81 FR 86915 - Revised Medical Criteria for Evaluating Human Immunodeficiency Virus (HIV) Infection and for Evaluating Functional Limitations in Immune System Disorders
SOCIAL SECURITY ADMINISTRATION Federal Register Volume 81, Issue 232 (December 2, 2016)
Federal Register Volume 81, Issue 232 (December 2, 2016)
| Page Range | 86915-86928 | |
| FR Document | 2016-28843 |
[Federal Register Volume 81, Number 232 (Friday, December 2, 2016)] [Rules and Regulations] [Pages 86915-86928] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28843] ======================================================================= ----------------------------------------------------------------------- SOCIAL SECURITY ADMINISTRATION 20 CFR Part 404 [Docket No. SSA-2007-0082] RIN 0960-AG71 Revised Medical Criteria for Evaluating Human Immunodeficiency Virus (HIV) Infection and for Evaluating Functional Limitations in Immune System Disorders AGENCY: Social Security Administration. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: We are revising the criteria in the Listing of Impairments (listings) that we use to evaluate claims involving human immunodeficiency virus (HIV) infection in adults and children under titles II and XVI of the Social Security Act (Act). We also are revising the introductory text of the listings that we use to evaluate functional limitations resulting from immune system disorders. The revisions reflect our program experience, advances in medical knowledge, our adjudicative experience, recommendations from a commissioned report, and comments from medical experts and the public. DATES: These rules are effective January 17, 2017. FOR FURTHER INFORMATION CONTACT: Cheryl Williams, Office of Disability Policy, Social Security Administration, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1020. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213, or TTY 1-800-325-0778, or visit our Internet site, Social Security Online, at http://www.socialsecurity.gov. SUPPLEMENTARY INFORMATION: Background We are revising and making final the rule for evaluating HIV infection we proposed in a Notice of Proposed Rulemaking (NPRM) published in the Federal Register on February 26, 2014 (79 FR 10730), and a correction to the proposed rule on March 25, 2014 (79 FR 16250). Even though this rule will not go into effect until January 17, 2017, for clarity, we refer to it in this preamble as the ``final'' rule. We are making several changes in this final rule from the NPRM based upon some of the public comments we received. We are also making minor editorial changes throughout this final rule. We explain these changes below in the ``Summary of Public Comments on the NPRM'' section of this preamble. The preamble to the NPRM provided an explanation of the changes from the current rules and our reasons for proposing those changes. To the extent that we are adopting the proposed rule as published, we are not repeating that information here. You can view the NPRM by visiting http://www.regulations.gov and searching for document SSA-2007-0082. Why are we revising the listings for evaluating HIV infection? We are revising the listings for evaluating HIV infection to reflect our program experience and advances in medical knowledge since we last revised the listings related to HIV infection, recommendations from a commissioned report,\1\ and a number of public comments. We received comments from medical experts and the public at an outreach policy conference, in response to an Advance Notice of Proposed Rulemaking (ANPRM),\2\ and in response to the NPRM. Although we published final rules for immune system disorders on March 18, 2008, that included changes to listings 14.08 and 114.08,\3\ the criteria in the current HIV infection listings are not substantively different from the criteria in the final rules we published on July 2, 1993.\4\ We indicated in the preamble to those rules that we would carefully monitor these listings to ensure that they continue to meet program purposes, and that we would update them if warranted. --------------------------------------------------------------------------- \1\ Institute of Medicine. (2010). HIV and Disability: Updating the Social Security Listings. Washington, DC: The National Academies Press. \2\ 73 FR 14409. \3\ 73 FR 14570. \4\ 58 FR 36051. --------------------------------------------------------------------------- Other Information In the NPRM, we proposed to remove listing 114.08H for evaluating growth disturbance with an involuntary weight loss (or failure to gain weight at an appropriate rate for age) that meets specified criteria. We proposed instead to evaluate this impairment under a growth impairment listing in 100.00 or a digestive system listing in 105.00. On April 13, 2015, we published a final rule for growth disorders and weight loss in children in 100.00 that retained a listing in 114.00 for growth failure due to HIV immune suppression.\5\ We are repeating that listing here for clarity. We have redesignated the listing as 114.11I and the related introductory text as 114.00F7. --------------------------------------------------------------------------- \5\ 80 FR 19522. --------------------------------------------------------------------------- Summary of Public Comments on the NPRM In the NPRM, we provided the public with a 60-day comment period, and we subsequently extended the comment [[Page 86916]] period to May 27, 2014. We received 68 comments from 22 commenters. The commenters included advocacy groups, legal services organizations, State agencies, a national group representing disability examiners in State agencies that make disability determinations for us, medical organizations, and individual members of the public. We carefully considered all of the comments relevant to this rulemaking. We have condensed and summarized the comments below. We present the commenters' concerns and suggestions, respond to all significant issues that are within the scope of this rule, and provide our reasons for adopting or not adopting the recommendations in our responses below. We received several comments supporting our proposed changes. We appreciate those comments; however, we did not include them. Other comments were on subjects not related to the proposed rule. Although we read and considered these comments, we did not summarize or respond to them below because they are outside the scope of this rulemaking. Documentation Comment: Several commenters disagreed with our proposal to remove guidance in the current introductory text that instructed our adjudicators how to consider documentation of HIV infection and manifestations of HIV infection that does not include the results of definitive laboratory testing. Two of these commenters urged us to retain language from the introductory text that explains that we will consider documentation of HIV infection and manifestations of HIV infection that is consistent with the prevailing state of medical knowledge and clinical practice. They also noted that one of the examples of a manifestation of HIV infection in 14.11I, lipodystrophy, is generally diagnosed by clinical observations instead of by a laboratory test. Another commenter requested clarification about making a disability determination when we cannot obtain definitive evidence or a persuasive report from a physician of a manifestation of an HIV infection. Response: We agree with these comments and have retained the current language in the introductory text for non-definitive documentation of HIV infection and manifestations of HIV infection. This guidance is found in 14.00F1c(ii) and 114.00F1c(ii) for documentation of HIV infection, and 14.00F2c(ii) and 114.00F2c(ii) for manifestations of HIV infection. We have also noted in 14.00F3 and 114.00F3 that, to establish a diagnosis of the disorders that we discuss in the section, we will accept other generally acceptable methods that are consistent with the prevailing state of medical knowledge and clinical practice. Retaining this language provides adjudicators with the information needed to make a disability determination when we cannot obtain either definitive evidence or a persuasive report from a physician of HIV infection or a manifestation of HIV infection. We have removed the statement ``we will not purchase laboratory testing to establish whether you have HIV infection'' from listing sections 14.00F1b and 114.00F1b, because it implies that we will never pay for diagnostic laboratory HIV testing. Instead, we have clarified that while we will not pay for diagnostic laboratory HIV testing as standard practice because our rules do not require claimants to have definitive laboratory testing documenting the existence of HIV to qualify for disability, we will purchase laboratory HIV testing under limited circumstances. Specifically, if the existing evidence is not sufficient for us to make a disability determination decision, and no other acceptable documentation exists, we will purchase the examinations or laboratory tests necessary to make a determination in your claim. At times, a specific laboratory test may be necessary to make a determination in a claim, such as a CD4 count that helps to predict clinical outcomes for a person living with HIV. Similarly, we removed the proposed language in 14.00F2b and 114.00F2b, and that indicated we would not purchase laboratory testing for manifestations of HIV infection. These sections now clarify we will purchase such laboratory tests when they are a necessary part of the disability determination process. Comment: One commenter asked whether we will use the degree of viremia (the presence of viruses in the blood) for the HIV p24 antigen (p24Ag) test to assess the severity of infection. Response: We did not make any changes in response to this comment. We cannot use HIV p24Ag to assess the severity of HIV infections because it is an inadequate indicator of immune suppression. In this final rule, we include criteria based on CD4 levels, which is a better measurement of immune suppression. However, we may accept a positive finding on HIV p24Ag testing as documentation of an HIV infection. Comment: One commenter was concerned that we are making assumptions about individuals and their levels of function based on blood tests and counts. Response: We have not made any changes in response to this comment. We do not, and will not, require blood tests in order for an HIV- related impairment to satisfy a listing or to find a person with an HIV infection to be disabled. Only listings 14.11F, 14.11G, 114.11F, and 114.11I require a CD4 count to meet the listing. We have set these criteria based on recommendations from experts in the field of HIV infection who believe that it would be appropriate to find people whose CD4 counts meet the requirements are disabled. However, these listings are not the only way that we may find a person with HIV infection to be disabled. If a person's impairment(s) does not meet or equal the severity of a listing, we may find that he or she is disabled at later steps of the sequential evaluation process. Comment: One commenter noted that proposed listings 14.11A-E and 114.11A-E rely heavily on information located in the proposed introductory text for proper application and understanding. This commenter recommended we revise these listings to include this guidance. The commenter also provided language for these suggested revisions. Response: We have adopted the commenter's suggested revisions. We have added the commenter's language to clarify that we only consider multicentric Castleman disease under 14.11A and 114.11A. In addition, we have also incorporated the commenter's suggestion to note that the values required by 14.11G do not have to be measured on the same date. We have also made appropriate conforming changes to the introductory text. Comment: One commenter opined that our proposed revisions discriminate against the poor, as the criteria include medical tests, such as HIV nucleic acid tests by polymerase chain reaction and examination of cerebral spinal fluid, and hospitalizations that many individuals cannot afford and that we are not willing to purchase. The commenter notes that, ``although some of the simpler tests may be available through public health departments and charity clinics, these organizations usually cannot afford to provide any of the more expensive tests and charity clinics are not . . . available in many areas.'' The commenter also requests that we delete the hospitalization criterion from the proposed listings, as we will not pay for hospitalizations. [[Page 86917]] Response: We did not adopt this comment. The Social Security Act and our regulations require medical evidence to establish a medically determinable impairment. We use medical evidence generally accepted in the medical community and available in medical records to establish and evaluate an impairment. We look at all available evidence about all of the claimant's impairments, not just information about a particular allegation such as HIV infection. We may find a person disabled even if he or she does not have a medical diagnosis for his or her impairments when applying for benefits, as long as we are able to establish a medically determinable severe physical or mental impairment or combination of impairments that meets the duration requirement. In response to public comments and as discussed above, we have retained the guidance in the introductory text that explains we will accept non-definitive evidence of HIV infection or manifestations of HIV infection. This will allow us to establish HIV infection and manifestations of HIV infection more easily without definitive tests. We will accept a persuasive report from a physician that a positive diagnosis of your HIV infection was confirmed by an appropriate laboratory test(s), such as those described in 14.00F1a. To be persuasive, this report must state that you had the appropriate definitive laboratory test(s) for diagnosing your HIV infection and provide the results. The report must also be consistent with the remaining evidence of record. We may also document HIV infection by the medical history, clinical and laboratory findings, and diagnoses indicated in the medical evidence, provided that this documentation is consistent with the rest of the medical evidence and the prevailing state of medical knowledge and clinical practice. For example, we will accept a diagnosis of HIV infection without definitive laboratory evidence of the HIV infection if you have an opportunistic disease that is predictive of a defect in cell-mediated immunity (for example, toxoplasmosis of the brain or Pneumocystis pneumonia (PCP)), and there is no other known cause of diminished resistance to that disease (for example, long-term steroid treatment or lymphoma). In such cases, we will make every reasonable effort to obtain full details of the history, medical findings, and results of testing. In the NPRM, we had proposed to accept only definitive tests as evidence of HIV infection or manifestations of HIV infection. Many of the tests that the commenter specifically named were these definitive tests. Allowing adjudicators to establish HIV infection or manifestations of HIV infection without the requirement of a definitive test result helps to allay concerns about the accessibility of tests that we had proposed to require. Furthermore, the hospitalization criterion is just one of multiple ways adjudicators can find a person is disabled in the sequential evaluation process.\6\ The hospitalization criterion is an advantage to a person who applies for disability benefits because it adds another way we may find him or her disabled at the third step of the sequential evaluation process, but it is not the only way we can find a person with HIV infection to be disabled. If a person with HIV infection meets our requirements for disability, but has not been hospitalized to the extent required by our listings, we can find that he or she is disabled based on a finding of medical equivalence, by meeting other listings, or at a later step in our adjudication process. These other mechanisms for finding a person is disabled help to account for the variation of claimants' access to medical treatment. --------------------------------------------------------------------------- \6\ See 20 CFR 404.1520 and 416.920 for the sequential evaluation process we use to determine disability for adults and 20 CFR 416.924 for the sequential evaluation process we use to determine disability for children. --------------------------------------------------------------------------- CD4 Counts Comment: A number of commenters provided suggestions related to our use of CD4 counts versus CD4 percentages in the proposed listings. One commenter requested that we provide a CD4 percentage for 14.00F1 that would be equivalent to an absolute CD4 count of 50 cells/mm\3\ or less. Two commenters requested that we make changes to proposed 114.11F in order to have greater consistency between the childhood and adult HIV listings. These commenters stated that in the proposed listings, children from birth to the attainment of age 5 may rely on a CD4 percentage of less than 15 percent to establish disability under 114.11F1 or 114.11F2, while children age 5 to the attainment of age 18 may rely only on an absolute CD4 count of 50 cells/mm\3\ to meet the listing. The commenters stated that they believe that children ages 5 to 18 should be able to use CD4 percentage in order to be consistent with the adult listing. Response: We will not add a CD4 percentage that is equivalent to an absolute CD4 count of 50 cells/mm\3\ or less, because there is no precise correlation between the two measurements. With regard to the commenters' concerns about consistency between the adult and childhood listings involving CD4 measurements, we believe that the commenter may have misread the proposed rule. We note that the criterion based on absolute CD4 measurement alone for adults, like that for children from age 5 to the attainment of age 18, does not include a CD4 percentage. The IOM indicated to us that CD4 levels in children correspond with adult levels by the age of 5 and that absolute CD4 count is generally the preferred metric for these age groups. Therefore, we believe that it is appropriate for the criterion for children in this older age group to mirror that for adults and require this type of measurement. Furthermore, 14.11G for adults, which was the only current or proposed adult criterion that includes CD4 percentage, requires a CD4 measurement (either absolute count or percentage) in conjunction with either a BMI measurement of less than 18.5 or a hemoglobin measurement of less than 8.0 grams per deciliter. The final rule for evaluating growth disorders and weight loss in children, published April 13, 2015, made changes to the immune system listings, which were not in the NPRM.\7\ Under current listing 114.08H for immune suppression and growth failure, we may find a child to be disabled based on a combination of CD4 measurement and growth failure (based on weight-for- length percentiles or body mass index (BMI), depending on age). For children age 5 to the attainment of age 18, the CD4 measurement may be an absolute count or a CD4 percentage. In this final rule, that listing will become 114.11I. Although 14.11G and 114.11I are not analogous (as we do not evaluate adults under listings related to growth impairments), we point this out to show the commenter that there are listings for both adults and children in which we consider CD4 percentages. --------------------------------------------------------------------------- \7\ 80 FR 19522. --------------------------------------------------------------------------- Comment: Two commenters disagreed with our proposal to require a single CD4 measurement under proposed listings 14.11F and 14.11G. One commenter remarked that this proposal is different from other listings in which we require two measurements at least 60 days apart and is inconsistent with our durational requirements. The other commenter noted that ``[a]dvances achieved with the availability of highly active antiretroviral therapy (HAART) have dramatically changed the prognosis and functional impact of HIV infection.'' Two commenters expressed concerns about establishing a 12-month [[Page 86918]] period of continuous disability based on one CD4 count alone, and one of the commenters suggested adding another CD4 count, hemoglobin level, or BMI assessment to the listing criteria. One commenter also suggested that we provide specific guidance in relation to low CD4 counts for claimants who do not have access to medical care. The commenter noted that such claimants would be expected to have a more aggressive clinical course of infection. Three commenters stated that claimants may present for medical care with very low CD4 counts, at which point a diagnosis of HIV infection would be made and treatment initiated. With treatment, the claimant's CD4 count would be expected to rise due to the suppression of HIV infection. Response: We have not adopted these comments. Anyone who meets the requirements in 14.11F or 14.11G occurring within the period that we are considering in connection with his or her application or continuing disability review, has an impairment of listing-level severity that will satisfy our duration requirement, whether or not he or she is receiving medical care. Even though a person's absolute CD4 count or percentage, BMI, or hemoglobin may increase with treatment, the person's immune deficiency will continue with an increased risk of morbidity and mortality for a continuous period of at least 12 months, which satisfies our duration requirement. Comment: One commenter recommended that we explain in the introductory text that adjudicators can use the lowest values within the entire rating period for CD4 count and BMI or hemoglobin levels to evaluate an impairment. The commenter was concerned that adjudicators might misinterpret the listings to mean these findings must occur simultaneously. Response: We adopted the comment by making changes to 14.00F5 to explain that the CD4 count and claimant BMI or hemoglobin levels evaluated under 14.11G do not have to be measured on the same date. Comment: One commenter noted that proposed listings 14.11F and 14.11G use the lowest absolute CD4 count or CD4 percent as the basis for allowance. This commenter requested that we clarify the guidance in the proposed introductory text that these measurements ``must occur within the period we are considering in connection with [the claimant's] application or continuing disability review.'' Response: We did not adopt this comment because it is already considered by our program rules. We are generally required to develop a complete medical history for at least 12 months preceding the month of the date of application. We will remind adjudicators about periods of consideration during our training on the HIV listings. Comment: One commenter stated that ``there are a number of HIV- infected individuals who have [a BMI of less than] 20 and are severely malnourished, but who fall short of the requirements under [proposed] 14.11G.'' This commenter asked that we ``consider adding a listing for [claimants] who have a BMI [greater than] 18.5 and [less than] 19, with a history of a documented current opportunistic infection and an absolute CD4 count of [less than] 200 in the [adjudicative timeframe].'' Response: We did not adopt the comment. The criteria in proposed 14.11G are appropriate for establishing listing-level severity when considering CD4 and BMI or hemoglobin measurements, as these data are highly predictive of an impairment that we consider disabling. We do not believe the findings proposed by the commenter will generally indicate an impairment that is severe enough to prevent an individual from doing any gainful activity. Moreover, we believe that the impact of adopting this comment would be negligible. Nevertheless, we may find that an individual who meets the criteria suggested by the commenter is disabled at steps 4 or 5 of our sequential evaluation process. Comment: One commenter pointed out that after the publication of our NPRM, the Centers for Disease Control and Prevention (CDC) published a surveillance case definition that extended CD4 counts and percentages to children as well as adults and adolescents.\8\ This updated case definition ``determines the stage of HIV infection in children age 6-12 years in the same way as adults and adolescents.'' Additionally, the commenter stated that staging is primarily based on the CD4 count, which takes precedence over the CD4 percentages; the percentage is considered only if the count is missing. The commenter requested that we make conforming changes to all instances of the listings in which we refer to a CD4 count or percentage. The commenter also wished to note that the CD4 number is the most important measurement and that the CDC made changes for the percentage ranges for immunosuppression in all age groups. --------------------------------------------------------------------------- \8\ Selik, R.M., Mokotoff, E.D., Branson, B., Owen, S.M., Whitmore, S., & Hall, H.I. (2014). Revised Surveillance Case Definition for HIV Infection--United States, 2014. Morbidity and Mortality Weekly Report (MMWR), 63(RR03), 1-10. --------------------------------------------------------------------------- Response: We did not adopt the comment. We use CD4 measurements for a different purpose than the CDC does in their surveillance case definition for HIV infection. The CDC provides surveillance case definitions only for public health surveillance purposes. We have provided CD4 counts in our listings to correspond to a specific level of impairment, which the CDC does not take into account in its surveillance case definitions. However, we have added CD4 counts in the final rule to HIV listings 114.11F1 for children from birth to attainment of age 1 and 114.11F2 for children from age 1 to attainment of age 5. Comment: One commenter recommended that we ``should not depend exclusively on CD4 count or [our] list of fatal or severely disabling HIV-related conditions'' when determining eligibility for benefits.'' The commenter noted that ``some people that live with HIV/[acquired immunodeficiency syndrome] (AIDS) with CD4 counts above 50 are very ill and not able to seek gainful employment,'' and asked that our ``adjudicators take into account all fatal or very debilitating conditions when determining . . . eligibility for benefits.'' Response: Although we agree that we should not depend exclusively on CD4 count in order to determine eligibility for benefits, we did not make any changes to our listings and note that our regulations include criteria reaching beyond the stated value. At step 3 of our five-step disability determination process, we consider whether the claimant's impairment(s) meets (or medically equals) any of the listings. Many listing criteria do not require a specific diagnosis or laboratory level. For example, the criteria in 14.11I allow us to consider all manifestations of HIV infection that result in significant, documented signs and symptoms and marked limitation in function. If we do not find that a claimant is disabled at step 3, we must still consider whether he or she is disabled at steps 4 or 5 of our sequential evaluation process.\9\ We always consider all of a person's impairments when determining whether he or she is disabled, not just the impairments that are in our listings. --------------------------------------------------------------------------- \9\ We evaluate disability differently for children under the age of 18. If we do not find that the child's impairment(s) meet or medically equal a medical listing at step 3, we will consider whether the impairment(s) functionally equal the listings. Steps 4 and 5 do not apply. 20 CFR 416.924, 416.926a. --------------------------------------------------------------------------- [[Page 86919]] Complications and Manifestations Comment: Two commenters recommended that we clarify the difference between complications of HIV infection in proposed listing 14.11H, which is based on multiple hospitalizations, and manifestations of HIV infection in proposed listing 14.11I, which is based on functional limitations. We provide examples of complications of HIV infection in the introductory text at 14.00F6 and examples of manifestations of HIV infection in listing 14.11I itself. These commenters noted that some of the conditions given as examples of complications in 14.00F6 are not provided as examples of manifestations in 14.11I, and considered this to be confusing. One of the commenters believed that ``any `complication' severe enough to result in hospitalization could also be severe enough to cause functional limitations and thus, should be referenced in the list of manifestations in 14.11I.'' Response: We agree with the commenters and have revised listing 14.11I so that the list of manifestations includes all examples of complications given in 14.00F6. Comment: Three commenters suggested that we consider signs or symptoms of HIV infection and adverse effects of HIV treatment instead of solely considering repeated manifestations of HIV infection when considering an impairment under proposed listing 14.11I. One commenter provided specific text for a suggested edit to this proposed listing that reflected consideration of signs and symptoms of HIV infection as well as the adverse effects of HIV treatment. Another commenter noted that, in particular, symptoms of HIV infection that are not the direct result of a manifestation of HIV infection, such as fatigue, malaise, and pain, would not be considered under 14.11I. Response: We did not adopt the comments. We require both repeated manifestations of HIV infection as well as a functional impairment in order to satisfy the criteria under 14.11I because both are necessary to reflect a level of impairment that indicates listing-level severity. If we find that a person's impairment does not meet listing 14.11I (or any of our listings), we will continue to apply the remaining steps in our sequential evaluation process to determine whether the person is disabled. In current 14.00G, which we did not propose to change and therefore did not include in the NPRM, we provide instructions on how we consider the effects of treatment, including adverse effects, in evaluating autoimmune disorders, immune deficiency disorders, or HIV infection. In current 14.00J, which we also did not propose to change and therefore did not include in the NPRM, we provide instructions on how we evaluate immune system disorders (including HIV infection) when it does not meet one of the listings. We apply these instructions when a person manifests signs or symptoms of HIV infection that are not specifically named in the HIV listings. Comment: One commenter was critical of the proposed listings, stating they discriminate in favor of those with only severe manifestations of HIV. The commenter stated that ``HIV infection can have a wide variety of manifestations such as diarrhea, fever, headache, thrush, skin rashes, weakness, weight loss, and dementia,'' and ``these problems can be compounded by the coexistence of a wide variety of heart, lung, orthopedic, mental and other disorders.'' The commenter noted the proposed listings do not include most of these possible combinations, and felt the proposed listings discriminate against those with combinations of manifestations of HIV infection and other disorders. Response: We did not make any changes in our final listings in response to these comments because we consider all of a claimant's impairments, related or unrelated to HIV infection, when determining whether a person is disabled.\10\ We explain in section 14.00I3 that adjudicators may consider multiple types of manifestations of HIV infection when determining whether a person's impairment meets listing 14.11I. While we do not consider impairments other than manifestations of HIV infection when evaluating whether a claimant's impairment meets listing 14.11I, the listings are only step 3 of our five step disability determination process. The purpose of these listings is to quickly identify impairments that we consider severe enough to prevent a person from doing any gainful activity, without the need to evaluate vocational factors. We may still find a person disabled later in our sequential evaluation process even if we find that his or her impairments do not meet or medically equal a listing. --------------------------------------------------------------------------- \10\ We evaluate disability claims for children from birth to the attainment of age 18 differently. Steps 4 and 5 of the adult sequential evaluation process do not apply. After we consider whether the child's impairment(s) meets or medically equals a listing, we consider whether the child's impairment(s) functionally equal a listing. --------------------------------------------------------------------------- Comment: One commenter requested that we add language to note that proposed listing 14.11I ``does not contain an exhaustive list of conditions that may qualify under step 3 of the sequential evaluation process.'' Response: We adopted the comment and have added wording to clarify that the examples given in 14.11I are not an exhaustive list. Comment: A number of commenters noted that HIV infection may also accelerate or interact with impairments in other body systems. One of these commenters stated that our proposed rule ``does not account for those individuals whose HIV disease effectively accelerates the onset of conditions such as diabetes, heart disease, or kidney disease.'' Two commenters asked that we include cardiovascular conditions in the list of manifestations of HIV infection in proposed 14.11I. These commenters cited the report on HIV and disability that we commissioned from the Institute of Medicine (IOM), which states ``an increased risk for cardiovascular disease in HIV-infected populations as compared with HIV-negative populations has been well documented.'' \11\ These commenters noted that the IOM report states, ``[cardiovascular disease] is also a leading cause of death in those infected with HIV, with an analysis of the Data Collection on Adverse Events of Anti-HIV Drugs Study finding that 11 percent of HIV-positive people die of a cardiovascular condition.'' \12\ --------------------------------------------------------------------------- \11\ Institute of Medicine. (2010). HIV and Disability: Updating the Social Security Listings. Washington, DC: The National Academies Press. \12\ Id. --------------------------------------------------------------------------- Two other commenters recommended that we include a cross-reference to the cardiovascular listings to ensure that adjudicators ``consider the impact and interplay of HIV infection and associated cardiovascular conditions.'' These commenters also suggested that we should cross- reference hepatitis in the HIV listings. Response: We agree with the comments and have added language to final 14.00J2 and 114.00J2 to note that HIV infection may affect the onset or course of, or treatment for, conditions in other body systems, such as cardiovascular disease and hepatitis. We have also revised 14.11I to provide examples of cardiovascular manifestations of HIV infection. Comment: One commenter requested that we either eliminate our proposed criteria in 14.11H regarding duration and intervals between hospitalizations or add language that instructs adjudicators to defer to the treating physician with regard to the medical [[Page 86920]] severity of the claimant's condition instead of relying on the hospitalization criteria for the listing. The commenter believes that we are incentivizing claimants to opt for longer hospital stays or abstain from treatment to prove the severity of their conditions and meet the listing criteria. Response: We did not adopt the comment. In our experience, individuals do not opt for unwarranted hospital stays or forgo treatment in order to possibly qualify for disability benefits. The benefit of having a listing that captures more disabled individuals at step 3 of our sequential evaluation process outweighs the concern that particular claimants may attempt to lengthen hospital stays or abstain from treatment to meet the listing. We believe that a complication(s) of HIV infection that warrants three hospitalizations of 48 hours or longer, 30 days or more apart, within a 12 month period that we are considering in connection with an application or continuing disability review will prevent a person from engaging in any gainful activity and, therefore, represents listing-level severity. Moreover, we are able to evaluate complications of HIV infection resulting in fewer than three hospitalizations in a consecutive 12-month period using medical equivalence, the other listing criteria for adults, the functional equivalence rules for children, or at other steps in our sequential evaluation process. For example, the criteria in listing 14.11I evaluate the functional impact of the person's impairment in the broad areas of activities of daily living, social functioning, and concentration, persistence, or pace, including the functional impact of treatment such as repeated outpatient visits for complications. Our medical equivalence rules permit us to find that a disorder is medically equivalent to a listing at step 3 if there are other findings related to the disorder that are at least of equal medical significance to the listing criteria (see Sec. Sec. 404.1526 and 416.926). Although some of our listings include criteria for repeated hospitalizations (14.11H and 114.11G), our medical equivalence policy accommodates recent trends in clinical care that emphasize quality of, rather than quantity of, medical treatment. The medical equivalence policy also accommodates claimants' varying level of access to medical care, the preference of some medical providers to reduce the use of emergency department and hospital-level medical interventions, and recent trends in clinical care that emphasize quality of, rather than quantity of, medical treatment. This accommodation accounts for differences in medical care people with similar disorders receive depending on the medical resources available to them. The medical equivalence policy provides some flexibility in determining whether a claimant is disabled at step 3 of the sequential evaluation process by allowing us to consider whether the claimant's impairment meets the listed criteria exactly or is at least equal in severity and duration to the criteria of any listed impairment. If we are not able to find that a person's impairment due to HIV infection is disabling using our listings, we may still find the person disabled at the final steps of the sequential evaluation process. Finally, the commenter's suggestion that we defer to the treating physician with regard to the medical severity of a person's condition in lieu of hospitalization frequency and duration in this listing means that we would be permitting the physician to determine whether the person is disabled. Under our rules, the finding of disability is an issue reserved to the Commissioner of Social Security.\13\ --------------------------------------------------------------------------- \13\ See 20 CFR 404.1527(c) and (d) and 416.927(c) and (d). --------------------------------------------------------------------------- Comment: One commenter requested that we train adjudicators to evaluate repeated manifestations of HIV infection correctly. The commenter states that, under the current listings, they ``rarely see adjudicators willing to approve claims of individuals with HIV based on repeated manifestations of [HIV infection].'' Response: We did not make any changes in our final listings as a result of this comment. We will provide training on the new listings, as we do for all listing updates. We will also conduct a study on the use of the listings after they have been in use for a year, as we do for all listing updates, and issue further training or policy guidance if needed. Comment: One commenter recommended that the introductory text be improved by adding a more significant definition of multicentric Castleman disease (MCD), particularly how it is very similar to a lymphoma, although it is not actually a cancer. Response: We adopted the comment and have provided expanded definitions for MCD in 14.00F3a and 114.00F3a. Function Comment: One commenter requested that we provide language to clarify that the examples in the introductory text of complications of HIV infection that may result in hospitalization are ``not an all- inclusive or inflexible list.'' Response: We adopted this comment and have provided text in 14.00F6b and 114.00F5b to indicate that the examples in 14.00F6a and 114.00F5a are not an exhaustive list. Comment: One commenter agreed with our revisions to section 14.00I5 of the introductory text to clarify our explanation of the term ``marked,'' but suggested that we construct ``this change in a manner that facilitates a better process for determining the `severity' of the disability.'' Response: We did not adopt this comment. We provide guidance in current sections 14.00I5 through 14.00I8 that explains how we take into consideration a ``marked'' level of limitation in functioning to determine the severity of a person's impairment. This guidance is sufficient to allow adjudicators to evaluate the functional limitations resulting from HIV infection and other immune system disorders. Comment: Two commenters asked that we ``recognize the validity of an HIV treating physician's objective evaluation of a patient's HIV- related functional limitations.'' They remarked, ``HIV affects individuals differently according to physiological and biological factors unique to the individual,'' and that ``responses to treatment, including side effects, vary greatly according to sex, age and co- occurring conditions.'' These commenters provided specific text that they wanted us to add to proposed listing 14.11I. The proposed text would instruct adjudicators to give special consideration to the opinion(s) of a claimant's primary care provider, in particular, an experienced HIV medical provider. Response: We did not adopt the comment. When we evaluate medical opinions, such as those described by the commenters, we consider several factors. Those factors include the treating relationship between the opining medical source and the claimant, how much the medical source's treatment records support the medical opinion, and the consistency of the medical opinion with the other evidence throughout the record as a whole, including a claimant's self-reporting.\14\ This is true for all impairments across all body systems, not just in cases involving HIV infection. --------------------------------------------------------------------------- \14\ See 20 CFR 404.1527(c) and 416.927(c). --------------------------------------------------------------------------- Additionally, the finding about whether a claimant is or is not disabled is an issue reserved to the Commissioner. We do not give any [[Page 86921]] special significance to the source of a statement on an issue reserved to the Commissioner, even if that source is a medical source who has treated the claimant.\15\ --------------------------------------------------------------------------- \15\ See 20 CFR 404.1527(d) and 416.927(d). --------------------------------------------------------------------------- Comment: One commenter suggested that we expand the role of evidence of a claimant's functional limitations, as required under 14.11I, from sources other than those that we consider acceptable medical sources. The commenter urged us to ``immediately adopt the IOM recommendation to expand acceptable medical sources to a wide array of licensed professionals and broaden the acceptable medical sources rule and guidance.'' Response: We did not adopt the comment because it is outside the scope of this rulemaking. However, under our rules, we may use evidence from sources other than acceptable medical sources in order to show the severity of a person's impairment and how that impairment affects the individual's ability to function.\16\ For example, we might request evidence from a social worker or another medical or professional source who has been treating a claimant, because this evidence can provide information about the claimant's functional capabilities. Other sources of evidence that we may consider include counselors, family members, caregivers, or neighbors. --------------------------------------------------------------------------- \16\ See 20 CFR 404.1513(d) and 20.CFR 416.913(d). --------------------------------------------------------------------------- Comment: One commenter disagreed with our proposal to remove diarrhea as a standalone listing (current listing 14.08I). The commenter stated that ``diarrhea is a `manifestation' of HIV infection that does not result in a corresponding `sign or symptom', and, at [a] certain degree of severity, automatically results in a marked functional limitation.'' The commenter suggested that we retain and revise the current standalone listing for diarrhea, and provided specific language for the revision. Response: We did not adopt this comment. While we agree that diarrhea is a manifestation of HIV infection that may result in a marked functional limitation, we do not believe it is best evaluated under a standalone listing. We agree with the recommendation of the IOM that diarrhea should be evaluated using functional impairment criteria.\17\ We have specifically listed diarrhea as an example of a manifestation of HIV infection that may be evaluated under 14.11I. --------------------------------------------------------------------------- \17\ Institute of Medicine. (2010). HIV and Disability: Updating the Social Security Listings. Washington, DC: The National Academies Press. --------------------------------------------------------------------------- Comment: Two commenters requested that we revise proposed listing 14.11I for clarity, to include ``neurocognitive or other mental limitations (including dementia, anxiety, depression, or other mental impairments not meeting the criteria in 12.02, 12.03, 12.04, or 12.06).'' Response: We did not add references to the specific mental disorders listings requested by the commenters, because doing so would appear to restrict the mental disorders we would consider under 14.11I to those specific conditions. Instead, we added language to 14.11I to clarify that we may consider any neurocognitive or other mental limitations not meeting the criteria in 12.00. Comment: One commenter asked how we would implement the evaluation of a neurocognitive limitation under proposed 14.11I and whether its presence in a claim would necessitate review of the case by a psychological consultant. Response: We did not make any changes in the final rule based on this comment. The need for a psychological consultant review depends on the facts in the individual case. The neurocognitive limitations provided as an example under listing 14.11I are considered a manifestation of HIV infection. We evaluate medical evidence based on the underlying disorder. If the level of limitation is such that we consider the neurocognitive limitation to be a mental impairment on its own, then a psychological consultant (or a medical consultant who is a psychiatrist) would review the case. Specific Groups With HIV Infection Comment: Numerous commenters disagreed with our proposal to remove the text in current section 14.00F4 about manifestations of HIV infection that are specific to women and requested that we restore this language in the final rule. The commenters were concerned that adjudicators who are unfamiliar with HIV infection may not immediately recognize that certain signs and symptoms are related to HIV infection in women. They believed that retaining the current language would help to instruct adjudicators to acknowledge and take these signs and symptoms into account as manifestations of HIV infection in women when making disability determinations. Response: We adopted these comments and have placed this guidance in section 14.00F7 of the final rule. Additionally, we have added language to 14.11I specifically noting that certain gynecologic conditions may be manifestations of HIV infection. Comment: One commenter recommended that we consider including the adolescent population more specifically in the listings. The commenter stated that youth ages 13 to 25 years ``constitute the fastest growing and largest group of new HIV infections in the United States.'' The commenter feels the listings ``should take into account adolescents who are transitioning from the Part B listings for children to the Part A listings for adults so that HIV-infected youth are not lost to care.'' Response: We did not adopt this comment. The Part A and Part B listings for adults and children are very similar and closely parallel one another. In addition, under our rules, we may use the criteria in Part A when those criteria give appropriate consideration to the effects of the impairment(s) in children.\18\ --------------------------------------------------------------------------- \18\ See 20 CFR 404.1525(b)(2) and 20 CFR 416.925(b)(2)(i). --------------------------------------------------------------------------- Other Body Systems Comment: One commenter suggested that we remove the information in the proposed revisions to 5.00D4 of the introductory text about how comorbid disorders, such as HIV infection, may affect chronic viral hepatitis infections. The commenter stated that the language ``does not provide meaningful guidance for the listings themselves.'' Response: We did not adopt the comment. We have based our final revisions on recommendations in the IOM report.\19\ These revisions also align with the requests of a number of commenters. In the introductory text, we include information that will be useful to our adjudicators when they evaluate impairments in a particular body system. Comorbid disorders, such as HIV infection, do have an impact on chronic viral hepatitis infections, and their presence can affect how we evaluate an impairment under the digestive body system. --------------------------------------------------------------------------- \19\ Institute of Medicine. (2010). HIV and Disability: Updating the Social Security Listings. Washington, DC: The National Academies Press. --------------------------------------------------------------------------- General Comments Comment: Two commenters made suggestions regarding setting diaries for continuing disability review (CDR) under the HIV/AIDS listings. One commenter recommended that ``individuals with HIV/AIDS associated malignancies have markedly improved survival rates,'' and suggested that ``these impairments should be assessed with the same three-year review diary as outlined for primary malignancies in the [cancer (malignant neoplastic)] listings.'' The other commenter suggested that all [[Page 86922]] HIV/AIDS listings should have a three-year review diary, with the decision to continue or cease benefits defined by the medical improvement review standard (the legal standard for determining whether disability continues in a CDR). The commenter noted ``the specter and presence of an indicator disease no longer portends a poor prognosis,'' and stated that ``improvements in medical care, HAART, and improved survival rates support the need for [a CDR].'' Response: We did not adopt these comments. We do not specify a particular period of disability in the medical listings unless we can uniformly expect medical improvement for an impairment in a specific listing such that a person would no longer be disabled (for example, listing 6.04 for chronic kidney disease with kidney transplant). This is not the case for the impairments in the listings for HIV infection. We will address any new considerations for diary length and CDRs related to HIV infection in our internal policy guidance, as we normally do. Comment: One commenter expressed concern that we do not provide quantitative data to show the validity of any of our proposed listings. The commenter stated that ``hundreds of thousands of individuals engage in substantial gainful activity while meeting requirements of [other] listings,'' such as hearing loss not treated with cochlear implantation. The commenter requested that we state the information and methods that we used to develop the listing criteria, and questioned whether it is ``possible to evaluate a person's ability to engage in gainful activities using . . . the listings.'' Response: We did not make any changes in the final rule based on this comment. In the NPRM, we provided a list of specific references that we used to inform the changes that we proposed.\20\ In this final rule, we are making changes to the proposed rule based on comments that we received in response to the NPRM. The listings in this final rule represent impairments that we consider severe enough to prevent a person from engaging in any gainful activity. --------------------------------------------------------------------------- \20\ 79 FR 10730. --------------------------------------------------------------------------- Comment: One commenter noted that medications for HIV infection affect people in different ways and may cause a person's other psychological and physical issues to worsen. Response: We did not make any changes in the final rule based on this comment. We take the effects of treatment, including medications for HIV infection, into account when evaluating a case. This guidance is provided in section 14.00G of the introductory text, which was not shown in the NPRM because we did not propose to change it. Specifically, in 14.00G5, we explain how we evaluate the effects of treatment of HIV infection, including the effects of antiretroviral drugs, on the ability to function. Comment: One commenter believed that the language in proposed listing 14.11I is unclear and discussed concerns with how we would apply the rule. The commenter requested that we clarify the listing by adding additional text noting that we consider more than repeated manifestations of HIV (for example, ``significant, documented manifestations, symptoms, or signs'') under 14.11I and asks that we provide training to our adjudicators to properly consider these criteria. Response: We did not make any changes in the final rule based on this comment. Our proposed language is clear and captures the intent of the listing. The changes that the commenter suggests would alter the meaning of the listing, not clarify it. We will address the concerns with the application of the rule in training for our adjudicators. Comment: One commenter requested that we provide our disability examiners with more training in evaluating a claim involving HIV infection and applying the HIV infection listings. Response: We did not make any changes in the final rule based on this comment. As we do with all updates to the listings, we will provide our disability examiners with training on the final rule for evaluating HIV infection. Other Changes In the NPRM, we proposed to remove listing 114.08L for evaluating functional limitations resulting from HIV infection in children. We explained that we were not including similar criteria in proposed listing 114.11 for HIV infection in children because of proposed changes in the mental disorders listings and because we may find children disabled under the Supplemental Security Income program based on functional equivalence to the listings.\21\ However, we did not propose to revise 114.00I, which notes the childhood listings that we use to evaluate functional limitations under the immune body system, to reflect the removal of 114.08L. After we published the NPRM, we published a final rule for evaluating mental disorders, which removed 114.08L as well as other childhood listing criteria that considered functional limitations under the immune disorders body system. In this final rule, we revised paragraph 114.00I to address how we will consider the impact of immune system disorders, including HIV, on a child's functioning. --------------------------------------------------------------------------- \21\ See 20 CFR 416.924(d). --------------------------------------------------------------------------- In order to provide consistent guidance, we are also making conforming changes to the listings for hematological disorders in 7.00A2 and 107.00A2 to explain that we will evaluate primary central nervous system lymphoma and primary effusion lymphoma associated with HIV infection under 14.11B, 14.11C, 114.11B, and 114.11C, respectively. When will we begin to use this final rule? We will begin to use this final rule on its effective date. We will continue to use the current listings until the date this final rule becomes effective. We will apply the final rule to new applications filed on or after the effective date of this final rule and to claims that are pending on or after the effective date.\22\ --------------------------------------------------------------------------- \22\ This means that we will use this final rule on and after their effective date, in any case in which we make a determination or decision. We expect that Federal courts will review our final decisions using the rules that were in effect at the time we issued the decisions. If a court reverses our final decision and remands a case for further administrative proceedings after the effective date of this final rule, we will apply this final rule to the entire period at issue in the decision we make after the court's remand. --------------------------------------------------------------------------- How long will this final rule be in effect? This final rule will remain in effect for 3 years after the date it becomes effective, unless we extend the expiration date. We will continue to monitor the rule and may revise it, as needed, before the end of the 3-year period. What is our authority to make rules and set procedures for determining whether a person is disabled under the statutory definition? Under the Act, we have full power and authority to make rules and regulations and to establish necessary and appropriate procedures to carry out such provisions. Sections 205(a), 702(a)(5), and 1631(d)(1). Regulatory Procedures Executive Order 12866, as Supplemented by Executive Order 13563 We consulted with the Office of Management and Budget (OMB) and determined that this final rule meets the [[Page 86923]] criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB reviewed it. Regulatory Flexibility Act We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it affects individuals only. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis. Paperwork Reduction Act These Final Rules do not create any new or affect any existing collections, and therefore, do not require OMB approval under the Paperwork Reduction Act. (Catalog of Federal Domestic Assistance Program Nos. 96.001, Social Security--Disability Insurance; 96.002, Social Security--Retirement Insurance; 96.004, Social Security--Survivors Insurance; and 96.006, Supplemental Security Income). List of Subjects in 20 CFR Part 404 Administrative practice and procedure, Blind, Disability benefits, Old-age, Survivors, and Disability insurance, Reporting and recordkeeping requirements, Social Security. Carolyn W. Colvin, Acting Commissioner of Social Security. For the reasons set out in the preamble, we are amending 20 CFR part 404 subpart P as set forth below: PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950-) Subpart P--Determining Disability and Blindness 0 1. The authority citation for subpart P of part 404 continues to read as follows: Authority: Secs. 202, 205(a)-(b) and (d)-(h), 216(i), 221(a), (i), and (j), 222(c), 223, 225, and 702(a)(5) of the Social Security Act (42 U.S.C. 402, 405(a)-(b) and (d)-(h), 416(i), 421(a), (i), and (j), 422(c), 423, 425, and 902(a)(5)); sec. 211(b), Public Law 104- 193, 110 Stat. 2105, 2189; sec. 202, Public Law 108-203, 118 Stat. 509 (42 U.S.C. 902 note). 0 2. Amend appendix 1 to subpart P of part 404 by: 0 a. Revising item 15 of the introductory text before part A; 0 b. Revising the last sentence of paragraph 5.00D4a(i) of part A; 0 c. Revising paragraph 5.00D4b of part A; 0 d. Revising paragraph 7.00A2 of part A; 0 e. Revising the last sentence of paragraph 8.00D3 of part A; 0 f. Revising paragraph 13.00A of part A; 0 g. Revising paragraphs 14.00A4, 14.00F, and 14.00I1 of part A; 0 h. Revising the first two sentences of paragraph 14.00I5 of part A; 0 i. Removing the first three sentences of paragraph 14.00J2 of part A and adding two sentences in their place; 0 j. Removing and reserving listing 14.08 of part A; 0 k. Adding listing 14.11 to part A; 0 l. Revising the last sentence of paragraph 105.00D4a(i) of part B; 0 m. Revising paragraph 105.00D4b of part B; 0 n. Revising paragraph 107.00A2 of part B; 0 o. Revising the last sentence of paragraph 108.00D3 of part B; 0 p. Revising paragraph 113.00A of part B; 0 q. Revising paragraphs 114.00A4, 114.00F, and 114.00I of part B; 0 r. Removing the first two sentences of 114.00J2 of part B and adding three sentences in their place; 0 s. Removing and reserving listing 114.08 of part B; and 0 t. Adding listing 114.11 to part B. The revisions and additions read as follows: Appendix 1 to Subpart P of Part 404--Listing of Impairments * * * * * 15. Immune System Disorders (14.00 and 114.00): January 17, 2020. * * * * * Part A * * * * * 5.00 Digestive System * * * * * D. * * * 4. * * * a. * * * (i) * * * Comorbid disorders, such as HIV infection, may accelerate the clinical course of viral hepatitis infection(s) or may result in a poorer response to medical treatment. * * * * * b. Chronic hepatitis B virus (HBV) infection. (i) Chronic HBV infection can be diagnosed by the detection of hepatitis B surface antigen (HBsAg) or hepatitis B virus DNA (HBV DNA) in the blood for at least 6 months. In addition, detection of the hepatitis B e antigen (HBeAg) suggests an increased likelihood of progression to cirrhosis, ESLD, and hepatocellular carcinoma. (HBeAg may also be referred to as ``hepatitis B early antigen'' or ``hepatitis B envelope antigen.'') (ii) The therapeutic goal of treatment is to suppress HBV replication and thereby prevent progression to cirrhosis, ESLD, and hepatocellular carcinoma. Treatment usually includes interferon injections, oral antiviral agents, or a combination of both. Common adverse effects of treatment are the same as noted in 5.00D4c(ii) for HCV, and generally end within a few days after treatment is discontinued. * * * * * 7.00 Hematological Disorders A. * * * 2. We evaluate malignant (cancerous) hematological disorders, such as lymphoma, leukemia, and multiple myeloma, under the appropriate listings in 13.00, except for two lymphomas associated with human immunodeficiency virus (HIV) infection. We evaluate primary central nervous system lymphoma associated with HIV infection under 14.11B, and primary effusion lymphoma associated with HIV infection under 14.11C. * * * * * 8.00 Skin Disorders * * * * * D. * * * 3. * * * We evaluate SLE under 14.02, scleroderma under 14.04, Sj[ouml]gren's syndrome under 14.10, and HIV infection under 14.11. * * * * * 13.00 Cancer (Malignant Neoplastic Diseases) A. What impairments do these listings cover? We use these listings to evaluate all cancers (malignant neoplastic diseases) except certain cancers associated with human immunodeficiency virus (HIV) infection. We use the criteria in 14.11B to evaluate primary central nervous system lymphoma, 14.11C to evaluate primary effusion lymphoma, and 14.11E to evaluate pulmonary Kaposi sarcoma if you also have HIV infection. We evaluate all other cancers associated with HIV infection, for example, Hodgkin lymphoma or non-pulmonary Kaposi sarcoma, under this body system or under 14.11F-I in the immune system disorders body system. * * * * * 14.00 Immune System Disorders A. * * * 4. Human immunodeficiency virus (HIV) infection (14.00F). HIV infection may be characterized by increased susceptibility to common infections as well as opportunistic infections, cancers, or other conditions listed in 14.11. * * * * * F. How do we document and evaluate HIV infection? Any individual with HIV infection, including one with a diagnosis of acquired immune deficiency syndrome (AIDS), may be found disabled under 14.11 if his or her impairment meets the criteria in that listing or is medically equivalent to the criteria in that listing. 1. Documentation of HIV infection. a. Definitive documentation of HIV infection. We may document a diagnosis of HIV infection by positive findings on one or more of the following definitive laboratory tests: (i) HIV antibody screening test (for example, enzyme immunoassay, or EIA), confirmed by a supplemental HIV antibody test such as the Western blot (immunoblot), an immunofluorescence assay, or an HIV-1/ [[Page 86924]] HIV-2 antibody differentiation immunoassay. (ii) HIV nucleic acid (DNA or RNA) detection test (for example, polymerase chain reaction, or PCR). (iii) HIV p24 antigen (p24Ag) test. (iv) Isolation of HIV in viral culture. (v) Other tests that are highly specific for detection of HIV and that are consistent with the prevailing state of medical knowledge. b. We will make every reasonable effort to obtain the results of your laboratory testing. Pursuant to Sec. Sec. 404.1519f and 416.919f of this chapter, we will purchase examinations or tests necessary to make a determination in your claim if no other acceptable documentation exists. c. Other acceptable documentation of HIV infection. We may also document HIV infection without definitive laboratory evidence. (i) We will accept a persuasive report from a physician that a positive diagnosis of your HIV infection was confirmed by an appropriate laboratory test(s), such as those described in 14.00F1a. To be persuasive, this report must state that you had the appropriate definitive laboratory test(s) for diagnosing your HIV infection and provide the results. The report must also be consistent with the remaining evidence of record. (ii) We may also document HIV infection by the medical history, clinical and laboratory findings, and diagnosis(es) indicated in the medical evidence, provided that such documentation is consistent with the prevailing state of medical knowledge and clinical practice and is consistent with the other evidence in your case record. For example, we will accept a diagnosis of HIV infection without definitive laboratory evidence of the HIV infection if you have an opportunistic disease that is predictive of a defect in cell- mediated immunity (for example, toxoplasmosis of the brain or Pneumocystis pneumonia (PCP)), and there is no other known cause of diminished resistance to that disease (for example, long-term steroid treatment or lymphoma). In such cases, we will make every reasonable effort to obtain full details of the history, medical findings, and results of testing. 2. Documentation of the manifestations of HIV infection. a. Definitive documentation of manifestations of HIV infection. We may document manifestations of HIV infection by positive findings on definitive laboratory tests, such as culture, microscopic examination of biopsied tissue or other material (for example, bronchial washings), serologic tests, or on other generally acceptable definitive tests consistent with the prevailing state of medical knowledge and clinical practice. b. We will make every reasonable effort to obtain the results of your laboratory testing. Pursuant to Sec. Sec. 404.1519f and 416.919f of this chapter, we will purchase examinations or tests necessary to make a determination of your claim if no other acceptable documentation exists. c. Other acceptable documentation of manifestations of HIV infection. We may also document manifestations of HIV infection without definitive laboratory evidence. (i) We will accept a persuasive report from a physician that a positive diagnosis of your manifestation of HIV infection was confirmed by an appropriate laboratory test(s). To be persuasive, this report must state that you had the appropriate definitive laboratory test(s) for diagnosing your manifestation of HIV infection and provide the results. The report must also be consistent with the remaining evidence of record. (ii) We may also document manifestations of HIV infection without the definitive laboratory evidence described in 14.00F2a, provided that such documentation is consistent with the prevailing state of medical knowledge and clinical practice and is consistent with the other evidence in your case record. For example, many conditions are now commonly diagnosed based on some or all of the following: Medical history, clinical manifestations, laboratory findings (including appropriate medically acceptable imaging), and treatment responses. In such cases, we will make every reasonable effort to obtain full details of the history, medical findings, and results of testing. 3. Disorders associated with HIV infection (14.11A-E). a. Multicentric Castleman disease (MCD, 14.11A) affects multiple groups of lymph nodes and organs containing lymphoid tissue. This widespread involvement distinguishes MCD from localized (or unicentric) Castleman disease, which affects only a single set of lymph nodes. While not a cancer, MCD is known as a lymphoproliferative disorder. Its clinical presentation and progression is similar to that of lymphoma, and its treatment may include radiation or chemotherapy. We require characteristic findings on microscopic examination of the biopsied lymph nodes or other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice to establish the diagnosis. Localized (or unicentric) Castleman disease does not meet or medically equal the criterion in 14.11A, but we may evaluate it under the criteria in 14.11H or 14.11I. b. Primary central nervous system lymphoma (PCNSL, 14.11B) originates in the brain, spinal cord, meninges, or eye. Imaging tests (for example, MRI) of the brain, while not diagnostic, may show a single lesion or multiple lesions in the white matter of the brain. We require characteristic findings on microscopic examination of the cerebral spinal fluid or of the biopsied brain tissue, or other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice to establish the diagnosis. c. Primary effusion lymphoma (PEL, 14.11C) is also known as body cavity lymphoma. We require characteristic findings on microscopic examination of the effusion fluid or of the biopsied tissue from the affected internal organ, or other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice to establish the diagnosis. d. Progressive multifocal leukoencephalopathy (PML, 14.11D) is a progressive neurological degenerative syndrome caused by the John Cunningham (JC) virus in immunosuppressed individuals. Clinical findings of PML include clumsiness, progressive weakness, and visual and speech changes. Personality and cognitive changes may also occur. We require appropriate clinical findings, characteristic white matter lesions on MRI, and a positive PCR test for the JC virus in the cerebrospinal fluid to establish the diagnosis. We also accept a positive brain biopsy for JC virus or other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice to establish the diagnosis. e. Pulmonary Kaposi sarcoma (Kaposi sarcoma in the lung, 14.11E) is the most serious form of Kaposi sarcoma (KS). Other internal KS tumors (for example, tumors of the gastrointestinal tract) have a more variable prognosis. We require characteristic findings on microscopic examination of the induced sputum, bronchoalveolar lavage washings, or of the biopsied transbronchial tissue, or by other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice to establish the diagnosis. 4. CD4 measurement (14.11F). To evaluate your HIV infection under 14.11F, we require one measurement of your absolute CD4 count (also known as CD4 count or CD4+ T-helper lymphocyte count). This measurement must occur within the period we are considering in connection with your application or continuing disability review. If you have more than one measurement of your absolute CD4 count within this period, we will use your lowest absolute CD4 count. 5. Measurement of CD4 and either body mass index or hemoglobin (14.11G). To evaluate your HIV infection under 14.11G, we require one measurement of your absolute CD4 count or your CD4 percentage, and either a measurement of your body mass index (BMI) or your hemoglobin. These measurements must occur within the period we are considering in connection with your application or continuing disability review. If you have more than one measurement of your CD4 (absolute count or percentage), BMI, or hemoglobin within this period, we will use the lowest of your CD4 (absolute count or percentage), BMI, or hemoglobin. The date of your lowest CD4 (absolute count or percentage) measurement may be different from the date of your lowest BMI or hemoglobin measurement. We calculate your BMI using the formulas in 5.00G2. 6. Complications of HIV infection requiring hospitalization (14.11H). a. Complications of HIV infection may include infections (common or opportunistic), cancers, and other conditions. Examples of complications that may result in hospitalization include: Depression; diarrhea; immune reconstitution inflammatory syndrome; malnutrition; and PCP and other severe infections. b. Under 14.11H, we require three hospitalizations within a 12- month period that are at least 30 days apart and that result from a complication(s) of HIV infection. The hospitalizations may be for the same complication or different complications of HIV infection and are not limited to the examples of complications that may result in [[Page 86925]] hospitalization listed in 14.00F6a. All three hospitalizations must occur within the period we are considering in connection with your application or continuing disability review. Each hospitalization must last at least 48 hours, including hours in a hospital emergency department immediately before the hospitalization. c. We will use the rules on medical equivalence in Sec. Sec. 404.1526 and 416.926 of this chapter to evaluate your HIV infection if you have fewer, but longer, hospitalizations, or more frequent, but shorter, hospitalizations, or if you receive nursing, rehabilitation, or other care in alternative settings. 7. HIV infection manifestations specific to women. a. General. Most women with severe immunosuppression secondary to HIV infection exhibit the typical opportunistic infections and other conditions, such as PCP, Candida esophagitis, wasting syndrome, cryptococcosis, and toxoplasmosis. However, HIV infection may have different manifestations in women than in men. Adjudicators must carefully scrutinize the medical evidence and be alert to the variety of medical conditions specific to, or common in, women with HIV infection that may affect their ability to function in the workplace. b. Additional considerations for evaluating HIV infection in women. Many of these manifestations (for example, vulvovaginal candidiasis or pelvic inflammatory disease) occur in women with or without HIV infection, but can be more severe or resistant to treatment, or occur more frequently in a woman whose immune system is suppressed. Therefore, when evaluating the claim of a woman with HIV infection, it is important to consider gynecologic and other problems specific to women, including any associated symptoms (for example, pelvic pain), in assessing the severity of the impairment and resulting functional limitations. We may evaluate manifestations of HIV infection in women under 14.11H-I, or under the criteria for the appropriate body system (for example, cervical cancer under 13.23). 8. HIV-associated dementia (HAD). HAD is an advanced neurocognitive disorder, characterized by a significant decline in cognitive functioning. We evaluate HAD under 14.11I. Other names associated with neurocognitive disorders due to HIV infection include: AIDS dementia complex, HIV dementia, HIV encephalopathy, and major neurocognitive disorder due to HIV infection. * * * * * I. How do we use the functional criteria in these listings? 1. The following listings in this body system include standards for evaluating the functional limitations resulting from immune system disorders: 14.02B, for systemic lupus erythematosus; 14.03B, for systemic vasculitis; 14.04D, for systemic sclerosis (scleroderma); 14.05E, for polymyositis and dermatomyositis; 14.06B, for undifferentiated and mixed connective tissue disease; 14.07C, for immune deficiency disorders, excluding HIV infection; 14.09D, for inflammatory arthritis; 14.10B, for Sj[ouml]gren's syndrome; and 14.11I, for HIV infection. * * * * * 5. Marked limitation means that the signs and symptoms of your immune system disorder interfere seriously with your ability to function. Although we do not require the use of such a scale, ``marked'' would be the fourth point on a five-point scale consisting of no limitation, mild limitation, moderate limitation, marked limitation, and extreme limitation. * * * * * * * * J. * * * 2. Individuals with immune system disorders, including HIV infection, may manifest signs or symptoms of a mental impairment or of another physical impairment. For example, HIV infection may accelerate the onset of conditions such as diabetes or affect the course of or treatment options for diseases such as cardiovascular disease or hepatitis. We may evaluate these impairments under the affected body system. * * * * * * * * 14.08 [Reserved] * * * * * 14.11 Human immunodeficiency virus (HIV) infection. With documentation as described in 14.00F1 and one of the following: A. Multicentric (not localized or unicentric) Castleman disease affecting multiple groups of lymph nodes or organs containing lymphoid tissue (see 14.00F3a). OR B. Primary central nervous system lymphoma (see 14.00F3b). OR C. Primary effusion lymphoma (see 14.00F3c). OR D. Progressive multifocal leukoencephalopathy (see 14.00F3d). OR E. Pulmonary Kaposi sarcoma (see 14.00F3e). OR F. Absolute CD4 count of 50 cells/mm\3\ or less (see 14.00F4). OR G. Absolute CD4 count of less than 200 cells/mm\3\ or CD4 percentage of less than 14 percent, and one of the following (values do not have to be measured on the same date) (see 14.00F5): 1. BMI measurement of less than 18.5; or 2. Hemoglobin measurement of less than 8.0 grams per deciliter (g/dL). OR H. Complication(s) of HIV infection requiring at least three hospitalizations within a 12-month period and at least 30 days apart (see 14.00F6). Each hospitalization must last at least 48 hours, including hours in a hospital emergency department immediately before the hospitalization. OR I. Repeated (as defined in 14.00I3) manifestations of HIV infection, including those listed in 14.11A-H, but without the requisite findings for those listings (for example, Kaposi sarcoma not meeting the criteria in 14.11E), or other manifestations (including, but not limited to, cardiovascular disease (including myocarditis, pericardial effusion, pericarditis, endocarditis, or pulmonary arteritis), diarrhea, distal sensory polyneuropathy, glucose intolerance, gynecologic conditions (including cervical cancer or pelvic inflammatory disease, see 14.00F7), hepatitis, HIV- associated dementia, immune reconstitution inflammatory syndrome (IRIS), infections (bacterial, fungal, parasitic, or viral), lipodystrophy (lipoatrophy or lipohypertrophy), malnutrition, muscle weakness, myositis, neurocognitive or other mental limitations not meeting the criteria in 12.00, oral hairy leukoplakia, osteoporosis, pancreatitis, peripheral neuropathy) resulting in significant, documented symptoms or signs (for example, but not limited to, fever, headaches, insomnia, involuntary weight loss, malaise, nausea, night sweats, pain, severe fatigue, or vomiting) and one of the following at the marked level: 1. Limitation of activities of daily living. 2. Limitation in maintaining social functioning. 3. Limitation in completing tasks in a timely manner due to deficiencies in concentration, persistence, or pace. * * * * * Part B * * * * * 105.00 Digestive System * * * * * D. * * * 4. * * * a. * * * (i) * * * Comorbid disorders, such as HIV infection, may accelerate the clinical course of viral hepatitis infection(s) or may result in a poorer response to medical treatment. * * * * * b. Chronic hepatitis B virus (HBV) infection. (i) Chronic HBV infection can be diagnosed by the detection of hepatitis B surface antigen (HBsAg) or hepatitis B virus DNA (HBV DNA) in the blood for at least 6 months. In addition, detection of the hepatitis B e antigen (HBeAg) suggests an increased likelihood of progression to cirrhosis, ESLD, and hepatocellular carcinoma. (HBeAg may also be referred to as ``hepatitis B early antigen'' or ``hepatitis B envelope antigen.'') (ii) The therapeutic goal of treatment is to suppress HBV replication and thereby prevent progression to cirrhosis, ESLD, and hepatocellular carcinoma. Treatment usually includes interferon injections, oral antiviral agents, or a combination of both. Common adverse effects of treatment are the same as noted in 105.00D4c(ii) for HCV, and generally end within a few days after treatment is discontinued. * * * * * 107.00 Hematological Disorders A. * * * 2. We evaluate malignant (cancerous) hematological disorders, such as lymphoma, [[Page 86926]] leukemia, and multiple myeloma, under the appropriate listings in 113.00, except for two lymphomas associated with human immunodeficiency virus (HIV) infection. We evaluate primary central nervous system lymphoma associated with HIV infection under 114.11B, and primary effusion lymphoma associated with HIV infection under 114.11C. * * * * * 108.00 Skin Disorders * * * * * D. * * * 3. * * * We evaluate SLE under 114.02, scleroderma under 114.04, Sj[ouml]gren's syndrome under 114.10, and HIV infection under 114.11. * * * * * 113.00 Cancer (Malignant Neoplastic Diseases) A. What impairments do these listings cover? We use these listings to evaluate all cancers (malignant neoplastic diseases) except certain cancers associated with human immunodeficiency virus (HIV) infection. We use the criteria in 114.11B to evaluate primary central nervous system lymphoma, 114.11C to evaluate primary effusion lymphoma, and 114.11E to evaluate pulmonary Kaposi sarcoma if you also have HIV infection. We evaluate all other cancers associated with HIV infection, for example, Hodgkin lymphoma or non- pulmonary Kaposi sarcoma, under this body system or under 114.11F-I in the immune system disorders body system. * * * * * 114.00 Immune System Disorders A. * * * 4. Human immunodeficiency virus (HIV) infection (114.00F). HIV infection may be characterized by increased susceptibility to common infections as well as opportunistic infections, cancers, or other conditions listed in 114.11. * * * * * F. How do we document and evaluate HIV infection? Any child with HIV infection, including one with a diagnosis of acquired immune deficiency syndrome (AIDS), may be found disabled under 114.11 if his or her impairment meets the criteria in that listing or is medically equivalent to the criteria in that listing. 1. Documentation of HIV infection. a. Definitive documentation of HIV infection. We may document a diagnosis of HIV infection by positive findings on one or more of the following definitive laboratory tests: (i) HIV antibody screening test (for example, enzyme immunoassay, or EIA), confirmed by a supplemental HIV antibody test such as the Western blot (immunoblot) or immunofluorescence assay, for any child age 18 months or older. (ii) HIV nucleic acid (DNA or RNA) detection test (for example, polymerase chain reaction, or PCR). (iii) HIV p24 antigen (p24Ag) test, for any child age 1 month or older. (iv) Isolation of HIV in viral culture. (v) Other tests that are highly specific for detection of HIV and that are consistent with the prevailing state of medical knowledge. b. We will make every reasonable effort to obtain the results of your laboratory testing. Pursuant to Sec. 416.919f of this chapter, we will purchase examinations or tests necessary to make a determination in your claim if no other acceptable documentation exists. c. Other acceptable documentation of HIV infection. We may also document HIV infection without definitive laboratory evidence. (i) We will accept a persuasive report from a physician that a positive diagnosis of your HIV infection was confirmed by an appropriate laboratory test(s), such as those described in 114.00F1a. To be persuasive, this report must state that you had the appropriate definitive laboratory test(s) for diagnosing your HIV infection and provide the results. The report must also be consistent with the remaining evidence of record. (ii) We may also document HIV infection by the medical history, clinical and laboratory findings, and diagnosis(es) indicated in the medical evidence, provided that such documentation is consistent with the prevailing state of medical knowledge and clinical practice and is consistent with the other evidence in your case record. For example, we will accept a diagnosis of HIV infection without definitive laboratory evidence of the HIV infection if you have an opportunistic disease that is predictive of a defect in cell- mediated immunity (for example, toxoplasmosis of the brain or Pneumocystis pneumonia (PCP)), and there is no other known cause of diminished resistance to that disease (for example, long-term steroid treatment or lymphoma). In such cases, we will make every reasonable effort to obtain full details of the history, medical findings, and results of testing. 2. Documentation of the manifestations of HIV infection. a. Definitive documentation of manifestations of HIV infection. We may document manifestations of HIV infection by positive findings on definitive laboratory tests, such as culture, microscopic examination of biopsied tissue or other material (for example, bronchial washings), serologic tests, or on other generally acceptable definitive tests consistent with the prevailing state of medical knowledge and clinical practice. b. We will make every reasonable effort to obtain the results of your laboratory testing. Pursuant to Sec. 416.919f of this chapter, we will purchase examinations or tests necessary to make a determination of your claim if no other acceptable documentation exists. c. Other acceptable documentation of manifestations of HIV infection. We may also document manifestations of HIV infection without definitive laboratory evidence. (i) We will accept a persuasive report from a physician that a positive diagnosis of your manifestation of HIV infection was confirmed by an appropriate laboratory test(s). To be persuasive, this report must state that you had the appropriate definitive laboratory test(s) for diagnosing your manifestation of HIV infection and provide the results. The report must also be consistent with the remaining evidence of record. (ii) We may also document manifestations of HIV infection without the definitive laboratory evidence described in 114.00F2a, provided that such documentation is consistent with the prevailing state of medical knowledge and clinical practice and is consistent with the other evidence in your case record. For example, many conditions are now commonly diagnosed based on some or all of the following: Medical history, clinical manifestations, laboratory findings (including appropriate medically acceptable imaging), and treatment responses. In such cases, we will make every reasonable effort to obtain full details of the history, medical findings, and results of testing. 3. Disorders associated with HIV infection (114.11A-E). a. Multicentric Castleman disease (MCD, 114.11A) affects multiple groups of lymph nodes and organs containing lymphoid tissue. This widespread involvement distinguishes MCD from localized (or unicentric) Castleman disease, which affects only a single set of lymph nodes. While not a cancer, MCD is known as a lymphoproliferative disorder. Its clinical presentation and progression is similar to that of lymphoma, and its treatment may include radiation or chemotherapy. We require characteristic findings on microscopic examination of the biopsied lymph nodes or other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice to establish the diagnosis. Localized (or unicentric) Castleman disease does not meet or medically equal the criterion in 114.11A, but we may evaluate it under the criteria in 114.11G or 14.11I in part A. b. Primary central nervous system lymphoma (PCNSL, 114.11B) originates in the brain, spinal cord, meninges, or eye. Imaging tests (for example, MRI) of the brain, while not diagnostic, may show a single lesion or multiple lesions in the white matter of the brain. We require characteristic findings on microscopic examination of the cerebral spinal fluid or of the biopsied brain tissue, or other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice to establish the diagnosis. c. Primary effusion lymphoma (PEL, 114.11C) is also known as body cavity lymphoma. We require characteristic findings on microscopic examination of the effusion fluid or of the biopsied tissue from the affected internal organ, or other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice to establish the diagnosis. d. Progressive multifocal leukoencephalopathy (PML, 114.11D) is a progressive neurological degenerative syndrome caused by the John Cunningham (JC) virus in immunosuppressed children. Clinical findings of PML include clumsiness, progressive weakness, and visual and speech changes. Personality and cognitive changes may also occur. We require appropriate clinical findings, characteristic white matter lesions on MRI, and a positive PCR test for the JC virus in the cerebrospinal fluid to [[Page 86927]] establish the diagnosis. We also accept a positive brain biopsy for JC virus or other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice to establish the diagnosis. e. Pulmonary Kaposi sarcoma (Kaposi sarcoma in the lung, 114.11E) is the most serious form of Kaposi sarcoma (KS). Other internal KS tumors (for example, tumors of the gastrointestinal tract) have a more variable prognosis. We require characteristic findings on microscopic examination of the induced sputum, bronchoalveolar lavage washings, or of the biopsied transbronchial tissue, or other generally acceptable methods consistent with the prevailing state of medical knowledge and clinical practice to establish the diagnosis. 4. CD4 measurement (114.11F). To evaluate your HIV infection under 114.11F, we require one measurement of your absolute CD4 count (also known as CD4 count or CD4+ T-helper lymphocyte count) or CD4 percentage for children from birth to attainment of age 5, or one measurement of your absolute CD4 count for children from age 5 to attainment of age 18. These measurements (absolute CD4 count or CD4 percentage) must occur within the period we are considering in connection with your application or continuing disability review. If you have more than one CD4 measurement within this period, we will use your lowest absolute CD4 count or your lowest CD4 percentage. 5. Complications of HIV infection requiring hospitalization (114.11G). a. Complications of HIV infection may include infections (common or opportunistic), cancers, and other conditions. Examples of complications that may result in hospitalization include: Depression; diarrhea; immune reconstitution inflammatory syndrome; malnutrition; and PCP and other severe infections. b. Under 114.11G, we require three hospitalizations within a 12- month period that are at least 30 days apart and that result from a complication(s) of HIV infection. The hospitalizations may be for the same complication or different complications of HIV infection and are not limited to the examples of complications that may result in hospitalization listed in 114.00F5a. All three hospitalizations must occur within the period we are considering in connection with your application or continuing disability review. Each hospitalization must last at least 48 hours, including hours in a hospital emergency department immediately before the hospitalization. c. We will use the rules on medical equivalence in Sec. 416.926 of this chapter to evaluate your HIV infection if you have fewer, but longer, hospitalizations, or more frequent, but shorter, hospitalizations, or if you receive nursing, rehabilitation, or other care in alternative settings. 6. Neurological manifestations specific to children (114.11H). The methods of identifying and evaluating neurological manifestations may vary depending on a child's age. For example, in an infant, impaired brain growth can be documented by a decrease in the growth rate of the head. In an older child, impaired brain growth may be documented by brain atrophy on a CT scan or MRI. Neurological manifestations may present in the loss of acquired developmental milestones (developmental regression) in infants and young children or, in the loss of acquired intellectual abilities in school-age children and adolescents. A child may demonstrate loss of intellectual abilities by a decrease in IQ scores, by forgetting information previously learned, by inability to learn new information, or by a sudden onset of a new learning disability. When infants and young children present with serious developmental delays (without regression), we evaluate the child's impairment(s) under 112.00. 7. Growth failure due to HIV immune suppression (114.11I). a. To evaluate growth failure due to HIV immune suppression, we require documentation of the laboratory values described in 114.11I1 and the growth measurements in 114.11I2 or 114.11I3 within the same consecutive 12-month period. The dates of laboratory findings may be different from the dates of growth measurements. b. Under 114.11I2 and 114.11I3, we use the appropriate table under 105.08B in the digestive system to determine whether a child's growth is less than the third percentile. (i) For children from birth to attainment of age 2, we use the weight-for-length table corresponding to the child's gender (Table I or Table II). (ii) For children from age 2 to attainment of age 18, we use the body mass index (BMI)-for-age corresponding to the child's gender (Table III or Table IV). (iii) BMI is the ratio of a child's weight to the square of his or her height. We calculate BMI using the formulas in 105.00G2c. * * * * * I. How do we consider the impact of your immune system disorder on your functioning? 1. We will consider all relevant information in your case record to determine the full impact of your immune system disorder, including HIV infection, on your ability to function. Functional limitation may result from the impact of the disease process itself on your mental functioning, physical functioning, or both your mental and physical functioning. This could result from persistent or intermittent symptoms, such as depression, diarrhea, severe fatigue, or pain, resulting in a limitation of your ability to acquire information, to concentrate, to persevere at a task, to interact with others, to move about, or to cope with stress. You may also have limitations because of your treatment and its side effects (see 114.00G). 2. Important factors we will consider when we evaluate your functioning include, but are not limited to: Your symptoms (see 114.00H), the frequency and duration of manifestations of your immune system disorder, periods of exacerbation and remission, and the functional impact of your treatment, including the side effects of your medication (see 114.00G). See Sec. Sec. 416.924a and 416.926a of this chapter for additional guidance on the factors we consider when we evaluate your functioning. 3. We will use the rules in Sec. Sec. 416.924a and 416.926a of this chapter to evaluate your functional limitations and determine whether your impairment functionally equals the listings. J. * * * 2. Children with immune system disorders, including HIV infection, may manifest signs or symptoms of a mental impairment or of another physical impairment. For example, HIV infection may accelerate the onset of conditions such as diabetes or affect the course of or treatment options for diseases such as cardiovascular disease or hepatitis. We may evaluate these impairments under the affected body system. * * * * * * * * 114.08 [Reserved] * * * * * 114.11 Human immunodeficiency virus (HIV) infection. With documentation as described in 114.00F1 and one of the following: A. Multicentric (not localized or unicentric) Castleman disease affecting multiple groups of lymph nodes or organs containing lymphoid tissue (see 114.00F3a). OR B. Primary central nervous system lymphoma (see 114.00F3b). OR C. Primary effusion lymphoma (see 114.00F3c). OR D. Progressive multifocal leukoencephalopathy (see 114.00F3d). OR E. Pulmonary Kaposi sarcoma (see 114.00F3e). OR F. Absolute CD4 count or CD4 percentage (see 114.00F4): 1. For children from birth to attainment of age 1, absolute CD4 count of 500 cells/mm\3\ or less, or CD4 percentage of less than 15 percent; or 2. For children from age 1 to attainment of age 5, absolute CD4 count of 200 cells/mm\3\ or less, or CD4 percentage of less than 15 percent; or 3. For children from age 5 to attainment of age 18, absolute CD4 count of 50 cells/mm\3\ or less. OR G. Complication(s) of HIV infection requiring at least three hospitalizations within a 12-month period and at least 30 days apart (see 114.00F5). Each hospitalization must last at least 48 hours, including hours in a hospital emergency department immediately before the hospitalization. OR H. A neurological manifestation of HIV infection (for example, HIV encephalopathy or peripheral neuropathy) (see 114.00F6) resulting in one of the following: 1. Loss of previously acquired developmental milestones or intellectual ability (including the sudden onset of a new learning disability), documented on two examinations at least 60 days apart; or 2. Progressive motor dysfunction affecting gait and station or fine and gross motor skills, [[Page 86928]] documented on two examinations at least 60 days apart; or 3. Microcephaly with head circumference that is less than the third percentile for age, documented on two examinations at least 60 days apart; or 4. Brain atrophy, documented by appropriate medically acceptable imaging. OR I. Immune suppression and growth failure (see 114.00F7) documented by 1 and 2, or by 1 and 3: 1. CD4 measurement: a. For children from birth to attainment of age 5, CD4 percentage of less than 20 percent; or b. For children from age 5 to attainment of age 18, absolute CD4 count of less than 200 cells/mm\3\ or CD4 percentage of less than 14 percent; and 2. For children from birth to attainment of age 2, three weight- for-length measurements that are: a. Within a consecutive 12-month period; and b. At least 60 days apart; and c. Less than the third percentile on the appropriate weight-for- length table under 105.08B1; or 3. For children from age 2 to attainment of age 18, three BMI- for-age measurements that are: a. Within a consecutive 12-month period; and b. At least 60 days apart; and c. Less than the third percentile on the appropriate BMI-for-age table under 105.08B2. [FR Doc. 2016-28843 Filed 12-1-16; 8:45 am] BILLING CODE 4191-02-P
![Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Rules and Regulations 86915
cm) wide x 2.27 inches (5.77 cm) long, SOCIAL SECURITY ADMINISTRATION current rules and our reasons for
and the dome-shaped labels have an proposing those changes. To the extent
outside dimension of 2.378 inches (6.04 20 CFR Part 404 that we are adopting the proposed rule
cm) wide x 2.717 (6.90 cm) inches long. [Docket No. SSA–2007–0082] as published, we are not repeating that
In addition, the black band across the information here. You can view the
top of the dome-shaped label is 0.277 RIN 0960–AG71 NPRM by visiting http://
inches (0.70 cm) wider than specified in www.regulations.gov and searching for
the Rule. The labels’ background and Revised Medical Criteria for Evaluating document SSA–2007–0082.
text insertions otherwise comply with Human Immunodeficiency Virus (HIV)
Infection and for Evaluating Functional Why are we revising the listings for
the Rule’s color scheme, content, and
Limitations in Immune System evaluating HIV infection?
font type and point size requirements.
Disorders We are revising the listings for
IV. Discussion evaluating HIV infection to reflect our
AGENCY: Social Security Administration.
The Commission reviewed mock-ups program experience and advances in
ACTION: Final rule.
of the proposed rectangular and dome- medical knowledge since we last
shaped labels and concludes that the SUMMARY: We are revising the criteria in revised the listings related to HIV
proposed labels adequately meet the the Listing of Impairments (listings) that infection, recommendations from a
Rule’s labeling requirements by we use to evaluate claims involving commissioned report,1 and a number of
providing clear and conspicuous human immunodeficiency virus (HIV) public comments. We received
disclosure of all the required infection in adults and children under comments from medical experts and the
information and maintaining the Rule’s titles II and XVI of the Social Security public at an outreach policy conference,
color scheme and font type and point Act (Act). We also are revising the in response to an Advance Notice of
size requirements. Moreover, the introductory text of the listings that we Proposed Rulemaking (ANPRM),2 and
Commission’s experience with similar use to evaluate functional limitations in response to the NPRM. Although we
exemptions does not indicate that resulting from immune system published final rules for immune system
button labels confuse consumers or disorders. The revisions reflect our disorders on March 18, 2008, that
otherwise impede comprehension of the program experience, advances in included changes to listings 14.08 and
fuel rating. To the contrary, these labels medical knowledge, our adjudicative 114.08,3 the criteria in the current HIV
may increase the likelihood that experience, recommendations from a infection listings are not substantively
consumers see the fuel rating because commissioned report, and comments different from the criteria in the final
they must choose and press the button from medical experts and the public. rules we published on July 2, 1993.4 We
before fueling. indicated in the preamble to those rules
DATES: These rules are effective January
Furthermore, pursuant to Rule 1.26, that we would carefully monitor these
the Commission for good cause finds 17, 2017.
listings to ensure that they continue to
that notice and comment is unnecessary FOR FURTHER INFORMATION CONTACT:
meet program purposes, and that we
in this case because the exemption Cheryl Williams, Office of Disability would update them if warranted.
involves a technical and minor Policy, Social Security Administration,
deviation from the Rule’s labeling 6401 Security Boulevard, Baltimore, Other Information
requirements and does not impose any Maryland 21235–6401, (410) 965–1020. In the NPRM, we proposed to remove
new legal obligations on parties subject For information on eligibility or filing listing 114.08H for evaluating growth
to the Rule.5 Moreover, the Commission for benefits, call our national toll-free disturbance with an involuntary weight
has previously granted similar number, 1–800–772–1213, or TTY 1– loss (or failure to gain weight at an
exemptions from the Rule’s labeling 800–325–0778, or visit our Internet site, appropriate rate for age) that meets
requirements, and this exemption is Social Security Online, at http:// specified criteria. We proposed instead
consistent with those prior www.socialsecurity.gov. to evaluate this impairment under a
determinations.6 SUPPLEMENTARY INFORMATION: growth impairment listing in 100.00 or
a digestive system listing in 105.00. On
V. Conclusion Background April 13, 2015, we published a final rule
Therefore, the Commission grants We are revising and making final the for growth disorders and weight loss in
Gilbarco and retailers permission to use rule for evaluating HIV infection we children in 100.00 that retained a listing
the proposed rectangular and dome- proposed in a Notice of Proposed in 114.00 for growth failure due to HIV
shaped button labels on Ethanol Flex Rulemaking (NPRM) published in the immune suppression.5 We are repeating
Fuel dispenser buttons, provided that Federal Register on February 26, 2014 that listing here for clarity. We have
Gilbarco and retailers comply with the (79 FR 10730), and a correction to the redesignated the listing as 114.11I and
Rule’s specifications in all other proposed rule on March 25, 2014 (79 FR the related introductory text as
respects. 16250). Even though this rule will not 114.00F7.
By direction of the Commission. go into effect until January 17, 2017, for
Summary of Public Comments on the
Donald S. Clark, clarity, we refer to it in this preamble as
NPRM
Secretary. the ‘‘final’’ rule. We are making several
changes in this final rule from the In the NPRM, we provided the public
[FR Doc. 2016–29006 Filed 12–1–16; 8:45 am]
NPRM based upon some of the public with a 60-day comment period, and we
BILLING CODE 6750–01–P
comments we received. We are also subsequently extended the comment
jstallworth on DSK7TPTVN1PROD with RULES
5 See 16 CFR 1.26. For these reasons, the making minor editorial changes
1 Institute of Medicine. (2010). HIV and
Commission also finds good cause for making this throughout this final rule. We explain
Disability: Updating the Social Security Listings.
exemption effective immediately. these changes below in the ‘‘Summary Washington, DC: The National Academies Press.
6 See, e.g., Rule exemptions granted to Gilbarco,
of Public Comments on the NPRM’’ 2 73 FR 14409.
60 FR 57584 (Nov. 16, 1995), 53 FR 29277 (Aug.
3, 1988); Dresser Industries, Inc., 56 FR 26821 (June section of this preamble. 3 73 FR 14570.
11, 1991); and Exxon Corporation, 54 FR 14072 The preamble to the NPRM provided 4 58 FR 36051.
(Apr. 7, 1989). an explanation of the changes from the 5 80 FR 19522.
VerDate Sep<11>2014 14:49 Dec 01, 2016 Jkt 241001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\02DER1.SGM 02DER1](https://thefederalregister.org/doc/81_FR_87147/page/1.svg)
![Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Rules and Regulations 86917
Response: We did not adopt this these definitive tests. Allowing commenters’ concerns about
comment. The Social Security Act and adjudicators to establish HIV infection consistency between the adult and
our regulations require medical or manifestations of HIV infection childhood listings involving CD4
evidence to establish a medically without the requirement of a definitive measurements, we believe that the
determinable impairment. We use test result helps to allay concerns about commenter may have misread the
medical evidence generally accepted in the accessibility of tests that we had proposed rule. We note that the
the medical community and available in proposed to require. criterion based on absolute CD4
medical records to establish and Furthermore, the hospitalization measurement alone for adults, like that
evaluate an impairment. We look at all criterion is just one of multiple ways for children from age 5 to the attainment
available evidence about all of the adjudicators can find a person is of age 18, does not include a CD4
claimant’s impairments, not just disabled in the sequential evaluation percentage. The IOM indicated to us
information about a particular allegation process.6 The hospitalization criterion is that CD4 levels in children correspond
such as HIV infection. We may find a an advantage to a person who applies with adult levels by the age of 5 and that
person disabled even if he or she does for disability benefits because it adds absolute CD4 count is generally the
not have a medical diagnosis for his or another way we may find him or her preferred metric for these age groups.
her impairments when applying for disabled at the third step of the Therefore, we believe that it is
benefits, as long as we are able to sequential evaluation process, but it is appropriate for the criterion for children
establish a medically determinable not the only way we can find a person in this older age group to mirror that for
severe physical or mental impairment or with HIV infection to be disabled. If a adults and require this type of
combination of impairments that meets person with HIV infection meets our measurement.
the duration requirement. requirements for disability, but has not Furthermore, 14.11G for adults, which
In response to public comments and been hospitalized to the extent required was the only current or proposed adult
as discussed above, we have retained by our listings, we can find that he or criterion that includes CD4 percentage,
the guidance in the introductory text she is disabled based on a finding of requires a CD4 measurement (either
that explains we will accept non- medical equivalence, by meeting other absolute count or percentage) in
definitive evidence of HIV infection or listings, or at a later step in our conjunction with either a BMI
manifestations of HIV infection. This adjudication process. These other measurement of less than 18.5 or a
will allow us to establish HIV infection mechanisms for finding a person is hemoglobin measurement of less than
and manifestations of HIV infection disabled help to account for the 8.0 grams per deciliter. The final rule for
more easily without definitive tests. We variation of claimants’ access to medical evaluating growth disorders and weight
will accept a persuasive report from a treatment. loss in children, published April 13,
physician that a positive diagnosis of 2015, made changes to the immune
CD4 Counts
your HIV infection was confirmed by an system listings, which were not in the
appropriate laboratory test(s), such as Comment: A number of commenters NPRM.7 Under current listing 114.08H
those described in 14.00F1a. To be provided suggestions related to our use for immune suppression and growth
persuasive, this report must state that of CD4 counts versus CD4 percentages failure, we may find a child to be
you had the appropriate definitive in the proposed listings. One disabled based on a combination of CD4
laboratory test(s) for diagnosing your commenter requested that we provide a measurement and growth failure (based
HIV infection and provide the results. CD4 percentage for 14.00F1 that would on weight-for-length percentiles or body
The report must also be consistent with be equivalent to an absolute CD4 count mass index (BMI), depending on age).
the remaining evidence of record. of 50 cells/mm3 or less. Two For children age 5 to the attainment of
We may also document HIV infection commenters requested that we make age 18, the CD4 measurement may be an
by the medical history, clinical and changes to proposed 114.11F in order to absolute count or a CD4 percentage. In
laboratory findings, and diagnoses have greater consistency between the this final rule, that listing will become
indicated in the medical evidence, childhood and adult HIV listings. These 114.11I. Although 14.11G and 114.11I
provided that this documentation is commenters stated that in the proposed are not analogous (as we do not evaluate
consistent with the rest of the medical listings, children from birth to the adults under listings related to growth
evidence and the prevailing state of attainment of age 5 may rely on a CD4 impairments), we point this out to show
medical knowledge and clinical percentage of less than 15 percent to the commenter that there are listings for
practice. For example, we will accept a establish disability under 114.11F1 or both adults and children in which we
diagnosis of HIV infection without 114.11F2, while children age 5 to the consider CD4 percentages.
definitive laboratory evidence of the attainment of age 18 may rely only on Comment: Two commenters disagreed
HIV infection if you have an an absolute CD4 count of 50 cells/mm3 with our proposal to require a single
opportunistic disease that is predictive to meet the listing. The commenters CD4 measurement under proposed
of a defect in cell-mediated immunity stated that they believe that children listings 14.11F and 14.11G. One
(for example, toxoplasmosis of the brain ages 5 to 18 should be able to use CD4 commenter remarked that this proposal
or Pneumocystis pneumonia (PCP)), and percentage in order to be consistent is different from other listings in which
there is no other known cause of with the adult listing. we require two measurements at least 60
diminished resistance to that disease Response: We will not add a CD4 days apart and is inconsistent with our
(for example, long-term steroid percentage that is equivalent to an durational requirements. The other
treatment or lymphoma). In such cases, absolute CD4 count of 50 cells/mm3 or commenter noted that ‘‘[a]dvances
we will make every reasonable effort to less, because there is no precise achieved with the availability of highly
jstallworth on DSK7TPTVN1PROD with RULES
obtain full details of the history, correlation between the two active antiretroviral therapy (HAART)
medical findings, and results of testing. measurements. With regard to the have dramatically changed the
In the NPRM, we had proposed to prognosis and functional impact of HIV
6 See 20 CFR 404.1520 and 416.920 for the
accept only definitive tests as evidence infection.’’ Two commenters expressed
sequential evaluation process we use to determine
of HIV infection or manifestations of disability for adults and 20 CFR 416.924 for the concerns about establishing a 12-month
HIV infection. Many of the tests that the sequential evaluation process we use to determine
commenter specifically named were disability for children. 7 80 FR 19522.
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![86918 Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Rules and Regulations
period of continuous disability based on complete medical history for at least 12 changes for the percentage ranges for
one CD4 count alone, and one of the months preceding the month of the date immunosuppression in all age groups.
commenters suggested adding another of application. We will remind Response: We did not adopt the
CD4 count, hemoglobin level, or BMI adjudicators about periods of comment. We use CD4 measurements
assessment to the listing criteria. consideration during our training on the for a different purpose than the CDC
One commenter also suggested that HIV listings. does in their surveillance case
we provide specific guidance in relation Comment: One commenter stated that definition for HIV infection. The CDC
to low CD4 counts for claimants who do ‘‘there are a number of HIV-infected provides surveillance case definitions
not have access to medical care. The individuals who have [a BMI of less only for public health surveillance
commenter noted that such claimants purposes. We have provided CD4 counts
than] 20 and are severely malnourished,
would be expected to have a more in our listings to correspond to a
but who fall short of the requirements
aggressive clinical course of infection. specific level of impairment, which the
under [proposed] 14.11G.’’ This
Three commenters stated that claimants CDC does not take into account in its
commenter asked that we ‘‘consider
may present for medical care with very surveillance case definitions. However,
adding a listing for [claimants] who
low CD4 counts, at which point a we have added CD4 counts in the final
have a BMI [greater than] 18.5 and [less
diagnosis of HIV infection would be rule to HIV listings 114.11F1 for
than] 19, with a history of a documented
made and treatment initiated. With children from birth to attainment of age
current opportunistic infection and an
treatment, the claimant’s CD4 count 1 and 114.11F2 for children from age 1
absolute CD4 count of [less than] 200 in
would be expected to rise due to the to attainment of age 5.
suppression of HIV infection. the [adjudicative timeframe].’’
Response: We did not adopt the Comment: One commenter
Response: We have not adopted these
comment. The criteria in proposed recommended that we ‘‘should not
comments. Anyone who meets the
requirements in 14.11F or 14.11G 14.11G are appropriate for establishing depend exclusively on CD4 count or
occurring within the period that we are listing-level severity when considering [our] list of fatal or severely disabling
considering in connection with his or CD4 and BMI or hemoglobin HIV-related conditions’’ when
her application or continuing disability measurements, as these data are highly determining eligibility for benefits.’’ The
review, has an impairment of listing- predictive of an impairment that we commenter noted that ‘‘some people
level severity that will satisfy our consider disabling. We do not believe that live with HIV/[acquired
duration requirement, whether or not he the findings proposed by the commenter immunodeficiency syndrome] (AIDS)
or she is receiving medical care. Even will generally indicate an impairment with CD4 counts above 50 are very ill
though a person’s absolute CD4 count or that is severe enough to prevent an and not able to seek gainful
percentage, BMI, or hemoglobin may individual from doing any gainful employment,’’ and asked that our
increase with treatment, the person’s activity. Moreover, we believe that the ‘‘adjudicators take into account all fatal
immune deficiency will continue with impact of adopting this comment would or very debilitating conditions when
an increased risk of morbidity and be negligible. Nevertheless, we may find determining . . . eligibility for
mortality for a continuous period of at that an individual who meets the benefits.’’
least 12 months, which satisfies our criteria suggested by the commenter is Response: Although we agree that we
duration requirement. disabled at steps 4 or 5 of our sequential should not depend exclusively on CD4
Comment: One commenter evaluation process. count in order to determine eligibility
recommended that we explain in the for benefits, we did not make any
Comment: One commenter pointed changes to our listings and note that our
introductory text that adjudicators can
out that after the publication of our regulations include criteria reaching
use the lowest values within the entire
NPRM, the Centers for Disease Control beyond the stated value. At step 3 of our
rating period for CD4 count and BMI or
and Prevention (CDC) published a five-step disability determination
hemoglobin levels to evaluate an
surveillance case definition that process, we consider whether the
impairment. The commenter was
extended CD4 counts and percentages to claimant’s impairment(s) meets (or
concerned that adjudicators might
children as well as adults and medically equals) any of the listings.
misinterpret the listings to mean these
adolescents.8 This updated case Many listing criteria do not require a
findings must occur simultaneously.
definition ‘‘determines the stage of HIV specific diagnosis or laboratory level.
Response: We adopted the comment
infection in children age 6–12 years in For example, the criteria in 14.11I allow
by making changes to 14.00F5 to
the same way as adults and us to consider all manifestations of HIV
explain that the CD4 count and claimant
adolescents.’’ Additionally, the infection that result in significant,
BMI or hemoglobin levels evaluated
commenter stated that staging is documented signs and symptoms and
under 14.11G do not have to be
primarily based on the CD4 count, marked limitation in function. If we do
measured on the same date.
Comment: One commenter noted that which takes precedence over the CD4 not find that a claimant is disabled at
proposed listings 14.11F and 14.11G use percentages; the percentage is step 3, we must still consider whether
the lowest absolute CD4 count or CD4 considered only if the count is missing. he or she is disabled at steps 4 or 5 of
percent as the basis for allowance. This The commenter requested that we make our sequential evaluation process.9 We
commenter requested that we clarify the conforming changes to all instances of always consider all of a person’s
guidance in the proposed introductory the listings in which we refer to a CD4 impairments when determining whether
text that these measurements ‘‘must count or percentage. The commenter he or she is disabled, not just the
occur within the period we are also wished to note that the CD4 impairments that are in our listings.
jstallworth on DSK7TPTVN1PROD with RULES
considering in connection with [the number is the most important
claimant’s] application or continuing measurement and that the CDC made 9 We evaluate disability differently for children
disability review.’’ under the age of 18. If we do not find that the
8 Selik, R.M., Mokotoff, E.D., Branson, B., Owen, child’s impairment(s) meet or medically equal a
Response: We did not adopt this
S.M., Whitmore, S., & Hall, H.I. (2014). Revised medical listing at step 3, we will consider whether
comment because it is already Surveillance Case Definition for HIV Infection— the impairment(s) functionally equal the listings.
considered by our program rules. We are United States, 2014. Morbidity and Mortality Steps 4 and 5 do not apply. 20 CFR 416.924,
generally required to develop a Weekly Report (MMWR), 63(RR03), 1–10. 416.926a.
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Complications and Manifestations including adverse effects, in evaluating proposed listing 14.11I ‘‘does not
Comment: Two commenters autoimmune disorders, immune contain an exhaustive list of conditions
recommended that we clarify the deficiency disorders, or HIV infection. that may qualify under step 3 of the
difference between complications of In current 14.00J, which we also did not sequential evaluation process.’’
HIV infection in proposed listing propose to change and therefore did not Response: We adopted the comment
14.11H, which is based on multiple include in the NPRM, we provide and have added wording to clarify that
hospitalizations, and manifestations of instructions on how we evaluate the examples given in 14.11I are not an
HIV infection in proposed listing 14.11I, immune system disorders (including exhaustive list.
HIV infection) when it does not meet Comment: A number of commenters
which is based on functional
one of the listings. We apply these noted that HIV infection may also
limitations. We provide examples of
instructions when a person manifests accelerate or interact with impairments
complications of HIV infection in the
signs or symptoms of HIV infection that in other body systems. One of these
introductory text at 14.00F6 and
are not specifically named in the HIV commenters stated that our proposed
examples of manifestations of HIV
listings. rule ‘‘does not account for those
infection in listing 14.11I itself. These Comment: One commenter was individuals whose HIV disease
commenters noted that some of the critical of the proposed listings, stating effectively accelerates the onset of
conditions given as examples of they discriminate in favor of those with conditions such as diabetes, heart
complications in 14.00F6 are not only severe manifestations of HIV. The disease, or kidney disease.’’ Two
provided as examples of manifestations commenter stated that ‘‘HIV infection commenters asked that we include
in 14.11I, and considered this to be can have a wide variety of cardiovascular conditions in the list of
confusing. One of the commenters manifestations such as diarrhea, fever, manifestations of HIV infection in
believed that ‘‘any ‘complication’ severe headache, thrush, skin rashes, proposed 14.11I. These commenters
enough to result in hospitalization weakness, weight loss, and dementia,’’ cited the report on HIV and disability
could also be severe enough to cause and ‘‘these problems can be that we commissioned from the Institute
functional limitations and thus, should compounded by the coexistence of a of Medicine (IOM), which states ‘‘an
be referenced in the list of wide variety of heart, lung, orthopedic, increased risk for cardiovascular disease
manifestations in 14.11I.’’ mental and other disorders.’’ The
Response: We agree with the in HIV-infected populations as
commenter noted the proposed listings compared with HIV-negative
commenters and have revised listing do not include most of these possible
14.11I so that the list of manifestations populations has been well
combinations, and felt the proposed documented.’’ 11 These commenters
includes all examples of complications listings discriminate against those with
given in 14.00F6. noted that the IOM report states,
combinations of manifestations of HIV ‘‘[cardiovascular disease] is also a
Comment: Three commenters infection and other disorders.
suggested that we consider signs or leading cause of death in those infected
Response: We did not make any with HIV, with an analysis of the Data
symptoms of HIV infection and adverse changes in our final listings in response
effects of HIV treatment instead of solely Collection on Adverse Events of Anti-
to these comments because we consider HIV Drugs Study finding that 11 percent
considering repeated manifestations of all of a claimant’s impairments, related
HIV infection when considering an of HIV-positive people die of a
or unrelated to HIV infection, when cardiovascular condition.’’ 12
impairment under proposed listing determining whether a person is
14.11I. One commenter provided Two other commenters recommended
disabled.10 We explain in section that we include a cross-reference to the
specific text for a suggested edit to this 14.00I3 that adjudicators may consider
proposed listing that reflected cardiovascular listings to ensure that
multiple types of manifestations of HIV adjudicators ‘‘consider the impact and
consideration of signs and symptoms of infection when determining whether a
HIV infection as well as the adverse interplay of HIV infection and
person’s impairment meets listing associated cardiovascular conditions.’’
effects of HIV treatment. Another 14.11I. While we do not consider
commenter noted that, in particular, These commenters also suggested that
impairments other than manifestations we should cross-reference hepatitis in
symptoms of HIV infection that are not of HIV infection when evaluating
the direct result of a manifestation of the HIV listings.
whether a claimant’s impairment meets Response: We agree with the
HIV infection, such as fatigue, malaise, listing 14.11I, the listings are only step
and pain, would not be considered comments and have added language to
3 of our five step disability final 14.00J2 and 114.00J2 to note that
under 14.11I. determination process. The purpose of
Response: We did not adopt the HIV infection may affect the onset or
these listings is to quickly identify course of, or treatment for, conditions in
comments. We require both repeated impairments that we consider severe
manifestations of HIV infection as well other body systems, such as
enough to prevent a person from doing cardiovascular disease and hepatitis. We
as a functional impairment in order to any gainful activity, without the need to
satisfy the criteria under 14.11I because have also revised 14.11I to provide
evaluate vocational factors. We may still examples of cardiovascular
both are necessary to reflect a level of find a person disabled later in our
impairment that indicates listing-level manifestations of HIV infection.
sequential evaluation process even if we Comment: One commenter requested
severity. If we find that a person’s find that his or her impairments do not
impairment does not meet listing 14.11I that we either eliminate our proposed
meet or medically equal a listing. criteria in 14.11H regarding duration
(or any of our listings), we will continue Comment: One commenter requested
to apply the remaining steps in our and intervals between hospitalizations
that we add language to note that or add language that instructs
jstallworth on DSK7TPTVN1PROD with RULES
sequential evaluation process to
determine whether the person is adjudicators to defer to the treating
10 We evaluate disability claims for children from
disabled. In current 14.00G, which we birth to the attainment of age 18 differently. Steps
physician with regard to the medical
did not propose to change and therefore 4 and 5 of the adult sequential evaluation process
11 Institute of Medicine. (2010). HIV and
do not apply. After we consider whether the child’s
did not include in the NPRM, we impairment(s) meets or medically equals a listing, Disability: Updating the Social Security Listings.
provide instructions on how we we consider whether the child’s impairment(s) Washington, DC: The National Academies Press.
consider the effects of treatment, functionally equal a listing. 12 Id.
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![86920 Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Rules and Regulations
severity of the claimant’s condition quantity of, medical treatment. This result in hospitalization are ‘‘not an all-
instead of relying on the hospitalization accommodation accounts for differences inclusive or inflexible list.’’
criteria for the listing. The commenter in medical care people with similar Response: We adopted this comment
believes that we are incentivizing disorders receive depending on the and have provided text in 14.00F6b and
claimants to opt for longer hospital stays medical resources available to them. 114.00F5b to indicate that the examples
or abstain from treatment to prove the The medical equivalence policy in 14.00F6a and 114.00F5a are not an
severity of their conditions and meet the provides some flexibility in determining exhaustive list.
listing criteria. whether a claimant is disabled at step 3 Comment: One commenter agreed
Response: We did not adopt the of the sequential evaluation process by with our revisions to section 14.00I5 of
comment. In our experience, allowing us to consider whether the the introductory text to clarify our
individuals do not opt for unwarranted claimant’s impairment meets the listed explanation of the term ‘‘marked,’’ but
hospital stays or forgo treatment in criteria exactly or is at least equal in suggested that we construct ‘‘this
order to possibly qualify for disability severity and duration to the criteria of change in a manner that facilitates a
benefits. The benefit of having a listing any listed impairment. better process for determining the
that captures more disabled individuals If we are not able to find that a ‘severity’ of the disability.’’
at step 3 of our sequential evaluation person’s impairment due to HIV Response: We did not adopt this
process outweighs the concern that infection is disabling using our listings, comment. We provide guidance in
particular claimants may attempt to we may still find the person disabled at current sections 14.00I5 through 14.00I8
lengthen hospital stays or abstain from the final steps of the sequential that explains how we take into
treatment to meet the listing. We believe evaluation process. consideration a ‘‘marked’’ level of
that a complication(s) of HIV infection Finally, the commenter’s suggestion limitation in functioning to determine
that warrants three hospitalizations of that we defer to the treating physician the severity of a person’s impairment.
48 hours or longer, 30 days or more with regard to the medical severity of a This guidance is sufficient to allow
apart, within a 12 month period that we person’s condition in lieu of adjudicators to evaluate the functional
are considering in connection with an hospitalization frequency and duration limitations resulting from HIV infection
application or continuing disability in this listing means that we would be and other immune system disorders.
review will prevent a person from permitting the physician to determine Comment: Two commenters asked
engaging in any gainful activity and, whether the person is disabled. Under that we ‘‘recognize the validity of an
therefore, represents listing-level our rules, the finding of disability is an HIV treating physician’s objective
severity. Moreover, we are able to issue reserved to the Commissioner of evaluation of a patient’s HIV-related
evaluate complications of HIV infection Social Security.13 functional limitations.’’ They remarked,
resulting in fewer than three Comment: One commenter requested ‘‘HIV affects individuals differently
hospitalizations in a consecutive 12- that we train adjudicators to evaluate according to physiological and
month period using medical repeated manifestations of HIV infection biological factors unique to the
equivalence, the other listing criteria for correctly. The commenter states that, individual,’’ and that ‘‘responses to
adults, the functional equivalence rules under the current listings, they ‘‘rarely treatment, including side effects, vary
for children, or at other steps in our see adjudicators willing to approve greatly according to sex, age and co-
sequential evaluation process. For claims of individuals with HIV based on occurring conditions.’’ These
example, the criteria in listing 14.11I repeated manifestations of [HIV commenters provided specific text that
evaluate the functional impact of the infection].’’ they wanted us to add to proposed
person’s impairment in the broad areas Response: We did not make any listing 14.11I. The proposed text would
of activities of daily living, social changes in our final listings as a result instruct adjudicators to give special
functioning, and concentration, of this comment. We will provide consideration to the opinion(s) of a
persistence, or pace, including the training on the new listings, as we do claimant’s primary care provider, in
functional impact of treatment such as for all listing updates. We will also particular, an experienced HIV medical
repeated outpatient visits for conduct a study on the use of the provider.
complications. listings after they have been in use for Response: We did not adopt the
Our medical equivalence rules permit a year, as we do for all listing updates, comment. When we evaluate medical
us to find that a disorder is medically and issue further training or policy opinions, such as those described by the
equivalent to a listing at step 3 if there guidance if needed. commenters, we consider several
are other findings related to the disorder Comment: One commenter factors. Those factors include the
that are at least of equal medical recommended that the introductory text treating relationship between the
significance to the listing criteria (see be improved by adding a more opining medical source and the
§§ 404.1526 and 416.926). Although significant definition of multicentric claimant, how much the medical
some of our listings include criteria for Castleman disease (MCD), particularly source’s treatment records support the
repeated hospitalizations (14.11H and how it is very similar to a lymphoma, medical opinion, and the consistency of
114.11G), our medical equivalence although it is not actually a cancer. the medical opinion with the other
policy accommodates recent trends in Response: We adopted the comment evidence throughout the record as a
clinical care that emphasize quality of, and have provided expanded definitions whole, including a claimant’s self-
rather than quantity of, medical for MCD in 14.00F3a and 114.00F3a. reporting.14 This is true for all
treatment. impairments across all body systems,
The medical equivalence policy also Function not just in cases involving HIV
jstallworth on DSK7TPTVN1PROD with RULES
accommodates claimants’ varying level Comment: One commenter requested infection.
of access to medical care, the preference that we provide language to clarify that Additionally, the finding about
of some medical providers to reduce the the examples in the introductory text of whether a claimant is or is not disabled
use of emergency department and complications of HIV infection that may is an issue reserved to the
hospital-level medical interventions, Commissioner. We do not give any
and recent trends in clinical care that 13 See 20 CFR 404.1527(c) and (d) and 416.927(c)
emphasize quality of, rather than and (d). 14 See 20 CFR 404.1527(c) and 416.927(c).
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![Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Rules and Regulations 86921
special significance to the source of a Comment: Two commenters requested Comment: One commenter
statement on an issue reserved to the that we revise proposed listing 14.11I recommended that we consider
Commissioner, even if that source is a for clarity, to include ‘‘neurocognitive or including the adolescent population
medical source who has treated the other mental limitations (including more specifically in the listings. The
claimant.15 dementia, anxiety, depression, or other commenter stated that youth ages 13 to
Comment: One commenter suggested mental impairments not meeting the 25 years ‘‘constitute the fastest growing
that we expand the role of evidence of criteria in 12.02, 12.03, 12.04, or and largest group of new HIV infections
a claimant’s functional limitations, as 12.06).’’ in the United States.’’ The commenter
required under 14.11I, from sources Response: We did not add references feels the listings ‘‘should take into
other than those that we consider to the specific mental disorders listings account adolescents who are
acceptable medical sources. The requested by the commenters, because transitioning from the Part B listings for
commenter urged us to ‘‘immediately doing so would appear to restrict the children to the Part A listings for adults
adopt the IOM recommendation to mental disorders we would consider so that HIV-infected youth are not lost
expand acceptable medical sources to a under 14.11I to those specific to care.’’
wide array of licensed professionals and conditions. Instead, we added language Response: We did not adopt this
broaden the acceptable medical sources to 14.11I to clarify that we may consider comment. The Part A and Part B listings
rule and guidance.’’ any neurocognitive or other mental for adults and children are very similar
Response: We did not adopt the limitations not meeting the criteria in and closely parallel one another. In
comment because it is outside the scope 12.00. addition, under our rules, we may use
of this rulemaking. However, under our Comment: One commenter asked how the criteria in Part A when those criteria
rules, we may use evidence from we would implement the evaluation of give appropriate consideration to the
sources other than acceptable medical a neurocognitive limitation under effects of the impairment(s) in
sources in order to show the severity of proposed 14.11I and whether its children.18
a person’s impairment and how that presence in a claim would necessitate
review of the case by a psychological Other Body Systems
impairment affects the individual’s
consultant. Comment: One commenter suggested
ability to function.16 For example, we
Response: We did not make any that we remove the information in the
might request evidence from a social
changes in the final rule based on this proposed revisions to 5.00D4 of the
worker or another medical or
comment. The need for a psychological introductory text about how comorbid
professional source who has been
consultant review depends on the facts disorders, such as HIV infection, may
treating a claimant, because this
in the individual case. The affect chronic viral hepatitis infections.
evidence can provide information about
neurocognitive limitations provided as The commenter stated that the language
the claimant’s functional capabilities. ‘‘does not provide meaningful guidance
an example under listing 14.11I are
Other sources of evidence that we may for the listings themselves.’’
considered a manifestation of HIV
consider include counselors, family Response: We did not adopt the
infection. We evaluate medical evidence
members, caregivers, or neighbors. comment. We have based our final
based on the underlying disorder. If the
Comment: One commenter disagreed revisions on recommendations in the
level of limitation is such that we
with our proposal to remove diarrhea as IOM report.19 These revisions also align
consider the neurocognitive limitation
a standalone listing (current listing with the requests of a number of
to be a mental impairment on its own,
14.08I). The commenter stated that commenters. In the introductory text,
then a psychological consultant (or a
‘‘diarrhea is a ‘manifestation’ of HIV we include information that will be
medical consultant who is a
infection that does not result in a useful to our adjudicators when they
psychiatrist) would review the case.
corresponding ‘sign or symptom’, and, evaluate impairments in a particular
at [a] certain degree of severity, Specific Groups With HIV Infection body system. Comorbid disorders, such
automatically results in a marked Comment: Numerous commenters as HIV infection, do have an impact on
functional limitation.’’ The commenter disagreed with our proposal to remove chronic viral hepatitis infections, and
suggested that we retain and revise the the text in current section 14.00F4 about their presence can affect how we
current standalone listing for diarrhea, manifestations of HIV infection that are evaluate an impairment under the
and provided specific language for the specific to women and requested that digestive body system.
revision. we restore this language in the final
Response: We did not adopt this General Comments
rule. The commenters were concerned
comment. While we agree that diarrhea that adjudicators who are unfamiliar Comment: Two commenters made
is a manifestation of HIV infection that with HIV infection may not immediately suggestions regarding setting diaries for
may result in a marked functional recognize that certain signs and continuing disability review (CDR)
limitation, we do not believe it is best symptoms are related to HIV infection under the HIV/AIDS listings. One
evaluated under a standalone listing. in women. They believed that retaining commenter recommended that
We agree with the recommendation of the current language would help to ‘‘individuals with HIV/AIDS associated
the IOM that diarrhea should be instruct adjudicators to acknowledge malignancies have markedly improved
evaluated using functional impairment and take these signs and symptoms into survival rates,’’ and suggested that
criteria.17 We have specifically listed account as manifestations of HIV ‘‘these impairments should be assessed
diarrhea as an example of a infection in women when making with the same three-year review diary as
manifestation of HIV infection that may disability determinations. outlined for primary malignancies in the
jstallworth on DSK7TPTVN1PROD with RULES
be evaluated under 14.11I. Response: We adopted these [cancer (malignant neoplastic)] listings.’’
comments and have placed this The other commenter suggested that all
15 See 20 CFR 404.1527(d) and 416.927(d). guidance in section 14.00F7 of the final
16 See 20 CFR 404.1513(d) and 20.CFR 18 See 20 CFR 404.1525(b)(2) and 20 CFR
rule. Additionally, we have added
416.913(d). 416.925(b)(2)(i).
17 Institute of Medicine. (2010). HIV and language to 14.11I specifically noting 19 Institute of Medicine. (2010). HIV and
Disability: Updating the Social Security Listings. that certain gynecologic conditions may Disability: Updating the Social Security Listings.
Washington, DC: The National Academies Press. be manifestations of HIV infection. Washington, DC: The National Academies Press.
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![86922 Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Rules and Regulations
HIV/AIDS listings should have a three- treatment, including medications for removed 114.08L as well as other
year review diary, with the decision to HIV infection, into account when childhood listing criteria that
continue or cease benefits defined by evaluating a case. This guidance is considered functional limitations under
the medical improvement review provided in section 14.00G of the the immune disorders body system. In
standard (the legal standard for introductory text, which was not shown this final rule, we revised paragraph
determining whether disability in the NPRM because we did not 114.00I to address how we will consider
continues in a CDR). The commenter propose to change it. Specifically, in the impact of immune system disorders,
noted ‘‘the specter and presence of an 14.00G5, we explain how we evaluate including HIV, on a child’s functioning.
indicator disease no longer portends a the effects of treatment of HIV infection, In order to provide consistent
poor prognosis,’’ and stated that including the effects of antiretroviral guidance, we are also making
‘‘improvements in medical care, drugs, on the ability to function. conforming changes to the listings for
HAART, and improved survival rates Comment: One commenter believed hematological disorders in 7.00A2 and
support the need for [a CDR].’’ that the language in proposed listing 107.00A2 to explain that we will
Response: We did not adopt these 14.11I is unclear and discussed evaluate primary central nervous system
comments. We do not specify a concerns with how we would apply the lymphoma and primary effusion
particular period of disability in the rule. The commenter requested that we lymphoma associated with HIV
medical listings unless we can clarify the listing by adding additional infection under 14.11B, 14.11C,
uniformly expect medical improvement text noting that we consider more than 114.11B, and 114.11C, respectively.
for an impairment in a specific listing repeated manifestations of HIV (for
When will we begin to use this final
such that a person would no longer be example, ‘‘significant, documented
rule?
disabled (for example, listing 6.04 for manifestations, symptoms, or signs’’)
chronic kidney disease with kidney under 14.11I and asks that we provide We will begin to use this final rule on
transplant). This is not the case for the training to our adjudicators to properly its effective date. We will continue to
impairments in the listings for HIV consider these criteria. use the current listings until the date
infection. We will address any new Response: We did not make any this final rule becomes effective. We
considerations for diary length and changes in the final rule based on this will apply the final rule to new
CDRs related to HIV infection in our comment. Our proposed language is applications filed on or after the
internal policy guidance, as we clear and captures the intent of the effective date of this final rule and to
normally do. listing. The changes that the commenter claims that are pending on or after the
Comment: One commenter expressed suggests would alter the meaning of the effective date.22
concern that we do not provide listing, not clarify it. We will address How long will this final rule be in
quantitative data to show the validity of the concerns with the application of the effect?
any of our proposed listings. The rule in training for our adjudicators.
commenter stated that ‘‘hundreds of Comment: One commenter requested This final rule will remain in effect
thousands of individuals engage in that we provide our disability examiners for 3 years after the date it becomes
substantial gainful activity while with more training in evaluating a claim effective, unless we extend the
meeting requirements of [other] involving HIV infection and applying expiration date. We will continue to
listings,’’ such as hearing loss not the HIV infection listings. monitor the rule and may revise it, as
treated with cochlear implantation. The Response: We did not make any needed, before the end of the 3-year
commenter requested that we state the changes in the final rule based on this period.
information and methods that we used comment. As we do with all updates to What is our authority to make rules
to develop the listing criteria, and the listings, we will provide our and set procedures for determining
questioned whether it is ‘‘possible to disability examiners with training on whether a person is disabled under the
evaluate a person’s ability to engage in the final rule for evaluating HIV statutory definition?
gainful activities using . . . the infection.
Under the Act, we have full power
listings.’’ Other Changes
Response: We did not make any and authority to make rules and
changes in the final rule based on this In the NPRM, we proposed to remove regulations and to establish necessary
comment. In the NPRM, we provided a listing 114.08L for evaluating functional and appropriate procedures to carry out
list of specific references that we used limitations resulting from HIV infection such provisions. Sections 205(a),
to inform the changes that we in children. We explained that we were 702(a)(5), and 1631(d)(1).
proposed.20 In this final rule, we are not including similar criteria in Regulatory Procedures
making changes to the proposed rule proposed listing 114.11 for HIV
infection in children because of Executive Order 12866, as
based on comments that we received in
proposed changes in the mental Supplemented by Executive Order
response to the NPRM. The listings in
disorders listings and because we may 13563
this final rule represent impairments
that we consider severe enough to find children disabled under the We consulted with the Office of
prevent a person from engaging in any Supplemental Security Income program Management and Budget (OMB) and
gainful activity. based on functional equivalence to the determined that this final rule meets the
Comment: One commenter noted that listings.21 However, we did not propose
medications for HIV infection affect to revise 114.00I, which notes the 22 This means that we will use this final rule on
people in different ways and may cause childhood listings that we use to and after their effective date, in any case in which
jstallworth on DSK7TPTVN1PROD with RULES
we make a determination or decision. We expect
a person’s other psychological and evaluate functional limitations under that Federal courts will review our final decisions
physical issues to worsen. the immune body system, to reflect the using the rules that were in effect at the time we
Response: We did not make any removal of 114.08L. After we published issued the decisions. If a court reverses our final
changes in the final rule based on this the NPRM, we published a final rule for decision and remands a case for further
administrative proceedings after the effective date
comment. We take the effects of evaluating mental disorders, which of this final rule, we will apply this final rule to
the entire period at issue in the decision we make
20 79 FR 10730. 21 See 20 CFR 416.924(d). after the court’s remand.
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hospitalization listed in 14.00F6a. All three arthritis; 14.10B, for Sjögren’s syndrome; and those listed in 14.11A–H, but without the
hospitalizations must occur within the 14.11I, for HIV infection. requisite findings for those listings (for
period we are considering in connection with * * * * * example, Kaposi sarcoma not meeting the
your application or continuing disability 5. Marked limitation means that the signs criteria in 14.11E), or other manifestations
review. Each hospitalization must last at least and symptoms of your immune system (including, but not limited to, cardiovascular
48 hours, including hours in a hospital disorder interfere seriously with your ability disease (including myocarditis, pericardial
emergency department immediately before to function. Although we do not require the effusion, pericarditis, endocarditis, or
the hospitalization. use of such a scale, ‘‘marked’’ would be the pulmonary arteritis), diarrhea, distal sensory
c. We will use the rules on medical fourth point on a five-point scale consisting polyneuropathy, glucose intolerance,
equivalence in §§ 404.1526 and 416.926 of of no limitation, mild limitation, moderate gynecologic conditions (including cervical
this chapter to evaluate your HIV infection if limitation, marked limitation, and extreme cancer or pelvic inflammatory disease, see
limitation. * * * 14.00F7), hepatitis, HIV-associated dementia,
you have fewer, but longer, hospitalizations,
immune reconstitution inflammatory
or more frequent, but shorter, * * * * * syndrome (IRIS), infections (bacterial, fungal,
hospitalizations, or if you receive nursing, J. * * * parasitic, or viral), lipodystrophy
rehabilitation, or other care in alternative 2. Individuals with immune system (lipoatrophy or lipohypertrophy),
settings. disorders, including HIV infection, may malnutrition, muscle weakness, myositis,
7. HIV infection manifestations specific to manifest signs or symptoms of a mental neurocognitive or other mental limitations
women. impairment or of another physical not meeting the criteria in 12.00, oral hairy
a. General. Most women with severe impairment. For example, HIV infection may leukoplakia, osteoporosis, pancreatitis,
immunosuppression secondary to HIV accelerate the onset of conditions such as peripheral neuropathy) resulting in
infection exhibit the typical opportunistic diabetes or affect the course of or treatment significant, documented symptoms or signs
infections and other conditions, such as PCP, options for diseases such as cardiovascular (for example, but not limited to, fever,
Candida esophagitis, wasting syndrome, disease or hepatitis. We may evaluate these headaches, insomnia, involuntary weight
cryptococcosis, and toxoplasmosis. However, impairments under the affected body system. loss, malaise, nausea, night sweats, pain,
HIV infection may have different * * * severe fatigue, or vomiting) and one of the
manifestations in women than in men. * * * * * following at the marked level:
Adjudicators must carefully scrutinize the 14.08 [Reserved] 1. Limitation of activities of daily living.
medical evidence and be alert to the variety 2. Limitation in maintaining social
of medical conditions specific to, or common * * * * * functioning.
in, women with HIV infection that may affect 14.11 Human immunodeficiency virus 3. Limitation in completing tasks in a
(HIV) infection. With documentation as timely manner due to deficiencies in
their ability to function in the workplace.
described in 14.00F1 and one of the concentration, persistence, or pace.
b. Additional considerations for evaluating
following:
HIV infection in women. Many of these * * * * *
A. Multicentric (not localized or
manifestations (for example, vulvovaginal
unicentric) Castleman disease affecting Part B
candidiasis or pelvic inflammatory disease)
multiple groups of lymph nodes or organs
occur in women with or without HIV containing lymphoid tissue (see 14.00F3a).
* * * * *
infection, but can be more severe or resistant
OR 105.00 Digestive System
to treatment, or occur more frequently in a
woman whose immune system is suppressed. B. Primary central nervous system * * * * *
Therefore, when evaluating the claim of a lymphoma (see 14.00F3b). D. * * *
woman with HIV infection, it is important to OR 4. * * *
consider gynecologic and other problems a. * * *
C. Primary effusion lymphoma (see
specific to women, including any associated (i) * * * Comorbid disorders, such as HIV
14.00F3c). infection, may accelerate the clinical course
symptoms (for example, pelvic pain), in OR
assessing the severity of the impairment and of viral hepatitis infection(s) or may result in
D. Progressive multifocal a poorer response to medical treatment.
resulting functional limitations. We may
leukoencephalopathy (see 14.00F3d). * * * * *
evaluate manifestations of HIV infection in
women under 14.11H–I, or under the criteria OR b. Chronic hepatitis B virus (HBV)
for the appropriate body system (for example, E. Pulmonary Kaposi sarcoma (see infection.
cervical cancer under 13.23). 14.00F3e). (i) Chronic HBV infection can be diagnosed
8. HIV-associated dementia (HAD). HAD is OR by the detection of hepatitis B surface antigen
an advanced neurocognitive disorder, (HBsAg) or hepatitis B virus DNA (HBV
F. Absolute CD4 count of 50 cells/mm3 or DNA) in the blood for at least 6 months. In
characterized by a significant decline in less (see 14.00F4).
cognitive functioning. We evaluate HAD addition, detection of the hepatitis B e
OR antigen (HBeAg) suggests an increased
under 14.11I. Other names associated with
G. Absolute CD4 count of less than 200 likelihood of progression to cirrhosis, ESLD,
neurocognitive disorders due to HIV
cells/mm3 or CD4 percentage of less than 14 and hepatocellular carcinoma. (HBeAg may
infection include: AIDS dementia complex,
percent, and one of the following (values do also be referred to as ‘‘hepatitis B early
HIV dementia, HIV encephalopathy, and
not have to be measured on the same date) antigen’’ or ‘‘hepatitis B envelope antigen.’’)
major neurocognitive disorder due to HIV (ii) The therapeutic goal of treatment is to
infection. (see 14.00F5):
1. BMI measurement of less than 18.5; or suppress HBV replication and thereby
* * * * * 2. Hemoglobin measurement of less than prevent progression to cirrhosis, ESLD, and
I. How do we use the functional criteria in 8.0 grams per deciliter (g/dL). hepatocellular carcinoma. Treatment usually
these listings? includes interferon injections, oral antiviral
OR
1. The following listings in this body agents, or a combination of both. Common
system include standards for evaluating the H. Complication(s) of HIV infection adverse effects of treatment are the same as
functional limitations resulting from immune requiring at least three hospitalizations noted in 105.00D4c(ii) for HCV, and
within a 12-month period and at least 30
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system disorders: 14.02B, for systemic lupus generally end within a few days after
erythematosus; 14.03B, for systemic days apart (see 14.00F6). Each hospitalization treatment is discontinued.
vasculitis; 14.04D, for systemic sclerosis must last at least 48 hours, including hours
in a hospital emergency department * * * * *
(scleroderma); 14.05E, for polymyositis and
dermatomyositis; 14.06B, for undifferentiated immediately before the hospitalization. 107.00 Hematological Disorders
and mixed connective tissue disease; 14.07C, OR A. * * *
for immune deficiency disorders, excluding I. Repeated (as defined in 14.00I3) 2. We evaluate malignant (cancerous)
HIV infection; 14.09D, for inflammatory manifestations of HIV infection, including hematological disorders, such as lymphoma,
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![Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Rules and Regulations 86927
establish the diagnosis. We also accept a an older child, impaired brain growth may be 3. We will use the rules in §§ 416.924a and
positive brain biopsy for JC virus or other documented by brain atrophy on a CT scan 416.926a of this chapter to evaluate your
generally acceptable methods consistent with or MRI. Neurological manifestations may functional limitations and determine whether
the prevailing state of medical knowledge present in the loss of acquired developmental your impairment functionally equals the
and clinical practice to establish the milestones (developmental regression) in listings.
diagnosis. infants and young children or, in the loss of J. * * *
e. Pulmonary Kaposi sarcoma (Kaposi acquired intellectual abilities in school-age 2. Children with immune system disorders,
sarcoma in the lung, 114.11E) is the most children and adolescents. A child may including HIV infection, may manifest signs
serious form of Kaposi sarcoma (KS). Other demonstrate loss of intellectual abilities by a or symptoms of a mental impairment or of
internal KS tumors (for example, tumors of decrease in IQ scores, by forgetting another physical impairment. For example,
the gastrointestinal tract) have a more information previously learned, by inability HIV infection may accelerate the onset of
variable prognosis. We require characteristic to learn new information, or by a sudden conditions such as diabetes or affect the
findings on microscopic examination of the onset of a new learning disability. When course of or treatment options for diseases
induced sputum, bronchoalveolar lavage infants and young children present with such as cardiovascular disease or hepatitis.
washings, or of the biopsied transbronchial serious developmental delays (without We may evaluate these impairments under
tissue, or other generally acceptable methods regression), we evaluate the child’s the affected body system. * * *
consistent with the prevailing state of impairment(s) under 112.00. * * * * *
medical knowledge and clinical practice to 7. Growth failure due to HIV immune 114.08 [Reserved]
establish the diagnosis. suppression (114.11I).
* * * * *
4. CD4 measurement (114.11F). To a. To evaluate growth failure due to HIV
114.11 Human immunodeficiency virus
evaluate your HIV infection under 114.11F, immune suppression, we require (HIV) infection. With documentation as
we require one measurement of your absolute documentation of the laboratory values described in 114.00F1 and one of the
CD4 count (also known as CD4 count or described in 114.11I1 and the growth following:
CD4+ T-helper lymphocyte count) or CD4 measurements in 114.11I2 or 114.11I3 within A. Multicentric (not localized or
percentage for children from birth to the same consecutive 12-month period. The unicentric) Castleman disease affecting
attainment of age 5, or one measurement of dates of laboratory findings may be different multiple groups of lymph nodes or organs
your absolute CD4 count for children from from the dates of growth measurements. containing lymphoid tissue (see 114.00F3a).
age 5 to attainment of age 18. These b. Under 114.11I2 and 114.11I3, we use the OR
measurements (absolute CD4 count or CD4 appropriate table under 105.08B in the
digestive system to determine whether a B. Primary central nervous system
percentage) must occur within the period we
child’s growth is less than the third lymphoma (see 114.00F3b).
are considering in connection with your
application or continuing disability review. If percentile. OR
you have more than one CD4 measurement (i) For children from birth to attainment of C. Primary effusion lymphoma (see
within this period, we will use your lowest age 2, we use the weight-for-length table 114.00F3c).
absolute CD4 count or your lowest CD4 corresponding to the child’s gender (Table I OR
percentage. or Table II). D. Progressive multifocal
5. Complications of HIV infection requiring (ii) For children from age 2 to attainment leukoencephalopathy (see 114.00F3d).
hospitalization (114.11G). of age 18, we use the body mass index (BMI)- OR
a. Complications of HIV infection may for-age corresponding to the child’s gender
(Table III or Table IV). E. Pulmonary Kaposi sarcoma (see
include infections (common or 114.00F3e).
opportunistic), cancers, and other conditions. (iii) BMI is the ratio of a child’s weight to
Examples of complications that may result in the square of his or her height. We calculate OR
hospitalization include: Depression; diarrhea; BMI using the formulas in 105.00G2c. F. Absolute CD4 count or CD4 percentage
immune reconstitution inflammatory * * * * * (see 114.00F4):
syndrome; malnutrition; and PCP and other I. How do we consider the impact of your 1. For children from birth to attainment of
severe infections. immune system disorder on your age 1, absolute CD4 count of 500 cells/mm3
b. Under 114.11G, we require three functioning? or less, or CD4 percentage of less than 15
hospitalizations within a 12-month period 1. We will consider all relevant percent; or
that are at least 30 days apart and that result information in your case record to determine 2. For children from age 1 to attainment of
from a complication(s) of HIV infection. The the full impact of your immune system age 5, absolute CD4 count of 200 cells/mm3
hospitalizations may be for the same disorder, including HIV infection, on your or less, or CD4 percentage of less than 15
complication or different complications of ability to function. Functional limitation may percent; or
3. For children from age 5 to attainment of
HIV infection and are not limited to the result from the impact of the disease process
age 18, absolute CD4 count of 50 cells/mm3
examples of complications that may result in itself on your mental functioning, physical
or less.
hospitalization listed in 114.00F5a. All three functioning, or both your mental and
hospitalizations must occur within the physical functioning. This could result from OR
period we are considering in connection with persistent or intermittent symptoms, such as G. Complication(s) of HIV infection
your application or continuing disability depression, diarrhea, severe fatigue, or pain, requiring at least three hospitalizations
review. Each hospitalization must last at least resulting in a limitation of your ability to within a 12-month period and at least 30
48 hours, including hours in a hospital acquire information, to concentrate, to days apart (see 114.00F5). Each
emergency department immediately before persevere at a task, to interact with others, to hospitalization must last at least 48 hours,
the hospitalization. move about, or to cope with stress. You may including hours in a hospital emergency
c. We will use the rules on medical also have limitations because of your department immediately before the
equivalence in § 416.926 of this chapter to treatment and its side effects (see 114.00G). hospitalization.
evaluate your HIV infection if you have 2. Important factors we will consider when OR
fewer, but longer, hospitalizations, or more we evaluate your functioning include, but are H. A neurological manifestation of HIV
frequent, but shorter, hospitalizations, or if not limited to: Your symptoms (see 114.00H), infection (for example, HIV encephalopathy
you receive nursing, rehabilitation, or other the frequency and duration of manifestations or peripheral neuropathy) (see 114.00F6)
jstallworth on DSK7TPTVN1PROD with RULES
care in alternative settings. of your immune system disorder, periods of resulting in one of the following:
6. Neurological manifestations specific to exacerbation and remission, and the 1. Loss of previously acquired
children (114.11H). The methods of functional impact of your treatment, developmental milestones or intellectual
identifying and evaluating neurological including the side effects of your medication ability (including the sudden onset of a new
manifestations may vary depending on a (see 114.00G). See §§ 416.924a and 416.926a learning disability), documented on two
child’s age. For example, in an infant, of this chapter for additional guidance on the examinations at least 60 days apart; or
impaired brain growth can be documented by factors we consider when we evaluate your 2. Progressive motor dysfunction affecting
a decrease in the growth rate of the head. In functioning. gait and station or fine and gross motor skills,
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![86928 Federal Register / Vol. 81, No. 232 / Friday, December 2, 2016 / Rules and Regulations
documented on two examinations at least 60 Maryland 21235–6401, (410) 965–1020. This final rule implements the new
days apart; or For information on eligibility or filing provisions in the statute, including
3. Microcephaly with head circumference for benefits, call our national toll-free requirements for FHWA approvals
that is less than the third percentile for age, number, 1–800–772–1213, or TTY 1– relating to the CM/GC method of
documented on two examinations at least 60
days apart; or
800–325–0778, or visit our Internet site, contracting for projects receiving
4. Brain atrophy, documented by Social Security Online, at http:// Federal-aid Highway Program funding.
appropriate medically acceptable imaging. www.socialsecurity.gov. DATES: This final rule is effective
OR SUPPLEMENTARY INFORMATION: We January 3, 2017.
I. Immune suppression and growth failure published a final rule in the Federal FOR FURTHER INFORMATION CONTACT: Mr.
(see 114.00F7) documented by 1 and 2, or by Register of September 26, 2016 (81 FR Gerald Yakowenko, Contract
1 and 3: 66137) titled, Revised Medical Criteria Administration Team Leader, Office of
1. CD4 measurement: for Evaluating Mental Disorders. The Program Administration, (202) 366–
a. For children from birth to attainment of final rule, among other things, amended 1562, or Ms. Janet Myers, Office of the
age 5, CD4 percentage of less than 20 percent;
20 CFR part 404. We inadvertently Chief Counsel, (202) 366–2019, Federal
or
b. For children from age 5 to attainment of included an amendatory instruction to Highway Administration, 1200 New
age 18, absolute CD4 count of less than 200 appendix 1 to subpart P of 20 CFR part Jersey Avenue SE., Washington, DC
cells/mm3 or CD4 percentage of less than 14 404, removing section 114.00I and 20590. Office hours are from 8 a.m. to
percent; and redesignating section 114.00J as section 4:30 p.m., E.T., Monday through Friday,
2. For children from birth to attainment of 114.00I. This document amends and except Federal holidays.
age 2, three weight-for-length measurements corrects the final regulation. SUPPLEMENTARY INFORMATION:
that are:
a. Within a consecutive 12-month period; (Catalog of Federal Domestic Assistance Electronic Access and Filing
and Program Nos. 96.001, Social Security—
b. At least 60 days apart; and Disability Insurance; 96.002, Social This document, the notice of
c. Less than the third percentile on the Security—Retirement Insurance; 96.004, proposed rulemaking (NPRM), and all
appropriate weight-for-length table under Social Security—Survivors Insurance; and comments received may be viewed
105.08B1; or 96.006, Supplemental Security Income). online through the Federal eRulemaking
3. For children from age 2 to attainment of In FR Doc. 2016–22908 appearing on portal at: http://www.regulations.gov.
age 18, three BMI-for-age measurements that page 66138 in the Federal Register of The Web site is available 24 hours each
are: Monday, September 26, 2016, the day, 365 days each year. Please follow
a. Within a consecutive 12-month period; following corrections are made: the instructions. An electronic copy of
and this document may also be downloaded
b. At least 60 days apart; and Appendix 1 to Subpart P of Part 404 by accessing the Office of the Federal
c. Less than the third percentile on the [Corrected]
appropriate BMI-for-age table under Register’s home page at: http://
105.08B2. ■ 1. On page 66161, in the first column, www.archives.gov/federal-register/, or
in appendix 1 to subpart P of part 404, the Government Publishing Office’s
[FR Doc. 2016–28843 Filed 12–1–16; 8:45 am] Web page at: http://www.gpo.gov/fdsys.
correct amendatory instruction 3 by
BILLING CODE 4191–02–P removing instruction 3.c.iii, and Executive Summary
redesignating instructions 3.c.iv. though
3.c.xvi. as instructions 3.c.iii. through This regulatory action fulfills the
SOCIAL SECURITY ADMINISTRATION statutory requirement in section 1303(b)
3.c.xv. respectively.
of MAP–21 requiring the Secretary to
20 CFR Part 404 Carolyn W. Colvin, promulgate a regulation to implement
[Docket No. SSA–2007–0101] Acting Commissioner of Social Security. the CM/GC method of contracting. The
[FR Doc. 2016–28845 Filed 12–1–16; 8:45 am] CM/GC contracting method allows a
RIN 0960–AF69
BILLING CODE 4191–02–P contracting agency to use a single
Revised Medical Criteria for Evaluating procurement to secure pre-construction
Mental Disorders; Correction and construction services. In the pre-
DEPARTMENT OF TRANSPORTATION construction services phase, a
AGENCY: Social Security Administration. contracting agency procures the services
ACTION: Final rules; correction. Federal Highway Administration of a construction contractor early in the
design phase of a project in order to
SUMMARY: We published a document in 23 CFR Parts 630 and 635 obtain the contractor’s input on
the Federal Register revising our rules constructability issues that may be
on September 26, 2016. That document [FHWA Docket No. FHWA–2015–0009]
affected by the project design. If the
inadvertently included incorrect RIN 2125–AF61 contracting agency and the construction
amendatory instructions to appendix 1 contractor reach agreement on price
to subpart P of 20 CFR part 404, Construction Manager/General reasonableness, they enter into a
removing section 114.00I and Contractor Contracting contract for the construction of the
redesignating section 114.00J as section project.
AGENCY: Federal Highway
114.00I. This document corrects the The CM/GC method has proven to be
Administration (FHWA), U.S.
final regulation by removing that an effective method of project delivery
Department of Transportation (DOT).
jstallworth on DSK7TPTVN1PROD with RULES
amendatory instruction. through its limited deployment in the
ACTION: Final rule.
DATES: These rules are effective January FHWA’s Special Experimental Project
17, 2017. SUMMARY: Section 1303 of the Moving Number 14 (SEP–14) Program. Utilizing
FOR FURTHER INFORMATION CONTACT: Ahead for Progress in the 21st Century the contractor’s unique construction
Cheryl A. Williams, Office of Medical Act (MAP–21) authorizes the use of the expertise in the design phase can
Policy, Social Security Administration, Construction Manager/General recommend for the contracting agency’s
6401 Security Boulevard, Baltimore, Contractor (CM/GC) contracting method. consideration innovative methods and
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Document Created: 2018-02-14 09:01:53
Document Modified: 2018-02-14 09:01:53
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | These rules are effective January 17, 2017. | |
| Contact | Cheryl Williams, Office of Disability Policy, Social Security Administration, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, (410) 965-1020. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213, or TTY 1-800-325-0778, or visit our Internet site, Social Security Online, at http://www.socialsecurity.gov. | |
| FR Citation | 81 FR 86915 | |
| RIN Number | 0960-AG71 | |
| CFR Associated | Administrative Practice and Procedure; Blind; Disability Benefits; Old-Age; Survivors; Disability Insurance; Reporting and Recordkeeping Requirements and Social Security |
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