Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Rules and Regulations 21159 

Points, is published yearly and effective 

on September 15. For further 

information, you can contact the 

Airspace Policy and ATC Regulations 

Group, Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 29591; 

telephone: 202–267–8783. 

For 14 CFR part 73: FAA Order 

7400.8X, Special Use Airspace, can be 

viewed online at the FAAs Air Traffic 

Plans and Publications Web site at 

https://www.faa.gov/airports_airtraffic/

air_traffic/publications/. For further 

information, contact the Airspace Policy 

and Regulations Group, Federal 

Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591: telephone (202) 

267–8783. 

FOR FURTHER INFORMATION CONTACT: 

Robert Frenzel, Manager, Rulemaking 

Division, Office of the Chief Counsel, 

Federal Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591, (telephone: 

202–267–3073). 

SUPPLEMENTARY INFORMATION: 

The Rule 

This amendment to Title 14, Code of 

Federal Regulations (14 CFR) part 71 

amends the authority citation for part 

71; Designation of Class A, B, C, D, and 

E Airspace Areas; Air Traffic Service 

routes; and Reporting Points, and also 

for part 73, Special Use Airspace, by 

adding an additional citation, 49 U.S.C. 

106(f), at the beginning of the authority 

citation string. This action updates and 

clarifies the Administrator’s rulemaking 

authority to be consistent with other 

parts of Title 14, Code of Federal 

Regulations. 

This is an administrative change 

reflecting clarification of rulemaking 

authority, therefore, notice and public 

procedure under 5 U.S.C. 553(b) is 

unnecessary. Also, as provided in 5 

U.S.C. 553(d), this rule is being 

published with an effective date of less 

than 30 days in order to keep current 

airspace actions previously published in 

the Federal Register with later effective 

dates, and other airspace actions soon to 

be published. 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current, is non-controversial and 

unlikely to result in adverse or negative 

comments. It, therefore, (1) is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034; February 26, 1979); and (3) 

does not warrant preparation of a 

Regulatory Evaluation as the anticipated 

impact is so minimal. Since this is a 

routine matter that only affects air traffic 

procedures and air navigation, it is 

certified that this rule, when 

promulgated, does not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. 

Subtitle I, Section 106 describes the 

authority of the FAA Administrator. 

Subtitle VII, Aviation Programs, 

describes in more detail the scope of the 

agency’s authority. This rulemaking is 

promulgated under the authority 

described in Subtitle VII, Part A, 

Subpart I, Section 40103. Under that 

section, the FAA is charged with 

prescribing regulations to assign the use 

of airspace necessary to ensure the 

safety of aircraft and the efficient use of 

airspace. This regulation is within the 

scope of that authority as it further 

describes the authority of the FAA 

Administrator for part 71 and part 73 

rulemaking. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1E, ‘‘Environmental 

Impacts: Policies and Procedures,’’ 

paragraph 311a. This airspace action is 

not expected to cause any potentially 

significant environmental impacts, and 

no extraordinary circumstances exist 

that warrant preparation of an 

environmental assessment. 

Lists of Subjects 

14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

14 CFR Part 73 

Airspace, Prohibited areas, Restricted 

areas. 

Adoption of the Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 71 and part 73 as 

follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for part 71 is 

amended to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40103, 

40113, 40120, E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

PART 73—SPECIAL USE AIRSPACE 

■ 2. The authority citation for part 73 is 

amended to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40103, 

40113, 40120, E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

Issued in Washington, DC, on April 10, 

2015. 

Mark W. Bury, 

Assistant Chief Counsel, Regulations 

Division. 

[FR Doc. 2015–08781 Filed 4–16–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 774 

The Commerce Control List 

CFR Correction 

In Title 15 of the Code of Federal 

Regulations, parts 300 to 799, revised as 

of January 1, 2015, on page 941, in 

supplement no. 1 to part 774, in ECCN 

6C992, under the List of Items 

Controlled, correct the Items paragraph 

to read as follows: ‘‘Items: The list of 

items controlled is contained in the 

ECCN heading.’’ 

[FR Doc. 2015–08985 Filed 4–16–15; 8:45 am] 

BILLING CODE 1505–01–D 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Part 404 

[Docket No. SSA–2010–0055] 

RIN 0960–AF88 

Revised Medical Criteria for Evaluating 

Hematological Disorders 

AGENCY: Social Security Administration. 

ACTION: Final rules. 

SUMMARY: We are revising the criteria in 

the Listing of Impairments (listings) that 

we use to evaluate cases involving 

hematological disorders in adults and 

children under titles II and XVI of the 

Social Security Act (Act). These 

revisions reflect our adjudicative 

experience, advances in medical 

knowledge, diagnosis, and treatment, 

and public comments we received in 

response to a Notice of Proposed 

Rulemaking (NPRM). 

DATES: These rules are effective May 18, 

2015. 


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21160 Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Rules and Regulations 

1See 50 FR 50068. We published some revisions 

to the hematological body system on April 24, 2002, 

and November 15, 2004. See 67 FR 20018 and 69 

FR 67017 (corrected at 70 FR 15227). These 

revisions were not comprehensive; they addressed 

only specific listings. 

2We have made it a priority to ensure that we 

keep the listings up to date and to report our 

progress. For example, see SSA’s Annual 

Performance Plan for Fiscal Year 2015, Revised 

Performance Plan for Fiscal Year 2014, and Annual 

Performance Report for Fiscal Year 2013 available 

at http://www.ssa.gov/agency/performance/2015/

FY2015-APP-APR.pdf. 

3See 20 CFR 404.1530 and 416.930; also see 

Social Security Ruling 82–59: Titles II and XVI: 

Failure to Follow Prescribed Treatment available at: 

http://www.socialsecurity.gov/OP_Home/rulings/di/

02/SSR82-59-di-02.html); and also see DI 23010 

Failure to Follow Prescribed Treatment— 

Procedures, Program Operations Manual System 

(POMS), available at: https://secure.ssa.gov/apps10/ 

poms.nsf/lnx/0423010000. 

FOR FURTHER INFORMATION CONTACT: 

Cheryl Williams, Office of Medical 

Policy, Social Security Administration, 

6401 Security Boulevard, Baltimore, 

Maryland 21235–6401, (410) 965–1020. 

For information on eligibility or filing 

for benefits, call our national toll-free 

number, 1–800–772–1213, or TTY 1– 

800–325–0778, or visit our Internet Web 

site, Social Security Online, at http://

www.socialsecurity.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

We are revising and making final the 

rules for evaluating hematological 

disorders that we proposed in an NPRM 

published in the Federal Register on 

November 19, 2013 at 78 FR 69324. 

Even though these rules will not go into 

effect until 30 days after publication of 

this document, for clarity, we refer to 

them in this preamble as the ‘‘final’’ 

rules. We refer to the rules in effect 

prior to that time as the ‘‘prior’’ rules. 

In the preamble to the NPRM, we 

discussed the revisions we proposed for 

the hematological disorders body 

system. Since we are mostly adopting 

those revisions as we proposed them, 

we are not repeating that information 

here. Interested readers may refer to the 

preamble to the NPRM for this 

information, available at http://

www.regulations.gov. 

We are making several changes in 

these final rules from the NPRM based 

upon some of the public comments we 

received. We explain these changes 

below in the ‘‘Summary of Public 

Comments on the NPRM’’ section of this 

preamble. 

Why are we revising the listings for 

hematological disorders? 

We developed these final rules as part 

of our ongoing review of the listings. 

When we last comprehensively revised 

the listings for the hematological 

disorders body system in final rules 

published on December 6, 1985, we 

indicated in the preamble to those rules 

that we would carefully monitor these 

listings to ensure that they continue to 

meet program purposes, and that we 

would update them if warranted.1

Summary of Public Comments on the 

NPRM 

In the NPRM, we provided the public 

with a 60-day comment period that 

ended on January 21, 2014. We received 

32 comments. The commenters 

included advocacy groups, a national 

group representing disability examiners 

in the State agencies that make 

disability determinations for us, State 

agencies, groups representing medical 

practitioners, and individual members 

of the public. A number of the letters 

provided identical comments and 

recommendations. 

We carefully considered all of the 

significant comments relevant to this 

rulemaking. We condensed and 

summarized the comments below. We 

presented the commenters’ concerns 

and suggestions and responded to all 

significant issues that were within the 

scope of these rules. We provide our 

reasons for adopting or not adopting the 

recommendations in our responses 

below. 

General Comments 

Comment: One commenter 

recommended that we review the 

medical criteria in the listings for 

evaluating hematological disorders 

every five years to ensure they reflect 

the latest advances in treatment and 

clinical practice. The commenter 

thought it especially important that we 

review ongoing clinical trials and 

published reports regarding advances in 

genetic testing and the clinical use of 

new blood derivatives and biologics. 

Response: While we agree with the 

commenter that it is important to keep 

abreast of advances in treatment and 

clinical practice for hematological 

disorders, we have not made any 

changes to our proposed listings as a 

result of this comment. As mentioned 

above, we will monitor the final rules to 

ensure they still meet our program 

purposes. While doing this, we will 

consider whether we need to revise the 

rules to reflect advances in medical 

knowledge and clinical practice.2

Comment: Several commenters 

expressed concern that people with 

hematological disorders may be 

disabled but their impairments do not 

satisfy the specific medical criteria in 

the listings. The commenters said these 

people may have periods of relative 

functional ability punctuated by 

unpredictable and episodic 

complications that result in an inability 

to work. They believed such 

complications do not necessarily have 

to be prolonged or frequent to be 

disabling and to result in loss of 

employment, failure in school, or other 

major disruptions in the person’s life. 

Response: We agree that many of 

these final listings have specific medical 

criteria. Some people with 

hematological disorders may have 

complications that do not occur with 

the severity or frequency that these 

listings require. We believe the 

functional criteria in our final rules 

address commenters’ concerns by 

providing criteria that may permit a 

finding of disability at the listing step of 

the sequential evaluation process in 

people who suffer repeated 

complications of their impairments, but 

who may not be continually restricted 

in their functioning between 

complications. For example, our intent 

in new functional listing 7.18 for adults, 

and in our functional equivalence rules 

for children, is to evaluate impairments 

that are difficult to assess in strict 

medical terms. We can use the 

functional criteria in listing 7.18, as well 

as our functional equivalence rules in 

claims for childhood disability under 

the Supplemental Security Income (SSI) 

program, to evaluate claims filed by 

people who become ill and improve, but 

become ill again, either with the same 

complications of their hematological 

disorders or with different ones. 

Comment: One commenter 

recommended we add a criterion in 

these final rules requiring compliance 

with prescribed therapy. 

Response: We did not adopt the 

commenter’s recommendation because 

we believe our adjudicators can 

establish the relevance of a person’s 

noncompliance under our current rules 

and current operating instructions 

regarding failure to follow prescribed 

treatment.3 Under our policy, we must 

assess a person’s noncompliance on an 

individual basis because the person may 

have good cause for not following 

prescribed treatment. Good cause may 

include concern about the cost or 

adverse effects of treatment, lack of 

access to treatment, religious beliefs, or 

other situations. We also provide 

information to our adjudicators in final 

sections 7.00H and 107.00G on how to 

consider whether a person is receiving 

or following treatment. 

Comment: Another commenter 

recommended that the final listings 

consider the cost of medication for 


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Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Rules and Regulations 21161 

4 78 FR at 69328. 

5Rogovik, A., et al., Admission and length of stay 

due to painful vasoocclusive crisis in children, The 

American Journal of Emergency Medicine, 

Sep;27(7), 797–801 (2008). 

6Fullerton, H., et al., Declining stroke rates in 

California children with sickle cell disease, Blood, 

Jul;104(2), 336–339 (2004). 

7Brousseau, D., et al., Acute care utilization and 

rehospitalizations for sickle cell disease, Journal of 

the American Medical Association, Apr;303(13), 

1288–1294 (2010). 

8Mirchandani, G.G., et al., Surveillance of 

bleeding disorders, Texas, 2007, American Journal 

of Preventive Medicine, Dec;41(6 Suppl 4), S354– 

359 (2011). 

9Balkan, C., et al., Iliopsoas haemorrhage in 

patients with haemophilia: Results of one centre, 

Haemophilia, Sep:11(5), 463–467 (2005). 

10Ashrani, A.A., et al., Iliopsoas haemorrhage in 

patients with bleeding disorders—experience from 

one centre, Haemophilia, Nov;9(6), 721–726 (2003). 

11Soucie, J.M., et al., Home-based factor infusion 

therapy and hospitalization for bleeding 

complications among males with haemophilia, 

Mar;7(2), 198–206 (2001). 

12The study findings only expand on, and 

confirm, the data in the studies we cited in the 

NPRM. They do not change either the methodology 

in the listing or any substantive criteria in it. 

treating hematological disorders before 

denying children’s disability claims. 

Response: We did not adopt the 

comment because, as just indicated, we 

will consider on an individual case 

basis whether a person, including a 

child, can afford, or has access to, 

medically necessary treatments. 

Comment: Some commenters objected 

to our use of hospitalization as a 

criterion in several final listings for 

determining listing-level severity of a 

person’s hematological disorder. These 

listings require hospitalization at least 

three times within a 12-month period, 

with each hospitalization occurring at 

least 30 days apart. The commenters 

believed health insurers and hospitals 

are actively trying to reduce hospital 

admissions, which may prevent some 

disabled people from receiving benefits. 

One commenter thought that 

discrimination and a lack of uniformity 

of treatment protocols among 

communities and hospitals could also 

affect decisions regarding 

hospitalization. The commenters 

recommended we delete the 

hospitalization requirement or require 

fewer than three hospitalizations in a 

12-month period. Some commenters 

also recommended we consider the 

frequency of outpatient visits as a 

measure of listing-level severity. 

Response: We decided to retain the 

hospitalization criterion because our 

intent in these final listings is to reflect 

criteria that result in an inability to 

perform any gainful activity, which can 

be demonstrated by a need for a level of 

care beyond more conventional 

treatments for hematological disorders. 

We believe the hospitalization criterion 

is an advantage to people who apply for 

disability benefits because it provides 

another way for us to find them disabled 

at the listing step. 

We want to assure the commenters 

that we are able to evaluate 

hematological disorders resulting in 

fewer than three hospitalizations in a 

consecutive 12-month period under the 

criteria in final listing 7.18 for adults, 

the functional equivalence rules for 

children, or at other steps in our 

sequential evaluation process. For 

example, the criteria in listing 7.18 

evaluate the functional impact of the 

person’s impairment in the broad areas 

of activities of daily living, social 

functioning, and concentration, 

persistence, or pace, including the 

functional impact of treatment such as 

repeated outpatient visits for 

complications. We are also able to 

evaluate hematological disorders that 

are ‘‘severe’’ but do not meet or equal 

any listing under the final steps of the 

sequential evaluation process. 

Comment: One commenter expressed 

concern that people with hematological 

disorders may have complications and 

co-occurring conditions for years, but 

their impairments never result in 

hospitalization. This commenter was 

also concerned that our adjudicators 

may not know about many of the 

hematological disorders, their effects, 

and how to recognize them. 

Response: As previously discussed, 

we believe the functional criteria in 

listing 7.18 and our childhood 

functional equivalence criteria under 

the SSI program will help us determine 

disability appropriately for people 

whose hematological disorders result in 

fewer than three hospitalizations in a 

12-month period. These criteria also 

cover people who have never been 

hospitalized. 

With regard to the commenter’s 

concerns about adjudicators’ knowledge 

of hematological disorders, the 

introductory text and listings provide 

common examples of hematological 

disorders and describe their 

complications. However, we do not 

think it is practical or necessary to list 

all hematological disorders and their 

complications. Instead, as we do with 

respect to other changes in our listings, 

we plan to provide instructions and 

training to our adjudicators. These 

instructions and the training will help 

our adjudicators recognize less common 

examples of hematological disorders 

and their associated complications and 

functional limitations. 

Comment: One commenter believed 

the requirement that the hospitalization 

must last at least 48 hours seems to be 

‘‘arbitrary’’ and not based on scientific 

or medical standards. The commenter 

thought it would be just as appropriate 

for us to require the hospitalization to 

last at least 24 hours, as listings in some 

other body systems require. 

Response: We disagree with the 

commenter that we should require 

hospital stays of at least 24 hours. As we 

noted in the preamble of the NPRM, the 

48-hour criterion more clearly defines 

our intent in prior listing 7.05B for an 

‘‘extended hospitalization.’’ 4 This 

criterion is more detailed than in the 

prior listing, but it is not stricter. We 

believe the scientific and medical 

literature shows that many people 

hospitalized for serious complications 

of hematological disorders are included 

in the 48-hour criterion, and that this 

criterion can help identify an 

impairment of listing-level severity. 

In sickle cell disease, for instance, a 

2008 study found 63 percent of children 

hospitalized for pain crises had hospital 

stays of at least 4 days, not counting 

time in the emergency department.5

Similarly, a 2004 study of children 

hospitalized for sickle cell disease 

complications other than strokes 

reported a median hospital stay of 3 

days 6; children with strokes had a 

median hospital stay of 6 days. A 2010 

study of adults and children with sickle 

cell complications reported an average 

initial hospital stay of 5.6 days.7

Children in the 2008 study with long 

hospital stays tended to have high pain 

scores, pain in multiple body sites, cooccurring complications, and a need for 

extensive treatment. 

In hemophilia, a study published in 

2011 of Texas patients with bleeding 

episodes reported a median hospital 

stay of 4 days.8 A 2005 study of patients 

with potentially life-threatening bleeds 

in the iliopsoas muscle reported a 

median hospital stay of 4.8 days.9

Hospital stays may be longer for 

iliopsoas bleeds in hemophiliacs with 

‘‘inhibitors’’ (replacement factor 

alloantibodies).10 Generally, 

hemophiliacs with inhibitors may 

require more extensive treatment than 

those without inhibitors because their 

bleeding episodes often are resistant to 

standard treatments.11

The study findings described above 

are consistent with our adjudicative 

experience that many claimants with 

listing-level hematological disorders 

satisfy the 48-hour criterion because 

their complications are difficult to treat 

and recoveries are prolonged.12 On the 

other hand, we believe requiring the 

hospitalization to last at least 24 hours 

would not be an accurate predictor of 

impairment severity because this 

criterion would include people who 


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13See 20 CFR 404.1513(a) and 416.913(a). 14 78 FR at 69333. 

recover relatively quickly and 

satisfactorily with standard treatments. 

These hospitalizations include people 

hospitalized only overnight, for 

example, to receive extra fluids after 

treatment in the emergency department, 

and those kept for observation after 

surgery. In this regard, a 24-hour 

criterion would not reflect our intent 

that the listing be used to evaluate 

impairments at the listing level, which 

require treatment beyond the usual 

course of treatment for the 

hematological disorder. 

Comment: One commenter questioned 

our use of the term ‘‘disorders of 

hemostasis’’ in the introductory text and 

the listings. The commenter noted that 

the medical community usually refers to 

the grouping of clotting and bleeding 

disorders as ‘‘disorders of thrombosis 

and hemostasis.’’ 

Response: We adopted the comment 

and modified the listings accordingly. 

Comment: Some commenters 

suggested minor editorial changes in the 

introductory text, such as a comment 

asking us to indicate that the examples 

of complications of hematological 

disorders in section 7.00C, section 

7.00D, and other final sections are not 

all-inclusive. 

Response: We made these minor 

editorial changes for clarity and 

consistency; none were substantive. 

Sections 7.00B and 107.00B—What 

evidence do we need to document that 

you have a hematological disorder? 

Comment: Some commenters 

expressed concern over the requirement 

in proposed sections 7.00B and 107.00B 

that laboratory reports of definitive tests 

establishing hematological disorders 

have a physician’s signature. These 

commenters thought this requirement 

too difficult or burdensome for some 

claimants because it may require them 

to obtain additional medical evidence. 

These commenters said it is not the 

usual practice for the overseeing 

physician in a laboratory to sign 

laboratory reports of definitive tests. 

They recommended we accept reports 

signed by treating physicians or other 

physicians if these reports state that the 

definitive hematological evidence is 

present in the medical records. They 

also believed we should accept a 

physician’s statement that a person has 

a hematological disorder, even if the 

definitive hematological evidence is not 

present in the medical records. 

Response: We did not adopt the 

comments. Under our policy, evidence 

establishing a medically determinable 

impairment (MDI) must be 

appropriately developed. To develop 

this evidence appropriately, it must 

come from acceptable medical sources, 

that is, medical or osteopathic doctors.13

A doctor’s signature on a definitive 

laboratory test establishing that the 

person has a hematological disorder 

confirms the evidence came from an 

acceptable medical source, and we do 

not need to develop the evidence further 

to establish an MDI. In situations in 

which a doctor did not sign the 

definitive laboratory test, we will 

continue to develop the evidence. Final 

sections 7.00B and 107.00B provide 

examples of additional evidence we 

may obtain from doctors to establish the 

MDI, and we believe these examples are 

comparable to what the commenters 

recommended. Consequently, final 

sections 7.00B and 107.00B clarify how 

we develop evidence establishing the 

MDI; they do not add new requirements. 

Sections 7.00C and 107.00C—What are 

hemolytic anemias, and how do we 

evaluate them under 7.05 and 107.05? 

Comment: One commenter pointed 

out that hemolytic anemias are 

sometimes acquired conditions. 

Response: We adopted this comment 

and revised final sections 7.00C1 and 

107.00C1 to provide examples of 

acquired hemolytic anemias. We made 

similar changes in final sections 7.00D1, 

107.00D1, 7.00E1, and 107.00E1. We 

also provided examples of acquired 

disorders of thrombosis and hemostasis, 

as well as disorders of bone marrow 

failure. 

Comment: A commenter 

recommended that we add hereditary 

spherocytosis to the list of common 

examples of hemolytic anemias in 

adults. The commenter also suggested 

that we add paroxysmal nocturnal 

hemoglobinuria to the list of examples. 

Response: We adopted this 

recommendation and added hereditary 

spherocytosis to the list in 7.00C1. We 

also added hereditary spherocytosis to 

the list of common examples of 

hemolytic anemias in children in 

107.00C1 to make the child listings 

consistent with the adult listings. 

We did not adopt the commenter’s 

recommendation that we add 

paroxysmal nocturnal hemoglobinuria 

to the list of examples. Although we 

evaluate paroxysmal nocturnal 

hemoglobinuria under the 

hematological disorders listings, it is a 

very rare disorder. We provide only 

examples of common hemolytic 

anemias in the listings because we do 

not believe it is practical or necessary to 

name all of the hematological disorders 

we evaluate under this body system. We 

plan to provide information to our 

adjudicators about less common 

examples of hematological disorders, 

such as paroxysmal nocturnal 

hemoglobinuria, through training and 

operating instructions. 

Comment: We received many 

comments expressing concern over our 

exclusion in proposed sections 7.00C4 

and 107.00C4 of prophylactic red blood 

cell (RBC) transfusions to prevent stroke 

in people with sickle cell disease. Some 

of these commenters recommended that 

we delete the statement in proposed 

section 7.00C4 that we do not consider 

prophylactic RBC transfusions for sickle 

cell disease to be of equal medical 

significance to transfusion-dependent 

thalassemia.14 They said people with 

sickle cell disease who require 

prophylactic RBC transfusions are 

usually chronically ill, and they cited 

articles in the current medical literature 

to support their views. Another 

commenter believed final sections 

7.00C4 and 107.00C4 needed more 

information to help adjudicators 

determine whether the need for RBC 

transfusions will be life-long. 

The commenters also believe people 

with sickle cell disease who receive 

prophylactic RBC transfusion to prevent 

stroke may be more severely impaired 

than people with transfusion-dependent 

beta thalassemia major because they 

have a far greater burden of 

cerebrovascular disease and intellectual 

and physical impairment. Additionally, 

a comment from a national advocacy 

group for physicians in pediatric 

hematology and oncology said its 

membership now considers sickle cell 

disease with stroke to be a transfusiondependent disorder like thalassemia 

because of the risk of recurrent strokes 

if prophylactic RBC transfusion stops. 

Response: We do not agree that 

treatment with prophylactic RBC 

transfusions alone should reflect a 

listing-level impairment in sickle cell 

disease and have not adopted the 

commenters’ recommendations. Under 

the Act, we cannot find that a person is 

disabled based on the risk of a 

complication occurring in the future, as, 

for example, when transfusion therapy 

is effective and the person has not 

experienced a stroke. 

However, we agree that people with 

sickle cell disease are chronically sick. 

We added language to final sections 

7.00C4 and 107.00C4 that directs 

evaluation under listings 11.00, 111.00, 

12.00, and 112.00 if a claimant has had 

a stroke. We also added language in 

final sections 7.00C4 and 107.00C4 

explaining that we will consider 

functional limitations associated with 


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Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Rules and Regulations 21163 

chronic RBC transfusions under final 

listing 7.18 for adults, the functional 

equivalence rules for children, as well 

as the listings for any affected body 

systems. The additional language also 

addresses complications resulting from 

chronic RBC transfusion, such as iron 

overload. 

We also deleted the term 

‘‘transfusion-dependent’’ in the final 

sections 7.00C4, 107.00C4, 7.00E3, and 

107.00E3 because comments 

demonstrated to us that this term may 

confuse adjudicators. We made a 

corresponding change in final listings 

7.05D, 107.05D, 7.10B, and 107.10B. 

Instead, we use the phrase, ‘‘requiring 

RBC transfusions at least once every 6 

weeks to maintain life.’’ We believe this 

phrase is more descriptive of our intent 

in these final rules, which is that listinglevel severity for hematological 

disorders requires treatment with RBC 

transfusions that are life-saving in 

nature and life-long in need. Moreover, 

we are confident our adjudicators will 

understand the requirement that the 

RBC transfusions must be ‘‘life-long,’’ as 

reflected in the ultimately fatal nature of 

beta thalassemia major and 

myelodysplastic syndrome if this 

treatment is withdrawn. 

Sections 7.00D and 107.00D—What are 

disorders of thrombosis and 

hemostasis, and how do we evaluate 

them under 7.08 and 107.08? 

Comment: A commenter noted that 

the future development of new 

treatments for hemophilia may make the 

term ‘‘factor infusions’’ less relevant. 

Response: We adopted the comment 

and use the term ‘‘clotting-factor 

proteins’’ in final sections 7.00D2 and 

107.00D2, instead of the term ‘‘factor 

infusions.’’ 

Comment: A commenter stated that 

the language in proposed sections 

7.00D2 and 107.00D2 was vague and did 

not make it clear that these sections 

included any surgery. 

Response: We revised final sections 

7.00D2 and 107.00D2 to state explicitly 

that we consider all surgeries in people 

with disorders of thrombosis or 

hemostasis to be complications of their 

disorders if they needed treatment with 

clotting-factor proteins or anticoagulant 

medications to control bleeding or 

coagulation in connection with the 

surgery. 

Sections 7.00I and 107.00H—How do 

we evaluate episodic events in 

hematological disorders? 

Comment: Some commenters thought 

proposed sections 7.00I and 107.00I 

could imply that the consecutive 12- 

month period required for episodic 

events could not include the months 

before a person files a disability claim, 

or the months before the person’s 

alleged onset date of disability. 

Response: In response to these 

comments, we added language to clarify 

the guidance in final sections 7.00I and 

107.00I. 

Listings 7.05 and 107.05—Hemolytic 

Anemias, Including Sickle Cell Disease, 

Thalassemia, and Their Variants 

Comment: Several commenters 

expressed concern about the criterion in 

proposed listings 7.05A and 107.05A 

requiring at least six pain crises treated 

with parenteral narcotic medications 

within a 12-month period and occurring 

at least 30 days apart. These 

commenters believed this criterion is 

too restrictive, particularly for 

evaluating sickle cell disease. They 

believed that recent scientific and 

medical literature points to three pain 

crises requiring parenteral narcotic 

medication within a 12-month period as 

a more appropriate standard. 

Some commenters also noted that 

pain crises treated with only oral 

narcotic medications may be severe 

enough to disrupt a person’s life for 

days or weeks. These commenters 

believed such pain crises greatly impair 

a person’s mobility, self-care, and 

mental capacity, and they noted that 

there can be long-term, cumulative 

tissue and organ damage associated with 

the crises. A national advocacy group 

for persons with hematological 

disorders recommended we consider the 

daily use of oral opioids as a criterion 

for listing-level severity. The group 

provided a suggested revision to final 

listing 7.05A that considered a person 

disabled if he or she required daily oral 

opioids for chronic pain for a period of 

at least 30 consecutive days, at least 

three times within a 12-month period. 

Response: We did not adopt these 

comments because we believe final 

listings 7.05A and 107.05A provide 

objective criteria that are more 

descriptive of our intent and more 

specific to listing-level determinations 

than the prior listings. In addition, as 

we noted previously, final listing 7.18 

provides criteria to evaluate claims from 

individuals whose impairments do not 

satisfy the medical criteria in final 

listing 7.05A, but whose impairments 

result in functional limitations that meet 

the criteria of listing 7.18. These effects 

may include chronic pain and other 

complications, as well as a frequent 

need for oral narcotic medication or 

other treatments that may cause 

negative side effects. Some people with 

sickle cell disease or other hemolytic 

anemia may have impairments that are 

less than listing-level severity, but may 

still be disabling. We can evaluate these 

impairments through the steps of our 

sequential evaluation process after the 

listing step. 

Comment: One commenter noted that 

a person hospitalized for pain crises 

may receive treatments other than 

parenteral narcotic medication, such as 

local or regional anesthetic blocks. The 

commenter believed pain crises 

requiring such treatments also result in 

functional impairments and are 

indicative of pain severity, but were not 

reflected in proposed listings 7.05A and 

107.05A. 

Response: While it is true final 

listings 7.05A and 107.05A do not 

specify these other treatments, we did 

not adopt this comment because we are 

able to evaluate hospitalizations for pain 

crises treated with other treatments 

under final listings 7.05B and 107.05B, 

or we can evaluate the functional 

impairments described by the 

commenter under final listing 7.18, or 

the functional equivalence rules for 

childhood disability claims under the 

SSI program. 

Comment: One commenter agreed 

with the requirement in listings 7.05B 

and 107.05B that a hospitalization 

should last at least 48 hours, but 

recommended that this criterion not 

include hours spent in the hospital 

emergency department immediately 

before the hospitalization. The 

commenter said hospitals may not 

always document patients’ arrival times 

in their emergency departments and 

times of discharge to inpatient units. 

Response: We did not adopt the 

commenter’s recommendation because 

our adjudicative experience shows that 

hospitals document these times in the 

great majority of cases. 

Comment: A commenter suggested we 

count the hours a person receives 

treatment in a comprehensive sickle cell 

disease center under our requirement in 

final listings 7.05B and 107.05B that 

hospitalizations for complications of 

hemolytic anemias last at least 48 hours. 

We received a similar comment 

regarding comprehensive hemophilia 

treatment centers. 

Response: We adopted these 

comments. We explain in final sections 

7.00C2 and 107.00C2 that we will count 

the hours the person receives treatment 

in a comprehensive sickle cell disease 

center if the treatment is comparable to 

the treatment provided in a hospital 

emergency department. We also revised 

final listings 7.08 and 107.08 and final 

sections 7.00D2 and 107.00D2 in 

response to the comment regarding 

comprehensive hemophilia treatment 

centers. 


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15See 20 CFR 404.1513(d), 20 CFR 416.913(d), 

and Social Security Ruling 06–03p: Titles II and 

XVI: Considering Opinions and Other Evidence 

from Sources Who Are Not ‘‘Acceptable Medical 

Sources’’ in Disability Claims, 71 FR 45593 (2006) 

(also available at: http://www.ssa.gov/OP_Home/

rulings/di/01/SSR2006-03-di-01.html). 

Comment: One commenter believed 

the requirement in proposed listings 

7.05B and 107.05B for three 

hospitalizations within a 12-month 

period is too restrictive because it 

applies only to a subset of people with 

sickle cell disease who the commenter 

described as ‘‘high-risk’’ patients. The 

commenter believed we should consider 

a person with sickle cell disease to be 

disabled if he or she has any of the 

complications described in final 

sections 7.00C2 and 107.00C2 because 

this person needs continual follow-up 

and monitoring regardless of 

hospitalization. 

Response: While we appreciate the 

commenter’s concerns—and we agree 

that people with sickle cell disease have 

serious impairments if they have any of 

the complications described in final 

sections 7.00C2 and 107.00C2—we did 

not adopt the comment. We can 

evaluate these claimants’ impairments 

under any appropriate listing in the 

affected body system, or at the steps of 

our sequential evaluation process after 

the listing step, if they do not meet or 

medically equal the criteria in listings 

7.05B and 107.05B. 

Comment: We received a comment 

recommending we add guidance to the 

listings that explains to adjudicators 

they can use hematocrit readings under 

final listings 7.05C and 107.05C if a 

person’s case record does not include 

hemoglobin measurements. The 

commenter was concerned adjudicators 

might misinterpret the listings to mean 

they cannot use hematocrit readings 

under any circumstances. 

Response: We did not adopt this 

recommendation. These final listings 

require hemoglobin measurements at 7.0 

grams per deciliter (g/dL) or less, 

occurring at least three times within a 

12-month period with at least 30 days 

between measurements. In the great 

majority of cases, our adjudicative 

experience shows a person’s case record 

provides both hemoglobin 

measurements and hematocrit readings. 

Moreover, we are confident that our 

adjudicators understand they can use 

comparable hematocrit levels to 

medically equal the listings if 

hemoglobin measurements are not 

available. The final listings do not 

provide substantive instructions to our 

adjudicators for determining such 

equivalence because we can better 

provide this information through 

operating instructions and training. 

Comment: Two commenters 

questioned whether we should use 

hemoglobin measurements at all. One 

commenter said the science and the 

medical communities have not 

established a critical threshold for 

hemoglobin for determining disability. 

The other commenter said disability 

depends on factors besides hemoglobin 

level, such as the duration of anemia, 

the bone marrow’s response, and 

associated cardiovascular or other organ 

dysfunction. For children, this 

commenter said we should also 

consider amount of fatigue, inability to 

concentrate, problems with executive 

function, and memory deficiencies. 

Response: We did not adopt these 

comments because we believe this 

criterion is reasonable for quickly 

identifying people whose hemolytic 

anemias are clearly disabling, and 

whose claims should be allowed at the 

listing step. Hemoglobin at 7.0 g/dL or 

less can result in an abnormal heartbeat, 

shortness of breath with mild exertion, 

significant fatigue, and other very 

serious complications. Given these 

complications, we believe the criteria in 

the final listings reflect a persistence of 

very low hemoglobin that can prevent 

an adult from working, or prevent a 

child from functioning independently, 

appropriately, and effectively in an ageappropriate manner. 

Comment: A commenter noted that 

people with sickle cell disease and a 

history of frequent pain crises or acute 

chest syndrome may be receiving 

prophylactic RBC transfusions to 

alleviate these complications and are 

not likely to have hemoglobin 

measurements of 7.0 g/dL. The 

commenter recommended that listings 

7.05C and 107.05C allow for a finding 

of disability for people who receive 

prophylactic RBC transfusions for these 

complications. 

Response: We did not adopt the 

comment because the intent of the 

hemoglobin finding in final listings 

7.05C and 107.05C is to provide a faster 

way for us to determine listing-level 

disability without needing to consider a 

person’s specific complications. 

Comment: The same commenter also 

thought that adjudicators will have 

difficulty identifying hemoglobin 

measurements of 7.0 g/dL among 

potentially hundreds of measurements 

in a person’s case record. 

Response: We did not adopt this 

comment. We agree that a person’s case 

record may provide many hemoglobin 

measurements; however, our 

adjudicators are accustomed to 

evaluating such evidence. 

Listing 7.18—Repeated Complications 

of Hematological Disorders 

Comment: One commenter suggested 

that we add ‘‘chronic skin ulcers’’ to the 

examples of complications in final 

listing 7.18. 

Response: We did not adopt this 

comment. Both the proposed rules and 

these final rules include skin ulcers as 

a possible complication that we will 

evaluate under listing 7.18. However, 

skin ulcers and other complications we 

evaluate under the listing do not have 

to be chronic. We explain in final 

section 7.00G2 that a person’s 

complications do not have to be the 

same each time, but can vary. A person 

could have skin ulcers once and may 

satisfy this criterion in the listing if he 

or she also has other complications 

during the period we are considering in 

connection with the application. 

Comment: A commenter suggested we 

include chronic, non-vascular necrosisrelated low back pain in final listing 

7.18 as a complication of a 

hematological disorder. The commenter 

also suggested that listing 7.18 take into 

consideration pain resulting from 

prolonged periods of standing or 

physical activity in people who have 

chronic pain from a hematological 

disorder such as sickle cell disease. 

Response: We did not believe it was 

necessary to adopt the commenter’s 

suggestions. The pain resulting from 

repeated complications of hematological 

disorders that listing 7.18 requires can 

include the chronic pain the commenter 

describes. 

Comment: One commenter believed 

that it is important for adjudicators to 

give appropriate weight to evaluations 

by nurses, social workers, and physical 

therapists when determining a person’s 

functional limitations under final listing 

7.18. 

Response: We agree that such sources 

can provide important information to 

show the severity of a person’s 

impairment and how it affects his or her 

ability to work, and we currently 

provide guidance to our adjudicators in 

our regulations for considering this 

evidence and who may provide it.15

Listing 107.08—Disorders of 

Hemostasis, Including Hemophilia and 

Thrombocytopenia 

Comment: A commenter believed 

proposed listing 107.08 did not 

recognize the developmental and 

functional impact that disability has on 

children and should reflect a need for 

frequent medical intervention, not only 

hospitalizations. The commenter stated 

that repeated hospitalizations and 

frequent outpatient medical treatment 


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16See sections 205(a), 702(a)(5), and 1631(d)(1). 

affect children much more profoundly 

than adults. 

Response: We did not adopt the 

commenter’s recommendation because 

we can evaluate the functional and 

developmental impact of a child’s 

frequent medical treatment under our 

functional equivalence rules. Under 

these rules, we evaluate how 

independently, appropriately, and 

effectively the child functions compared 

to children of the same age who do not 

have a hematological disorder. This 

evaluation includes assessing what 

activities the child cannot do, has 

difficulty doing, or is restricted from 

doing because of the interactive and 

cumulative effects of his or her disorder 

and medical care. 

Listing 107.10—Disorders of Bone 

Marrow Failure, Including 

Myelodysplastic Syndromes, Aplastic 

Anemia, Granulocytopenia, and 

Myelofibrosis 

Comment: A commenter stated that 

the requirement in 107.10A for three 

hospitalizations within a 12-month 

period may be too restrictive for 

children because ‘‘impairment can be 

severe in a child’’ following a single 

hospitalization. 

Response: We did not modify the 

proposed listing as a result of this 

comment. We believe the 

hospitalization criterion for disorders of 

bone marrow failure is an advantage to 

children and adults who apply for 

disability benefits because it provides 

another way we may find them disabled 

at the listing step. Additionally, the 

child functional equivalence rules help 

us evaluate SSI claims filed by children 

whose hematological disorders result in 

fewer than three hospitalizations in a 

12-month period. 

What is our authority to make rules 

and set procedures for determining 

whether a person is disabled under the 

statutory definition? 

Under the Act, we have authority to 

make rules and regulations and to 

establish necessary and appropriate 

procedures to carry out such 

provisions.16

How long will these final rules be in 

effect? 

These final rules will be in effect for 

5 years after their effective date, unless 

we extend them. We will continue to 

monitor these rules to ensure that they 

continue to meet program purposes, and 

may revise them before the end of the 

5-year period if warranted. 

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 final rules meet 

the requirements for a significant 

regulatory action under Executive Order 

12866, as supplemented by Executive 

Order 13563 and was reviewed by OMB. 

Regulatory Flexibility Act 

We certify that these final rules will 

not have a significant economic impact 

on a substantial number of small entities 

because they affect only individuals. 

Therefore, the Regulatory Flexibility 

Act, as amended, does not require us to 

prepare a regulatory flexibility analysis. 

Paperwork Reduction Act 

These final rules do not impose new 

or affect any existing reporting or 

recordkeeping requirements and are not 

subject to OMB clearance. 

(Catalog of Federal Domestic Assistance 

Program Nos. 96.001, Social Security— 

Disability Insurance; 96.002, Social 

Security—Retirement Insurance; 96.004, 

Social Security—Survivors Insurance; and 

96.006, Supplemental Security Income). 

List of Subjects in 20 CFR Part 404 

Administrative practice and 

procedure, Blind, Disability benefits, 

Old-age, Survivors and Disability 

Insurance, Reporting and recordkeeping 

requirements, Social Security. 

Dated: April 10, 2015. 

Carolyn W. Colvin, 

Acting Commissioner of Social Security. 

For the reasons set out in the 

preamble, we are amending 20 CFR part 

404, subpart P as set forth below: 

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950– ) 

Subpart P—[Amended] 

■ 1. The authority citation for subpart P 

of part 404 continues to read as follows: 

Authority: Secs. 202, 205(a)–(b) and (d)– 

(h), 216(i), 221(a), (i), and (j), 222(c), 223, 

225, and 702(a)(5) of the Social Security Act 

(42 U.S.C. 402, 405(a)–(b) and (d)–(h), 416(i), 

421(a), (i), and (j), 422(c), 423, 425, and 

902(a)(5)); sec. 211(b), Pub. L. 104–193, 110 

Stat. 2105, 2189; sec. 202, Pub. L. 108–203, 

118 Stat. 509 (42 U.S.C. 902 note). 

■ 2. Amend appendix 1 to subpart P of 

part 404 by revising: 

■ a. Item 8 of the introductory text 

before part A; 

■ b. Section 7.00 of part A; 

■ c. Section 13.00K2c(ii) of part A; 

■ d. Second sentence of section 13.00K3 

of part A; and 

■ e. Section 107.00 of part B. 

The revisions read as follows: 

Appendix 1 to Subpart P of Part 404— 

Listing of Impairments 

* * * * * 

8. Hematological Disorders (7.00 and 

107.00): May 18, 2020. 

* * * * * 

Part A 

* * * * * 

7.00 HEMATOLOGICAL DISORDERS 

A. What hematological disorders do we 

evaluate under these listings? 

1. We evaluate non-malignant (noncancerous) hematological disorders, such as 

hemolytic anemias (7.05), disorders of 

thrombosis and hemostasis (7.08), and 

disorders of bone marrow failure (7.10). 

These disorders disrupt the normal 

development and function of white blood 

cells, red blood cells, platelets, and clottingfactor proteins (factors). 

2. We evaluate malignant (cancerous) 

hematological disorders, such as lymphoma, 

leukemia, and multiple myeloma, under the 

appropriate listings in 13.00, except for 

lymphoma associated with human 

immunodeficiency virus (HIV) infection, 

which we evaluate under 14.08E. 

B. What evidence do we need to document 

that you have a hematological disorder? 

We need the following evidence to 

document that you have a hematological 

disorder: 

1. A laboratory report of a definitive test 

that establishes a hematological disorder, 

signed by a physician; or 

2. A laboratory report of a definitive test 

that establishes a hematological disorder that 

is not signed by a physician and a report 

from a physician that states you have the 

disorder; or 

3. When we do not have a laboratory report 

of a definitive test, a persuasive report from 

a physician that a diagnosis of your 

hematological disorder was confirmed by 

appropriate laboratory analysis or other 

diagnostic method(s). To be persuasive, this 

report must state that you had the 

appropriate definitive laboratory test or tests 

for diagnosing your disorder and provide the 

results, or explain how your diagnosis was 

established by other diagnostic method(s) 

consistent with the prevailing state of 

medical knowledge and clinical practice. 

4. We will make every reasonable effort to 

obtain the results of appropriate laboratory 

testing you have had. We will not purchase 

complex, costly, or invasive tests, such as 

tests of clotting-factor proteins, and bone 

marrow aspirations. 

C. What are hemolytic anemias, and how do 

we evaluate them under 7.05? 

1. Hemolytic anemias, both congenital and 

acquired, are disorders that result in 

premature destruction of red blood cells 

(RBCs). Hemolytic disorders include 

abnormalities of hemoglobin structure 


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(hemoglobinopathies), abnormal RBC enzyme 

content and function, and RBC membrane 

(envelope) defects that are congenital or 

acquired. The diagnosis of hemolytic anemia 

is based on hemoglobin electrophoresis or 

analysis of the contents of the RBC (enzymes) 

and membrane. Examples of congenital 

hemolytic anemias include sickle cell 

disease, thalassemia and their variants, and 

hereditary spherocytosis. Acquired hemolytic 

anemias may result from autoimmune 

disease (for example, systemic lupus 

erythematosus) or mechanical devices (for 

example, heart valves, intravascular patches). 

2. The hospitalizations in 7.05B do not all 

have to be for the same complication of the 

hemolytic anemia. They may be for three 

different complications of the disorder. 

Examples of complications of hemolytic 

anemia that may result in hospitalization 

include osteomyelitis, painful (vasoocclusive) crisis, pulmonary infections or 

infarctions, acute chest syndrome, 

pulmonary hypertension, chronic heart 

failure, gallbladder disease, hepatic (liver) 

failure, renal (kidney) failure, nephrotic 

syndrome, aplastic crisis, and stroke. We will 

count the hours you receive emergency 

treatment in a comprehensive sickle cell 

disease center immediately before the 

hospitalization if this treatment is 

comparable to the treatment provided in a 

hospital emergency department. 

3. For 7.05C, we do not require hemoglobin 

to be measured during a period in which you 

are free of pain or other symptoms of your 

disorder. We will accept hemoglobin 

measurements made while you are 

experiencing complications of your 

hemolytic anemia. 

4. 7.05D refers to the most serious type of 

beta thalassemia major in which the bone 

marrow cannot produce sufficient numbers 

of normal RBCs to maintain life. The only 

available treatments for beta thalassemia 

major are life-long RBC transfusions 

(sometimes called hypertransfusion) or bone 

marrow transplantation. For purposes of 

7.05D, we do not consider prophylactic RBC 

transfusions to prevent strokes or other 

complications in sickle cell disease and its 

variants to be of equal significance to lifesaving RBC transfusions for beta thalassemia 

major. However, we will consider the 

functional limitations associated with 

prophylactic RBC transfusions and any 

associated side effects (for example, iron 

overload) under 7.18 and any affected body 

system(s). We will also evaluate strokes and 

resulting complications under 11.00 and 

12.00. 

D. What are disorders of thrombosis and 

hemostasis, and how do we evaluate them 

under 7.08? 

1. Disorders of thrombosis and hemostasis 

include both clotting and bleeding disorders, 

and may be congenital or acquired. These 

disorders are characterized by abnormalities 

in blood clotting that result in 

hypercoagulation (excessive blood clotting) 

or hypocoagulation (inadequate blood 

clotting). The diagnosis of a thrombosis or 

hemostasis disorder is based on evaluation of 

plasma clotting-factor proteins (factors) and 

platelets. Protein C or protein S deficiency 

and Factor V Leiden are examples of 

hypercoagulation disorders. Hemophilia, von 

Willebrand disease, and thrombocytopenia 

are examples of hypocoagulation disorders. 

Acquired excessive blood clotting may result 

from blood protein defects and acquired 

inadequate blood clotting (for example, 

acquired hemophilia A) may be associated 

with inhibitor autoantibodies. 

2. The hospitalizations in 7.08 do not all 

have to be for the same complication of a 

disorder of thrombosis and hemostasis. They 

may be for three different complications of 

the disorder. Examples of complications that 

may result in hospitalization include 

anemias, thromboses, embolisms, and 

uncontrolled bleeding requiring multiple 

factor concentrate infusions or platelet 

transfusions. We will also consider any 

surgery that you have, even if it is not related 

to your hematological disorder, to be a 

complication of your disorder of thrombosis 

and hemostasis if you require treatment with 

clotting-factor proteins (for example, factor 

VIII or factor IX) or anticoagulant medication 

to control bleeding or coagulation in 

connection with your surgery. We will count 

the hours you receive emergency treatment in 

a comprehensive hemophilia treatment 

center immediately before the hospitalization 

if this treatment is comparable to the 

treatment provided in a hospital emergency 

department. 

E. What are disorders of bone marrow failure, 

and how do we evaluate them under 7.10? 

1. Disorders of bone marrow failure may be 

congenital or acquired, characterized by bone 

marrow that does not make enough healthy 

RBCs, platelets, or granulocytes (specialized 

types of white blood cells); there may also be 

a combined failure of these bone marrowproduced cells. The diagnosis is based on 

peripheral blood smears and bone marrow 

aspiration or bone marrow biopsy, but not 

peripheral blood smears alone. Examples of 

these disorders are myelodysplastic 

syndromes, aplastic anemia, 

granulocytopenia, and myelofibrosis. 

Acquired disorders of bone marrow failure 

may result from viral infections, chemical 

exposure, or immunologic disorders. 

2. The hospitalizations in 7.10A do not all 

have to be for the same complication of bone 

marrow failure. They may be for three 

different complications of the disorder. 

Examples of complications that may result in 

hospitalization include uncontrolled 

bleeding, anemia, and systemic bacterial, 

viral, or fungal infections. 

3. For 7.10B, the requirement of life-long 

RBC transfusions to maintain life in 

myelodysplastic syndromes or aplastic 

anemias has the same meaning as it does for 

beta thalassemia major. (See 7.00C4.) 

F. How do we evaluate bone marrow or stem 

cell transplantation under 7.17? 

We will consider you to be disabled for 12 

months from the date of bone marrow or stem 

cell transplantation, or we may consider you 

to be disabled for a longer period if you are 

experiencing any serious post-transplantation 

complications, such as graft-versus-host 

(GVH) disease, frequent infections after 

immunosuppressive therapy, or significant 

deterioration of organ systems. We do not 

restrict our determination of the onset of 

disability to the date of the transplantation in 

7.17. We may establish an earlier onset date 

of disability due to your transplantation if 

evidence in your case record supports such 

a finding. 

G. How do we use the functional criteria in 

7.18? 

1. When we use the functional criteria in 

7.18, we consider all relevant information in 

your case record to determine the impact of 

your hematological disorder on your ability 

to function independently, appropriately, 

effectively, and on a sustained basis in a 

work setting. Factors we will consider when 

we evaluate your functioning under 7.18 

include, but are not limited to: Your 

symptoms, the frequency and duration of 

complications of your hematological 

disorder, periods of exacerbation and 

remission, and the functional impact of your 

treatment, including the side effects of your 

medication. 

2. Repeated complications means that the 

complications occur on an average of three 

times a year, or once every 4 months, each 

lasting 2 weeks or more; or the complications 

do not last for 2 weeks but occur 

substantially more frequently than three 

times in a year or once every 4 months; or 

they occur less frequently than an average of 

three times a year or once every 4 months but 

last substantially longer than 2 weeks. Your 

impairment will satisfy this criterion 

regardless of whether you have the same kind 

of complication repeatedly, all different 

complications, or any other combination of 

complications; for example, two of the same 

kind of complication and a different one. You 

must have the required number of 

complications with the frequency and 

duration required in this section. 

Additionally, the complications must occur 

within the period we are considering in 

connection with your application or 

continuing disability review. 

3. To satisfy the functional criteria in 7.18, 

your hematological disorder must result in a 

‘‘marked’’ level of limitation in one of three 

general areas of functioning: Activities of 

daily living, social functioning, or difficulties 

in completing tasks due to deficiencies in 

concentration, persistence, or pace. 

Functional limitations may result from the 

impact of the disease process itself on your 

mental functioning, physical functioning, or 

both your mental and physical functioning. 

This limitation could result from persistent 

or intermittent symptoms, such as pain, 

severe fatigue, or malaise, resulting in a 

limitation of your ability to do a task, to 

concentrate, to persevere at a task, or to 

perform the task at an acceptable rate of 

speed. (Severe fatigue means a frequent sense 

of exhaustion that results in significant 

reduced physical activity or mental function. 

Malaise means frequent feelings of illness, 

bodily discomfort, or lack of well-being that 

result in significantly reduced physical 

activity or mental function.) You may also 

have limitations because of your treatment 

and its side effects. 

4. Marked limitation means that the 

symptoms and signs of your hematological 


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Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Rules and Regulations 21167 

disorder interfere seriously with your ability 

to function. Although we do not require the 

use of such a scale, ‘‘marked’’ would be the 

fourth point on a five-point scale consisting 

of no limitation, mild limitation, moderate 

limitation, marked limitation, and extreme 

limitation. We do not define ‘‘marked’’ by a 

specific number of different activities of daily 

living or different behaviors in which your 

social functioning is impaired, or a specific 

number of tasks that you are able to 

complete, but by the nature and overall 

degree of interference with your functioning. 

You may have a marked limitation when 

several activities or functions are impaired, 

or even when only one is impaired. 

Additionally, you need not be totally 

precluded from performing an activity to 

have a marked limitation, as long as the 

degree of limitation interferes seriously with 

your ability to function independently, 

appropriately, and effectively. The term 

‘‘marked’’ does not imply that you must be 

confined to bed, hospitalized, or in a nursing 

home. 

5. Activities of daily living include, but are 

not limited to, such activities as doing 

household chores, grooming and hygiene, 

using a post office, taking public 

transportation, or paying bills. We will find 

that you have a ‘‘marked’’ limitation in 

activities of daily living if you have a serious 

limitation in your ability to maintain a 

household or take public transportation 

because of symptoms such as pain, severe 

fatigue, anxiety, or difficulty concentrating, 

caused by your hematological disorder 

(including complications of the disorder) or 

its treatment, even if you are able to perform 

some self-care activities. 

6. Social functioning includes the capacity 

to interact with others independently, 

appropriately, effectively, and on a sustained 

basis. It includes the ability to communicate 

effectively with others. We will find that you 

have a ‘‘marked’’ limitation in maintaining 

social functioning if you have a serious 

limitation in social interaction on a sustained 

basis because of symptoms such as pain, 

severe fatigue, anxiety, or difficulty 

concentrating, or a pattern of exacerbation 

and remission, caused by your hematological 

disorder (including complications of the 

disorder) or its treatment, even if you are able 

to communicate with close friends or 

relatives. 

7. Completing tasks in a timely manner 

involves the ability to sustain concentration, 

persistence, or pace to permit timely 

completion of tasks commonly found in work 

settings. We will find that you have a 

‘‘marked’’ limitation in completing tasks if 

you have a serious limitation in your ability 

to sustain concentration or pace adequate to 

complete work-related tasks because of 

symptoms, such as pain, severe fatigue, 

anxiety, or difficulty concentrating caused by 

your hematological disorder (including 

complications of the disorder) or its 

treatment, even if you are able to do some 

routine activities of daily living. 

H. How do we consider your symptoms, 

including your pain, severe fatigue, and 

malaise? 

Your symptoms, including pain, severe 

fatigue, and malaise, may be important 

factors in our determination whether your 

hematological disorder(s) meets or medically 

equals a listing, or in our determination 

whether you are otherwise able to work. We 

cannot consider your symptoms unless you 

have medical signs or laboratory findings 

showing the existence of a medically 

determinable impairment(s) that could 

reasonably be expected to produce the 

symptoms. If you have such an 

impairment(s), we will evaluate the intensity, 

persistence, and functional effects of your 

symptoms using the rules throughout 7.00 

and in our other regulations. (See sections 

404.1528, 404.1529, 416.928, and 416.929 of 

this chapter.) Additionally, when we assess 

the credibility of your complaints about your 

symptoms and their functional effects, we 

will not draw any inferences from the fact 

that you do not receive treatment or that you 

are not following treatment without 

considering all of the relevant evidence in 

your case record, including any explanations 

you provide that may explain why you are 

not receiving or following treatment. 

I. How do we evaluate episodic events in 

hematological disorders? 

Some of the listings in this body system 

require a specific number of events within a 

consecutive 12-month period. (See 7.05, 7.08, 

and 7.10A.) When we use such criteria, a 

consecutive 12-month period means a period 

of 12 consecutive months, all or part of 

which must occur within the period we are 

considering in connection with your 

application or continuing disability review. 

These events must occur at least 30 days 

apart to ensure that we are evaluating 

separate events. 

J. How do we evaluate hematological 

disorders that do not meet one of these 

listings? 

1. These listings are only common 

examples of hematological disorders that we 

consider severe enough to prevent a person 

from doing any gainful activity. If your 

disorder does not meet the criteria of any of 

these listings, we must consider whether you 

have a disorder that satisfies the criteria of 

a listing in another body system. For 

example, we will evaluate hemophilic joint 

deformity or bone or joint pain from 

myelofibrosis under 1.00; polycythemia vera 

under 3.00, 4.00, or 11.00; chronic iron 

overload resulting from repeated RBC 

transfusion (transfusion hemosiderosis) 

under 3.00, 4.00, or 5.00; and the effects of 

intracranial bleeding or stroke under 11.00 or 

12.00. 

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 sections 404.1526 and 416.926 of 

this chapter.) Hematological 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 

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, and, if necessary, the 

fifth steps of the sequential evaluation 

process in sections 404.1520 and 416.920. 

We use the rules in sections 404.1594, 

416.994, and 416.994a of this chapter, as 

appropriate, when we decide whether you 

continue to be disabled. 

7.01 Category of Impairments, 

Hematological Disorders 

7.05 Hemolytic anemias, including sickle 

cell disease, thalassemia, and their variants 

(see 7.00C), with: 

A. Documented painful (vaso-occlusive) 

crises requiring parenteral (intravenous or 

intramuscular) narcotic medication, 

occurring at least six times within a 12- 

month period with at least 30 days between 

crises. 

OR 

B. Complications of hemolytic anemia 

requiring at least three hospitalizations 

within a 12-month period and occurring at 

least 30 days apart. Each hospitalization must 

last at least 48 hours, which can include 

hours in a hospital emergency department or 

comprehensive sickle cell disease center 

immediately before the hospitalization (see 

7.00C2). 

OR 

C. Hemoglobin measurements of 7.0 grams 

per deciliter (g/dL) or less, occurring at least 

three times within a 12-month period with at 

least 30 days between measurements. 

OR 

D. Beta thalassemia major requiring lifelong RBC transfusions at least once every 6 

weeks to maintain life (see 7.00C4). 

7.08 Disorders of thrombosis and 

hemostasis, including hemophilia and 

thrombocytopenia (see 7.00D), with 

complications requiring at least three 

hospitalizations within a 12-month period 

and occurring at least 30 days apart. Each 

hospitalization must last at least 48 hours, 

which can include hours in a hospital 

emergency department or comprehensive 

hemophilia treatment center immediately 

before the hospitalization (see 7.00D2). 

7.10 Disorders of bone marrow failure, 

including myelodysplastic syndromes, 

aplastic anemia, granulocytopenia, and 

myelofibrosis (see 7.00E), with: 

A. Complications of bone marrow failure 

requiring at least three hospitalizations 

within a 12-month period and occurring at 

least 30 days apart. Each hospitalization must 

last at least 48 hours, which can include 

hours in a hospital emergency department 

immediately before the hospitalization (see 

7.00E2). 

OR 

B. Myelodysplastic syndromes or aplastic 

anemias requiring life-long RBC transfusions 

at least once every 6 weeks to maintain life 

(see 7.00E3). 

7.17 Hematological disorders treated by 

bone marrow or stem cell transplantation 

(see 7.00F). Consider under a disability for at 

least 12 consecutive months from the date of 

transplantation. After that, evaluate any 

residual impairment(s) under the criteria for 

the affected body system. 

7.18 Repeated complications of 

hematological disorders (see 7.00G2), 

including those complications listed in 7.05, 

7.08, and 7.10 but without the requisite 

findings for those listings, or other 


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complications (for example, anemia, 

osteonecrosis, retinopathy, skin ulcers, silent 

central nervous system infarction, cognitive 

or other mental limitation, or limitation of 

joint movement), resulting in significant, 

documented symptoms or signs (for example, 

pain, severe fatigue, malaise, fever, night 

sweats, headaches, joint or muscle swelling, 

or shortness of breath), and one of the 

following at the marked level (see 7.00G4): 

A. Limitation of activities of daily living 

(see 7.00G5). 

B. Limitation in maintaining social 

functioning (see 7.00G6). 

C. Limitation in completing tasks in a 

timely manner due to deficiencies in 

concentration, persistence, or pace (see 

7.00G7). 

* * * * * 

13.00 MALIGNANT NEOPLASTIC 

DISEASES 

* * * * * 

K. How do we evaluate specific malignant 

neoplastic diseases? 

* * * * * 

2. Leukemia. 

* * * * * 

c. Chronic lymphocytic leukemia. 

* * * * * 

ii. We evaluate the complications and 

residual impairment(s) from chronic 

lymphocytic leukemia (CLL) under the 

appropriate listings, such as 13.05A2 or an 

appropriate listing in 7.00. 

* * * * * 

3. Macroglobulinemia or heavy chain 

disease. * * * We evaluate the resulting 

impairment(s) under the criteria of 7.00 or 

any other affected body system. 

* * * * * 

Part B 

* * * * * 

107.00 HEMATOLOGICAL DISORDERS 

A. What hematological disorders do we 

evaluate under these listings? 

1. We evaluate non-malignant (noncancerous) hematological disorders, such as 

hemolytic anemias (107.05), disorders of 

thrombosis and hemostasis (107.08), and 

disorders of bone marrow failure (107.10). 

These disorders disrupt the normal 

development and function of white blood 

cells, red blood cells, platelets, and clottingfactor proteins (factors). 

2. We evaluate malignant (cancerous) 

hematological disorders, such as lymphoma, 

leukemia, and multiple myeloma under the 

appropriate listings in 113.00, except for 

lymphoma associated with human 

immunodeficiency virus (HIV) infection, 

which we evaluate under 114.08E. 

B. What evidence do we need to document 

that you have a hematological disorder? 

We need the following evidence to 

document that you have a hematological 

disorder: 

1. A laboratory report of a definitive test 

that establishes a hematological disorder, 

signed by a physician; or 

2. A laboratory report of a definitive test 

that establishes a hematological disorder that 

is not signed by a physician and a report 

from a physician that states you have the 

disorder; or 

3. When we do not have a laboratory report 

of a definitive test, a persuasive report from 

a physician that a diagnosis of your 

hematological disorder was confirmed by 

appropriate laboratory analysis or other 

diagnostic method(s). To be persuasive, this 

report must state that you had the 

appropriate definitive laboratory test or tests 

for diagnosing your disorder and provide the 

results, or explain how your diagnosis was 

established by other diagnostic method(s) 

consistent with the prevailing state of 

medical knowledge and clinical practice. 

4. We will make every reasonable effort to 

obtain the results of appropriate laboratory 

testing you have had. We will not purchase 

complex, costly, or invasive tests, such as 

tests of clotting-factor proteins, and bone 

marrow aspirations. 

C. What are hemolytic anemias, and how do 

we evaluate them under 107.05? 

1. Hemolytic anemias, both congenital and 

acquired, are disorders that result in 

premature destruction of red blood cells 

(RBCs). Hemolytic anemias include 

abnormalities of hemoglobin structure 

(hemoglobinopathies), abnormal RBC enzyme 

content and function, and RBC membrane 

(envelope) defects that are congenital or 

acquired. The diagnosis of hemolytic anemia 

is based on hemoglobin electrophoresis or 

analysis of the contents of the RBC (enzymes) 

and membrane. Examples of congenital 

hemolytic anemias include sickle cell 

disease, thalassemia, and their variants, and 

hereditary spherocytosis. Acquired hemolytic 

anemias may result from autoimmune 

disease (for example, systemic lupus 

erythematosus) or mechanical devices (for 

example, heart valves, intravascular patches). 

2. The hospitalizations in 107.05B do not 

all have to be for the same complication of 

the hemolytic anemia. They may be for three 

different complications of the disorder. 

Examples of complications of hemolytic 

anemia that may result in hospitalization 

include dactylitis, osteomyelitis, painful 

(vaso-occlusive) crisis, pulmonary infections 

or infarctions, acute chest syndrome, 

pulmonary hypertension, chronic heart 

failure, gallbladder disease, hepatic (liver) 

failure, renal (kidney) failure, nephrotic 

syndrome, aplastic crisis, and strokes. We 

will count the hours you receive emergency 

treatment in a comprehensive sickle cell 

disease center immediately before the 

hospitalization if this treatment is 

comparable to the treatment provided in a 

hospital emergency department. 

3. For 107.05C, we do not require 

hemoglobin to be measured during a period 

in which you are free of pain or other 

symptoms of your disorder. We will accept 

hemoglobin measurements made while you 

are experiencing complications of your 

hemolytic anemia. 

4. 107.05D refers to the most serious type 

of beta thalassemia major in which the bone 

marrow cannot produce sufficient numbers 

of normal RBCs to maintain life. The only 

available treatments for beta thalassemia 

major are life-long RBC transfusions 

(sometimes called hypertransfusion) or bone 

marrow transplantation. For purposes of 

107.05D, we do not consider prophylactic 

RBC transfusions to prevent strokes or other 

complications in sickle cell disease and its 

variants to be of equal significance to lifesaving RBC transfusions for beta thalassemia 

major. However, we will consider the 

functional limitations associated with 

prophylactic RBC transfusions and any 

associated side effects (for example, iron 

overload) under functional equivalence and 

any affected body system(s). We will also 

evaluate strokes and resulting complications 

under 111.00 and 112.00. 

D. What are disorders of thrombosis and 

hemostasis, and how do we evaluate them 

under 107.08? 

1. Disorders of thrombosis and hemostasis 

include both clotting and bleeding disorders, 

and may be congenital or acquired. These 

disorders are characterized by abnormalities 

in blood clotting that result in 

hypercoagulation (excessive blood clotting) 

or hypocoagulation (inadequate blood 

clotting). The diagnosis of a thrombosis or 

hemostasis disorder is based on evaluation of 

plasma clotting-factor proteins (factors) and 

platelets. Protein C or protein S deficiency 

and Factor V Leiden are examples of 

hypercoagulation disorders. Hemophilia, von 

Willebrand disease, and thrombocytopenia 

are examples of hypocoagulation disorders. 

Acquired excessive blood clotting may result 

from blood protein defects and acquired 

inadequate blood clotting (for example, 

acquired hemophilia A) may be associated 

with inhibitor autoantibodies. 

2. The hospitalizations in 107.08 do not all 

have to be for the same complication of a 

disorder of thrombosis and hemostasis. They 

may be for three different complications of 

the disorder. Examples of complications that 

may result in hospitalization include 

anemias, thromboses, embolisms, and 

uncontrolled bleeding requiring multiple 

factor concentrate infusions or platelet 

transfusions. We will also consider any 

surgery that you have, even if it is not related 

to your hematological disorder, to be a 

complication of your disorder of thrombosis 

and hemostasis if you require treatment with 

clotting-factor proteins (for example, factor 

VIII or IX) or anticoagulant medication to 

control bleeding or coagulation in connection 

with your surgery. We will count the hours 

you receive emergency treatment in a 

comprehensive hemophilia treatment center 

immediately before the hospitalization if this 

treatment is comparable to the treatment 

provided in a hospital emergency 

department. 

E. What are disorders of bone marrow failure, 

and how do we evaluate them under 107.10? 

1. Disorders of bone marrow failure may be 

congenital or acquired, characterized by bone 

marrow that does not make enough healthy 

RBCs, platelets, or granulocytes (specialized 

types of white blood cells); there may also be 

a combined failure of these bone marrowproducing cells. The diagnosis is based on 

peripheral blood smears and bone marrow 


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aspiration or bone marrow biopsy, but not 

peripheral blood smears alone. Examples of 

these disorders are myelodysplastic 

syndromes, aplastic anemia, 

granulocytopenia, and myelofibrosis. 

Acquired disorders of bone marrow failure 

may result from viral infections, chemical 

exposure, or immunologic disorders. 

2. The hospitalizations in 107.10A do not 

all have to be for the same complication of 

bone marrow failure. They may be for three 

different complications of the disorder. 

Examples of complications that may result in 

hospitalization include uncontrolled 

bleeding, anemia, and systemic bacterial, 

viral, or fungal infections. 

3. For 107.10B, the requirement of life-long 

RBC transfusions to maintain life in 

myelodysplastic syndromes or aplastic 

anemias has the same meaning as it does for 

beta thalassemia major. (See 107.00C4.) 

F. How do we evaluate bone marrow or stem 

cell transplantation under 107.17? 

We will consider you to be disabled for 12 

months from the date of bone marrow or stem 

cell transplantation, or we may consider you 

to be disabled for a longer period if you are 

experiencing any serious post-transplantation 

complications, such as graft-versus-host 

(GVH) disease, frequent infections after 

immunosuppressive therapy, or significant 

deterioration of organ systems. We do not 

restrict our determination of the onset of 

disability to the date of the transplantation in 

107.17. We may establish an earlier onset of 

disability due to your transplantation if 

evidence in your case record supports such 

a finding. 

G. How do we consider your symptoms, 

including your pain, severe fatigue, and 

malaise? 

Your symptoms, including pain, severe 

fatigue, and malaise, may be important 

factors in our determination whether your 

hematological disorder meets or medically 

equals a listing, or in our determination 

whether you otherwise have marked and 

severe functional limitations. We cannot 

consider your symptoms unless you have 

medical signs or laboratory findings showing 

the existence of a medically determinable 

impairment(s) that could reasonably be 

expected to produce the symptoms. If you 

have such an impairment(s), we will evaluate 

the intensity, persistence, and functional 

effects of your symptoms using the rules 

throughout 107.00 and in our other 

regulations. (See sections 416.928 and 

416.929 of this chapter.) Additionally, when 

we assess the credibility of your complaints 

about your symptoms and their functional 

effects, we will not draw any inferences from 

the fact that you do not receive treatment or 

that you are not following treatment without 

considering all of the relevant evidence in 

your case record, including any explanations 

you provide on why you are not receiving or 

following treatment. 

H. How do we evaluate episodic events in 

hematological disorders? 

Some of the listings in this body system 

require a specific number of events within a 

consecutive 12-month period. (See 107.05, 

107.08, and 107.10A.) When we use such 

criteria, a consecutive 12-month period 

means a period of 12 consecutive months, all 

or part of which must occur within the 

period we are considering in connection with 

your application or continuing disability 

review. These events must occur at least 30 

days apart to ensure that we are evaluating 

separate events. 

I. How do we evaluate hematological 

disorders that do not meet one of these 

listings? 

1. These listings are only common 

examples of hematological disorders that we 

consider severe enough to result in marked 

and severe functional limitations. If your 

disorder does not meet the criteria of any of 

these listings, we must consider whether you 

have a disorder that satisfies the criteria of 

a listing in another body system. For 

example, we will evaluate hemophilic joint 

deformity under 101.00; polycythemia vera 

under 103.00, 104.00, or 111.00; chronic iron 

overload resulting from repeated RBC 

transfusion (transfusion hemosiderosis) 

under 103.00, 104.00, or 105.00; and the 

effects of intracranial bleeding or stroke 

under 111.00 or 112.00. 

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 section 416.926 of this chapter.) 

Hematological 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 medically equal a 

listing, we will also consider whether it 

functionally equals the listings. (See section 

416.926a of this chapter.) We use the rules 

in § 416.994a of this chapter when we decide 

whether you continue to be disabled. 

107.01 Category of Impairments, 

Hematological Disorders 

107.05 Hemolytic anemias, including 

sickle cell disease, thalassemia, and their 

variants (see 107.00C), with: 

A. Documented painful (vaso-occlusive) 

crises requiring parenteral (intravenous or 

intramuscular) narcotic medication, 

occurring at least six times within a 12- 

month period with at least 30 days between 

crises. 

OR 

B. Complications of hemolytic anemia 

requiring at least three hospitalizations 

within a 12-month period and occurring at 

least 30 days apart. Each hospitalization must 

last at least 48 hours, which can include 

hours in a hospital emergency department or 

comprehensive sickle cell disease center 

immediately before the hospitalization (see 

107.00C2). 

OR 

C. Hemoglobin measurements of 7.0 grams 

per deciliter (g/dL) or less, occurring at least 

three times within a 12-month period with at 

least 30 days between measurements. 

OR 

D. Beta thalassemia major requiring lifelong RBC transfusions at least once every 6 

weeks to maintain life (see 107.00C4). 

107.08 Disorders of thrombosis and 

hemostasis, including hemophilia and 

thrombocytopenia (see 107.00D), with 

complications requiring at least three 

hospitalizations within a 12-month period 

and occurring at least 30 days apart. Each 

hospitalization must last at least 48 hours, 

which can include hours in a hospital 

emergency department or comprehensive 

hemophilia treatment center immediately 

before the hospitalization (see 107.00D2). 

107.10 Disorders of bone marrow failure, 

including myelodysplastic syndromes, 

aplastic anemia, granulocytopenia, and 

myelofibrosis (see 107.00E), with: 

A. Complications of bone marrow failure 

requiring at least three hospitalizations 

within a 12-month period and occurring at 

least 30 days apart. Each hospitalization must 

last at least 48 hours, which can include 

hours in a hospital emergency department 

immediately before the hospitalization (see 

107.00E2). 

OR 

B. Myelodysplastic syndromes or aplastic 

anemias requiring life-long RBC transfusions 

at least once every 6 weeks to maintain life 

(see 107.00E3). 

107.17 Hematological disorders treated by 

bone marrow or stem cell transplantation 

(see 107.00F). Consider under a disability for 

at least 12 consecutive months from the date 

of transplantation. After that, evaluate any 

residual impairment(s) under the criteria for 

the affected body system. 

* * * * * 

[FR Doc. 2015–08849 Filed 4–16–15; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9674] 

RIN 1545–BM07 

Guidelines for the Streamlined Process 

of Applying for Recognition of Section 

501(c)(3) Status; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final rule; correction. 

SUMMARY: This document contains a 

correction to final and temporary 

regulations (TD 9674) that were 

published in the Federal Register on 

Wednesday, July 2, 2014 (79 FR 37630). 

The final and temporary regulations 

provide guidance to eligible 

organizations seeking recognition of taxexempt status under section 501(c)(3) of 

the Internal Revenue Code. 

DATES: This correction is effective April 

17, 2015 and applicable July 2, 2014. 

FOR FURTHER INFORMATION CONTACT: 

James R. Martin and Robin Ehrenberg, at 

(202) 317–5800 (not a toll free number). 

SUPPLEMENTARY INFORMATION: 


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