only a slight impairment. One commenter stated that this section is in direct conflict with all of the safeguards established in other sections of the regulations. Some commenters were concerned about the quality of and lack of timeframes for the medical report required under this section. One commenter said that these special procedures should not be mandated, and if implemented, they should be optional.

Response:

We agree that there should not be a different procedure for determinations of nondisability for title XVI claimants than for title II claimants; therefore, we have decided to delete the proposed provision.

§§ 404.1519e/416.919e Purchase of consultative examinations at the reconsideration level.

Comment:

One commenter indicated that the regulations should include the circumstances when a consultative examination will be needed at the reconsideration level. Several commenters stated that the requirement to purchase a consultative examination at the reconsideration level based on a treating source's statement would not be cost-effective or productive if the statement was adequately considered at the initial level. Other commenters stated that it would be inappropriate to allow the same treating source to perform a consultative examination at the initial and reconsideration levels. They believed that the regulations should require that a consultative examination at the reconsideration level be performed by a different physician. Others believed that the purchase of a consultative examination from the claimant's treating physician should be mandatory;

Response:

We have deleted §§ 404.1519e and 416.919e and §§ 404.1519f and 416.919f, as set out in the Notice of Proposed Rulemaking, from these final regulations since we did not intend to create different standards at the reconsideration or other appeals levels. The rules set forth in §§ 404.1519a and 416.919a and §§ 404.1519b and 416.919b of these final regulations for purchasing a consultative examination are applicable at the reconsideration and other appeals levels of review. When the treating source expresses the opinion that the claimant is disabled, a consultative examination may be purchased at the reconsideration level to ensure that all relevant evidence has been obtained and that we have thoroughly reconsidered the claim. We believe it is appropriate to have the same treating source perform the consultative examination, when possible, at both the initial and reconsideration levels because the treating source is often in the best position to provide detailed longitudinal information about a claimant. Therefore, the treating source is the preferred source for a consultative examination at every level of adjudication, subject to the exceptions in these rules.

§§ 404.1519f/416.919f Securing medical evidence at the Administrative Law Judge hearing level.

Comment:

One commenter stated that there should be specific language in this section against administrative law judge ex parte contacts with either treating or consultative physicians. Several commenters stated that this section excuses the administrative law judge from making every reasonable effort to get information from treating sources. Two commenters said that the same provisions for consultative examinations at the reconsideration level should apply at the administrative law judge hearing level.

Response:

Subpart P and subpart I of the regulations are not the appropriate places to state policy on administrative law judge ex parte contacts because ex parte contacts can involve all types of determinations, not only those about disability and blindness. We will consider addressing this issue in Subpart J of the regulations. The agency's "every reasonable effort" standard to help a claimant get medical evidence from his or her own medical source, as set forth in §§ 404.1512(c)(1) and 416.912(c)(1) also applies to the administrative law judge. We did not intend to create different rules for obtaining a consultative examination at the reconsideration and the hearing levels. The rules that apply at the initial level also apply at the reconsideration, administrative law judge and Appeals Council levels of review.

Standards for the Type of Referral and for Report Content

§§ 404.1519g/416.919g Who we will select to perform a consultative examination.

Comment:

One commenter recommended that to allow the State agency to exercise judgment in determining when to order a specific test or a comprehensive examination to determine the person's fitness to undergo the procedures involved in the test or examination, the term "we may" should be substituted for the phrase "we will" purchase only the specific evidence needed. One commenter stated that certain test procedures should never be ordered without a concurrent medical examination.

Response:

The regulations, as well as our operating instructions, clearly intend to allow the State agency to exercise judgment in obtaining only the type of examination and/or test needed for adjudication. We will order only the specific examination or test needed. Sections 404.1519m and 416.919m of these final regulations ensure that certain test procedures that may entail significant risk to the claimant are not ordered for the evaluation of disability. The disability interview form and pertinent medical evidence available permits the examining physician to be aware of the claimant's condition.

Comment:

Several commenters stated that it was unreasonable and virtually impossible to expect monitoring of the credentials of the support staff of consultative examination providers because of their sheer size in numbers, their rapid turnover rate, and the broad range of certifications needed to operate or perform certain functions that would be involved.

Response:

We recognize the overwhelming task it would be for the State agency to monitor continually 100 percent of the support staff of all of their consultative examination providers. We also recognize that this task will become even greater as more new treating sources are used for consultative examinations. However, we are also committed to ensuring that program safeguards are in place. Additionally, congressional concerns have been raised regarding the use of unqualified support staff to assist the consultative examination physician in the examination process. Therefore, we have retained the requirement outlined in this section governing the qualifications of consultative examination providers. We will add to our operating instructions the requirement that each consultative examination panel source provides the State agency for which he or she agrees to do consultative examinations, a signed agreement certifying that all support staff he or she uses in the performance of a consultative examination meet the appropriate licensing or certification requirements of the State. If the State agency discovers a violation of this agreement by a consultative examination provider, it will take appropriate action to ensure that the problem is corrected. If the problem persists, the State agency will cease using that consultative examination provider.

Comment:

One commenter wanted to know who constitutes "support staff" and what documentation of the "appropriate licensing or certification" must be maintained by the State agency. Another commenter indicated that medical sources should be instructed to note on the report when support staff assisted, their qualifications, what they did, and the amount of supervision exercised by the consultative examination provider.

Response:

We have added an example of "support staff" in §§ 404.1519g(c) and 416.919g(c) of these final regulations. We have not adopted the suggestion that consultative examination sources be instructed to note on the report when support staff assisted, their qualifications, what they did, and the amount of supervision exercised by the consultative examination provider. We believe such requirements are excessive because consultative examination sources are already aware of their responsibility and liability for the welfare of the claimant during the consultative examination as well as for the accuracy of the consultative examination report. The consultative examination sources' motivation to maintain qualified support staff will be reinforced by the signed agreement discussed above. This signed agreement will also serve as the documentation maintained by the State agency regarding the qualifications of the support staff used by its consultative examination providers.

Comment:

Two other commenters wanted to know what constitutes the training and experience to perform the type of examination or test requested and how this is to be applied to treating sources selected to perform consultative examinations.

Response:

Where the treating source believes that he or she is experienced in the care of the person with the alleged impairment and is willing and able to do the examination, the treating source will be the preferred source to perform the consultative examination.

§§ 404.1519h/416.919h Your treating physician or psychologist.

Comment:

Some commenters indicated that the policy on utilizing the treating source as the primary source for a consultative examination could reward a treating source who does not submit adequate evidence by purchasing a necessary consultative examination from that source. Two commenters felt this section as written allows SSA to justify excluding most treating sources from use as consultative examiners. Two commenters stated that there should be a provision notifying the claimant of the reasons his or her treating source was not selected to perform the consultative examination;

Response:

There is always the potential that a treating source may not provide us with the existing evidence we need. However, the treating source is the preferred source for a consultative examination. We do not intend this provision to mean that a treating source should not be used for a consultative examination. We see no benefit in notifying the claimant of the reasons why a source other than the treating source was utilized for the consultative examination. The claimant or the claimant's representative retains the right to object to the use of a specific physician.

§§ 404.1519i/416.919i Other sources for consultative examinations.

Comment:

One commenter suggested that the regulations reflect that licensed professional counselors be recognized to perform psychological examinations. Another commenter stated that school officials, clinicians, and others may have critical information needed in the determination of disability.

Response:

Sections 404.1513 and 416.913 of the regulations indicate that we need evidence from acceptable medical sources to determine the existence or severity of an impairment. Since licensed professional counselors are not physicians or psychologists, they cannot serve as consultative examination providers. However, medical evidence from other sources of medical information and evidence from nonmedical persons may be added to the record.

§§ 404.1519j/416.919j Objections to the designated physician or psychologist.

Comment:

Several commenters indicated that there should be guidelines as to how the State agency will process objections based on this provision and how these objections will be fairly resolved. Two commenters stated that there should be a requirement that claimants be informed of their right to object to a consultative examination. One commenter said that the claimant should be provided an opportunity to object to an examination both before and after the examination has occurred. Another commenter stated that the regulations should emphasize that claimants or their representatives have the right to purchase an examination with any physician they choose and to have SSA consider that report in the determination process.

Response:

The regulations and current operating instructions contain guidelines about how objections by the claimant or his or her representative to a specific physician should be handled. Claimants have the right to object to any and every step in the processing of their claims. To single out the consultative examination would appear to give that step undue emphasis or weight in the process;

Sections 404.1517 and 416.917 of these final regulations indicate that the claimant or his or her representative can submit evidence from a purchased examination from the physician of his or her choice. However, we will not pay for any medical examination arranged by the claimant or his or her representative without our advance approval. When the evidence is received, it is considered along with all medical and other evidence in the individual's case record in making a determination as to disability.

§§ 404.1519k/416.919k Purchase of medical examinations, laboratory tests and other services.

Some commenters indicated that SSA should consider issuing its own Federal fee schedule, perhaps based on comparable Medicare reimbursement rates. Some commenters noted that §§ 404.1519k(a) and 416.919k(a) do not consider the problem of a State with such a low fee schedule that poor quality evidence is purchased and recruitment of consultative examination providers is impossible. One commenter stated that the word "nominal" handling fee in paragraph (b)(2) should be better defined. Some commenters were concerned that in paragraph (b)(2), the situation where the examining physician uses an independent laboratory for testing and bills the State agency for a higher amount, was not clearly addressed. There was also some concern that applicant travel costs might increase because the examining physicians would not provide services with these payment restrictions. Some commenters were concerned that paragraph (c) did not fully address how the State could document the rates of payment it uses.

Response:

Under existing regulations, the State determines the rates of payment to be used for purchasing medical or other services necessary to make determinations of disability. The rates may not exceed the highest rate paid by Federal or other public agencies in the State for the same or similar type of service. The States have traditionally been responsible for determining rates of payment. With the exception of a few State agencies and isolated fee schedule problems, this arrangement has worked well over the years. However, SSA is considering whether a maximum fee schedule for laboratory tests, based on Medicare's limitation amounts for laboratory test fee schedules is feasible. We are currently studying the issue and what course of action, if any, we should take.

We do not believe a minimum payment standard is needed for the purchase of medical examinations, laboratory tests and other services. When a State is experiencing problems with poor quality medical evidence because of low payment rates, SSA will try to assist the State agency or its parent agency to correct the problem. We wish to point out, however, that there are many States with low fee schedules that nevertheless obtain high quality evidence. A high rate of payment does not guarantee quality evidence.

We do not believe publishing an exact amount for a physician's handling fee in regulations form is appropriate. We believe determining the actual amount should be based on local circumstances in accordance with general operating guidelines provided by SSA.

We have added clarifying language to this section which provides that when an examining physician uses an independent laboratory for testing, the amount of reimbursement will not exceed the independent laboratory's billed cost of the service or the State's rates of payment, whichever is the lesser amount.

Although some concern was expressed that claimant travel costs might increase because some physicians would not want to work pursuant to these payment restrictions, we do not believe this would outweigh the other considerations of regulating and limiting reimbursement to the service providers within reasonable bounds.

The intent of this section is to ensure that there are no excessive payments or markups for laboratory tests and other services billed by physician providers or laboratories.

For purposes of audit as well as other reasons, State agencies continue to be responsible for documenting the basis for the rates of payment they use. These include such factors as:

1. Blue Cross/Blue Shield physician payment profiles,

2. Rates of payment of other State and Federal agencies using same or similar services (i.e., Medicaid and Medicare),

3. State surveys of physicians, hospitals and laboratory charges,

4. Consumer price index and wage data of the medical community, and

5. Requests by providers for rate changes.

The State agency will be required to submit a copy to SSA of the fee schedule and a statement indicating what methodology was used.

§§ 404.1519 /416.919 Requesting examination by a specific physician, psychologist, or institution—Administrative Law Judge hearing level.

Comment:

Two commenters stated that this section inappropriately limits the administrative law judge's obligation to seek evidence from the treating source. Some commenters indicated that this provision allows the administrative law judge to designate his or her "favorite" physician.

Response:

We have deleted §§ 404.1519 and 416.919, as set out in the Notice of Proposed Rulemaking, from these final regulations since an administrative law judge and the Appeals Council will follow the same procedures for development of evidence and obtaining consultative examinations that are followed at the initial and reconsideration levels. There may be special circumstances aside from those listed in §§ 404.1519a and 416.919a in which an administrative law judge will request a consultative examination; even in these circumstances, the claimant's treating source will be the preferred source for the consultative examination.

§§ 404.1519m/416.919m Diagnostic tests or procedures.

Comment:

One commenter suggested that this section be expanded to ensure that diagnostic procedures of any sort that would be life-threatening will not be ordered. One commenter suggested that this section should include an exhaustive list of diagnostic procedures that are precluded. One commenter stated that the regulations should include a provision for consulting with treating sources prior to ordering extensive and perhaps invasive examinations;

Response:

The intent of this provision is that diagnostic tests or procedures that may be of significant risk to the claimant shall not be ordered. It would be impossible to provide an exhaustive list of diagnostic procedures that are precluded. The situations provided in the regulations are examples of such procedures and are not all-inclusive. Although we do not routinely contact the treating source prior to ordering consultative examinations, sound medical judgment is exercised in determining when to purchase an examination. The medical and/or background report(s) containing information about the claimant will serve as pertinent evidence in determining when an examination should be purchased. As an additional safeguard, we are adding a requirement that a medical consultant must approve the ordering of any diagnostic test or procedure where there is a question of significant risk to the claimant.

§§ 404.1519n/416.919n Informing the examining physician or psychologist of examination scheduling, report content, and signature requirements.

Comment:

Several commenters expressed concern that the solicited "statements of what a person can still do" will cause additional work for the State agency and result in additional difficulty in the decisionmaking process. One commenter suggested that a statement should be added that the physician's opinions must be supported by medical findings. Two commenters stated that the regulations put treating and consultative physicians in a role of assessing residual functional capacity.

Response:

We agree that the solicited statement of what a claimant can still do despite his or her impairment results in additional work for the State agency. But the statements are important to the assessment of residual functional capacity in the decisionmaking process because they are the opinions of medical sources who have examined the claimant. Sections 404.1527 and 416.927 of the final regulations contain policy with respect to treating source opinions. Among other things they provide instructions on evaluating treating source medical opinions with respect to the nature and severity of an impairment that are well-supported by medical findings, those opinions that are not supported by medical findings, and those opinions that are inconsistent with medical or other evidence. We will not request the treating source or consultative examination source to provide a residual functional capacity assessment. The State agency medical or psychological consultant, the administrative law judge, or the Appeals Council is responsible for assessing residual functional capacity. A treating source or consultative examiner will be requested to provide a statement of what work-related activities such as sitting, standing, etc., the claimant can do despite impairments based on his or her knowledge of the claimant. Each statement received will be considered along with the medical and other evidence in arriving at an assessment of the claimant's residual functional capacity based on all of the evidence.

Comment:

One commenter stated that this subsection should indicate that only examining physicians, not nonexamining staff persons, should furnish the statement of what a person can still do despite impairment(s). One commenter said that a similar statement is needed from every treating source;

Response:

The first comment was not entirely clear to us, but we assume that by "nonexamining staff persons" the commenter meant State agency medical or psychological consultants. As we have explained, State agency medical or psychological consultants do not furnish "statements about what a person can still do," which we have defined in §§ 404.1513(b)(6) and 416.913(b)(6) as statements from medical sources based on their own findings.

The firs State agency medical or psychological consultants provide assessments of residual functional capacity, which are formal administrative determinations based on consideration of the entire case record, including the medical and the pertinent nonmedical evidence. The final regulations indicate, in §§ 404.1513 and 416.913, that the statement of what a person can still do despite his or her impairment(s) should be included in medical reports from treating sources or sources of record. The final regulations also provide that the absence of the medical source's statement of what the claimant can still do does not make the medical report incomplete. Additionally, §§ 404.1519n and 416.919n of the final regulations clearly indicate that the statement is to be made by the physician or psychologist who performs the consultative examinations. Also, operating instructions indicate that statements will be solicited from all treating sources and/or consultative examining physicians or psychologists;

Comment:

One commenter suggested that the initial request for evidence to treating sources be more complete;

Response:

The final regulations stress the importance of indicating to the treating source and/or consultative source what a complete examination should contain. We ask the treating source to provide the evidence already in the records of the claimant and a statement of what the claimant can do in spite of his or her impairments(s). Sections 404.1513(b) and 416.913(b) pertain to what a treating source's medical report should include, and §§ 404.1519n(b) and (c) and 416.919n(b) and (c) of these final regulations pertain to the report content for a consultative examiner.

Comment:

Several commenters were concerned with how the State agency would be able to monitor consultative examination scheduling, and one believed it could not be done unless the consultative examination provider scheduled only Social Security referrals. Another commenter stated that the provision setting minimum timeframes for the scheduling of consultative examinations be deleted. This commenter believed that there is no guarantee that any given examination will meet the limits as proposed because much depends on the claimant's subjective perception of the length of the consultative examination.

Concerns were also raised that the consultative examination physician's or psychologist's intelligence would be insulted by the scheduling interval requirements;

Response:

We are committed to protecting the public interest by maintaining program safeguards against overscheduling consultative examinations. Both the Subcommittee on Intergovernmental Relations and Human Resources of the House Committee on Government Operations and the General Accounting Office recommended that minimum scheduling intervals become requirements for consultative examination providers. Therefore, we have retained the scheduling interval requirements in this regulation.

We are aware that in the past the State agencies were heavily dependent upon the claimant's subjective perception of the length of the consultative examination as an indicator that overscheduling of consultative examinations might be occurring. We are also cognizant of the extra work that will be imposed on State agencies in monitoring the new scheduling intervals especially when Social Security claimants represent only a part of the consultative examination provider's caseload. For these reasons, we will add to our operating instructions the requirement that key consultative examination providers will sign a statement of agreement with the State agencies certifying that consultative examinations will not be scheduled any closer together than the minimum timeframes set forth in this regulation.

A State agency will maintain its normal consultative examination oversight activities. If a State agency discovers a violation of the above agreement by a consultative examination provider, it will take appropriate actions to ensure that the problem is remedied. If the problem persists, the State agency will cease using that consultative examination provider.

Finally, there is no intent to demean the intelligence or professional integrity of consultative examination physicians and psychologists by establishing scheduling interval requirements; rather, we believe there is a legitimate need to ensure that sufficient time is allowed for examining the claimant.

Comment:

Several commenters suggested that the word "minimum" precede the scheduling intervals to avoid the misunderstanding that State agency fees can be multiplied incrementally by the specified times. One commenter thought minimum timeframes were a good idea but thought it may be better to also list average times (which will always exceed the minimum) to help avoid examination mills based on the minimum scheduling intervals;

Response:

We adopted the suggestion to add the word "minimum" in front of "scheduling intervals." We did not choose to show average times for scheduling intervals since we believe the minimum times listed are sufficient to prevent overscheduling.

Comment:

Several commenters did not think the difference between a "General Medical Examination" and a "Comprehensive General Medical Examination" was clear, while still another commenter thought the phrase "greater or less frequency," which refers to scheduling intervals of consultative examinations by a consultative provider, was not consistent with the language that preceded it;

Response:

To clarify the potential confusion between the terms "general medical examination" and "comprehensive general medical examination," we deleted "general medical examination" from the list of examinations. In response to the other commenter, we reworded the sentence immediately following the list of examinations to read: "We recognize that actual practice will dictate that some examinations may require longer scheduling intervals depending on the circumstances in a particular situation."

Comment:

One commenter thought that the time spent with the patient face-to-face should be recorded. Another commenter wanted to know if this regulation was actually discussing scheduling intervals or the length of the consultative examination itself. Finally, one commenter questioned whether the scheduling interval times were sufficient if they were to include the administering of needed tests.

Response:

We did not adopt the comment that the time spent face-to-face with the patient be recorded because this section deals with overscheduling of consultative examinations and not with the duration of the examination. We deleted the word "duration" from the title of the section for clarity.

Also for clarity, we have added an explanation that the term "scheduling intervals" pertains to time set aside for the individual, not to the duration of the consultative examination;

These scheduling intervals are minimum time periods, and we contemplate that increased time may be necessary for the administration of additional laboratory tests or procedures.

Comment:

Two commenters expressed concerns with the provision allowing support staff to help perform consultative examinations because they believed this area was open to liberal interpretation and was a potential area for abuse.

Response:

We believe that the concerns raised about the possible liberal interpretation and potential abuse of the provision allowing support staff to help perform consultative examinations are not justified. The assistance to consultative examination providers by their support staff in the performance of a consultative examination has been a part of the consultative examination process since its inception and has worked successfully. As stated previously, the purpose of this regulation is to provide program safeguards to help ensure that when support staff are used, they are properly qualified and the validity of the consultative examination is not jeopardized. The consultative examination provider remains responsible for the examination and must sign the report to attest to that responsibility.

§§ 404.1519o/416.919o When a properly signed consultative examination report has not been received.

Comment:

One commenter indicated that when an unsigned consultative examination report is consistent with existing evidence and supports a favorable decision, another consultative examination should not be obtained when the original consultative examination was performed by a now deceased physician. Two commenters stated that it was unnecessary or not cost-effective to duplicate consultative examinations to obtain signatures.

Response:

We agree that it would be unnecessary to obtain a second consultative examination when a consultative examination performed by a now deceased physician is consistent with existing evidence and supports a fully favorable decision. We have revised the final regulations accordingly at §§ 404.1519o(a) and 416.919o(a). We will not use an unsigned consultative examination report to make disability determinations or decisions that are unfavorable to the claimant. If necessary, and notwithstanding the cost, we will obtain a second consultative examination to obtain a properly signed consultative examination report.

§§ 404.1519p/416.919p Reviewing reports of consultative examinations.

Comment:

One commenter stated that the examples which used "flail limb" and "claw hands" were offensive, were obvious, and reflected physical impairments. Two commenters said that the examples should be expanded to include pain, alcoholism, and depression.

Response:

We have revised the examples to reflect the commenters' suggestions.

Comment:

Several commenters thought that the adequacy of the consultative examination report is determined by SSA standards, not "the course of a medical education."

Response:

The intent here is that the report be made by physicians according to recognized writing standards set by the medical community and the disease, impairments, and complaints are adequately addressed as required by SSA.

Comment:

One commenter stated that this section should include provisions that the claimant or his representative may submit questions to the consultative examiner. One commenter stated that SSA should obtain the claimant's authorization before any report is automatically released to a treating source. Another commenter added that any consultative examination report should be given to the treating source for comments unless the claimant objects;

Response:

We have no objections to the claimant or his or her representative submitting questions to the consultative examiner. We believe, however, that this does not have to be included in regulations. Claimant authorization for providing a copy of the consultative examination report to the treating source is covered in existing operating instructions. However, we are adding language stating our policy on claimant authorization for providing a copy of the consultative examination report to the claimant's treating source as a provision in the final regulation at §§ 404.1519p(c) and 416.919p(c). Our operating instructions also provide that when a claimant attends a consultative examination performed by a nontreating source and returns a completed, signed authorization, a copy of the consultative examination report is then mailed to the treating source. When the consultative examination turns up diagnostic information or test results that indicate a condition that is life-threatening to the claimant, we will refer the consultative examination report to the claimant's treating source regardless of authorization. It is administratively impractical to routinely furnish the consultative examination report to the treating source for comments.

§§ 404.1519q/416.919q Conflict of interest.

Comment:

Two commenters recommended that the "family members" of State agency medical or psychological consultants who cannot hold financial interests in a business which provides consultative examinations in order to avoid a conflict of interest be defined in the regulations.

Response:

We have not adopted the recommendation that "family members" be defined because we prefer to decide on a case-by-case basis whether a conflict exists between the financial interest of a particular family member and the responsibilities of the State agency medical or psychological consultant.

Comment:

One commenter suggested that if State agency review physicians and psychologists get approval to perform consultative examinations, claimants should be notified of this fact so they can object to having their consultative examination performed by the designated physician or psychologist.

Response:

We disagree. We believe that the claimant does not need to know that the physician or psychologist designated to perform the consultative examination is a State agency medical or psychological consultant. In the following situations, State agency review physicians and psychologists might be permitted to perform a consultative examination:

1. When no other physician or psychologist with the prerequisite special expertise is reasonably available. For example, the only psychiatrist in Guam willing to perform consultative examinations is also a State agency review physician. Similar situations exist elsewhere (especially in large and sparsely populated States) where the limited physician population in certain available specialties requires occasional use of a State agency review physician to perform a consultative examination.

2. When to do otherwise would result in inordinate scheduling delays or extensive travel by the claimant.

3. When, despite a large physician population to choose from, no other option is available because of the conditions under which the consultative examination must be performed (e.g., the consultative examination must be performed on a claimant confined in an institution or other facility).

In the above situations, it is to the claimant's advantage to have the State agency review physician or psychologist perform the consultative examination. Regulations §§ 404.1517, 404.1519j, 416.917, and 416.919j, and our operating instructions provide that the claimant or his or her representative will be given the name of the physician or psychologist who will perform the consultative examination and the procedures to follow when the claimant objects to using a specific physician or psychologist.

Comment:

One commenter suggested that we add "financial interest in a corporation" to the list of prohibited financial interests of State agency medical or psychological consultants or their family members to make it clear that "corporations" were included with "medical partnerships" and "similar relationships."

Response:

We agree and have revised the first paragraph of §§ 404.1519q and 416.919q to include the word "corporation."

§§ 404.1519s/416.919s Authorizing and monitoring the consultative examination.

Comment:

Numerous commenters objected to the requirement of medical or supervisory approval of a consultative examination authorization or purchase because it did not recognize the professional competence of experienced disability examiners. One commenter wanted to know if medical or supervisory approval of the authorization of a consultative examination was going to be required for every type of case and every adjudicator regardless of individual consultative examination rates.

Response:

Our basic objective is to regulate to the extent necessary to assure effective, efficient, and uniform administration of SSA's disability programs throughout the United States.

Procedures for medical or supervisory approval of a consultative examination authorization or purchase are necessary for every type of case at the initial and reconsideration levels, including continuing disability reviews, for the following reasons:

1. It serves to help standardize and make less subjective the consultative examination authorization and purchase process by adding an additional level of professional review and control;

2. It will provide additional program safeguards to help ensure that disability claimants are not subjected to unnecessary consultative examinations; and

3. It will serve to keep consultative examination costs down by assuring that only necessary procedures are ordered.

This requirement also allows a State agency flexibility in deciding which professional review (medical or supervisory), or combination thereof, is best for its management of the consultative examination process.

Comment:

One commenter wanted to know if this section applied to open-ended administrative law judge authorizations. (We believe that the commenter was referring to the fact that the State agencies are usually not supposed to question administrative law judge requests for consultative examinations. In other words, such requests are normally open-ended in that they are not restricted by the judgment of the State agencies.)

Response:

Administrative law judge requests for consultative examinations will only need to be approved by a State agency medical consultant when a significant risk to a claimant may be involved if the examination is performed.

Comment:

One commenter acknowledged the importance of onsite reviews but thought they were disruptive to physicians' offices and that too many people on the visiting team would be counterproductive. It was suggested that these reviews be handled more like "visits" rather than "inspections" with no more than two people on the team.

Response:

Comprehensive onsite reviews by SSA are essential to an effective and successful consultative examination oversight process. The Secretary's responsibility for the effective stewardship of SSA's disability programs coupled with SSA's commitment to protect both the public welfare and the trust fund, requires that SSA exercise ongoing consultative examination oversight/quality reviews of every aspect of the consultative examination process, from the consultative examination report to the consultative examination itself. In addition, both Congress and the General Accounting Office have called for the more comprehensive, specific, and uniform consultative examination oversight procedures which are now reflected in this regulation. We expect the high level of scrutiny by the public, Congress, General Accounting Office, and other interested parties will continue. The sensitivities of the medical/professional relationship between the State agency and the consultative examination sources must be held in proper perspective in view of these realities. It is for these reasons that we have retained the consultative examination onsite review requirements as written in the Notice of Proposed Rulemaking. These will be conducted in a professional manner as reviews and not merely as "visits," and the number of review team members will be determined by the scope of that review.

Comment:

One commenter wanted a requirement that the State agency must make unannounced monitoring visits of consultative examination providers, particularly key providers.

Response:

We do not believe that State agencies should routinely conduct unannounced visits to their consultative examination providers. We believe that such a requirement is excessive and would place an unnecessary strain on the State agencies' relationship with their consultative examination providers. On the other hand, we recognize that situations do exist when unannounced visits are warranted and should be made. We believe the State agencies are usually in the best position to judge when this is necessary and they should exercise this option when circumstances indicate it should be used.

Comment:

Several commenters wanted the second condition under the definition of key providers, which lists providers with practices of medicine and osteopathy as possible consultative examination providers, to include psychologists.

Response:

We agree with the comment and have amended the definition of key consultative examination providers to include psychologists.

Comment:

Several commenters expressed concern about the requirement for onsite reviews of key providers where claimants are present, causing interference with the consultative examination and placing undue strain on the claimant.

Response:

Obtaining the views of the claimant on the quality of consultative examination providers is also a vital part of consultative examination oversight. Onsite reviews provide the opportunity for face-to-face interviews with claimants. Generally, our experience has shown that these interviews have no adverse impact on claimants. We believe that the comments from claimants will facilitate more effective management of consultative examination providers, provide incentives to providers to maintain quality examinations, and improve public relations.

Additionally, the General Accounting Office stated in its December 1985 report on the consultative examination process that "claimants' perception of their consultative examination experience is central to the program's overall credibility." We agree, and therefore, have also retained this requirement for procedures for evaluating claimant reactions to key providers. SSA's operating instructions, which were developed to provide the State agencies with specific procedures for evaluating claimant reactions relating to §§ 404.1519s(f)(10) and 416.919s(f)(10), require routine surveys of claimants by using various methods (questionnaire, post card, telephone, personal interview) as soon as possible after the consultative examination is completed and before any decision is made on the claim. The purpose of these surveys is to obtain the claimant's opinion on matters such as ease of location of, and physical access to the consultative examination provider's facility; cleanliness of the facility; courtesy and professional conduct; timeliness and duration of the examination; and privacy of the examination.

Comment:

Another commenter thought that the regulation should be amended to require the State agency to supply the claimant with a copy of the consultative examination report before the State agency interviews the claimant about his or her reaction to a key provider.

Response:

We do not believe that the regulations should be amended to require the State agency to supply the claimant with a copy of the consultative examination report before the State agency interviews the claimant about his or her reaction to a key provider. SSA's basic policy is not to release a consultative examination report directly to the claimant. SSA has procedures to send the consultative examination report to the claimant's treating source when the claimant authorizes SSA to do so, and also has procedures for disclosure of the consultative examination report to the claimant's treating source without consent when the consultative examination uncovers a potentially life-threatening situation. The rationale is that the consultative examination report contains information that may prove harmful to the claimant's mental well-being, or which could be easily misinterpreted by the claimant. SSA believes that, when it is necessary to divulge the contents of the consultative examination report, the information in the consultative examination report should be provided directly to the claimant's treating source because the treating source is in the best position to judge, in each individual case, how to explain the information to the claimant. Additionally, in most cases, the report will not have been completed before the State agency interviews the claimant about his or her reaction to a key provider, and even if it were, we believe that knowledge of its contents may jeopardize the claimant's objectivity.

Comment:

One commenter raised concerns about the requirement of the State agency to orient, train and review the work of new consultative examination providers. This commenter went on to say that this is possible when the number of consultative examination providers is relatively small, but when the range of consultative examination providers is continually expanding to include new treating sources, the burden of training and orienting these potential providers becomes overwhelming. This commenter also thought that this language is unclear and may imply to some readers that the State agency is responsible for medical training of the consultative physician, a responsibility clearly beyond the scope of the State agency.

Two commenters expressed concern that a State could use this requirement to create an obstacle to treating physicians being used as consultative examination sources;

Response:

The intent of the regulation is to provide new consultative examination providers with information on SSA's program requirements involving consultative examination report content, and not to make the State agency responsible for training the consultative physician in medical techniques, which, we agree, is beyond the scope of the State's responsibility. We have clarified the language in §§ 404.1519s(f)(2) and 416.919s(f)(2) of the final regulations to show that only orientation, training, and review of new consultative examination providers are required. Training or review of medical techniques is not included.

We recognize that the universe of consultative examination providers will continue to expand to include new treating sources as the preferred consultative examination providers. However, we also recognize the unavoidable fact that the State agencies must orient, train, and review their consultative examination providers to ensure that they are conducting proper examinations and are providing complete reports containing the necessary medical evidence.

The State agencies should use a common sense approach towards orientation, training, and review of their consultative examination providers based upon their expected frequency of use. For example, a consultative examination physician or psychologist who is a member of the panel of consultative examination providers that the State agency routinely uses should receive more in-depth training, orientation, and review than a treating source who may only be asked to perform a consultative examination occasionally.

Comment:

One commenter thought that, to allow the State agency more latitude, this entire section should be a recommendation rather than a mandate.

Response:

As stated earlier, the Secretary's responsibility for the effective stewardship of SSA's disability programs, coupled with SSA's commitment to manage these programs in a way that will be in the best interest of the public and the trust funds, requires that SSA exercise greater management responsibility for the consultative examination process. Therefore, this section will remain mandatory.

Comment:

One commenter thought the regulations should contain language that a claimant's failure to raise objections at the time of the consultative examination does not waive objections at reconsideration or at the administrative law judge level. This commenter also thought that there should be a requirement that complaints about any provider (key or not) must be referred to the State licensing authority responsible for licensing doctors and psychologists. Another commenter stated that where SSA finds inadequate reports from a consultative examination provider, all cases where the provider was used should be reviewed to see if they should be reopened, and, in cases where the claim is still being considered, or where the decision is made not to reopen, the claimant should be informed. The commenter thought this should be done in all cases where a provider is no longer used because of fraud;

Response:

Although we agree that the claimant's failure to raise objections at the time of the consultative examination does not waive objections at the reconsideration or administrative law judge level, we see no need to include this in the regulations. We see no purpose in referring all complaints about consultative examination providers to the State licensing authority, unless the complaint has something to do with the consultative examination provider's competency to practice. We will refer any question of competency of the physician to the State licensing authority. Where SSA finds inadequate reports from a consultative examination provider, it would be administratively impractical in terms of cost to routinely review all prior cases where that provider was used or to notify the claimant. We would not preclude such review, however. Any case in which there is a question of fraud will be re-reviewed. When a provider is no longer used because of fraud, it would be administratively impractical to routinely review all prior cases when that provider was used.

404.1519t/416.919t Consultative examination oversight.

Comment:

One commenter thought the original intent of these regulations was to monitor the larger State agencies and wanted to know if this was still the situation or would all State agencies be open to consultative examination monitoring by an independent medical source. This commenter also questioned the cost effectiveness of hiring an independent third-party medical specialist. Another commenter wanted to know who the independent medical specialists under contract with SSA were and if the State agency is required to participate in their recruitment. This commenter was also concerned about related budget considerations. Finally, one commenter recommended that such reviews not be mandatory.

Response:

Complete and reliable medical evidence is a key element in making accurate disability decisions. We spend considerable sums annually to obtain consultative examinations. Because of these expenditures and the need to obtain accurate and complete reports, it is imperative that the consultative examinations and the accompanying reports be of the highest quality. Therefore, it is our intent that all State agencies be open to monitoring, including reviews by independent medical specialists under contract with SSA, as the need arises. We believe these contractors will demonstrate their value and cost effectiveness in providing us an objective and credible evaluation of a consultative examination provider's practices and competence, which in turn will help ensure the integrity and public confidence in SSA's disability programs.

The identities of the contractors will be determined through appropriate procedures on an "as needed" basis. The contractors could come from various sources such as insurance companies, the American Medical Association, and the American Psychiatric Association. State agency staff may be asked for their advice in the selection of contractors and in related budget considerations.

We agree with the commenter who indicated that independent reviews should not be made mandatory and we have reflected this change in §§ 404.1519t(a) and 416.919t(a).

Comment:

One commenter thought that comprehensive reviews of the State's consultative examination management and onsite visits of consultative examination providers should be done only at the invitation of State agency staff.

Response:

SSA has the ultimate responsibility for oversight of the consultative examination process. Also, as stated earlier, Congress and the General Accounting Office have called for more comprehensive, specific, and uniform consultative examination oversight. In order to carry out its oversight responsibilities, SSA cannot limit itself to oversight activities solely at the invitation of the State agencies. SSA will undertake comprehensive reviews of State agencies periodically and reserves the right to conduct reviews at such times as necessary to assure compliance with pertinent Federal statutes and regulations;

Comment:

One commenter questioned the significance of including a regional physician in the State agency review process since the commenter felt that the regional physician could only comment on the report format, deficiencies, or how the examination was conducted. Several commenters also thought that the travel and contracting costs for the regional physician would be considerable. Another commenter thought that the requirements for regional office reviews of the State agencies may adversely affect the relationship between State agency medical staff and the consultative examination source as well as constitute a drain on an already strained regional medical consultant time resource.

Response:

We agree with the commenters on the issue of regional physician participation and are therefore, deleting the requirement for participation by the regional medical advisor or a regional physician delegate from the regulation.

We do not believe the State agency review requirements we are imposing will adversely affect the relationship between State agency medical staff and the consultative examination providers. SSA and the State agencies are mindful of the need to preserve and foster a cooperative relationship with the medical community.

§§ 404.1519u/416.919u Direct purchase of medical services across State lines.

Comment:

Several commenters stated that changing our longstanding practice of using the fee schedule of a neighboring State, as the Notice of Proposed Rulemaking provided, when it becomes necessary to use a source in that State for a consultative examination, will create medical relations problems as well as greater cost and delay. According to the commenter, these medical relations problems could occur, for example, when the consultative examination source's payment in the neighboring State's fee schedule is higher than the requesting State's fee schedule.

One commenter also indicated that this is not an aspect of program administration that seriously affects our relationship with the public and that internal program directives and understandings among the States should suffice.

Response:

We agree with the commenters on both points and, therefore, have decided to remove this section from the regulation. States will continue to follow current operating policy in these situations.

§§ 404.1520/416.920 Evaluation of disability.

Comment:

One commenter indicated that mention should be made here of our policy on multiple not severe impairments or a cross- reference to the section.

Response:

We agree with the commenter and have amended §§ 404.1520 and 416.920 to include our policy on multiple not severe impairments.

§§ 404.1527/416.927 Evaluating medical opinions about your impairment(s) or disability.

Comment:

One commenter stated that proposed §§ 404.1527 and 416.927 were beyond the scope of Pub. L. 98-460 and that we did not have the authority to publish these regulations. He argued that section 9 of Pub. L. 98-460 required the Secretary to promulgate regulations addressing the standards for consultative examinations and did not provide authority for promulgating regulations on other issues, such as treating source opinions. The commenter suggested that §§ 404.1527 and 416.927 be withdrawn.

Response:

This section has not been withdrawn as suggested by the commenter. We agree that section 9 of Pub. L. 98-460, which required the Secretary to issue regulations addressing standards for consultative examinations, does not provide specific authority for the issuance of this provision. However, the Secretary has general authority, under section 205(a) of the Act, to promulgate regulations on issues consistent with establishing the right to benefits under the Act. Further, section 221(k) of the Act requires the Secretary to establish, by regulations, uniform standards to be applied to all levels of determination, review, and adjudication in determining whether individuals are "disabled" as defined under the Act.

Comment:

Several commenters argued that our proposed policy in §§ 404.1527(b) and (c) and 416.927(b) and (c) to give "conclusive" weight only to treating source opinions that were "fully supported by medically acceptable clinical and laboratory diagnostic techniques and...not inconsistent with the other substantial medical evidence of record" was unfair and contrary to the view of many circuits. Several commenters pointed out that under the proposed standard such opinions could be viewed as superfluous, since they would follow inevitably from the known facts. Some commenters thought that the proposed standard overlooked the fundamental principle common to decisions in their respective circuits: That treating sources have special knowledge and understanding of their patients by virtue of the treatment relationship. This special knowledge is not necessarily evident in the objective medical findings and cannot necessarily be verified by single examinations, such as consultations, or by simply reviewing medical records. Some commenters thought that the proposed rules would mislead adjudicators into overlooking treating source opinions about their patients' symptomatology. Some thought that the proposed rules would permit us to disregard most treating source opinions. Many of the commenters pointed out that the decisions of their respective circuits required us to adopt certain treating source opinions unless we could overcome the opinions with other substantial evidence.

In addition, some commenters thought that the language of the proposed rule was unclear. They questioned what we meant by the term "fully supported" and how we would determine whether an opinion was fully supported. One commenter expressed a belief that the view of the Second Circuit was based in part on a principle that adjudicators are not experts and are, therefore, not in a position to evaluate whether treating source opinions are supported. Commenters from other circuits generally conceded that opinions were subject to a standard of support and that we were the ultimate finders of the facts. Commenters from the Sixth Circuit stated that the standards for support in their circuit were "sufficient medical data" or "consistent with clinical or laboratory findings." A commenter from the Seventh Circuit stated that the view in that circuit was "fully supported by medically acceptable clinical and laboratory diagnostic techniques and there exists no factual evidence of bias on the part of the treating physician." A commenter from the Tenth Circuit stated that the standard should be that "a treating physician's opinion might be rejected if it is brief, conclusory, and unsupported by medical evidence." However, irrespective of the standards in their individual circuits, all of the commenters were concerned that our proposed rules did not require adjudicators to articulate reasons for rejecting any treating source opinions.

Response:

We believe that we have tried to be responsive to most of the comments we have received on this subject, and that we have crafted a regulation that is fair, balanced, and takes into account the concerns raised by the commenters and by the courts.

As stated above, while the circuit courts vary somewhat in their formulation of a standard on how treating source evidence is to be considered, the majority of the circuit courts generally agree on two basic principles. First, they agree that treating source evidence tends to have greater value by virtue of the treating source's relationship with the claimant, because this relationship allows the treating source to have the best idea of how the physical or mental impairment has affected the claimant. Second, they agree that if the Secretary decides to reject such an opinion, he should provide the claimant with good reasons for doing so. We have been guided by these principles in our development of the final rule.

When we decide claims for disability benefits, we have a responsibility (1) to be impartial; (2) to provide each claimant with the fairest possible assessment of the evidence, and even to assist each claimant in developing the evidence when necessary; and (3) to protect the public interest by providing benefits only to those claimants who are truly disabled;

We have revised our regulations to reflect these responsibilities and to address the concerns expressed by the commenters. Consistent with our responsibility to make correct determinations and decisions, the final rules provide that unsupported opinions cannot be determinative. However, we will never disregard a treating source's opinion, and we will make an effort to obtain evidence from the source in support of the opinion.

Under the law, we are the ultimate deciders of each case. We have, however, indicated when a treating source's opinion will be controlling. When it is not controlling, we have provided several rules which recognize the special status of treating sources, and which accord their opinions greater weight—even when they are unsupported or contradicted—than such opinions would otherwise be entitled to if they came from a nontreating source. Moreover, consistent with the concerns raised by the courts and in public comments, we have required our adjudicators to provide good reasons in their notices of determination or decision whenever they do not find a treating source's medical opinion as to the nature or extent of an impairment to be controlling.

Comment:

Some commenters were concerned that the proposed language of §§ 404.1527(b) and (c), and 416.927(b) and (c) permitted us to discount a treating source's apparently unsupported opinion without recontacting the source, and that the rules placed highly restrictive conditions on obtaining additional information from treating sources.

Response:

To the contrary, recontact with treating sources to complete the case record and to resolve any inconsistencies in the evidence is one of the principal provisions of this set of rules. See §§ 404.1512(d) and 416.912(d) of these final regulations. Far from being restrictive, the intent of these rules is to require such contacts.

Comment:

One commenter thought that the language of §§ 404.1527(b) and (c), and 416.927(b) and (c) would encourage the inefficient and costly use of consultative examinations.

Response:

This was not our intent. Our revisions to the regulations at §§ 404.1519a and 416.919a clarify when a consultative examination will be needed to complete a case record or to help resolve any inconsistencies. If there is sufficient evidence in the case record to decide all of the issues, we will not obtain a consultative examination.

Comment:

Several commenters expressed concern that, because our proposed definition of treating source in §§ 404.1502 and 416.902 seemed to exclude sources who had treated claimants in the past but who no longer maintained treatment relationships, many source opinions that should be deserving of special weight would not be entitled to such weight under proposed §§ 404.1527 and 416.927.

Response:

We did not intend to exclude sources who had provided treatment in the past. We have, therefore, revised our definition in §§ 404.1502 and 416.902 to include former treating sources, and it should be understood that the provisions of §§ 404.1527 and 416.927 will apply to opinions from these sources.

Comment:

Commenters from the Second, Sixth and Tenth Federal Judicial Circuits expressed concern about the phrase "some extra weight" given to the supported opinions of treating sources when resolving an inconsistency with the evidence of record in proposed §§ 404.1527(d) and 416.927(d), stating a belief that the standard implied by the term was inconsistent with the views of their respective circuits. One commenter stated that the standard was contrary to the views of all relevant circuits. Other commenters stated that the phrase was unclear and that it would be difficult to apply.

Response:

The term "some extra weight" was actually taken from a case on treating source evidence in the Second Circuit, Schisler v. Heckler, 787 F.2d 76, 81, (2d Cir., 1986). See also, Schisler v. Bowen, 851 F.2d 43, (2d Cir., 1988). However, we agree with the commenters that the term "some extra weight" may be unclear. We have, therefore, clarified the regulations by deleting the phrase and adding more detail to the rules.

We believe that the revisions make clear that our policy provides a very specific and detailed process for evaluating medical opinions, a process that takes into account and, in large measure, was shaped by, the kinds of concerns raised by the circuit courts. If a particular treating source is an individual who is more familiar with a claimant's medical condition, we will always give special deference to the source's opinions about the nature and degree of a claimant's impairment(s). If such an opinion is well-supported by medically acceptable clinical and laboratory diagnostic techniques and is not inconsistent with other substantial evidence in the record, we will give it controlling weight. However, a treating source's opinion does not have to be consistent with other substantial evidence, and it does not necessarily have to be supported by objective evidence in order to receive some special deference.

We will give greater weight to a well-supported medical opinion from a treating source than to an equally well-supported medical opinion from another source that is inconsistent with the treating source's opinion. Moreover, in recognition of the special kind of knowledge and understanding of a claimant's condition that only a treating source can have, we will also give greater weight to a treating source's medical opinion that is not well-supported than we would otherwise have given it if it had come from a nontreating source. We will also never reject a treating source's opinion simply because it is not well-supported or because it conflicts with other substantial evidence. We will try to recontact the source to obtain additional evidence—which may consist of nothing more than a more detailed explanation—in support of the opinion or to resolve the conflict.

Comment:

One commenter thought that the example we proposed in §§ 404.1527(d) and 416.927(d) which describes a case involving arthritis of the shoulder presumed that a treating source has the burden of justifying his or her opinion while a consultative examiner need not give any such justification.

Response:

We certainly did not intend to give the impression arrived at by the commenter, but agree that the example could be misinterpreted. We have therefore deleted the example and provided more detailed rules. In general, we will not give great weight to any opinion, including a treating source's opinion, unless we can understand the basis for the opinion, either by reviewing the complete case record or by obtaining an explanation from the medical source who offered the opinion.

Comment:

A significant number of the commenters took issue with the statement in proposed §§ 404.1527(e) and 416.927(e) that we would "not consider as conclusive nor give extra weight to medical opinions which are not in accord with the statutory or regulatory standards for establishing disability." Some commenters thought that this meant we would disregard any treating source opinions that were not couched in the exact terminology of the law or regulations; others thought that the provision meant that we would never give any extra weight to such opinions. In support of their interpretation of the language, several commenters pointed to the second example at the end of the paragraph.

Response:

We agree with the commenters that the proposed language could be misinterpreted, and have therefore deleted the examples and replaced the entire section with new §§ 404.1527(e) and 416.927(e). We did not intend to suggest a policy that would permit adjudicators to ignore or reject any opinion evidence on the grounds that the opinions used the wrong terminology.

Our final rule affirms that the ultimate determination of disability is the Secretary's responsibility, and clarifies our policy on how we consider opinions about "disability," "inability to work," and other issues reserved to the Secretary, including determinations about meeting or equalling the Listings, residual functional capacity, the ability of claimants to perform their past relevant work, and the ability of claimants to adjust to other work considering their residual functional capacity together with their age, education, and work experience. However, in response to the comments, we have also added language to §§ 404.1527(e)(2) and 416.927(e)(2) to indicate that we will never disregard an opinion about an issue that is reserved to the Secretary. Furthermore, as we will do in any case in which we have a treating source opinion that is not otherwise controlling and that requires further explanation, we will attempt to recontact the treating source who offers an opinion on any of these issues for additional evidence or explanation whenever necessary. We will always provide an explanation in our notice of determination or decision of our reason why we have not adopted a treating source's opinion.

Comment:

One commenter noted that §§ 404.1527(e) and 416.927(e) addressed opinions about meeting the Listings but failed to acknowledge our own provisions for evaluating equivalencies.

Response:

The commenter was correct. We have included equivalency in our revision of §§ 404.1527(e) and 416.927(e).

Comment:

Two commenters argued, in identical language, that the proposed rules in §§ 404.1527(e) and 416.927(e) would permit us simply to disregard a treating source's opinion about whether a claimant's impairment(s) meets or equals the Listings and stated that the proposal "ignores one of the most important sources of expert testimony" on whether a claimant's impairments are equivalent to the requirements for any listed impairment. A third commenter submitted what appeared to be a paraphrase of the comment submitted by the other two commenters. All three urged that the provision be withdrawn.

Response:

As we have indicated in previous responses, it was not our intention to create a rule that would permit adjudicators to "disregard" or "ignore" any treating source opinions for any reason. We have revised the language of §§ 404.1527(e) and 416.927(e) to make this clear.

However, we did intend to restate in the regulations our policy that determinations of meeting the Listings and equivalency are reserved to the Secretary. We agree with the commenters that meeting the Listings is more a question of medical fact than a question of medical opinion. In most instances, the requirements of listed impairments are objective, and whether an individual manifests these requirements is simply a matter of documentation. To the extent that treating sources are usually the best sources of this documentation, we look to them for evidence with which we can determine whether an individual's impairment meets the Listings, and such evidence can have great weight in our determination. When a treating source provides an opinion based on evidence that demonstrates that an individual has an impairment that meets a listing, we will ordinarily adopt the opinion unless we have a good reason to doubt it. However, since meeting the Listings is an ultimate conclusion about disability, it is our responsibility and we cannot give any special weight to treating source or any other medical source opinion about whether an individual's impairment meets the requirements of the Listings of Impairments.

We do not agree with the comment which suggests that the concept of equivalency is strictly medical and, therefore, within the expertise of treating sources. When we address equivalency as a "medical consideration" in §§ 404.1526 and 416.926, and as a determination "based...on medical facts alone" in §§ 404.1520(e) and 416.920(e), we mean to distinguish Listings determinations from determinations which consider the nonmedical factors of past work experience, age, and education. In fact, determinations of equivalency are not solely medical; they also require familiarity with our regulations, with which most physicians lack expertise. They involve findings not only about the nature and severity of medical impairments, including associated signs, symptoms and laboratory findings, but also about whether the findings comport with a legal standard of severity that is not generally understood by most physicians who are not employed by the Social Security Administration; Social Security's concept of "equivalency" is not taught in medical school, and it is not part of the normal practice of medicine.

We do consider treating sources to be important sources of expert testimony on the nature and severity of a claimant's impairments. Moreover, we will always carefully consider treating source opinions about whether a claimant's impairment(s) meets or equals the requirements of the Listings. However, although treating source opinions that an impairment(s) meets or equals the Listings may be considered to be important expert testimony, we do not consider them to be controlling. Such an opinion, if controlling, would amount to a determination that a claimant is under a disability. Under the law, only the State agency or the Secretary can make that determination. Moreover, as the first two commenters pointed out in a separate comment, "[v]ery few treating physicians are experts at the complexities of the Social Security disability standards."

When a treating source offers an opinion that a claimant's impairment or impairments are equivalent in severity to an impairment in the Listings, we will evaluate all of the evidence to determine if it supports that opinion. If the evidence does not support the opinion and we cannot ascertain from the record the basis of the treating source's opinion, we will make every reasonable effort to recontact the source for clarification of the reasons for the opinion. Also, if after the recontact we do not agree with the opinion, we will provide an explanation of our reasons for not adopting the opinion in our notice of determination or decision, as we will do whenever we do not give a treating source's opinion controlling weight. When we weigh the opinion, we will apply all of the applicable rules in §§ 404.1527(d) and 416.927(d), which may require us to give deference to treating source opinions on issues which relate to the ultimate conclusion of whether a claimant's impairment(s) is equivalent to a listed impairment, such as issues about diagnosis, symptoms, and prognosis; but we will not give special weight to any opinion on the ultimate conclusion regarding whether the impairment(s) is equivalent.

Comment:

In connection with Example 2 in proposed §§ 404.1527(e) and 416.927(e), two commenters questioned the propriety of entrusting the responsibility for assessing residual functional capacity to State agency physicians and psychologists. Both suggested that treating sources should be asked to provide the assessments; one requested that we amend our rules to require State agencies to obtain such assessments from treating sources whenever appropriate. Both commenters indicated that residual functional capacity assessments made by nonexamining medical sources or other personnel are given little or no weight by the courts. One of the commenters also questioned how assessments of residual functional capacity made by disability hearing officers, administrative law judges, and the Appeals Council, all of whom are nonmedical adjudicators, could override an opinion about a claimant's work capabilities submitted by a treating source.

Response:

We have deleted both of the examples we proposed and have revised and expanded the text of the rules.

Our regulations contain provisions describing two kinds of assessments of what a person can do despite the presence of a severe impairment(s). One assessment, described in §§ 404.1513(b) and (c) and 416.913(b) and (c), is the "statement about what you can still do" submitted by medical sources, including treating sources and consulting examiners. Medical sources offer these statements based upon their own records and examinations to express opinions about claimants' abilities to perform work-related activities on a sustained basis. Although we will not consider reports from medical sources to be incomplete without such statements, these final rules provide that we will always request the statements.

The second kind of assessment is the residual functional capacity assessment. "Residual functional capacity assessment" is a term of art in §§ 404.1545 and 416.945 and 404.1546 and 416.946 intended to describe the ultimate finding about a person's ability to do work-related activities. It is a determination made by an adjudicator based upon his or her review of the entire case record. Residual functional capacity assessments are based upon consideration of all relevant evidence in the case record, including medical evidence of which an individual treating source may not be aware, and relevant nonmedical evidence, such as observations of lay witnesses of a claimant's apparent symptomatology, a claimant's own statement of what he or she is able or unable to do, and many other factors that could help an adjudicator determine the most reasonable findings in light of all of the evidence.

Thus, a medical source's statement about what an individual can still do is opinion evidence that an adjudicator considers together with all of the other evidence when assessing a claimant's residual functional capacity. However, a State agency medical or psychological consultant's assessment constitutes the findings of an adjudicator based on all the evidence in file and cannot be considered evidence by the State agency. It cannot be weighed against the opinion of a medical source in the case file at the initial and reconsideration levels, since the State agency medical or psychological consultant is participating in the determination at those levels.

The administrative determination of a claimant's residual functional capacity may be the most critical finding contributing to the final decision. We do ask treating sources to provide us with their opinions about their patients' functional abilities based upon the information they are competent to assess, their own knowledge of their patients, and we weigh these opinions carefully. However, we would be abrogating our responsibility under the law to decide cases independently if we were to adopt the suggestion that we ask treating sources to make the ultimate determination of residual functional capacity for us. The State agency medical or psychological consultant, the administrative law judge, or the Appeals Council is responsible for assessing residual functional capacity.

We follow a special procedure at the hearing and appeals levels. Since administrative law judges consider the issues that are before them de novo, that is, as though the cases were being decided for the first time, findings made by State agency medical or psychological consultants are not binding on them. Because State agency medical or psychological consultants are highly qualified physicians or psychologists and are experts on our program, administrative law judges may not ignore their findings; instead, we require administrative law judges to give consideration to these findings and to evaluate them using the same rules as apply to the evaluation of opinions of nonexamining medical sources. Of course, since administrative law judges decide the issues of disability de novo, they will not consider any State agency findings about whether an individual is or is not disabled, except for opinions about whether the individual has an impairment(s) equivalent to any listed impairment as required by §§ 404.1526 and 416.926. The same rules apply to the Appeals Council when it issues a decision. We have added new §§ 404.1512(b)(6) and 416.912(b)(6) and a new paragraph (f) to §§ 404.1527 and 416.927 to explain these longstanding policies.

We agree with the commenters that it is probably true that the courts usually give less weight to the opinions of nonexamining sources than to the opinions of treating or other examining medical sources. In fact, these final regulations take this into account. The regulations provide progressively less rigorous tests for weighing opinions as the ties between the medical source and the claimant become progressively stronger. We generally give the most weight to the opinions of treating sources who have known their patients for long periods or who otherwise have expert knowledge of their patients that cannot be obtained through single examinations or a brief relationship. The opinions of physicians or psychologists who do not have a treatment relationship with the claimant are weighed by stricter standards, based to a greater degree on medical evidence, qualifications, and explanations for the opinions than are required of treating sources or other examining sources. The opinions of nonexamining sources can be given weight only insofar as they are supported by evidence in the case record. This is not to say that opinions from nonexamining sources cannot outweigh the opinions of treating sources; rather, that we require adjudicators to have solid, well-articulated reasons when they determine that the opinions of nonexamining sources are entitled to greater weight than the opinions of treating sources;

§§ 404.1545/416.945 Your residual functional capacity.

No comments were directed to this section.

§§ 404.1546/416.946 Responsibility for assessing and determining residual functional capacity.

Comment:

Several commenters suggested amending this section to be consistent with work simplification initiatives, to have the residual functional capacity assessment prepared by a disability examiner for review and approval by the State agency medical consultant. One commenter said that evidence from workshops and psychologists should be recognized and included in preparing residual functional capacity assessments instead of restricting it to medical evidence.

Response:

The work simplification initiative referred to in the comment has been discontinued. There will be no change in the regulatory language because the State agency medical consultant is the person responsible for assessing residual functional capacity. A residual functional capacity assessment is based on all of the medical and other relevant evidence included in an individual's case file. Therefore, if evidence from a workshop or psychologist is in the individual's case file, it will be considered along with the other evidence of record. Observations of the individual's work limitations in addition to those usually made during formal medical examinations may also be used.

§§ 404.1593/416.993 Medical evidence in continuing disability review cases.

Comment:

One commenter stated that this section should be revised to be consistent with other related sections of the regulations. This same commenter stated that the termination of benefits should not occur if a beneficiary unsuccessfully attempts to obtain reports from treating sources.

Response:

The rules for development of medical evidence that apply in determining initial disability also apply to that portion of the continuing disability review which involves consideration of the individual's current impairments. We have revised this section to be consistent with §§ 404.1512 and 416.912 of the regulations. We make special efforts to ensure against ceasing benefits solely because the beneficiary is unable to furnish evidence from a source for reasons beyond the beneficiary's control.