[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Proposed Rules]
[Pages 7967-7985]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02165]



[[Page 7967]]

Vol. 78

Monday,

No. 23

February 4, 2013

Part V





Social Security Administration





-----------------------------------------------------------------------





20 CFR Parts 404 and 416





Revised Medical Criteria for Evaluating Respiratory System Disorders; 
Proposed Rule

Federal Register / Vol. 78 , No. 23 / Monday, February 4, 2013 / 
Proposed Rules

[[Page 7968]]


-----------------------------------------------------------------------

SOCIAL SECURITY ADMINISTRATION

20 CFR Parts 404 and 416

[Docket No. SSA-2006-0149]
RIN 0960-AF58


Revised Medical Criteria for Evaluating Respiratory System 
Disorders

AGENCY: Social Security Administration.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: We propose to revise the criteria in the Listing of 
Impairments (listings) that we use to evaluate claims involving 
respiratory disorders in adults and children under titles II and XVI of 
the Social Security Act (Act). The proposed revisions reflect our 
program experience, advances in medical knowledge, and comments we 
received from medical experts and the public at an outreach policy 
conference and in response to an Advance Notice of Proposed Rulemaking 
(ANPRM).

DATES: To ensure that your comments are considered, we must receive 
them by no later than April 5, 2013.

ADDRESSES: You may submit comments by any one of three methods--
Internet, fax, or mail. Do not submit the same comments multiple times 
or by more than one method. Regardless of which method you choose, 
please state that your comments refer to Docket No. SSA-2006-0149 so 
that we may associate your comments with the correct regulation.
    Caution: You should be careful to include in your comments only 
information that you wish to make publicly available. We strongly urge 
you not to include in your comments any personal information, such as 
Social Security numbers or medical information.
    1. Internet: We strongly recommend that you submit your comments 
via the Internet. Please visit the Federal eRulemaking portal at http://www.regulations.gov. Use the Search function to find docket number 
SSA-2006-0149. The system will issue you a tracking number to confirm 
your submission. You will not be able to view your comment immediately 
because we must post each comment manually. It may take up to a week 
for your comment to be viewable.
    2. Fax: Fax comments to (410) 966-2830.
    3. Mail: Address your comments to the Office of Regulations and 
Reports Clearance, Social Security Administration, 107 Altmeyer 
Building, 6401 Security Boulevard, Baltimore, Maryland 21235-6401.
    Comments are available for public viewing on the Federal 
eRulemaking portal at http://www.regulations.gov or in person, during 
regular business hours, by arranging with the contact person identified 
below.

FOR FURTHER INFORMATION CONTACT: Cheryl Williams, Office of Medical 
Listings Improvement, 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:

What revisions are we proposing?

    We propose to:
     Revise and expand the introductory text to the respiratory 
system listings for both adults (section 3.00) and children (section 
103.00);
     Remove reference listings; and
     Update the listing criteria to reflect medical advances in 
evaluating respiratory disorders.

Why are we proposing these revisions and on what information are they 
based?

    We are proposing these revisions to reflect our program experience 
and medical advances in evaluating respiratory disorders. We last 
published final rules making comprehensive revisions to section 3.00--
the respiratory system listings for adults (people who are at least 18 
years old)--and section 103.00--the respiratory system listings for 
children (people under age 18)--on October 7, 1993.\1\ In the preamble 
to those rules, we indicated that we would periodically review and 
update the listings in light of medical advances and our program 
experience. Since that time, however, we have only extended the 
effective date of the rules.\2\
---------------------------------------------------------------------------

    \1\ 58 FR 52346; corrected at 59 FR 1274 (January 10, 1994). 
These listings appear in appendix 1 to subpart P of part 404.
    \2\ See 65 FR 57946 (2000), 67 FR 43537 (2002), 68 FR 36911 
(2003), 70 FR 35028 (2005), 72 FR 33662 (2007), and 73 FR 31025 
(2008). The current listings will no longer be effective as of July 
2, 2012 unless we extend them. 75 FR 33166 (2010).
---------------------------------------------------------------------------

    In developing these proposed rules, we considered the public 
comments that we received in response to an ANPRM that we published in 
the Federal Register on April 13, 2005.\3\ In the ANPRM, we announced 
our plans to update and revise this body system, and we invited 
interested people and organizations to send us written comments and 
suggestions. We also received public comments at an outreach policy 
conference on ``Respiratory Disorders in the Disability Programs'' that 
we hosted in Chicago, Illinois, on August 25-26, 2005.\4\
---------------------------------------------------------------------------

    \3\ 70 FR 19358 (2005).
    \4\ Although we indicated in the ANPRM that we would not 
summarize or respond to the comments, we read and considered them 
carefully. You can read the ANPRM, the comments we received in 
response to the ANPRM, and a transcript of the policy conference at 
http://www.regulations.gov. Use the Search function to find docket 
number SSA-2006-0149.
---------------------------------------------------------------------------

    In developing these proposed rules, we also used information from a 
variety of sources, including:
     Medical experts in the field of pulmonology, experts in 
other related fields, advocacy groups for people with respiratory 
disorders, and people with respiratory disorders and their families;
     People who make and review disability determinations and 
decisions for us in State agencies, in our Office of Quality 
Performance, and in our Office of Disability Adjudication and Review; 
and
     The published sources we list in the References section at 
the end of this preamble.
    We describe in more detail below the revisions we propose to make 
to the introductory text of the adult listings, the adult listings 
text, the introductory text of the childhood listings, and the 
childhood listings text.

What changes are we proposing to the introductory text of the 
respiratory disorders listings for adults?

    In the following paragraphs, we describe the significant changes we 
propose to make to the introductory text of the adult respiratory 
listings in part A of appendix 1 to subpart P of part 404 using the 
order of the current introductory text.

Section 3.00A

    We propose to reorganize and revise current 3.00A (Introduction) by 
creating separate sections for easier reference. These sections include 
the following: The kinds of disorders we evaluate in this body system 
(proposed 3.00A); the common signs and symptoms of respiratory 
disorders (proposed 3.00B); the abbreviations we use in this body 
system (proposed 3.00C); and the documentation we may need to evaluate 
respiratory disorders (proposed 3.00D).
    We propose to clarify our guidance regarding documentation of 
respiratory disorders. For example, we state in proposed 3.00D1 that we 
may not need all of the different kinds of medical evidence we describe 
in that paragraph, depending upon the person's particular respiratory 
disorder and its effects on

[[Page 7969]]

the person. We would also clarify in proposed 3.00D1 that medical 
evidence should include descriptions of any prescribed treatment and 
the response to it. We are including this provision because treatment 
may have improved a person's functional status. As under our current 
rules, however, we would not require a person to receive treatment to 
show the existence of an impairment that meets the criteria of a 
listing.
    We also propose to add section 3.00S (How do we evaluate 
respiratory disorders that do not meet one of these listings?). For 
easier reference and to conform to the order in which this guidance 
appears in other body systems, we would include this guidance in a new 
section at the end of the introductory text rather than in section 
3.00A as it now appears in the current introductory text.

Section 3.00B

    We propose to revise current 3.00B (Mycobacterial, mycotic, and 
other chronic persistent infections of the lung) and redesignate it as 
3.00R (How do we evaluate mycobacterial, mycotic, and other chronic 
infections of the lungs?). We also propose to clarify that we would 
evaluate chronic infections of the lungs under 3.02.

Section 3.00C

    We propose to remove current 3.00C (Episodic respiratory disease), 
which explains how we evaluate respiratory disorders that can be 
episodic in nature, such as asthma, cystic fibrosis (CF), and 
bronchiectasis. For easier reference, we would create separate sections 
for each of these disorders. The proposed sections are: 3.00I (What is 
asthma, and how do we evaluate it?), 3.00J (What is CF, and how do we 
evaluate it?), and 3.00L (What is bronchiectasis, and how do we 
evaluate it?). In these sections, we explain the nature of each 
disorder, the evidence we need to document the disorder, and how we 
would evaluate the disorder under the applicable listing.
    Several of the proposed listings for episodic disorders would 
require a specific number of events within a 12-month period. We 
provide additional information about this requirement in proposed 3.00O 
(How do we evaluate episodic respiratory disorders?). This guidance 
describing the 12-month period is not in current 3.00C.

Section 3.00D

    As a result of the proposed changes to current 3.00C described 
above, we propose to revise current 3.00D (Cystic fibrosis) and 
redesignate it as 3.00J.

Sections 3.00E and 3.00F

    We propose to reorganize and revise current 3.00E (Documentation of 
pulmonary function testing) and current 3.00F (Documentation of chronic 
impairment of gas exchange), by creating separate sections for three 
major types of pulmonary function tests (PFTs). The proposed sections 
for these tests are: Spirometry (3.00E, What is spirometry, and what 
are our requirements for an acceptable test and report?), diffusing 
capacity of the lungs for carbon monoxide (DLCO) (3.00F, What is a DLCO 
test, and what are our requirements for an acceptable test and 
report?), and arterial blood gas (ABG) testing (3.00G, What is an ABG 
test, and what are our requirements for an acceptable test and 
report?). In each of these sections, we explain the nature of each test 
and simplify our documentation requirements for an acceptable test and 
report.
    We propose to modify some of our current documentation requirements 
for spirometry, which simply restate testing standards. Such testing 
standards are usually not documented in medical records, and our 
program experience has shown that there is no need to require 
verification that the person administering the test followed such 
testing standards. For example, we would no longer require proof of 
equipment calibration on the day of the spirometric measurement because 
we believe that we can reasonably presume that the device has been 
properly calibrated. Daily equipment calibration is the current 
standard of care for providers who administer spirometry, and in our 
experience that standard of care has been met.
    We would also no longer require the spirometric tracings for the 
satisfactory forced expiratory maneuvers. The current standard of care 
requires the performance of at least three satisfactory forced 
expiratory maneuvers. The person administering the test uses the 
spirometric tracings to determine whether the maneuvers are 
satisfactory before reporting the person's highest values. This 
modification would be consistent with our documentation requirements in 
other areas where we routinely rely on the reports of test results 
rather than require additional documentation to enable independent 
verification. For example, we rely on findings referenced in 
radiologists' reports; we do not require the x-rays to verify those 
findings independently.
    We believe that these modifications of our current spirometry 
documentation requirements may reduce the number of CEs we purchase and 
decrease case processing time without affecting the quality of our 
determinations and decisions. We are specifically interested in any 
comments and suggestions you have about the proposed modifications to 
our current spirometry documentation requirements.
    We also propose to remove the requirement that our program 
physician must determine whether obtaining a particular PFT would 
present a significant risk to the person because this requirement is 
redundant of our other regulations that require a program physician to 
approve the ordering of a test whenever there is any significant risk. 
See 20 CFR 404.1519m and 416.919m. However, we would include a reminder 
in each of the proposed sections on PFTs that the medical source we 
designate to administer the particular PFT is solely responsible for 
deciding whether it is safe for the person to do the test and for how 
to administer the test. This provision is consistent with our current 
regulations, which provide that the responsibility for deciding whether 
to administer the test rests with the medical source designated to 
perform the consultative examination.
    We explain in proposed 3.00G3a that we would not purchase exercise 
ABG tests. Spirometry, DLCO tests, resting ABG tests, and pulse 
oximetry offer a sufficiently comprehensive range of PFTs to properly 
evaluate respiratory disorders. Therefore, we propose to remove current 
3.00F3 and 3.00F4, which explain our rules for exercise testing with 
ABGs we may purchase under the current listings, because we would no 
longer need these sections.
    We also propose to provide guidance on the use of pulse oximetry in 
proposed 3.00H (What is pulse oximetry, and what are our requirements 
for an acceptable test and report?). We explain the nature of the test 
and our documentation requirements for an acceptable test and report. 
We believe that, to evaluate impairments of gas exchange, we may 
substitute an acceptable pulse oximetry test for DLCO and ABG tests, 
which are often difficult to obtain. Pulse oximetry is a simple, non-
invasive method of assessing a person's respiratory function by 
measuring the oxygen saturation of arterial blood. To increase the 
reliability and validity of pulse oximetry results, we would require a 
graphical printout showing the oximetry values concurrently with the 
pulse (see proposed 3.00H3b). A pulse wave helps ensure that the 
associated pulse oximetry value is a true measure of the oxygen 
saturation of arterial blood and not the result of certain artifactual

[[Page 7970]]

inaccuracies, such as movement. We recognize that printouts of pulse 
readings are not routinely done in pulse oximetry. Thus, we expect that 
we would use only pulse oximetry that we purchase to determine that an 
impairment meets proposed 3.02C4 or 3.04D4.
    We provide guidance in proposed 3.00K (What is respiratory failure, 
and how do we evaluate it?) for the evaluation of respiratory failure 
because we are proposing a new separate listing, proposed 3.14 
(Respiratory failure), and we include a criterion for respiratory 
failure associated with CF in proposed 3.04D2. Respiratory failure 
requiring continuous assisted (mechanical) ventilatory support for the 
period specified in 3.04D2 and 3.14 reflects the failure of the lungs 
to perform their basic function of gas exchange and is a serious 
complication regardless of the underlying chronic respiratory disorder.

Section 3.00G

    We propose to redesignate and revise current 3.00G (Chronic cor 
pulmonale and pulmonary vascular disease) to proposed 3.00M (What is 
chronic pulmonary hypertension, and how do we evaluate it?) to reflect 
current medical terminology for this disorder. We explain the nature of 
the disorder and our documentation requirements under proposed 3.09.

Section 3.00H

    We propose to redesignate and revise current 3.00H (Sleep-related 
breathing disorders) to proposed 3.00Q (What are sleep-related 
breathing disorders, and how do we evaluate them?). Since we propose to 
remove current 3.10 (Sleep-related breathing disorders), we would 
further explain the nature of sleep-related breathing disorders and 
their complications, including how we evaluate those complications 
under the affected body system(s). We also state that we would not 
purchase a polysomnography test to evaluate a sleep-related breathing 
disorder.

Section 3.00I

    We propose to redesignate and revise current 3.00I (Effects of 
obesity) to proposed 3.00P (How do we consider the effects of obesity 
when we evaluate your respiratory disorder?). We also propose minor 
editorial revisions in this section.

Section 3.00N

    We propose to add 3.00N (How do we evaluate lung transplantation?) 
to explain how we would evaluate a respiratory disorder after a person 
has received a lung transplant. Under current 3.11, we consider a 
person who has received a lung transplant to be disabled for 1 year 
after the date of transplantation. We propose to extend that time to 3 
years. We base this proposal on a recommendation we received at our 
policy conference and on our program experience. The revision would 
recognize that, although most lung transplant recipients do well within 
1 year of transplantation, nearly all deteriorate after 1 year. We also 
explain that lung transplant patients generally have impairments that 
meet our definition of disability before they get their transplants. 
This section would clarify that we may decide that a lung transplant 
recipient's disability began before the impairment met proposed 3.11. 
We would determine the onset of disability based on the facts of the 
case.

What changes are we proposing to the respiratory disorders listings for 
adults?

    The following chart provides a comparison of the current adult 
listings and the proposed listings.

------------------------------------------------------------------------
                Current                              Proposed
------------------------------------------------------------------------
3.02 Chronic pulmonary insufficiency...  3.02 Chronic respiratory
                                          disorders
3.03 Asthma............................  3.03 Asthma
3.04 Cystic fibrosis...................  3.04 Cystic fibrosis
3.05 [Reserved]........................  3.05 [Reserved]
3.06 Pneumoconiosis....................  3.06 [Reserved]
                                         Would be evaluated under
                                          proposed 3.02
3.07 Bronchiectasis....................  3.07 Bronchiectasis
3.08 Mycobacterial, mycotic, and other   3.08 [Reserved]
 chronic persistent infections of the    Would be evaluated under
 lung.                                    proposed 3.02
3.09 Cor pulmonale secondary to chronic  3.09 Chronic pulmonary
 pulmonary vascular hypertension.         hypertension due to any cause
3.10 Sleep-related breathing disorders.  3.10 [Reserved]
                                         Would be evaluated under a
                                          listing in the affected body
                                          system
3.11 Lung transplant...................  3.11 Lung transplantation
                                         3.12 [Reserved]
                                         3.13 [Reserved]
                                         3.14 Respiratory failure
------------------------------------------------------------------------

    We are proposing to remove current 3.06 (Pneumoconiosis), 3.07A 
(for bronchiectasis that results in pulmonary insufficiency), 3.08 
(Mycobacterial, mycotic, and other chronic persistent infections of the 
lung), 3.09B (for cor pulmonale), and 3.10 (Sleep-related breathing 
disorders). These listings simply cross-refer to other listings and do 
not contain separate medical criteria. We would instead evaluate these 
disorders under proposed 3.02, another respiratory listing, or another 
listing in an affected body system. For example, we are including a 
reference to pneumoconiosis in proposed 3.00A1.
    We describe the significant changes to the respiratory listings for 
adults below, using the headings of the proposed listings.

Listing 3.02, Chronic Respiratory Disorders

    We propose to make the following changes to current 3.02, which we 
use to evaluate chronic respiratory disorders that impair lung 
function, except for CF:
     Revise the heading of current 3.02, (Chronic pulmonary 
insufficiency), to Chronic respiratory disorders, to simplify our 
terminology. We also propose to clarify that this listing does not 
apply to people with CF because we would continue to have a separate 
listing to evaluate that disorder.
     Revise and reorganize current 3.02. Depending on the 
nature of the disorder, we may use the results of a number of PFTs to 
assess the severity of a person's respiratory disorder under 3.02. We 
explain each of these PFTs and our documentation requirements in 
proposed 3.00D, 3.00E, 3.00F, 3.00G, and 3.00H.

[[Page 7971]]

     Add categories for age and gender to the spirometry tables 
and modify the spirometry values for 3.02A (forced expiratory volume 
(FEV1)) and 3.02B (forced vital capacity (FVC)) to recognize 
the differences in predicted normal values between females and males. 
We base the tables on reference values from Hankinson, et al.,\5\ who 
used data from the Third National Health and Nutrition Examination 
Survey conducted by the Centers for Disease Control and Prevention 
(CDC).
---------------------------------------------------------------------------

    \5\ Hankinson, J. L., Odencrantz, J. R., & Fedan, K. B. (1999). 
Spirometric reference values from a sample of the general U.S. 
population. American Journal of Respiratory and Critical Care 
Medicine, 159(1), 179-187. We relied on reference values from 
Hankinson, et al., in modifying all of the spirometric tables 
referenced in our proposed rules.
---------------------------------------------------------------------------

     Revise the height categories in the spirometry tables to 
provide equivalent values for height both in centimeters and in inches.
     Provide separate tables for people age 18 to the 
attainment of age 20 (proposed tables I-A and II-A) and age 20 and 
older (proposed tables I-B and II-B) under proposed 3.02A and 3.02B to 
account for the continuing physical maturation process for such young 
adults.
     Remove the term ``chronic obstructive pulmonary disease'' 
from 3.02A and the term ``chronic restrictive ventilatory disease'' 
from current 3.02B, but retain revised FEV1 and FVC tables 
(proposed tables I and II) for evaluating certain chronic respiratory 
disorders, except CF. A chronic respiratory disorder may be 
obstructive, restrictive, or a combination of both. The distinction is 
not important for our adjudicative purposes.
     Add a table (proposed table III) for evaluating chronic 
respiratory disorders under proposed 3.02C1 using DLCO. We are 
proposing this change because we believe that we need to provide 
specific values that account for a person's gender and height, as we do 
for the spirometry criteria under 3.02A and 3.02B.
     Add a listing (proposed 3.02C4) based on a combination of 
pulse oximetry and spirometry results. The new listing would reflect 
technological advancements in the assessment of respiratory disorders 
that affect gas exchange impairment. We believe that, because of these 
advancements, we are now able to accept pulse oximetry, subject to the 
requirements in proposed 3.00H, as an alternative method for the 
assessment of respiratory disorders. We would also provide separate 
tables for the necessary spirometry values in proposed 3.02C4b(i) 
(tables V-A and V-B) and 3.02C4b(ii) (tables VI-A and VI-B).

Listing 3.03, Asthma

    We propose to make the following changes to current 3.03:
     Remove current 3.03A because it only cross-refers to 
current 3.02A.
     Move the requirement for baseline airflow obstruction from 
current 3.00C to proposed 3.03A and add spirometry criteria to the 
proposed listing (using the spirometry values in proposed tables V-A 
and V-B) to quantify the degree of baseline airflow obstruction.
     Use the term ``exacerbations'' in proposed 3.03B, instead 
of ``attacks,'' the term we use in current 3.03B, because we believe 
the term ``exacerbations'' provides a clearer and more medically 
appropriate description of the asthmatic condition.
     Revise the length of hospitalization due to an 
exacerbation of asthma from at least 24 hours to at least 48 hours, 
including hours in an emergency department immediately before the 
hospitalization. We would also require at least 30 days between each 
hospitalization to be certain that each exacerbation is a separate 
event. This provision for requiring at least 30 days between events is 
consistent with the criteria in similar listings in other body systems.
     Require three hospitalizations instead of exacerbations 
requiring outpatient physician intervention occurring every 2 months or 
at least six times a year. Based on the advice of medical experts and 
our program experience, we believe such interventions do not accurately 
identify people with listing-level impairments.
     Remove the requirement that an exacerbation occur despite 
following prescribed treatment. We would consider any hospitalization 
for an exacerbation of asthma lasting at least 48 hours to be despite 
prescribed treatment, unless we have evidence to the contrary.
     Add a criterion that we would consider a person to be 
disabled for 1 year from the discharge date of the last 
hospitalization. Our program experience has shown that people who have 
experienced the type of exacerbations in proposed 3.03B need a period 
of 1 year for medical improvement to occur.

Listing 3.04, Cystic Fibrosis

    We propose to make the following changes to current 3.04:
     Add categories for age and gender to the spirometry tables 
and modify the values in proposed 3.04A (FEV1) to recognize 
the differences in predicted normal values between females and males.
     Provide separate tables for people age 18 to the 
attainment of age 20 (proposed table VII-A) and age 20 and older 
(proposed table VII-B) under proposed 3.04A to account for the 
continuing physical maturation process for such young adults.
     Require a less severe ventilatory defect for listing-level 
impairment in proposed 3.04A in recognition of the fact that people 
with CF are disabled at a comparatively higher level of lung function 
than others who do not have CF.
     Add criteria for evaluating a chronic impairment of gas 
exchange to include ABG test values for the evaluation of CF (proposed 
3.04B).
     Replace current 3.04B (for episodes of bronchitis, 
pneumonia, hemoptysis, or respiratory failure) and current 3.04C (for 
persistent pulmonary infection) with proposed 3.04C, for exacerbations 
and complications of CF, and revise the criteria for how we consider 
hospitalizations under this proposed listing. We do not specify a 
minimum length of hospitalization because hospitalizations for 
exacerbations and complications of CF are invariably long enough for 
purposes of our listings. For complications of bronchitis, pneumonia, 
or hemoptysis (more than blood-streaked sputum), in people with CF, we 
would no longer consider physician interventions, either as an 
outpatient or in an emergency department. When these types of 
complications in CF occur, they are too severe to treat on an 
outpatient basis. We consider this level of severity more reflective of 
a listing-level impairment.
     Provide an expanded list of acute and chronic CF 
complications that, when in specified combinations, reflect a listing-
level impairment under proposed 3.04D. We would add the following 
criteria for acute CF complications: Spontaneous pneumothorax requiring 
chest tube treatment (proposed 3.04D1), respiratory failure requiring 
continuous assisted ventilation (proposed 3.04D2), and pulmonary 
hemorrhage requiring vascular embolization (proposed 3.04D3). We would 
also add the following criteria for chronic CF complications: Hypoxemia 
(proposed 3.04D4), weight loss accompanied by certain other 
requirements for a specified period (proposed 3.04D5), and CF-related 
diabetes (CFRD, proposed 3.04D6). We may also evaluate any of these 
complications under proposed 3.04C if they result in hospitalization.

[[Page 7972]]

Listing 3.07, Bronchiectasis

    We propose to revise current 3.07, Bronchiectasis, by removing the 
criterion for outpatient physician intervention in current 3.07B for 
the same reason we propose to remove the criterion from current 3.03B. 
We would include the same requirement for hospitalizations due to 
exacerbations or complications of bronchiectasis as in proposed 3.03B.

Listing 3.09, Chronic Pulmonary Hypertension Due to Any Cause

    We propose to rename and revise current 3.09, Cor pulmonale 
secondary to chronic pulmonary vascular hypertension, to Chronic 
pulmonary hypertension due to any cause, to reflect current medical 
terminology. We propose to remove the criterion for arterial hypoxemia 
(current 3.09B) because it only cross-refers to 3.02C2, and we are 
removing all reference listings. We would revise the criteria in 
current 3.09A for pulmonary mean artery pressure determined by cardiac 
catheterization to include 40 mm Hg based on a recommendation by the 
Institute of Medicine in its report, Cardiovascular Disability--
Updating the Social Security Listings.\6\
---------------------------------------------------------------------------

    \6\ Institute of Medicine. (2010). Cardiovascular disability: 
Updating the Social Security listings. Washington, DC: The National 
Academies Press.
---------------------------------------------------------------------------

    We would add criteria in proposed 3.09B for systolic pulmonary 
artery pressure determined by echocardiogram. We have determined that 
the criteria we are proposing for echocardiography results would also 
be acceptable for our purposes, and we see the results of this kind of 
testing in medical evidence more often than cardiac catheterization. 
Thus, the proposed listing would help us to adjudicate some cases more 
quickly while still maintaining the accuracy of our adjudications.

Listing 3.11, Lung Transplantation

    We propose to rename and revise current 3.11 to be consistent with 
similar listings in other body systems. For reasons we have already 
explained, we also propose to extend the period for which the 
impairment would meet the listing from 1 year to 3 years. After that, 
we will evaluate the residual impairment(s) a person has to determine 
if he or she is still disabled. This provision for evaluating the 
residual impairment(s) is the same as in current 3.11 and is consistent 
with the criteria in similar listings in other body systems.

Listing 3.14, Respiratory Failure

    We propose to add 3.14, Respiratory failure, to provide criteria 
that recognize the medical severity of respiratory disorders that lead 
to two or more episodes of respiratory failure requiring continuous 
assisted ventilation for a specified period within a 12-month period.

What changes are we proposing to the introductory text of the 
respiratory disorders listings for children?

    The same basic rules for evaluating respiratory disorders in adults 
also apply to children. Except for minor editorial changes to make the 
text specific to children, we have repeated much of the introductory 
text of proposed 3.00 in the introductory text of proposed 103.00, 
although we provide fewer sections because we provide fewer childhood 
listings. Since we have already described these proposed rules under 
the explanation of proposed 3.00, we describe here only sections of the 
proposed rules that are unique to children or that require further 
explanation.
     We would remove the guidance regarding ABGs and pulse 
oximetry in current section 103.00C because we do not include this 
testing as a criterion in the proposed childhood listings. However, in 
the rare case where ABG or pulse oximetry results are in the medical 
evidence, we would consider these results in determining disability.
     In proposed section 103.00E (What is spirometry, and what 
are our requirements for an acceptable test and report?), we explain 
that before we purchase spirometry for children, a medical consultant, 
preferably one experienced in the care of children with respiratory 
disorders, must review the case record to determine if we need the 
test. Unlike adults, children do not routinely undergo spirometry, and 
we recognize that the decision to obtain spirometry for assessing 
disability in children involves medical expertise.
     We would redesignate and revise current 103.00E 
(Bronchopulmonary dysplasia (BPD)) to proposed 103.00F (What is CLD, 
and how do we evaluate it?). The change would reflect current medical 
terminology. There have been advances in the treatment and management 
of chronic lung disease of infancy (CLD), and we no longer believe it 
is appropriate to find disability in all infants with CLD whose 
impairments meet the criteria of current 103.02E at birth or shortly 
after birth. Within the first 6 months of life, most infants with CLD 
improve and are successfully weaned from assisted ventilation and 
oxygen supplementation. The proposed rule provides that, if an infant 
with CLD receives oxygen supplementation, we would not evaluate the CLD 
under proposed 103.02C until he or she has attained age 6 months. If 
the child was born prematurely, we would use a corrected chronological 
age. The infant would need to be on oxygen supplementation then or 
afterwards to have CLD that meets this proposed listing. We also 
provide that we may make a fully favorable determination before age 6 
months under other rules. For a child from birth up to the attainment 
of age 2, we would evaluate the frequency of the child's CLD 
exacerbations or related complications that require hospitalization 
under proposed 103.02E. After the child attains age 2, we would 
evaluate the CLD under the proposed 103.03 asthma listing.
     We would add guidance in proposed 103.00H (What is CF, and 
how do we evaluate it?) that is the same as in proposed 3.00J. We also 
indicate in proposed 103.00H7 that we can evaluate CF-related growth 
failure under 100.00 or 105.00, and CFRD under 109.00 or under another 
body system affected by the disorder.
     We would add proposed 103.00J (How do we evaluate growth 
failure due to any chronic respiratory disorder?) because we are 
removing current 103.02E6, 103.02F2, 103.02H, 103.03D, and 103.04E. We 
explain that we may evaluate growth failure under a growth impairment 
listing in 100.00 or under 105.00.

What changes are we proposing to the respiratory disorders listings for 
children?

    The proposed childhood respiratory listings are designated 103.02, 
103.03, 103.04, 103.11, and 103.14. They have the same headings as 
their counterparts in the proposed adult listings. Some of the criteria 
we propose for children are the same as, or based on, the current 
childhood respiratory criteria. For example, proposed 103.02D includes 
the same rule for children under age 3 who have tracheostomies as in 
current 103.02D, but also includes a new rule for children age 3 and 
older.
    We are not proposing childhood rules to correspond to proposed 
adult listings 3.07 (for bronchiectasis) and 3.09 (for chronic 
pulmonary hypertension due to any cause). Bronchiectasis in children is 
not a distinct disorder as it is in adults, but is associated with CF, 
which we would evaluate under 103.04. Chronic pulmonary hypertension is 
unusual in children, but when it does occur, we can evaluate it under 
the adult listings

[[Page 7973]]

or under 104.02 for chronic heart failure.

Listing 103.02, Chronic Respiratory Disorders

    We propose to make the following changes to current 103.02:
     Revise the heading of current 103.02, Chronic pulmonary 
insufficiency, to Chronic respiratory disorders, to parallel what we 
proposed in 3.02 for adults because we apply the same principles to 
children as we do for adults.
     Add categories for age and gender to the spirometry tables 
for children age 13 to the attainment of age 18 and modify the 
spirometry tables in 103.02A and 103.02B to recognize the differences 
in predicted normal values between females and males that start at 
puberty. For children age 6 to the attainment of age 13, we propose to 
add spirometry values without a distinction for gender, as prepubertal 
females and males have similar normal spirometry values. We do not 
include values for children under age 6 in our proposed tables because 
we do not expect those children to have undergone spirometric testing, 
and predicted normal values have not been established for this age 
group.
     Provide FEV1 and FVC values for females and 
males age 13 to the attainment of age 18.
     Increase the number of height categories in the spirometry 
tables in 103.02A and 103.02B to provide better differentiation by 
height for listing-level impairments, and provide equivalent values for 
height both in centimeters and in inches.
     Remove current 103.02C1 (the frequent need for 
``mechanical ventilation'') because we are proposing 103.14 for 
respiratory failure requiring continuous assisted ventilation and 
defining what we mean by how frequently such failure must occur under 
the listing.
     Revise the criterion for oxygen supplementation in current 
103.02C2, and specify in proposed 103.02C the amount and duration of 
oxygen supplementation that is listing-level for children.
     Replace current 103.02E with the same requirement for 
three hospitalizations in a 12-month period as in other proposed 
listings. We would remove current 103.02E1 through 103.02E4 because 
these criteria are out of date. Due to advances in pediatric therapy, 
the clinical and radiographic findings and the bronchodilator and 
diuretic therapies in the current listing no longer reflect listing-
level severity for CLD.
     Remove current 103.02E5 because we would evaluate the need 
for supplemental oxygen under proposed 103.02C.
     Remove current 103.02E6, which refers to involuntary 
weight loss or failure to gain weight at an appropriate rate, because 
we would evaluate growth failure due to any chronic respiratory 
disorder (not just CLD) under a growth impairment listing in 100.00 or 
under 105.00. We also provide that we would consider a child whose 
impairment meets 103.02E under a disability for 1 year from the 
discharge date of the last hospitalization or until the attainment of 
age 2, whichever is later, after which we would evaluate the 
impairment(s) under 103.03 or as otherwise appropriate. This is because 
CLD exacerbations after age 2 are clinically similar to asthmatic 
exacerbations, and medical treatment is the same as for asthma.
     Remove current 103.02F because we would evaluate 
hospitalizations due to a chronic respiratory disorder under proposed 
103.02E and growth failure due to any chronic respiratory disorder 
under a growth listing in 100.00 or under 105.00.
     Remove current 103.02G, for chronic hypoventilation or 
chronic cor pulmonale. Chronic hypoventilation of the magnitude in 
current 103.02G (elevated PaCO2) is likely to be 
treated as respiratory failure, which we would evaluate under proposed 
103.14, Respiratory failure. For chronic cor pulmonale, we only cross-
refer to current 104.02, and we are removing all reference listings.
     Remove current 103.02H, which is a reference listing to 
100.00. We would evaluate growth failure under a growth impairment 
listing in 100.00 or under 105.00.

Listing 103.03, Asthma

    We propose to make the following changes to current 103.03:
     Provide the same listing criteria as in proposed 3.03B for 
adults. Current 103.03A is based on spirometry, and physicians rarely 
obtain spirometry for children with asthma because these children often 
have normal spirometry between asthma exacerbations. However, in the 
rare case where spirometry results are in the medical evidence, we 
would consider these results in determining disability.
     Remove current 103.03C because it is out of date. 
Persistent low-grade wheezing, nocturnal use of bronchodilators, and 
short-course steroids (current 103.03C) are no longer reliable 
indicators of listing-level severity.
     Remove current 103.03D because it only cross-refers to 
100.00.

Listing 103.04, Cystic Fibrosis

    We propose to make the following changes to current 103.04:
     Add categories for age and gender to the spirometry tables 
for children age 13 to the attainment of age 18 and modify the 
spirometry tables in 103.04A to recognize the differences in predicted 
normal values between females and males starting at puberty. For 
children age 6 to the attainment of age 13, we would add spirometry 
values without a distinction for gender because prepubertal females and 
males have similar normal spirometry values.
     Revise and reorganize current 103.04B to clarify that the 
criteria in proposed 103.04B apply only to children under age 6 (that 
is, children who cannot have pulmonary function testing). We would 
require findings of abnormalities on imaging in every case because 
imaging is essential for identifying such abnormalities. We would also 
revise current 103.04B1 into two separate criteria for clarity and 
remove the criterion for cyanosis, which we would evaluate under 
proposed 103.04C.
     Add criteria for hypoxemia documented by a specified level 
of continuous oxygen supplementation in proposed 103.04C to parallel 
what we propose in 103.02C for chronic respiratory disorders due to any 
cause except CF.
     Remove current 103.04E for growth impairment (a reference 
listing to 100.00), and replace it with proposed 103.04E5 for weight 
loss in combination with another CF complication. We agreed with CF 
experts at our policy conference who told us that the decision to 
initiate and continue supplemental enteral or parenteral nutrition 
indicates a serious worsening of CF and in combination with another CF 
complication represents a listing-level impairment. We may also 
evaluate growth failure under a growth impairment listing in 100.00 or 
under 105.00.

Other Change

    We also propose to remove the first example of functional 
equivalence from 20 CFR 416.926a(m), which is for a documented need for 
major organ transplant. We no longer need this example because our 
rules now include specific listings for the major organs that can be 
transplanted.

[[Page 7974]]

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).

How long would these proposed rules be effective?

    If we publish these proposed rules as final rules, they will remain 
in effect for 5 years after the date they become effective, unless we 
extend them, or revise and issue them again.

Clarity of These Proposed Rules

    Executive Order 12866, as supplemented by Executive Order 13563, 
requires each agency to write all rules in plain language. In addition 
to your substantive comments on these proposed rules, we invite your 
comments on how to make them easier to understand.
    For example:
     Would more, but shorter sections be better?
     Are the requirements in the rules clearly stated?
     Have we organized the material to suit your needs?
     Could we improve clarity by adding tables, lists, or 
diagrams?
     What else could we do to make the rules easier to 
understand?
     Do the rules contain technical language or jargon that is 
not clear?
     Would a different format make the rules easier to 
understand, e.g., grouping and order of sections, use of headings, 
paragraphing?

When will we start to use these rules?

    We will not use these rules until we evaluate public comments and 
publish final rules in the Federal Register. All final rules we issue 
include an effective date. We will continue to use our current rules 
until that date. If we publish final rules, we will include a summary 
of those relevant comments we received along with responses and an 
explanation of how we will apply the new rules.

Regulatory Procedures

Executive Order 12866, as Supplemented by Executive Order 13563

    We consulted with the Office of Management and Budget (OMB) and 
determined that these proposed rules meet the criteria for a 
significant regulatory action under Executive Order 12866, as 
supplemented by Executive Order 13563. Therefore, OMB reviewed them.

Regulatory Flexibility Act

    We certify that these proposed rules would not have a significant 
economic impact on a substantial number of small entities because they 
affect individuals only. Therefore, a regulatory flexibility analysis 
is not required under the Regulatory Flexibility Act, as amended.

Paperwork Reduction Act

    These proposed rules do not create any new or affect any existing 
collections and do not require OMB approval under the Paperwork 
Reduction Act.

References

    We consulted the following references when we developed these 
proposed rules:
    Al Ameri, H.F.S. (2006). Six minute walk test in respiratory 
diseases: A university hospital experience. Annals of Thoracic 
Medicine, 1, 16-19. doi:10.4103/1817-1737.25865.
    Belkin, R.A., Henig, N.R., Singer, L.G., Chaparro, C., 
Rubenstein, R.C., Xie, S. X., * * * Bunin, G.R. (2006). Risk factors 
for death of patients with cystic fibrosis awaiting lung 
transplantation. American Journal of Respiratory and Critical Care 
Medicine, 173, 659-666. doi:10.1164/rccm.200410-1369OC.
    Borowitz, D., Baker, R.D., & Stallings, V. (2002). Consensus 
report on nutrition for pediatric patients with cystic fibrosis. 
Journal of Pediatric Gastroenterology and Nutrition, 35, 246-259. 
doi:10.1097/00005176-200209000-00004.
    Boyle, M.P. (2007). Adult cystic fibrosis. Journal of the 
American Medical Association, 298, 1787-1793. doi:10.1001/
jama.298.15.1787.
    Braman, S.S. (2005). Update on the ATS guidelines for COPD. 
Medscape Pulmonary Medicine, 9(1). Retrieved from http://www.medscape.org/viewarticle/498648.
    Calverley, P.M.A. (2003). Closing the NETT on lung volume 
reduction surgery. [Editorial]. Thorax, 58, 651-653. doi:10.1136/
thorax.58.8.651.
    Carter, B.G., Carlin, J.B., Tibballs, J., Mead, H., Hochmann, 
M., & Osborne, A. (1998). Accuracy of two pulse oximeters at low 
arterial hemoglobin-oxygen saturation. Critical Care Medicine, 26, 
1128-1133. doi:10.1097/00003246-199806000-00040.
    Chernick, V., Boat, T.F., Wilmott, R.W., & Bush, A. (2006). 
Kendig's disorders of the respiratory tract in children (7th ed.). 
Philadelphia, PA: Saunders Elsevier.
    Cleveland, R.H., Zurakowski, D., Slattery, D.M., & Colin, A. A. 
(2007). Chest radiographs for outcome assessment in cystic fibrosis. 
Proceedings of the American Thoracic Society, 4, 302-305. 
doi:10.1513/pats.200611-179HT.
    College of Physicians and Surgeons of Ontario (CPSO). (2008). 
Clinical practice parameters and facility standards: Diagnostic 
spirometry and flow volume loop studies (3rd ed.). Toronto, Ontario 
(Canada): CPSO Publications. Retrieved from http://www.cpso.on.ca/uploadedFiles/policies/guidelines/facilties/Diagnostic%20Spirometry_Apr08.pdf.
    Crapo, R.O., & Morris, A.H. (1981). Standardized single-breath 
normal values for carbon monoxide diffusing capacity. American 
Review of Respiratory Disease, 123, 185-189.
    Drazen, J.M., & Epstein, A.M. (2003). Guidance concerning 
surgery for emphysema. [Editorial]. New England Journal of Medicine, 
348, 2134-2136. doi:10.1056/NEJMe030058.
    Fitzgerald, R.K., & Johnson, A. (2001). Pulse oximetry in sickle 
cell anemia. Critical Care Medicine, 29, 1803-1806. doi: 10.1097/
00003246-200109000-00025.
    Flume, P. A., Mogayzel, P.J., Robinson, K.A., Goss, C.H., 
Rosenblatt, R.L, Kuhn, R.J., & Marshall, B.C. (2009). Cystic 
fibrosis pulmonary guidelines: Treatment of pulmonary exacerbations. 
American Journal of Respiratory and Critical Care Medicine, 180, 
802-809. doi:10.1164/rccm.200812-1845PP.
    Flume, P.A., Strange, C., Ye, X., Ebeling, M., Hulsey, T., & 
Clark, L. (2005). Pneumothorax in cystic fibrosis. Chest, 128, 720-
728. doi:10.1378/chest.128.2.720.
    Hankinson, J.L., Odencrantz, J.R., & Fedan, K.B. (1999). 
Spirometric reference values from a sample of the general U.S. 
population. American Journal of Respiratory and Critical Care 
Medicine, 159, 179-187. Retrieved from http://ajrccm.atsjournals.org/.
    Institute of Medicine. (2010). Cardiovascular disability: 
Updating the Social Security listings. Washington, DC: The National 
Academies Press.
    Jensen, L. A., Onyskiw, J. E., & Prasad, N. G. (1998). Meta-
analysis of arterial oxygen saturation monitoring by pulse oximetry 
in adults. Heart and Lung: The Journal of Acute and Critical Care, 
27, 387-408. doi:10.1016/S0147-9563(98)90086-3.
    Jubran, A. (1999). Advances in respiratory monitoring during 
mechanical ventilation. Chest, 116, 1416-1425. doi:10.1378/
chest.116.5.1416.
    Kaza, V., Katz, M. F., Cumming, S., Frost, A. E., & Safdar, Z. 
(2007). Correlation of chest radiograph pattern with genotype, age, 
and gender in adult cystic fibrosis: A single-center study. Chest, 
132, 569-574. doi:10.1378/chest.06-3082.
    Kelly, P. T., Swanney, M. P., Frampton, C., Seccombe, L. M., 
Peters, M. J., & Beckert, L. E. (2006). Normobaric hypoxia 
inhalation test vs. response to airline flight in healthy 
passengers. Aviation, Space, and Environmental Medicine, 77, 1143-
1147. Retrieved from http://www.ingentaconnect.com/content/asma/asem.
    Kotecha, S., & Allen, J. (2002). Oxygen therapy for infants with 
chronic lung disease. Archives of Disease in Childhood: Fetal and 
Neonatal Edition, 87, F11-F14. doi:10.1136/fn.87.1.F11.
    Kotecha, S., & Allen, J. (2002). Correction: Oxygen therapy for 
infants with chronic lung disease. Archives of Disease in Childhood: 
Fetal and Neonatal Edition, 87, F234. doi:10.1136/fn.87.3.F234-a.
    Kress, J. P., Pohlman, A. S., & Hall, J. B. (1999). 
Determination of hemoglobin

[[Page 7975]]

saturation in patients with acute sickle chest syndrome: A 
comparison of arterial blood gases and pulse oximetry. Chest, 115, 
1316-1320. doi:10.1378/chest.115.5.1316.
    Lai, H. J. (2006). Classification of nutritional status in 
cystic fibrosis. Current Opinion in Pulmonary Medicine, 12, 422-427. 
doi:10.1097/01.mcp.0000245709.66762.f9.
    Lenfant, C. (2006). Will lung volume reduction surgery be widely 
applied? Annals of Thoracic Surgery, 82, 385-387. doi:10.1016/
j.athoracsur.2006.06.049.
    Liou, T. G., Adler, F. R., FitzSimmons, S. C., Cahill, B. C., 
Hibbs, J. R., & Marshall, B. C. (2001). Predictive 5-year 
survivorship model of cystic fibrosis. American Journal of 
Epidemiology, 153, 345-352. doi:10.1093/aje/153.4.345.
    Mayer-Hamblett, N., Rosenfeld, M., Emerson, J., Goss, C. H., & 
Aitken, M. L. (2002). Developing cystic fibrosis lung transplant 
referral criteria using predictors of 2-year mortality. American 
Journal of Respiratory and Critical Care Medicine, 166, 1550-1555. 
doi:10.1164/rccm.200202-087OC.
    McGovern, J. P., Sasse, S. A., Stansbury, D. W., Causing, L. A., 
& Light, R. W. (1996). Comparison of oxygen saturation by pulse 
oximetry and co-oximetry during exercise testing in patients with 
COPD. Chest, 109, 1151-1155. doi:10.1378/chest.109.5.1151.
    Milla, C. E. (2004). Association of nutritional status and 
pulmonary function in children with cystic fibrosis. Current Opinion 
in Pulmonary Medicine, 10, 505-509. doi: 10.1097/
01.mcp.0000138995.08494.69.
    Montgomery, G. S., & Howenstine, M. (2009). Cystic fibrosis. 
Pediatrics in Review, 30, 302-310. doi:10.1542/pir.30-8-302.
    Nick, J. A., & Rodman, D. M. (2005). Manifestations of cystic 
fibrosis diagnosed in adulthood. Current Opinion in Pulmonary 
Medicine, 11, 513-518. doi:10.1097/01.mcp.0000183052.56728.76.
    Perkins, G. D., McAuley, D. F., Giles, S., Routledge, H., & Gao, 
F. (2003). Do changes in pulse oximeter oxygen saturation predict 
equivalent changes in arterial oxygen saturation? Critical Care, 7, 
R67-R71. doi:10.1186/cc2339.
    Pesola, G. R., Huggins, G., & Sherpa, T. Y. (2006). Abnormal 
predicted diffusion capacities in healthy Asians: An inequality with 
a solution. Respiration, 73, 799-807. doi:10.1159/000094391.
    Petty, T. L., Burns, M., & Tiep, B. L. (2005). Essentials of 
pulmonary rehabilitation: A do it yourself guide to enjoying life 
with chronic lung disease. Lomita, CA: Pulmonary Education and 
Research Foundation. Retrieved from http://www.perf2ndwind.org/Essentials%204-15-5%20a.pdf.
    Ramsey, S. D., & Sullivan, S. D. (2005). Evidence, economics, 
and emphysema: Medicare's long journey with lung volume reduction 
surgery. Health Affairs, 24, 55-66. doi: 10.1377/hlthaff.24.1.55.
    Ries, A. L., Kaplan, R. M., Myers, R., & Prewitt, L. M. (2003). 
Maintenance after pulmonary rehabilitation in chronic lung disease: 
A randomized trial. American Journal of Respiratory and Critical 
Care Medicine, 167, 880-888. doi:10.1164/rccm.200204-318OC.
    Roemmich, W., Blumenfeld, H. L., & Moritz, H. (1972). Evaluating 
remaining capacity to work in miner applicants with simple 
pneumoconiosis under 65 years of age under title IV of Public Law 
91-173. Annals of the New York Academy of Sciences, 200, 608-616. 
doi:10.1111/j.1749-6632.1972.tb40219.x.
    Rosenstein, B. J., & Cutting, G. R. (1998). The diagnosis of 
cystic fibrosis: A consensus statement. Journal of Pediatrics, 132, 
589-595. doi:10.1016/S0022-3476(98)70344-0.
    Russi, E. W., Bloch, K. E., & Weder, W. (2003). Lung volume 
reduction surgery: What can we learn from the National Emphysema 
Treatment Trial? European Respiratory Journal, 22, 571-573. 
doi:10.1183/09031936.03.00077503.
    Schuh, S., Dick, P. T., Stephens, D., Hartley, M., Khaikin, S., 
Rodrigues, L., & Coates, A. L. (2006). High-dose inhaled fluticasone 
does not replace oral prednisone in children with mild to moderate 
acute asthma. Pediatrics, 118, 644-650. doi:10.1542/peds.2005-2842.
    Schutz, S. L. (2001). Oxygen saturation monitoring by pulse 
oximetry. In D. J. Lynn-McHale and K. K. Carlson (Eds.), AACN 
procedure manual for critical care (4th ed.) (pp.77-82). 
Philadelphia, PA: W. B. Saunders Company.
    Sokol, R. J., & Durie, P. R. (1999). Recommendations for 
management of liver and biliary tract disease for cystic fibrosis. 
Journal of Pediatric Gastroenterology and Nutrition, 28(Suppl. 1), 
S1-S13. doi:10.1097/00005176-199900001-00001.
    Stam, H., Splinter, T. A. W., & Versprille, A. (2000). 
Evaluation of diffusing capacity in patients with a restrictive lung 
disease. Chest, 117, 752-757. doi:10.1378/chest.117.3.752.
    Troosters, T., Casaburi, R., Gosselink, R., & Decramer, M. 
(2005). Pulmonary rehabilitation in chronic obstructive pulmonary 
disease. American Journal of Respiratory and Critical Care Medicine, 
172, 19-38. doi:10.1164/rccm.200408-1109SO.
    Ugramurthy, S., N. R., Naik, S. D., & Kurtkoti, S. S. (2004). 
Comparative study of blood gas and acid base parameters of capillary 
with arterial blood samples. Indian Journal of Anaesthesia, 48(6), 
469-471. Retrieved from http://medind.nic.in/iad/iadm.shtml.
    U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention. (2003). Key clinical activities for 
quality asthma care: Recommendations of the National Asthma 
Education and Prevention Program. Morbidity and Mortality Weekly 
Report, 52(RR-6), 1-8. Retrieved from http://www.cdc.gov/mmwr/.
    U.S. Department of Health and Human Services, National 
Institutes of Health, National Heart, Lung, and Blood Institute. 
(2003, May 20). National Emphysema Treatment Trial (NETT): 
Evaluation of lung volume reduction surgery for emphysema. Retrieved 
from http://www.nhlbi.nih.gov/health/prof/lung/nett/lvrsweb.htm.
    U.S. Department of Health and Human Services, National 
Institutes of Health, National Heart, Lung, and Blood Institute. 
(2007). Expert panel report 3: Guidelines for the diagnosis and 
management of asthma (NIH Publication No. 07-4051). Bethesda, MD: 
National Heart, Lung, and Blood Institute Health Information Center. 
Retrieved from http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf.
    U.S. Department of Health and Human Services, National 
Institutes of Health, National Heart, Lung, and Blood Institute. 
(2008, September). What is pulmonary hypertension? Retrieved from 
http://www.nhlbi.nih.gov/health/dci/Diseases/pah/pah_what.html.
    U.S. Department of Health and Human Services, National 
Institutes of Health, National Heart, Lung, and Blood Institute. 
(2009, May). What is bronchiectasis? Retrieved from http://www.nhlbi.nih.gov/health/dci/Diseases/brn/brn_whatis.html.
    U.S. Department of Health and Human Services, National 
Institutes of Health, National Library of Medicine. (2010, September 
15). Bronchiectasis. Retrieved from http://www.nlm.nih.gov/medlineplus/ency/article/000144.htm.
    Wang, X., Dockery, D. W., Wypij, D., Fay, M. E., & Ferris, B. 
G., Jr. (1993). Pulmonary function between 6 and 18 years of age. 
Pediatric Pulmonology, 15, 75-88. doi:10.1002/ppul.1950150204.
    Wilson, D. R. (2000). Gender vs. sex. [Letter to the editor]. 
Journal of the American Medical Association, 284, 2997-2998. 
doi:10.1001/jama.284.23.2997.
    Yamaya, Y., Bogaard, H. J., Wagner, P. D., Niizeki, K., & 
Hopkins, S. R. (2002). Validity of pulse oximetry during maximal 
exercise in normoxia, hypoxia, and hyperoxia. Journal of Applied 
Physiology, 92, 162-168. Retrieved from http://jap.physiology.org/.
    Yildizdas, D., Yapicioglu, H., Yilmaz, H. L., & Sertdemir, Y. 
(2004). Correlation of simultaneously obtained capillary, venous, 
and arterial blood gases of patients in a paediatric intensive care 
unit. Archives of Disease in Childhood, 89, 176-180. doi:10.1136/
adc.2002.016261.
    Yusen, R. D., & Littenberg, B. (2005). Integrating survival and 
quality of life data in clinical trials of lung disease: The case of 
lung volume reduction surgery. Chest, 127(4), 1094-1096. 
doi:10.1378/chest.127.4.1094.
    In addition, the American Thoracic Society (ATS) 
(www.thoracic.org) and the European Respiratory Society (ERS) 
(dev.ersnet.org) published the following joint statements:
    --(2004). Standards for the diagnosis and treatment of patients 
with COPD: A summary of the ATS/ERS position paper. European 
Respiratory Journal, 23, 932-946. doi:10.1183/09031936.04.00014304.
    --(2005). General considerations for lung function testing. 
European Respiratory Journal, 26, 153-161. doi:10.1183/
09031936.05.00034505.
    --(2005). Interpretative strategies for lung function tests. 
European Respiratory Journal, 26, 948-968. doi:10.1183/
09031936.05.00035205.
    --(2005). Standardisation of the measurement of lung volumes. 
European Respiratory Journal, 26, 511-522. doi:10.1183/
09031936.05.00035005.
    --(2005). Standardisation of the single-breath determination of 
carbon monoxide uptake in the lung. European Respiratory Journal, 
26, 720-735. doi:10.1183/09031936.05.00034905.

[[Page 7976]]

    --(2005). Standardisation of spirometry. European Respiratory 
Journal, 26, 319-338. doi:10.1183/09031936.05.00034805.
    --(2007). An official American Thoracic Society/European 
Respiratory Society statement: Pulmonary function testing in 
preschool children. American Journal of Respiratory and Critical 
Care Medicine, 175, 1304-1345. doi:10.1164/rccm.200605-642ST.

    We will make these references available to you for inspection if 
you are interested in reading them. Please make arrangements with the 
contact person shown in this preamble if you would like to review any 
reference materials.

(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

20 CFR Part 404

    Administrative practice and procedure; Blind, Disability benefits; 
Old-Age, Survivors, and Disability Insurance; Reporting and 
recordkeeping requirements; Social Security.

20 CFR Part 416

    Administrative practice and procedure; Aged, Blind, Disability 
benefits; Public assistance programs; Reporting and recordkeeping 
requirements; Supplemental Security Income (SSI).

    Dated: January 25, 2013.
Michael J. Astrue,
Commissioner of Social Security.

    For the reasons set out in the preamble, we propose to amend 20 CFR 
part 404 subpart P and part 416 subpart I as set forth below:

PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE 
(1950- )

Subpart P--[Amended]

0
1. The authority citation for subpart P of part 404 is revised 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), Pub. L. 104-193, 
110 Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 
U.S.C. 902 note).

0
2. Amend appendix 1 to subpart P of part 404 by revising item 4 of the 
introductory text before part A of appendix 1 to read as follows:

Appendix 1 to Subpart P of Part 404--Listing of Impairments

* * * * *
    4. Respiratory Disorders (3.00 and 103.00): [DATE 5 YEARS FROM 
THE EFFECTIVE DATE OF THE FINAL RULES].
* * * * *
0
3. Amend part A of appendix 1 to subpart P of part 404 by revising the 
body system name for section 3.00 in the table of contents to read as 
follows:

Part A

* * * * *
    3.00 Respiratory Disorders.
* * * * *
0
4. Revise section 3.00 in part A of appendix 1 to subpart P of part 404 
to read as follows:
* * * * *

3.00 RESPIRATORY DISORDERS

    A. What disorders do we evaluate in this body system?
    1. We evaluate respiratory disorders that result in obstruction 
(difficulty moving air out of the lungs) or restriction (difficulty 
moving air into the lungs), or that interfere with diffusion (gas 
exchange) across cell membranes in the lungs. Examples of such 
disorders and the listings we use to evaluate them include chronic 
obstructive pulmonary disease (primarily, chronic bronchitis and 
emphysema) (3.02), pulmonary fibrosis and pneumoconiosis (3.02), 
asthma (3.02 and 3.03), cystic fibrosis (3.04), and bronchiectasis 
(3.02 and 3.07). We also use listings in this body system to 
evaluate recurrent episodes of respiratory failure (3.04D2 and 
3.14), chronic pulmonary hypertension due to any cause (3.09), and 
lung transplantation (3.11).
    2. We evaluate cancers affecting the respiratory system under 
the malignant neoplastic diseases listings in 13.00. We evaluate 
neuromuscular disorders affecting the respiratory system under the 
neurological listings in 11.00 or under the immune system disorders 
listings in 14.00.
    B. What are common signs and symptoms of respiratory disorders? 
Common signs and symptoms of respiratory disorders are shortness of 
breath, coughing, wheezing, sputum production, hemoptysis (coughing 
up blood from the respiratory tract), and chest pain.
    C. What abbreviations do we use in this body system?
    1. ABG means arterial blood gas.
    2. BTPS means body temperature and ambient pressure, saturated 
with water vapor.
    3. CF means cystic fibrosis.
    4. CFRD means CF-related diabetes.
    5. CO means carbon monoxide.
    6. COPD means chronic obstructive pulmonary disease.
    7. DLCO means diffusing capacity of the lungs for carbon 
monoxide.
    8. FEV1 means forced expiratory volume in the first second of a 
forced expiratory maneuver.
    9. FVC means forced vital capacity.
    10. L means liter.
    11. mL CO (STPD)/min/mmHg means milliliters of carbon monoxide 
in standard temperature and pressure, dry, per minute, per 
millimeters of mercury.
    12. PaO2 means arterial blood partial 
pressure of oxygen.
    13. PaCO2 means arterial blood partial 
pressure of carbon dioxide.
    14. SpO2 means percentage of oxygen 
saturation of blood hemoglobin, as measured by pulse oximetry.
    15. 6MWT means six-minute walk test, which is a standardized 
test of sub-maximal exercise ability in people with heart and 
respiratory disorders.
    16. VI means volume of inhaled gas.
    D. What documentation do we need to evaluate your respiratory 
disorder?
    1. We need medical evidence to assess the effects of your 
respiratory disorder. Medical evidence should include your medical 
history, physical examination findings, the results of imaging (see 
3.00D2), pulmonary function tests (see 3.00D3), other relevant 
laboratory tests, and descriptions of any prescribed treatment and 
your response to it. If you use supplemental oxygen, we still need 
medical evidence to establish the severity of your respiratory 
disorder. We may not need all of this information depending upon 
your particular respiratory disorder and its effects on you.
    2. Imaging refers to medical imaging techniques, such as x-ray, 
computerized tomography, and echocardiography. The imaging must be 
consistent with the prevailing state of medical knowledge and 
clinical practice as the proper technique to support the evaluation 
of the disorder.
    3. Pulmonary function tests include spirometry (which measures 
ventilation of the lungs), DLCO tests (which measures gas diffusion 
in the lungs), ABG tests (which measure dissolved oxygen and carbon 
dioxide in the arterial blood), and pulse oximetry (which measures 
oxygen saturation of hemoglobin in the blood). Pulmonary function 
tests must be conducted in accordance with the most recently 
published standards of the American Thoracic Society (ATS).
    E. What is spirometry, and what are our requirements for an 
acceptable test and report?
    1. Spirometry measures how well you move air into and out of 
your lungs. In accordance with ATS testing standards, spirometry 
involves at least three forced expiratory maneuvers. A forced 
expiratory maneuver is a maximum inhalation followed by a forced 
maximum exhalation, and measures exhaled volumes of air over time. 
The volume of air you exhale in the first second of the forced 
expiratory maneuver is the FEV1. The total volume of air 
that you exhale during the entire forced expiratory maneuver is the 
FVC. We use your highest FEV1 value to evaluate your 
respiratory disorder under 3.02A, 3.02C4b(i), 3.03A, and 3.04A. We 
use your highest FVC value to evaluate your respiratory disorder 
under 3.02B and 3.02C4b(ii).
    2. We have the following requirements for spirometry under these 
listings:
    a. You must be medically stable at the time of the test. 
Examples of when we would not

[[Page 7977]]

consider you to be medically stable include when you are:
    (i) Within 2 weeks of a change in your prescribed respiratory 
medication.
    (ii) Experiencing, or within 30 days of completion of treatment 
for, a lower respiratory tract infection.
    (iii) Experiencing, or within 30 days of completion of treatment 
for, an acute exacerbation (temporary worsening) of a chronic 
respiratory disorder. Chronic wheezing by itself does not indicate 
that you are not medically stable.
    (iv) Hospitalized for, or within 30 days of a hospital discharge 
for, an acute myocardial infarction (heart attack).
    b. During testing, if your FEV1 is less than 70 
percent of your predicted normal value, we require repeat spirometry 
after inhalation of a bronchodilator to evaluate your respiratory 
disorder under these listings, unless it is medically 
contraindicated. If you used a bronchodilator before the test and 
your FEV1 is less than 70 percent of your predicted 
normal value, we still require a post-bronchodilator test unless the 
supervising physician determines that it is not safe for you to take 
a bronchodilator again. If you do not have post-bronchodilator 
spirometry, the test report must explain why. We can use the results 
of spirometry administered without bronchodilators when the use of 
bronchodilators is contraindicated.
    c. We use the highest of at least three FEV1 values 
and the highest of at least three FVC values obtained during the 
same test session, regardless of whether the highest FEV1 
value and the highest FVC value are from the same forced expiratory 
maneuver or different forced expiratory maneuvers. If the results of 
your spirometry include only one FEV1 value and one FVC 
value, we will presume each reported value is the highest value from 
the test session, unless we have evidence to the contrary and 
subject to the post-bronchodilator requirements in 3.00E2b.
    3. The spirometry report must include the following information:
    a. The date of the test and your name, age or date of birth, 
gender, and height without shoes. (We will assume that your recorded 
height on the date of the test is without shoes, unless we have 
evidence to the contrary.) If your spine is abnormally curved (for 
example, you have kyphoscoliosis), we will substitute the longest 
distance between your outstretched fingertips with your arms 
abducted 90 degrees in place of your height when this measurement is 
greater than your standing height without shoes.
    b. Any factors, if applicable, that can affect the 
interpretation of the test results (for example, your lack of 
cooperation or effort in doing the test).
    4. If we purchase spirometry, the medical source we designate to 
administer the test is solely responsible for deciding whether it is 
safe for you to do the test and for how to administer it.
    F. What is a DLCO test, and what are our requirements for an 
acceptable test and report?
    1. A DLCO test measures the gas exchange across cell membranes 
in your lungs. It measures how well CO diffuses from the alveoli 
(air sacs) of your lungs into your blood. DLCO may be severely 
reduced in some disorders, such as interstitial lung disease (for 
example, idiopathic pulmonary fibrosis, asbestosis, and sarcoidosis) 
and COPD (particularly emphysema), even when the results of 
spirometry are not significantly reduced. We use your unadjusted 
measured DLCO (that is, uncorrected for hemoglobin concentration) 
reported in mL CO (STPD)/min/mmHg to evaluate your respiratory 
disorder under 3.02C1.
    2. We have the following requirements for DLCO tests under these 
listings:
    a. You must be medically stable at the time of the test. See 
3.00E2a.
    b. The test must use the single-breath technique.
    (i) The VI during the DLCO maneuver must be at least 85 percent 
of your current FVC, and your time of inhalation must be less than 4 
seconds. See 3.00E for our rules for programmatically acceptable 
spirometry. If you do not have an FVC measurement on the same day as 
the DLCO test, we may use a programmatically acceptable FVC 
administered no more than 90 days before the DLCO test.
    (ii) Your breath-hold time must be between 8 and 12 seconds.
    (iii) Your total exhalation time must be less than or equal to 4 
seconds, with a sample collection time of less than 3 seconds. If 
your FVC is at least 2.0 L, the washout volume must be between 0.75 
L and 1.0 L. If your FVC is less than 2.0 L, the washout volume must 
be at least 0.5 L.
    3. The DLCO test report must include the following information:
    a. The date of the test and your name, age or date of birth, 
gender, and height without shoes. (We will assume that your recorded 
height on the date of the test is without shoes, unless we have 
evidence to the contrary.) If your spine is abnormally curved (for 
example, you have kyphoscoliosis), we will substitute the longest 
distance between your outstretched fingertips with your arms 
abducted 90 degrees in place of your height when this measurement is 
greater than your standing height without shoes.
    b. Any factors, if applicable, that can affect the 
interpretation of the test results (for example, your lack of 
cooperation or effort in doing the test).
    c. Tracings of your VI, breath-hold maneuver, and volume of 
exhaled gas showing your name and the date of the test for each DLCO 
maneuver.
    d. The average of at least two acceptable DLCO measurements, as 
defined above (see 3.00F2), within 3 mL CO (STPD)/min/mmHg of each 
other or within 10 percent of the highest value.
    4. We may need to purchase a DLCO test to determine whether your 
disorder meets 3.02C1 when we have evidence showing that you have a 
chronic respiratory disorder that could result in impaired gas 
exchange, unless we can make a fully favorably determination or 
decision on another basis. Since the DLCO calculation requires a 
current FVC measurement, we may also purchase spirometry at the same 
time as the DLCO test, even if we already have programmatically 
acceptable spirometry.
    5. Before we purchase a DLCO test, a medical consultant (see 
Sec. Sec.  404.1616 and 416.1016 of this chapter), preferably one 
with experience in the care of people with respiratory disorders, 
must review your case record to determine if we need the test. The 
medical source we designate to administer the test is solely 
responsible for deciding whether it is safe for you to do the test 
and for how to administer it.
    G. What is an ABG test, and what are our requirements for an 
acceptable test and report?
    1. General. An ABG test measures PaO2, 
PaCO2, and the concentration of hydrogen ions 
in your arterial blood. We use a resting ABG measurement to evaluate 
your respiratory disorder under 3.02C2 and 3.04B1. We use an 
exercise ABG measurement to evaluate your respiratory disorder under 
3.02C3 and 3.04B2.
    2. Resting ABG tests.
    a. We have the following requirements for resting ABG tests 
under these listings:
    (i) You must be medically stable at the time of the test. See 
3.00E2a.
    (ii) The test must be administered while you are breathing room 
air; that is, without oxygen supplementation.
    b. The resting ABG test report must include the following 
information:
    (i) Your name, the date of the test, and either the altitude or 
both the city and State of the test site.
    (ii) The PaO2 and 
PaCO2 values.
    c. We may need to purchase resting ABG tests to determine 
whether your disorder meets 3.02C2 or 3.04B1 when we have evidence 
showing that you have a chronic respiratory disorder that could 
result in impaired gas exchange, unless we can make a fully 
favorably determination or decision on another basis. If your case 
record contains a report of one programmatically acceptable resting 
ABG test with the values in the appropriate table (Table IV-A, IV-B, 
or IV-C), we may purchase a second resting ABG test to determine if 
your disorder meets 3.02C2 or 3.04B1, even if you have not had 
programmatically acceptable spirometry or a DLCO test.
    d. Before we purchase a resting ABG test, a medical consultant 
(see Sec. Sec.  404.1616 and 416.1016 of this chapter), preferably 
one with experience in the care of people with respiratory 
disorders, must review your case record to determine if we need the 
test. The medical source we designate to administer the test is 
solely responsible for deciding whether it is safe for you to do the 
test and for how to administer it.
    3. Exercise ABG tests.
    a. We will not purchase an exercise ABG test. We have the 
following requirements for exercise ABG tests under these listings:
    (i) You must have done the exercise under steady state 
conditions while breathing room air. If you were tested on a 
treadmill or bicycle ergometer, you generally must have exercised 
for at least 4 minutes at a grade and speed providing oxygen 
(O2) consumption of approximately 17.5 ml/kg/min (5 
metabolic equivalents (METs)).
    (ii) We may use a test in which you have not exercised for at 
least 4 minutes. If you were unable to complete at least 4 minutes 
of steady state exercise, we need a statement by the person 
administering the test about

[[Page 7978]]

whether the results are a valid indication of your respiratory 
status. For example, this statement may include information about 
your cooperation or effort in doing the test and whether you were 
limited in completing the test because of your respiratory disorder 
or another impairment.
    b. The exercise ABG test report must include the following 
information:
    (i) Your name, the date of the test, and either the altitude or 
both the city and State of the test site.
    (ii) The PaO2 and 
PaCO2 values.
    H. What is pulse oximetry, and what are our requirements for an 
acceptable test and report?
    1. Pulse oximetry measures the SpO2 of 
blood hemoglobin. We need pulse oximetry and spirometry to evaluate 
your respiratory disorder under 3.02C4 and only pulse oximetry to 
evaluate your CF under 3.04D4.
    2. We have the following requirements for pulse oximetry under 
these listings:
    a. You must be medically stable at the time of the test. See 
3.00E2a.
    b. Your pulse oximetry measurement must be recorded while you 
are breathing room air; that is, without oxygen supplementation.
    c. Your pulse oximetry measurement (while at rest and, if 
needed, after a 6MWT) must be stable and show a concurrent, 
acceptable pulse wave, as described in 3.00H3b. By ``stable,'' we 
mean that the range of pulse oximetry values (that is, lowest to 
highest) during any 15-second interval cannot exceed 2 percentage 
points. For example: (1) The measurement is stable if the lowest 
pulse oximetry value during a 15-second interval is 87 percent and 
the highest value is 89 percent--a range of 2 percentage points. (2) 
The measurement is not stable if the lowest value is 86 percent and 
the highest value is 89 percent--a range of 3 percentage points.
    d. If you have had two tests (that is, at rest and after a 
6MWT), we will use the values from the test with the lower oximetry 
values.
    3. The pulse oximetry report must include the following 
information:
    a. Your name, the date of the test, and either the altitude or 
both the city and State of the test site.
    b. A graphical printout showing your pulse oximetry values 
concurrently with your pulse. An acceptable pulse wave is one that 
shows the characteristic pulse wave; that is, sawtooth-shaped with a 
rapid systolic upstroke (nearly vertical) followed by a slower 
diastolic downstroke (angled downward).
    4. We may purchase resting pulse oximetry to determine whether 
your disorder meets 3.02C4 or 3.04D4 when we have evidence showing 
that you have a chronic respiratory disorder that could result in 
impaired gas exchange, unless we can make a fully favorably 
determination or decision on another basis. We may purchase pulse 
oximetry after a 6MWT if your resting pulse oximetry measurements 
are greater than the values in 3.02C4 or 3.04D4.
    5. Before we purchase pulse oximetry, a medical consultant (see 
Sec. Sec.  404.1616 and 416.1016 of this chapter), preferably one 
with experience in the care of people with respiratory disorders, 
must review your case record to determine if we need the test. The 
medical source we designate to administer the test is solely 
responsible for deciding whether it is safe for you to do the test 
and for how to administer it.
    I. What is asthma, and how do we evaluate it?
    1. Asthma is a chronic inflammatory disorder of the lung airways 
that we evaluate under 3.02 or 3.03.
    2. Under 3.03:
    a. We need evidence showing that you have documented baseline 
airflow obstruction (see Table V in 3.02) while you are medically 
stable.
    b. The phrase ``consider under a disability for 1 year'' in 
3.03B explains how long your asthma can meet the requirements of the 
listing. It does not refer to the date on which your disability 
began, only to the date on which we must reevaluate whether your 
asthma continues to meet a listing or is otherwise disabling.
    c. We will determine the onset of your disability based on the 
facts of your case, but it will be no later than the admission date 
of your first of three hospitalizations that satisfy the criteria of 
3.03B.
    J. What is CF, and how do we evaluate it?
    1. CF, which we evaluate under 3.04, is a genetic disorder that 
results in abnormal functioning of the cells lining the lung airways 
and of the cells in other body systems. We need the evidence 
described in 3.00J2, 3.00J3, or 3.00J4 to establish that you have 
CF.
    2. A report signed by a physician showing both a. and b.:
    a. One of the following:
    (i) A positive newborn screen for CF; or
    (ii) A history of CF in a sibling; or
    (iii) Documentation of at least one specific CF phenotype or 
clinical criterion (for example, chronic sino-pulmonary disease with 
persistent colonization or infections with typical CF pathogens, 
pancreatic insufficiency, or salt-loss syndromes); and
    b. One of the following definitive laboratory tests:
    (i) An elevated sweat chloride concentration equal to or greater 
than 60 millimoles per L; or
    (ii) The identification of two CF gene mutations affecting the 
cystic fibrosis transmembrane conductance regulator (CFTR); or
    (iii) Characteristic abnormalities in ion transport across the 
nasal epithelium.
    3. When we have the report described in 3.00J2 but it is not 
signed by a physician, we also need a report from a physician 
stating that you have CF.
    4. When we do not have the report described in 3.00J2, we need a 
report from a physician that is persuasive that a positive diagnosis 
was confirmed by appropriate laboratory analysis or another method. 
To be persuasive, this report must state that you had the 
appropriate definitive laboratory study or studies for diagnosing CF 
and provide the results or explain how your diagnosis was 
established by other methods consistent with the prevailing state of 
medical knowledge and clinical practice.
    5. In 3.04C, examples of exacerbations or complications of CF 
that may result in hospitalizations include increased cough and 
sputum production, hemoptysis, increased shortness of breath, 
increased fatigue, and reduction in pulmonary function.
    6. For 3.04D, you must have at least two complications from the 
list of complications in 3.04D1 through 3.04D6 occurring within a 
12-month period. You may have two of the same complications or two 
different ones.
    a. If you have two of the acute complications we describe in 
3.04D1 (spontaneous pneumothorax), 3.04D2 (respiratory failure), and 
3.04D3 (pulmonary hemorrhage), there must be at least 30 days 
between the two complications; for example, between an episode of 
spontaneous pneumothorax and an episode of respiratory failure or 
between two episodes of respiratory failure.
    b. The chronic complications we describe in 3.04D4 through 
3.04D6 can occur at the same time as any of the other complications 
in 3.04D. For example, your CF meets 3.04D if you have the weight 
loss we describe in 3.04D5 and the CFRD we describe in 3.04D6 even 
if they do not occur 30 days apart. Your CF also meets 3.04D if you 
have the weight loss we describe in 3.04D5 and the spontaneous 
pneumothorax we describe in 3.04D1 even if the spontaneous 
pneumothorax occurs during the same 90-day period we describe in 
3.04D5.
    c. Your CF also meets 3.04D if you have two episodes of one of 
the chronic complications in 3.04D4 through 3.04D6.
    7. CF may also affect the digestive and endocrine body systems. 
We evaluate nonpulmonary CF-related digestive disorders that are not 
covered by 3.04D under 5.00. We evaluate CFRD under 3.04D or under a 
body system affected by the diabetes.
    K. What is bronchiectasis, and how do we evaluate it? 
Bronchiectasis is a chronic respiratory disorder that is 
characterized by abnormal and irreversible dilatation of the bronchi 
(airways below the trachea), which may be associated with the 
accumulation of mucus, bacterial infections, and eventual airway 
scarring. We require imaging (see 3.00D2) to document this disorder. 
We evaluate your bronchiectasis under 3.02, or under 3.07 if you are 
having acute exacerbations.
    L. What is chronic pulmonary hypertension, and how do we 
evaluate it?
    1. Chronic pulmonary hypertension is an increase in the pressure 
of the blood vessels of the lungs. We evaluate chronic pulmonary 
hypertension due to any cause under 3.09.
    2. We will not purchase cardiac catheterization. We may purchase 
echocardiography to determine if your impairment meets 3.09B. Before 
we purchase an echocardiogram, a medical consultant (see Sec. Sec.  
404.1616 and 416.1016 of this chapter), preferably one with 
experience in the care of people with respiratory disorders, must 
review your case record to determine if we need the test. The 
medical source we designate to administer the test is solely 
responsible for deciding whether it is safe for you to do the test 
and for how to administer it.
    M. How do we evaluate lung transplantation? If you receive a 
lung transplant (or a lung transplant simultaneous

[[Page 7979]]

with other organs, such as the heart), we will consider you to be 
disabled under 3.11 for 3 years from the date of the transplant. 
After that, we will evaluate your residual impairment(s) by 
considering the adequacy of your post-transplant function, the 
frequency and severity of any rejection episodes you have, 
complications in other body systems, and adverse treatment effects. 
People who receive organ transplants generally have impairments that 
meet our definition of disability before they undergo 
transplantation. We will determine the onset of your disability 
based on the facts of your case.
    N. What is respiratory failure, and how do we evaluate it? 
Respiratory failure is the inability of the lungs to perform their 
basic function of gas exchange. We use 3.04D2 if you have CF-related 
respiratory failure. We use 3.14 if you have respiratory failure due 
to any other respiratory disorder. Respiratory therapy that only 
increases air pressure in your throat, such as continuous positive 
airway pressure (CPAP) or bi-level positive airway pressure (BiPAP), 
does not meet the criterion for continuous assisted (mechanical) 
ventilation in 3.04D2 or 3.14.
    O. How do we evaluate episodic respiratory disorders? Some 
respiratory disorders listings require a specific number of events 
within a 12-month period. See 3.02C2, 3.03B, 3.04B1, 3.04C, 3.04D, 
3.07, and 3.14. When we use such criteria, the 12-month period must 
occur within the period we are considering in connection with your 
application or continuing disability review.
    P. How do we consider the effects of obesity when we evaluate 
your respiratory disorder? Obesity is a medically determinable 
impairment that is often associated with disorders of the 
respiratory system. Obesity makes it harder for the chest and lungs 
to expand. This means that the respiratory system must work harder 
to provide needed oxygen. This in turn makes the heart work harder 
to pump blood to carry oxygen to the body. Since the body is working 
harder at rest, its ability to perform additional work is less than 
would otherwise be expected. Thus, the combined effects of obesity 
with respiratory impairments can be greater than the effects of each 
of the impairments considered separately. We must consider any 
additional and cumulative effects of your obesity when we determine 
whether you have a severe respiratory impairment, a listing-level 
respiratory impairment, a combination of impairments that medically 
equals the severity of a listed impairment, and when we assess your 
residual functional capacity.
    Q. What are sleep-related breathing disorders, and how do we 
evaluate them?
    1. Sleep-related breathing disorders (for example, sleep apnea) 
are characterized by transient episodes of interrupted breathing 
during sleep that disrupt normal sleep patterns. Prolonged episodes 
can result in disorders such as hypoxemia (low blood oxygen) and 
pulmonary vasoconstriction (restricted blood flow in pulmonary blood 
vessels). Over time, these disorders may lead to chronic pulmonary 
hypertension. We will not purchase polysomnography (sleep study).
    2. We evaluate the complications of sleep-related breathing 
disorders under the affected body system(s). For example, we 
evaluate chronic pulmonary hypertension due to any cause under 3.09; 
chronic heart failure under 4.02; and disturbances in mood, 
cognition, and behavior under 12.02 or another appropriate mental 
disorders listing.
    R. How do we evaluate mycobacterial, mycotic, and other chronic 
infections of the lungs? We evaluate chronic infections of the lungs 
that result in limitations in your respiratory function under 3.02.
    S. How do we evaluate respiratory disorders that do not meet one 
of these listings?
    1. These listings are only examples of common respiratory 
disorders that we consider severe enough to prevent you from doing 
any gainful activity. If your impairment(s) does not meet the 
criteria of any of these listings, we must also consider whether you 
have an impairment(s) that meets the criteria of a listing in 
another body system. For example, if your CF has resulted in chronic 
pancreatic or hepatobiliary disease, we will evaluate your 
impairment under the digestive system listings in 5.00.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. See Sec. Sec.  404.1526 
and 416.926 of this chapter. Respiratory disorders may be associated 
with disorders in other body systems, and we consider the combined 
effects of multiple impairments when we determine whether they 
medically equal a listing. If your impairment(s) does not meet or 
medically equal a listing, you may or may not have the residual 
functional capacity to engage in substantial gainful activity. We 
proceed to the fourth step and, if necessary, the fifth step of the 
sequential evaluation process in Sec. Sec.  404.1520 and 416.920 of 
this chapter. We use the rules in Sec. Sec.  404.1594 and 416.994 of 
this chapter, as appropriate, when we decide whether you continue to 
be disabled.

3.01 Category of Impairments, Respiratory Disorders

    3.02 Chronic respiratory disorders due to any cause except 
cystic fibrosis (see 3.04), with:
    A. FEV1 (see 3.00E1) less than or equal to the value 
in Table I-A or I-B for your age, gender, and height without shoes 
(see 3.00E3a).
    OR
    B. FVC (see 3.00E1) less than or equal to the value in Table II-
A or II-B for your age, gender, and height without shoes (see 
3.00E3a).
    OR
    C. Chronic impairment of gas exchange with one of the following:
    1. Single-breath DLCO test (see 3.00F1) less than or equal to 
the value in Table III for your gender and height without shoes (see 
3.00F3a); or
    2. Arterial PaO2 and 
PaCO2 (see 3.00G1) measured concurrently while 
at rest breathing room air (see 3.00G2) less than or equal to the 
applicable values in Table IV-A, IV-B, or IV-C, twice within a 12-
month period and at least 30 days apart; or
    3. Arterial PaO2 and 
PaCO2 measured concurrently during steady 
state exercise breathing room air (the level of exercise less than 
or equal to 17.5 mL O2 consumption/kg/min) (see 3.00G3) 
less than or equal to the applicable values in Table IV-A, IV-B, or 
IV-C; or
    4. With both a and b.
    a. SpO2 measured by pulse oximetry (see 
3.00H), either at rest or after a 6MWT, which is:
    (i) Less than or equal to 87 percent for test sites less than 
3,000 feet above sea level; or
    (ii) Less than or equal to 85 percent for test sites from 3,000 
through 6,000 feet above sea level; or
    (iii) Less than or equal to 83 percent for test sites over 6,000 
feet above sea level; and
    b. One of the following:
    (i) FEV1 (see 3.00E1) less than or equal to the value 
in Table V-A or V-B for your age, gender, and height without shoes 
(see 3.00E3a); or
    (ii) FVC (see 3.00E1) less than or equal to the value in Table 
VI-A or VI-B for your age, gender, and height without shoes (see 
3.00E3a).

                                        Table I--FEV1 Criteria for 3.02A
----------------------------------------------------------------------------------------------------------------
                                                             Table I-A                       Table I-B
                                                 ---------------------------------------------------------------
                                 Height without   Age 18 to attainment of age 20          Age 20 or older
     Height without shoes        shoes  (inches) ---------------------------------------------------------------
  (centimeters)  < means less     < means less        Females          Males          Females          Males
             than                     than        FEV[bdi1] less  FEV[bdi1] less  FEV[bdi1] less  FEV[bdi1] less
                                                   than or equal   than or equal   than or equal   than or equal
                                                   to  (L, BTPS)   to  (L, BTPS)   to  (L, BTPS)   to  (L, BTPS)
----------------------------------------------------------------------------------------------------------------
<153.0........................  <60.25..........            1.30            1.40            1.10            1.20
153.0 to <159.0...............  60.25 to <62.50.            1.40            1.50            1.20            1.30
159.0 to <164.0...............  62.50 to <64.50.            1.50            1.60            1.30            1.40
164.0 to <169.0...............  64.50 to <66.50.            1.60            1.70            1.40            1.50
169.0 to <174.0...............  66.50 to <68.50.            1.70            1.80            1.50            1.60

[[Page 7980]]

 
174.0 to <180.0...............  68.50 to <70.75.            1.80            1.90            1.60            1.70
180.0 to <185.0...............  70.75 to <72.75.            1.90            2.00            1.70            1.80
185.0 or more.................  72.75 or more...            2.00            2.10            1.80            1.90
----------------------------------------------------------------------------------------------------------------


                                        Table II--FVC Criteria for 3.02B
----------------------------------------------------------------------------------------------------------------
                                                            Table II-A                      Table II-B
                                                 ---------------------------------------------------------------
                                 Height without   Age 18 to attainment of age 20          Age 20 or older
     Height without shoes        shoes  (inches) ---------------------------------------------------------------
  (centimeters)  < means less     < means less      Females FVC                     Females FVC
             than                     than         less than or   Males FVC less   less than or   Males FVC less
                                                   equal to  (L,   than or equal   equal to  (L,   than or equal
                                                       BTPS)       to  (L, BTPS)       BTPS)       to  (L, BTPS)
----------------------------------------------------------------------------------------------------------------
<153.0........................  <60.25..........            1.55            1.65            1.35            1.45
153.0 to <159.0...............  60.25 to <62.50.            1.65            1.75            1.45            1.55
159.0 to <164.0...............  62.50 to <64.50.            1.75            1.85            1.55            1.65
164.0 to <169.0...............  64.50 to <66.50.            1.85            1.95            1.65            1.75
169.0 to <174.0...............  66.50 to <68.50.            1.95            2.05            1.75            1.85
174.0 to <180.0...............  68.50 to <70.75.            2.05            2.15            1.85            1.95
180.0 to <185.0...............  70.75 to <72.75.            2.15            2.25            1.95            2.05
185.0 or more.................  72.75 or more...            2.25            2.35            2.05            2.15
----------------------------------------------------------------------------------------------------------------


                                       Table III--DLCO Criteria for 3.02C1
----------------------------------------------------------------------------------------------------------------
                                        Height without shoes     Females DLCO less than
 Height without shoes  (centimeters)   (inches)  < means less    or equal to  (mL/min/   Males DLCO less than or
          < means less than                     than                     mmHg)           equal to  (mL/min/mmHg)
----------------------------------------------------------------------------------------------------------------
<153.0..............................  < 60.25.................                      8.0                      9.0
153.0 to <159.0.....................  60.25 to <62.50.........                      8.5                      9.5
159.0 to <164.0.....................  62.50 to <64.50.........                      9.0                     10.0
164.0 to <169.0.....................  64.50 to <66.50.........                      9.5                     10.5
169.0 to <174.0.....................  66.50 to <68.50.........                     10.0                     11.0
174.0 to <180.0.....................  68.50 to <70.75.........                     10.5                     11.5
180.0 to <185.0.....................  70.75 to <72.75.........                     11.0                     12.0
185.0 or more.......................  72.75 or more...........                     11.5                     12.5
----------------------------------------------------------------------------------------------------------------

Tables IV-A, IV-B, and IV-C: ABG Criteria for 3.02C2, 3.02C3, and 3.04B

                               Table IV-A
     [Applicable at test sites less than 3,000 feet above sea level]
------------------------------------------------------------------------
                                                     Arterial PaO[bdi2]
         Arterial PaCO[bdi2]  (mm Hg) and            less than or equal
                                                         to (mm Hg)
------------------------------------------------------------------------
30 or below.......................................                    65
31................................................                    64
32................................................                    63
33................................................                    62
34................................................                    61
35................................................                    60
36................................................                    59
37................................................                    58
38................................................                    57
39................................................                    56
40 or above.......................................                    55
------------------------------------------------------------------------


                               Table IV-B
[Applicable at test sites from 3,000 through 6,000 feet above sea level]
------------------------------------------------------------------------
                                                     Arterial PaO[bdi2]
         Arterial PaCO[bdi2]  (mm Hg) and            less than or equal
                                                         to (mm Hg)
------------------------------------------------------------------------
30 or below.......................................                    60
31................................................                    59
32................................................                    58
33................................................                    57
34................................................                    56
35................................................                    55
36................................................                    54
37................................................                    53
38................................................                    52
39................................................                    51
40 or above.......................................                    50
------------------------------------------------------------------------


                               Table IV-C
       [Applicable at test sites over 6,000 feet above sea level]
------------------------------------------------------------------------
                                                     Arterial PaO[bdi2]
         Arterial PaCO[bdi2]  (mm Hg) and            less than or equal
                                                         to (mm Hg)
------------------------------------------------------------------------
30 or below.......................................                    55
31................................................                    54
32................................................                    53
33................................................                    52
34................................................                    51
35................................................                    50
36................................................                    49
37................................................                    48
38................................................                    47
39................................................                    46
40 or above.......................................                    45
------------------------------------------------------------------------


[[Page 7981]]


                                 Table V--FEV1 Criteria for 3.02C4b(i) and 3.03A
----------------------------------------------------------------------------------------------------------------
                                                             Table V-A                       Table V-B
                                                 ---------------------------------------------------------------
                                                   Age 18 to  attainment of age           Age 20 or older
     Height without shoes        Height without                 20               -------------------------------
  (centimeters)  < means less    shoes  (inches) --------------------------------
             than                 < means less     Females FEV1     Males FEV1        Females          Males
                                      than         less than or    less than or   FEV[bdi1] less  FEV[bdi1] less
                                                   equal to  (L,   equal to  (L,   than or equal   than or equal
                                                       BTPS)           BTPS)       to  (L, BTPS)   to  (L, BTPS)
----------------------------------------------------------------------------------------------------------------
<153.0........................  <60.25..........            1.55            1.65            1.35            1.45
153.0 to <159.0...............  60.25 to <62.50.            1.65            1.75            1.45            1.55
159.0 to <164.0...............  62.50 to <64.50.            1.75            1.85            1.55            1.65
164.0 to <169.0...............  64.50 to <66.50.            1.85            1.95            1.65            1.75
169.0 to <174.0...............  66.50 to <68.50.            1.95            2.05            1.75            1.85
174.0 to <180.0...............  68.50 to <70.75.            2.05            2.15            1.85            1.95
180.0 to <185.0...............  70.75 to <72.75.            2.15            2.25            1.95            2.05
185.0 or more.................  72.75 or more...            2.25            2.35            2.05            2.15
----------------------------------------------------------------------------------------------------------------


                                     Table VI--FVC Criteria for 3.02C4b(ii)
----------------------------------------------------------------------------------------------------------------
                                                            Table VI-A                      Table VI-B
                                                 ---------------------------------------------------------------
                                                   Age 18 to  attainment of age           Age 20 or older
     Height without shoes        Height without                 20               -------------------------------
  (centimeters)  < means less    shoes  (inches) --------------------------------
             than                 < means less      Females FVC                     Females FVC   Males FVC less
                                      than         less than or   Males FVC less   less than or    than or equal
                                                   equal to  (L,   than or equal   equal to  (L,   to  (L, BTPS)
                                                       BTPS)       to  (L, BTPS)       BTPS)
----------------------------------------------------------------------------------------------------------------
<153.0........................  <60.25..........            1.90            2.00            1.70            1.80
153.0 to <159.0...............  60.25 to <62.50.            2.00            2.10            1.80            1.90
159.0 to <164.0...............  62.50 to <64.50.            2.10            2.20            1.90            2.00
164.0 to <169.0...............  64.50 to <66.50.            2.20            2.30            2.00            2.10
169.0 to <174.0...............  66.50 to <68.50.            2.30            2.40            2.10            2.20
174.0 to <180.0...............  68.50 to <70.75.            2.40            2.50            2.20            2.30
180.0 to <185.0...............  70.75 to <72.75.            2.50            2.60            2.30            2.40
185.0 or more.................  72.75 or more...            2.60            2.70            2.40            2.50
----------------------------------------------------------------------------------------------------------------

    3.03 Asthma (see 3.00I), with both A and B:
    A. FEV1 (see 3.00E1) less than or equal to the value 
in Table V-A or V-B (under 3.02) for your age, gender, and height 
without shoes (see 3.00E3a) within the same 12-month period as the 
hospitalizations in 3.03B.
    AND
    B. Exacerbations requiring three hospitalizations within a 12-
month period and at least 30 days apart. Each hospitalization must 
last at least 48 hours, including hours in a hospital emergency 
department immediately before the hospitalization. Consider under a 
disability for 1 year from the discharge date of the last 
hospitalization; after that, evaluate the residual impairment(s).
    3.04 Cystic fibrosis (documented as described in 3.00J), with:
    A. FEV1 (see 3.00E1) less than or equal to the value 
in Table VII-A or VII-B for your age, gender, and height without 
shoes (see 3.00E3a).

                                       Table VII--FEV1 Criteria for 3.04A
----------------------------------------------------------------------------------------------------------------
                                                            Table VII-A                     Table VII-B
                                                 ---------------------------------------------------------------
                                                   Age 18 to  attainment of age           Age 20 or older
     Height without shoes        Height without                 20               -------------------------------
  (centimeters)  < means less    shoes  (inches) --------------------------------
             than                 < means less        Females          Males          Females          Males
                                      than        FEV[bdi1] less  FEV[bdi1] less  FEV[bdi1] less  FEV[bdi1] less
                                                   than or equal   than or equal   than or equal   than or equal
                                                   to  (L, BTPS)   to  (L, BTPS)   to  (L, BTPS)   to  (L, BTPS)
----------------------------------------------------------------------------------------------------------------
<153.0........................  <60.25..........            1.55            1.65            1.35            1.45
153.0 to <159.0...............  60.25 to <62.50.            1.65            1.75            1.45            1.55
159.0 to <164.0...............  62.50 to <64.50.            1.75            1.85            1.55            1.65
164.0 to <169.0...............  64.50 to <66.50.            1.85            1.95            1.65            1.75
169.0 to <174.0...............  66.50 to <68.50.            1.95            2.05            1.75            1.85
174.0 to <180.0...............  68.50 to <70.75.            2.05            2.15            1.85            1.95
180.0 to <185.0...............  70.75 to <72.75.            2.15            2.25            1.95            2.05
185.0 or more.................  72.75 or more...            2.25            2.35            2.05            2.15
----------------------------------------------------------------------------------------------------------------


[[Page 7982]]

    OR
    B. Chronic impairment of gas exchange with one of the following:
    1. Arterial PaO2 and 
PaCO2 (see 3.00G1) measured concurrently while 
at rest breathing room air (see 3.00G2) less than or equal to the 
applicable values in Table IV-A, IV-B, or IV-C (under 3.02), twice 
within a 12-month period and at least 30 days apart; or
    2. Arterial PaO2 and 
PaCO2 measured concurrently during steady 
state exercise breathing room air (see 3.00G3) less than or equal to 
the applicable values in Table IV-A, IV-B, or IV-C (under 3.02).
    OR
    C. Exacerbations or complications of CF (see 3.00J5) requiring 
three hospitalizations of any length within a 12-month period and at 
least 30 days apart.
    OR
    D. Any two of the following complications of CF that occur 
within a 12-month period. There must be at least 30 days between the 
acute complications in 3.04D1, 3.04D2, and 3.04D3 (see 3.00J6).
    1. Spontaneous pneumothorax requiring chest tube treatment.
    2. Respiratory failure (see 3.00N) requiring continuous assisted 
(mechanical) ventilation for at least 48 hours, or for at least 72 
hours if postoperatively.
    3. Pulmonary hemorrhage requiring vascular embolization to 
control bleeding.
    4. Hypoxemia documented by one SpO2 
measurement, measured by pulse oximetry (see 3.00H), which is:
    a. Less than or equal to 89 percent for test sites less than 
3,000 feet above sea level; or
    b. Less than or equal to 87 percent for test sites from 3,000 
through 6,000 feet above sea level; or
    c. Less than or equal to 85 percent for test sites over 6,000 
feet above sea level.
    5. Weight loss requiring daily supplemental enteral nutrition 
via a gastrostomy for at least 90 consecutive days or parenteral 
nutrition via a central venous catheter for at least 90 consecutive 
days.
    6. CFRD requiring daily insulin therapy for at least 90 
consecutive days.
    3.05 [Reserved]
    3.06 [Reserved]
    3.07 Bronchiectasis (see 3.00K), documented by imaging (see 
3.00D2) with exacerbations or complications requiring three 
hospitalizations within a 12-month period and at least 30 days 
apart. Each hospitalization must last at least 48 hours, including 
hours in a hospital emergency department immediately before the 
hospitalization.
    3.08 [Reserved]
    3.09 Chronic pulmonary hypertension due to any cause (see 3.00L) 
lasting or expected to last at least 12 months, documented while 
medically stable (see 3.00E2a) by A or B:
    A. Mean pulmonary artery pressure equal to or greater than 40 mm 
Hg as determined by cardiac catheterization.
    OR
    B. Systolic pulmonary artery pressure equal to or greater than 
65 mm Hg as determined by echocardiogram.
    3.10 [Reserved]
    3.11 Lung transplantation (see 3.00M). Consider under a 
disability for 3 years from the date of the transplant; after that, 
evaluate the residual impairment(s).
    3.12 [Reserved]
    3.13 [Reserved]
    3.14 Respiratory failure (see 3.00N) resulting from any 
underlying chronic respiratory disorder except CF, requiring 
continuous assisted (mechanical) ventilation for at least 48 hours, 
or for at least 72 hours if postoperatively, and with two episodes 
within a 12-month period. The episodes must be at least 30 days 
apart. (For CF, see 3.04D.)
* * * * *

0
5. Amend part B of appendix 1 to subpart P of part 404 by revising the 
body system name for section 103.00 in the table of contents to read as 
follows:

Part B

* * * * *
    103.00 Respiratory Disorders.
* * * * *

0
6. Revise section 103.00 in part B of appendix 1 to subpart P of part 
404 to read as follows:

103.00 Respiratory Disorders

    A. What disorders do we evaluate in this body system?
    1. We evaluate respiratory disorders that result in obstruction 
(difficulty moving air out of the lungs) or restriction (difficulty 
moving air into the lungs), or that interfere with diffusion (gas 
exchange) across cell membranes in the lungs. Examples of such 
disorders and the listings we use to evaluate them include chronic 
obstructive pulmonary disease (103.02), chronic lung disease of 
infancy (previously known as bronchopulmonary dysplasia) (103.02C 
and 103.02E), pulmonary fibrosis (103.02), asthma (103.02 and 
103.03), and cystic fibrosis (103.04). We also use listings in this 
body system to evaluate recurrent episodes of respiratory failure 
(103.04E2 and 103.14) and lung transplantation (103.11).
    2. We evaluate cancers affecting the respiratory system under 
the malignant neoplastic diseases listings in 113.00. We evaluate 
neuromuscular disorders affecting the respiratory system under the 
neurological listings in 111.00 or under the immune system disorders 
listings in 114.00.
    B. What are common signs and symptoms of respiratory disorders? 
Common signs and symptoms of respiratory disorders are shortness of 
breath, coughing, wheezing, sputum production, hemoptysis (coughing 
up blood from the respiratory tract), and chest pain.
    C. What abbreviations do we use in this body system?
    1. BTPS means body temperature and ambient pressure, saturated 
with water vapor.
    2. CF means cystic fibrosis.
    3. CFRD means CF-related diabetes.
    4. CLD means chronic lung disease of infancy.
    5. FEV1 means forced expiratory volume in the first second of a 
forced expiratory maneuver.
    6. FVC means forced vital capacity.
    7. L means liter.
    D. What documentation do we need to evaluate your respiratory 
disorder?
    1. We need medical evidence to assess the effects of your 
respiratory disorder. Medical evidence should include your medical 
history, physical examination findings, the results of imaging (see 
103.00D2), spirometry if age appropriate (see 103.00E), other 
relevant laboratory tests, and descriptions of any prescribed 
treatment and your response to it. We may not need all of this 
information depending upon your particular respiratory disorder and 
its effects on you.
    2. Imaging refers to medical imaging techniques, such as x-ray, 
computerized tomography, and echocardiography. The imaging must be 
consistent with the prevailing state of medical knowledge and 
clinical practice as the proper technique to support the evaluation 
of the disorder.
    3. Spirometry must be conducted in accordance with the most 
recently published standards of the American Thoracic Society (ATS).
    E. What is spirometry, and what are our requirements for an 
acceptable test and report?
    1. Spirometry measures how well you move air into and out of 
your lungs. In accordance with ATS testing standards, spirometry 
involves at least three forced expiratory maneuvers. A forced 
expiratory maneuver is a maximum inhalation followed by a forced 
maximum exhalation, and measures exhaled volumes of air over time. 
The volume of air you exhale in the first second of the forced 
expiratory maneuver is the FEV1. The total volume of air 
that you exhale during the entire forced expiratory maneuver is the 
FVC. We use your highest FEV1 value to evaluate your 
respiratory disorder under 103.02A and 103.04A. We use your highest 
FVC value to evaluate your respiratory disorder under 103.02B.
    2. We have the following requirements for spirometry under these 
listings:
    a. You must be medically stable at the time of the test. 
Examples of when we would not consider you to be medically stable 
include when you are:
    (i) Within 2 weeks of a change in your prescribed respiratory 
medication.
    (ii) Experiencing, or within 30 days of completion of treatment 
for, a lower respiratory tract infection.
    (iii) Experiencing, or within 30 days of completion of treatment 
for, an acute exacerbation (temporary worsening) of a chronic 
respiratory disorder. Chronic wheezing by itself does not indicate 
that you are not medically stable.
    b. During testing, if your FEV1 is less than 70 
percent of your predicted normal value, we require repeat spirometry 
after inhalation of a bronchodilator to evaluate your respiratory 
disorder under these listings, unless it is medically 
contraindicated. If you used a bronchodilator before the test and 
your FEV1 is less than 70 percent of your predicted 
normal value, we still require a post-bronchodilator test unless the 
supervising physician determines that it is not safe for you to take 
a bronchodilator again. If you do not have post-bronchodilator

[[Page 7983]]

spirometry, the test report must explain why. We can use the results 
of spirometry administered without bronchodilators when the use of 
bronchodilators is contraindicated.
    c. We use the highest of at least three FEV1 values 
and the highest of at least three FVC values obtained during the 
same test session, regardless of whether the highest FEV1 
value and the highest FVC value are from the same forced expiratory 
maneuver or different forced expiratory maneuvers. If the results of 
your spirometry include only one FEV1 value and one FVC 
value, we will presume each reported value is the highest value from 
the test session, unless we have evidence to the contrary and 
subject to the post-bronchodilator requirements in 103.00E2b.
    3. The spirometry report must include the following information:
    a. The date of the test and your name, age or date of birth, 
gender, and height without shoes. (We will assume that your recorded 
height on the date of the test is without shoes, unless we have 
evidence to the contrary.) If your spine is abnormally curved (for 
example, you have kyphoscoliosis), we will substitute the longest 
distance between your outstretched fingertips with your arms 
abducted 90 degrees in place of your height when this measurement is 
greater than your standing height without shoes.
    b. Any factors, if applicable, that can affect the 
interpretation of the test results (for example, your lack of 
cooperation or effort in doing the test).
    4. If you have attained age 6, we may need to purchase 
spirometry to determine whether your disorder meets a listing, 
unless we can make a fully favorable determination or decision on 
another basis. We will not purchase spirometry for children who have 
not attained age 6 or any other pulmonary function tests for 
children of any age.
    5. Before we purchase spirometry for a child age 6 or older, a 
medical consultant (see Sec.  416.1016 of this chapter), preferably 
one with experience in the care of children with respiratory 
disorders, must review your case record to determine if we need the 
test. The medical source we designate to administer the test is 
solely responsible for deciding whether it is safe for you to do the 
test and for how to administer it.
    F. What is CLD, and how do we evaluate it?
    1. CLD, previously known as bronchopulmonary dysplasia, or BPD, 
is scarring of the immature lung. CLD may develop as a complication 
of assisted ventilation and oxygen therapy for infants with 
significant neonatal respiratory problems. Within the first 6 months 
of life, most infants with CLD are successfully weaned from assisted 
ventilation, and then weaned from oxygen supplementation. Two 
listings apply to children under age 2 with CLD: 103.02C and 
103.02E.
    2. We will evaluate your CLD under 103.02C if you are at least 6 
months old and need 24-hour-per-day oxygen supplementation. If you 
were born prematurely, we use your corrected chronological age. See 
Sec.  416.924b(b) of this chapter. We will use 103.02C if you were 
not weaned off oxygen supplementation by the time you were 6 months 
old, or were weaned off oxygen supplementation but needed it again 
by the time you were 6 months old or older.
    3. If you have CLD, are not yet 6 months old, and need 24-hour-
per-day oxygen supplementation, we will not adjudicate your case 
under 103.02C until you are 6 months old. Depending on the evidence 
in your case record, we may make a favorable determination or 
decision under other rules before you are 6 months old.
    4. We use 103.02E if you are any age from birth to the 
attainment of age 2 and have recurrent CLD exacerbations or related 
complications (for example, wheezing, lower respiratory tract 
infections, or acute respiratory distress) that require 
hospitalization. For the purpose of 103.02E, we will count your 
initial birth hospitalization as one hospitalization.
    5. After you have attained age 2, we will evaluate your CLD 
under 103.03.
    G. What is asthma, and how do we evaluate it?
    1. Asthma is a chronic inflammatory disorder of the lung airways 
that we evaluate under 103.02 or 103.03.
    2. Under 103.03:
    a. The phrase ``consider under a disability for 1 year'' 
explains how long your asthma can meet the requirements of the 
listing. It does not refer to the date on which your disability 
began, only to the date on which we must reevaluate whether your 
asthma continues to meet a listing or is otherwise disabling.
    b. We will determine the onset of your disability based on the 
facts of your case, but it will be no later than the admission date 
of your first of three hospitalizations that satisfy the criteria of 
103.03.
    H. What is CF, and how do we evaluate it?
    1. CF, which we evaluate under 103.04, is a genetic disorder 
that results in abnormal functioning of the cells lining the lung 
airways and of the cells in other body systems. We need the evidence 
described in 103.00H2, 103.00H3, or 103.00H4 to establish that you 
have CF.
    2. A report signed by a physician showing both a. and b.:
    a. One of the following:
    (i) A positive newborn screen for CF; or
    (ii) A history of CF in a sibling; or
    (iii) Documentation of at least one specific CF phenotype or 
clinical criterion (for example, chronic sino-pulmonary disease with 
persistent colonization or infections with typical CF pathogens, 
pancreatic insufficiency, or salt-loss syndromes); and
    b. One of the following definitive laboratory tests:
    (i) An elevated sweat chloride concentration equal to or greater 
than 60 millimoles per L; or
    (ii) The identification of two CF gene mutations affecting the 
cystic fibrosis transmembrane conductance regulator (CFTR); or
    (iii) Characteristic abnormalities in ion transport across the 
nasal epithelium.
    3. When we have the report described in 103.00H2 but it is not 
signed by a physician, we also need a report from a physician 
stating that you have CF.
    4. When we do not have the report described in 103.00H2, we need 
a report from a physician that is persuasive that a positive 
diagnosis was confirmed by appropriate laboratory analysis or 
another method. To be persuasive, this report must state that you 
had the appropriate definitive laboratory study or studies for 
diagnosing CF and provide the results or explain how your diagnosis 
was established by other methods consistent with the prevailing 
state of medical knowledge and clinical practice.
    5. In 103.04D, examples of exacerbations or complications of CF 
that may result in hospitalizations include increased cough and 
sputum production, hemoptysis, increased shortness of breath, 
increased fatigue, and reduction in pulmonary function.
    6. For 103.04E, you must have at least two complications from 
the list of complications in 103.04E1 through 103.04E6 occurring 
within a 12-month period. You may have two of the same complications 
or two different ones.
    a. If you have two of the acute complications we describe in 
103.04E1 (spontaneous pneumothorax), 103.04E2 (respiratory failure), 
and 103.04E3 (pulmonary hemorrhage), there must be at least 30 days 
between the two complications; for example, between an episode of 
spontaneous pneumothorax and an episode of respiratory failure or 
between two episodes of respiratory failure.
    b. The chronic complications we describe in 103.04E4 through 
103.04E6 can occur at the same time as any of the other 
complications in 103.04E. For example, your CF meets 103.04E if you 
have the weight loss we describe in 103.04E5 and the CFRD we 
describe in 103.04E6 even if they do not occur 30 days apart. Your 
CF also meets 103.04E if you have the weight loss we describe in 
103.04E5 and the spontaneous pneumothorax we describe in 103.04E1 
even if the spontaneous pneumothorax occurs during the same 90-day 
period we describe in 103.04E5.
    c. Your CF also meets 103.04E if you have two episodes of one of 
the chronic complications in 103.04E4 through 103.04E6.
    7. CF may also affect the growth, digestive, and endocrine body 
systems. We evaluate CF-related growth failure under 100.00 or 
105.00. We evaluate nonpulmonary CF-related digestive disorders that 
are not covered by 103.04E under 105.00. We evaluate CFRD under 
103.04E, under 109.00, or under a body system affected by the 
diabetes.
    I. How do we evaluate lung transplantation? If you receive a 
lung transplant (or a lung transplant simultaneous with other 
organs, such as the heart), we will consider you to be disabled 
under 103.11 for 3 years from the date of the transplant. After 
that, we will evaluate your residual impairment(s) by considering 
the adequacy of your post-transplant function, the frequency and 
severity of rejection episodes you have, complications in other body 
systems, and adverse treatment effects. Children who receive organ 
transplants generally have impairments that meet our definition of 
disability before they undergo transplantation. We will determine 
the onset of your disability based on the facts of your case.

[[Page 7984]]

    J. What is respiratory failure, and how do we evaluate it? 
Respiratory failure is the inability of the lungs to perform their 
basic function of gas exchange. We use 103.04E2 if you have CF-
related respiratory failure. We use 103.14 if you have respiratory 
failure due to any other respiratory disorder. Respiratory therapy 
that only increases air pressure in your throat, such as continuous 
positive airway pressure (CPAP) or bi-level positive airway pressure 
(BiPAP), does not meet the criterion for continuous assisted 
(mechanical) ventilation in 103.04E2 or 103.14.
    K. How do we evaluate growth failure due to any chronic 
respiratory disorder? We evaluate linear growth failure under a 
growth impairment listing in 100.00. If your growth failure does not 
meet or medically equal the criteria of a listing in 100.00, we will 
consider whether your respiratory disorder meets or medically equals 
the criteria of a listing in another body system. For example, if 
your respiratory disorder has resulted in weight loss or a 
combination of weight loss and linear growth failure, we will 
evaluate your impairment under a digestive system listing in 105.00.
    L. How do we evaluate episodic respiratory disorders? Some 
respiratory disorders listings require a specific number of events 
within a 12-month period. See 103.02E, 103.03, 103.04D, 103.04E, and 
103.14. When we use such criteria, the 12-month period must occur 
within the period we are considering in connection with your 
application or continuing disability review.
    M. How do we evaluate respiratory disorders that do not meet one 
of these listings?
    1. These listings are only examples of common respiratory 
disorders that we consider severe enough to result in marked and 
severe functional limitations. If your impairment(s) does not meet 
the criteria of any of these listings, we must also consider whether 
you have an impairment(s) that meets the criteria of a listing in 
another body system. For example, if your CF has resulted in chronic 
pancreatic or hepatobiliary disease, we will evaluate your 
impairment under the digestive system listings in 105.00.
    2. If you have a severe medically determinable impairment(s) 
that does not meet a listing, we will determine whether your 
impairment(s) medically equals a listing. See Sec.  416.926 of this 
chapter. Respiratory disorders may be associated with disorders in 
other body systems, and we consider the combined effects of multiple 
impairments when we determine whether they medically equal a 
listing. If your impairment(s) does not meet or medically equal a 
listing, we will also consider whether it functionally equals the 
listings. See Sec.  416.926a of this chapter. We use the rules in 
Sec.  416.994a of this chapter when we decide whether you continue 
to be disabled.
    103.01 Category of Impairments, Respiratory Disorders
    103.02 Chronic respiratory disorders due to any cause except 
cystic fibrosis (see 103.04), with:
    A. FEV[bdi1] (see 103.00E1) less than or equal to the value in 
Table I-A or I-B for your age, gender, and height without shoes (see 
103.00E3a).

                                                           Table I--FEV1 Criteria for 103.02A
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                 Table I-A                                                                    Table I-B
--------------------------------------------------------------------------------------------------------------------------------------------------------
        Age 6 to attainment of age 13 (For both females and males)                                 Age 13 to  attainment of age 18
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                           Females FEV1     Males FEV1
Height without shoes  (centimeters)   Height without shoes  FEV1 less than   Height without shoes   Height without shoes   less than or    less than or
         < means less than           (inches) < means less    or equal to   (centimeters) < means  (inches) < means less   equal to (L,    equal to (L,
                                              than             (L, BTPS)          less than                 than               BTPS)           BTPS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
<123.0.............................  <48.50...............            0.70  <153.0...............  <60.25...............            1.30            1.40
123.0 to <129.0....................  48.50 to <50.75......            0.80  153.0 to <159.0......  60.25 to <62.50......            1.40            1.50
129.0 to <134.0....................  50.75 to <52.75......            0.90  159.0 to <164.0......  62.50 to <64.50......            1.50            1.60
134.0 to <139.0....................  52.75 to <54.75......            1.00  164.0 to <169.0......  64.50 to <66.50......            1.60            1.70
139.0 to <144.0....................  54.75 to <56.75......            1.10  169.0 to <174.0......  66.50 to <68.50......            1.70            1.80
144.0 to <149.0....................  56.75 to <58.75......            1.20  174.0 to <180.0......  68.50 to <70.75......            1.80            1.90
149.0 or more......................  58.75 or more........            1.30  180.0 or more........  70.75 or more........            1.90            2.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

    OR
    B. FVC (see 103.00E1) less than or equal to the value in Table 
II-A or II-B for your age, gender, and height without shoes (see 
103.00E3a).

                                                           Table II--FVC Criteria for 103.02B
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                Table II-A                                                                   Table II-B
--------------------------------------------------------------------------------------------------------------------------------------------------------
        Age 6 to attainment of age 13 (For both females and males)                                 Age 13 to attainment of age 18
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                            Females FVC
       Height witihout shoes          Height without shoes   FVC less than   Height without shoes   Height without shoes   less than or   Males FVC less
  (centimeters)  < means less than   (inches) < means less    or equal to      (centimeters)  <      (inches)  < means     equal to (L,    than or equal
                                              than             (L, BTPS)       means less than           less than             BTPS)       to  (L, BTPS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
<123.0.............................  <48.50...............            0.95  <153.0...............  <60.25...............            1.55            1.65
123.0 to <129.0....................  48.50 to <50.75......            1.05  153.0 to <159.0......  60.25 to <62.50......            1.65            1.75
129.0 to <134.0....................  50.75 to <52.75......            1.15  159.0 to <164.0......  62.50 to <64.50......            1.75            1.85
134.0 to <139.0....................  52.75 to <54.75......            1.25  164.0 to <169.0......  64.50 to <66.50......            1.85            1.95
139.0 to <144.0....................  54.75 to <56.75......            1.35  169.0 to <174.0......  66.50 to <68.50......            1.95            2.05
144.0 to <149.0....................  56.75 to <58.75......            1.45  174.0 to <180.0......  68.50 to <70.75......            2.05            2.15
149.0 or more......................  58.75 or more........            1.55  180.0 or more........  70.75 or more........            2.15            2.25
--------------------------------------------------------------------------------------------------------------------------------------------------------

    OR
    C. Hypoxemia with the need for at least 1.0 L/min of continuous 
(24 hours per day) oxygen supplementation for at least 90 
consecutive days.
    OR
    D. The presence of a tracheostomy, with one of the following:

[[Page 7985]]

    1. For children who have not attained age 3, consider under a 
disability until the attainment of age 3; after that, evaluate under 
103.02D2, or evaluate the residual impairment(s); or
    2. For children age 3 to the attainment of age 18, documented 
need for assisted (mechanical) ventilation via a tracheostomy for at 
least 4 hours per day and for at least 90 consecutive days.
    OR
    E. For children who have not attained age 2, CLD with 
exacerbations or related complications requiring three 
hospitalizations within a 12-month period (see 103.00F4). Each 
hospitalization must be at least 30 days apart. Consider under a 
disability for 1 year from the discharge date of the last 
hospitalization or until the attainment of age 2, whichever is 
later. After that, evaluate the impairment(s) under 103.03 or as 
otherwise appropriate.
    103.03 Asthma, for children of any age, with exacerbations (see 
103.00G) requiring three hospitalizations within a 12-month period 
and at least 30 days apart. Each hospitalization must last at least 
48 hours, including hours in a hospital emergency department 
immediately before the hospitalization. Consider under a disability 
for 1 year from the discharge date of the last hospitalization; 
after that, evaluate the residual impairment(s).
    103.04 Cystic fibrosis (documented as described in 103.00H), 
with:
    A. FEV1 (see 103.00E1) less than or equal to the 
value in Table III-A or Table III-B for your age, gender, and height 
without shoes (see 103.00E3a).

                                                        Table III--FEV[bdi1] Criteria for 103.04A
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                Table III-A                                                                  Table III-B
--------------------------------------------------------------------------------------------------------------------------------------------------------
        Age 6 to attainment of age 13  (For both females and males)                                Age 13 to attainment of age 18
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                           Females FEV1     Males FEV1
 Height without shoes (centimeters)   Height without shoes  FEV1 less than   Height without shoes   Height without shoes   less than or    less than or
         < means less than           (inches) < means less    or equal to   (centimeters) < means  (inches) < means less   equal to (L,    equal to (L,
                                              than             (L, BTPS)          less than                 than               BTPS)           BTPS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
<123.0.............................  <48.50...............            0.95  <153.0...............  <60.25...............            1.55            1.65
123.0 to <129.0....................  48.50 to <50.75......            1.05  153.0 to <159.0......  60.25 to <62.50......            1.65            1.75
129.0 to <134.0....................  50.75 to <52.75......            1.15  159.0 to <164.0......  62.50 to <64.50......            1.75            1.85
134.0 to <139.0....................  52.75 to <54.75......            1.25  164.0 to <169.0......  64.50 to <66.50......            1.85            1.95
139.0 to <144.0....................  54.75 to <56.75......            1.35  169.0 to <174.0......  66.50 to <68.50......            1.95            2.05
144.0 to <149.0....................  56.75 to <58.75......            1.45  174.0 to <180.0......  68.50 to <70.75......            2.05            2.15
149.0 or more......................  58.75 or more........            1.55  180.0 or more........  70.75 or more........            2.15            2.25
--------------------------------------------------------------------------------------------------------------------------------------------------------

    OR
    B. For children who have not attained age 6, findings on imaging 
(see 103.00D2) of thickening of the proximal bronchial airways, 
nodular-cystic lesions, segmental or lobular atelectasis, or 
consolidation, and documentation of one of the following:
    1. Shortness of breath with activity; or
    2. Accumulation of secretions as manifested by repetitive 
coughing; or
    3. Bilateral rales or rhonchi, or reduction of breath sounds.
    OR
    C. Hypoxemia with the need for at least 1.0 L/min of continuous 
(24 hours per day) oxygen supplementation for at least 90 
consecutive days.
    OR
    D. Exacerbations or complications of CF (see 103.00H5) requiring 
three hospitalizations of any length within a 12-month period and at 
least 30 days apart.
    OR
    E. Any two of the following complications of CF that occur 
within a 12-month period. There must be at least 30 days between the 
acute complications in 103.04E1, 103.04E2, and 103.04E3 (see 
103.00H6).
    1. Spontaneous pneumothorax requiring chest tube treatment.
    2. Respiratory failure (see 103.00J) requiring continuous 
assisted (mechanical) ventilation for at least 48 hours, or for at 
least 72 hours if postoperatively.
    3. Pulmonary hemorrhage requiring vascular embolization to 
control bleeding.
    4. Hypoxemia with the need for at least 1.0 L/min of oxygen 
supplementation for at least 4 hours per day and for at least 90 
consecutive days.
    5. Weight loss requiring daily supplemental enteral nutrition 
via a gastrostomy for at least 90 consecutive days or parenteral 
nutrition via a central venous catheter for at least 90 consecutive 
days.
    6. CFRD requiring daily insulin therapy for at least 90 
consecutive days.
    103.05 [Reserved]
    103.06 [Reserved]
    103.07 [Reserved]
    103.08 [Reserved]
    103.09 [Reserved]
    103.10 [Reserved]
    103.11 Lung transplantation (see 103.00I). Consider under a 
disability for 3 years from the date of the transplant; after that, 
evaluate the residual impairment(s).
    103.12 [Reserved]
    103.13 [Reserved]
    103.14 Respiratory failure (see 103.00J) resulting from any 
underlying chronic respiratory disorder except CF, requiring 
continuous assisted (mechanical) ventilation for at least 48 hours, 
or for at least 72 hours if postoperatively, and with two episodes 
within a 12-month period. The episodes must be at least 30 days 
apart. (For CF, see 103.04E2.)

PART 416--SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND 
DISABLED

Subpart I--[Amended]

0
7. The authority citation for subpart I of part 416 continues to read 
as follows:

    Authority:  Secs. 221(m), 702(a)(5), 1611, 1614, 1619, 1631(a), 
(c), (d)(1), and (p), and 1633 of the Social Security Act (42 U.S.C. 
421(m), 902(a)(5), 1382, 1382c, 1382h, 1383(a), (c), (d)(1), and 
(p), and 1383b); secs. 4(c) and 5, 6(c)-(e), 14(a), and 15, Pub. L. 
98-460, 98 Stat. 1794, 1801, 1802, and 1808 (42 U.S.C. 421 note, 423 
note, and 1382h note).


Sec.  416.926a  [Amended]

0
8. Amend Sec.  416.926a by removing paragraph (m)(1) and redesignating 
paragraphs (m)(2) through (m)(8) as (m)(1) through (m)(7).
[FR Doc. 2013-02165 Filed 2-1-13; 8:45 am]
BILLING CODE 4191-02-P