Medical Examination of Aliens-Removal of Human Immunodeficiency Virus (HIV) Infection From Definition of Communicable Disease of Public Health Significance, 31798-31809 [E9-15814]
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inadmissible into the United States
based solely on the grounds they are
infected with HIV and they would no
longer undergo HIV testing as part of the
routine medical examination.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Written comments must be
received on or before August 17, 2009.
Comments received after August 17,
2009 will be considered to the extent
possible.
DATES:
42 CFR Part 34
[Docket No. CDC–2008–0001]
RIN 0920–AA26
Medical Examination of Aliens—
Removal of Human Immunodeficiency
Virus (HIV) Infection From Definition of
Communicable Disease of Public
Health Significance
AGENCY: Centers for Disease Control and
Prevention (CDC), U.S. Department of
Health and Human Services (HHS).
ACTION: Notice of Proposed Rulemaking
(NPRM).
SUMMARY: The Centers for Disease
Control and Prevention (CDC), within
the U.S. Department of Health and
Human Services (HHS), is proposing to
revise the Part 34 regulation to remove
‘‘Human Immunodeficiency Virus (HIV)
infection’’ from the definition of
‘‘communicable disease of public health
significance.’’ HHS/CDC is also
proposing to remove references to
‘‘HIV’’ from the scope of examinations
in its regulations. Aliens infected with
a ‘‘communicable disease of public
health significance’’ are inadmissible
into the United States under the
Immigration and Nationality Act (INA).
The Tom Lantos and Henry Hyde
United States Global Leadership Against
HIV/AIDS, Tuberculosis, and Malaria
Reauthorization Act of 2008 (the July
2008 legislation reauthorizing the
President’s Emergency Plan for AIDS
Relief (PEPFAR)) removed language
from the INA which had previously
mandated that HIV be on the list of
diseases that can bar entry to the U.S.
This legislative change allowed HHS/
CDC to reassess whether HIV infection
should be retained or removed from
regulations based on sound public
health science and current
understanding of HIV epidemiology.
There are other diseases, including
sexually transmitted diseases, which
CDC may remove from the definition of
‘‘communicable disease of public health
significance’’ through future rulemaking
after scientific review.
While HIV infection is a serious
health condition, it does not represent a
communicable disease that is a
significant threat for introduction,
transmission, and spread to the U.S.
population through casual contact. As a
result of these proposed regulatory
changes, aliens would no longer be
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You may submit written
comments, identified by Docket No.
CDC–2008–0001 to the following
address: Division of Global Migration
and Quarantine, Centers for Disease
Control and Prevention, U.S.
Department of Health and Human
Services, Attn: Part 34 NPRM
Comments, 1600 Clifton Road, NE., MS
E–03, Atlanta, Georgia 30333. You may
also submit written comments
electronically via the Internet at the
following Address: https://
regulations.gov, or via e-mail to
Part34HIVcomments@cdc.gov.
Comments will be available for public
inspection from Monday through
Friday, except for legal holidays, from 9
a.m. until 5 p.m., Eastern Time, at 1600
Clifton Road, NE., Atlanta, Georgia
30333. Please call ahead to 1–404–498–
1600, and ask for a representative in the
Division of Global Migration and
Quarantine to schedule your visit.
Comments will also be available for
viewing at the following Internet
address: https://www.cdc.gov//ncidod/
dq. To download an electronic version
of the NPRM, please go to the following
Internet address: https://regulations.gov.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Stacy M. Howard, Division of Global
Migration and Quarantine, Centers for
Disease Control and Prevention, U.S.
Department of Health and Human
Services, 1600 Clifton Road, NE., MS
E–03, Atlanta, Georgia 30333; telephone
1–404–498–1600.
SUPPLEMENTARY INFORMATION:
The NPRM is organized as follows:
I. Legal Authority
II. Background
i. Inadmissibility and the Medical
Examination
ii. Legislative and Regulatory History
iii. Immigration and Relevant Visa
Categories
iv. Current Scientific Knowledge for HIV
Transmission
v. Global Context
III. Summary of Proposed Changes to 42 CFR
part 34
IV. Required Regulatory Analyses Under
Executive Order 12866
V. Regulatory Flexibility Analysis
VI. Other Administrative Requirements
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I. Legal Authority
HHS/CDC is promulgating this rule
under the authority of 42 U.S.C. 252 and
8 U.S.C. 1182 and 1222.
II. Background
i. Inadmissibility and the Medical
Examination
Under section 212(a)(1) of the
Immigration and Nationality Act (INA)
(8 U.S.C. 1182(a)(1)), any alien who is
determined to have a communicable
disease of public health significance is
inadmissible to the United States. Those
aliens outside the United States with a
communicable disease of public health
significance (see below) are ineligible to
receive a visa and ineligible for
admission into the United States. The
grounds of inadmissibility for specified
health-related grounds also pertain to
aliens in the United States who are
applying for adjustment of their status
to that of a lawful permanent resident.
In addition to other potential grounds
of inadmissibility, aliens are
inadmissible if they are determined: (1)
To have a communicable disease of
public health significance (as currently
defined by regulations); (2) to have a
physical or mental disorder and
behavior associated with that disorder
that may pose, or has posed, a threat to
the property, safety, or welfare of the
alien or others; (3) to have had a
physical or mental disorder and a
history of behavior associated with the
disorder, which has posed a threat to
the property, safety, or welfare of the
alien or others and which is likely to
recur or lead to other harmful behavior;
or (4) to be a drug abuser or addict.
Further, except for certain adopted
children 10 years of age or younger, any
alien who seeks admission as an
immigrant, or seeks adjustment of their
immigration status to that of a lawful
permanent resident, is inadmissible if
the alien fails to present documentation
of having received vaccination against
vaccine-preventable diseases, including
mumps, measles, rubella, polio, tetanus
and diphtheria toxoids, pertussis,
Haemophilus influenzae type B,
hepatitis B, and any other vaccination
against vaccine-preventable disease
recommended by the Advisory
Committee for Immunization Practices
(ACIP).
Medical examinations, including a
physical and mental evaluation, to
determine whether an alien could have
such a health-related condition, are
authorized under section 232 of the
INA. (8 U.S.C. 1222) Under sections
212(a)(1) and 232 of the INA, and
section 325 of the Public Health Service
Act (42 U.S.C. 252), the Secretary of
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Health and Human Services (HHS)
promulgates regulations establishing the
requirements for the medical
examination and lists the health-related
conditions that make aliens ineligible
for admission into the United States.
The regulations, administered by the
HHS/Centers for Disease Control and
Prevention (CDC), are promulgated at 42
CFR part 34.
The provisions in part 34 apply to the
medical examination of: (1) Aliens
outside the United States who are
applying for a visa at an embassy or
consulate of the United States; (2) aliens
arriving in the United States; and (3)
aliens required by the U.S. Department
of Homeland Security (DHS) to have a
medical examination in connection with
determination of their admissibility into
the United States; and (4) aliens who
apply for adjustment of their
immigration status to that of lawful
permanent resident.
While 42 CFR part 34 can apply to
individuals who wish to come to the
United States on a temporary basis, such
as leisure or business travelers, a
medical examination is not routinely
required as a condition for issuance of
non-immigrant visas or entry into the
United States.
On October 6, 2008, HHS/CDC revised
42 CFR part 34 to amend the definition
of communicable disease of public
health significance and revise the scope
of the medical examination. This update
addressed emerging and reemerging
diseases in immigrant or refugee
populations who are bound for the
United States. See 73 FR 58047 and 73
FR 62210. The current definition of
communicable disease of public health
significance contained in 42 CFR 34.2(b)
includes: active tuberculosis, infectious
syphilis, gonorrhea, infectious leprosy,
chancroid, lymphogranuloma
venereum, granuloma inguinale, and
HIV infection; quarantinable diseases
designated by Presidential Executive
Order; and a communicable disease that
may pose a public health emergency of
international concern in accordance
with the International Health
Regulations of 2005, provided it meets
specified criteria.
Panel physicians, designated by
Department of State (DoS) consular
officers, perform medical examinations
on refugees and/or persons living
outside of the United States who are
seeking to immigrate to the United
States, and civil surgeons, designated by
U.S. Citizenship and Immigration
Services within DHS, perform medical
examinations for aliens who are already
present in the United States seeking a
change of status. Aliens determined to
have a communicable disease of public
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health significance may request a waiver
of inadmissibility to enter the United
States under sections 207(c)(3),
212(d)(3)(A) and 212(g) of the INA (8
U.S.C. 1157(c)(3), 1182(d)(3)(A) and
1182(g)).
HHS/CDC issues Technical
Instructions and provides the technical
consultation and guidance to panel
physicians and civil surgeons who
conduct the medical examinations of
aliens. The CDC Technical Instructions
for Medical Examination of Aliens,
including the most current updates,
which panel physicians and civil
surgeons must follow in accordance
with these regulations, are available to
the public on the CDC Web site, located
at the following Internet address: https://
www.cdc.gov/ncidod/dq/technica.htm.
ii. Legislative and Regulatory History
Beginning in 1952, the INA mandated
that aliens ‘‘who are afflicted with any
dangerous contagious disease’’ are
ineligible to receive a visa and are to be
excluded from admission into the
United States. In April, 1986, prior to
the recent developments in medicine
and epidemiologic principles, HHS
proposed to include acquired
immunodeficiency syndrome (AIDS) as
a dangerous contagious disease and in
June, 1987 issued a final rule adopting
the proposal. 51 FR 15354 (April 23,
1986); 52 FR 21532 (June 8, 1987).
Separately, HHS proposed to substitute
HIV infection for AIDS on the list of
dangerous contagious diseases since
individuals who are so infected, but do
not actually have AIDS, are also
contagious. 52 FR 21607 (June 8, 1987).
While the proposed rule was pending
for public comment, Congress added
HIV infection to the list of dangerous
contagious diseases. Public Law 100–71,
section 518, 101 Stat. 475 (July 11,
1987). HHS issued final regulations in
August of that year complying with the
congressional mandate. 52 FR 32540
(August 28, 1987). Accordingly and
immediately, aliens infected with HIV
became ineligible to receive visas and
were excluded from admission into the
United States because of infection with
a dangerous contagious disease. See INA
section 212(a)(6), 8 U.S.C.
1182(a)(6)(1988).
In 1990, Congress amended the INA
by revising the classes of excludable
aliens to provide that an alien who is
determined (in accordance with
regulation prescribed by the Secretary of
Health and Human Services) to have a
communicable disease of public health
significance is excludable from the
United States. Immigration Act of 1990,
Public Law 101–649, section 601, 104
Stat. 4978 January 23, 1990; INA section
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212(a)(1)(A)(i), 8 U.S.C. 1182(a)(1)(A)(i)
(effective June 1, 1991). HHS/CDC
subsequently published a proposed rule
that would have removed from the list
all diseases, including HIV infection,
except for infectious tuberculosis. 56 FR
2484 (January 23, 1991). Based on
comments received and reconsideration
of the issues, HHS published an interim
final rule retaining all diseases on the
list, including HIV infection, and
committing its initial proposal for
further study. 56 FR 25000 (May 31,
1991). Congress subsequently amended
INA section 212(a)(1) to specify that
‘‘infection with the etiologic agent for
acquired immune deficiency syndrome’’
is a communicable disease of public
health significance, thereby making
explicit in the INA that aliens with HIV
are ineligible for admission into the
United States. National Institutes of
Health Revitalization Act of 1993,
Public Law 103–43, section 2007, 107
Stat. 122 (June 10, 1993).
In the summer of 2008, Congress
amended the INA by striking ‘‘which
shall include infection with the
etiologic agent for acquired immune
deficiency syndrome,’’ thereby leaving
to the Secretary of HHS the discretion
for determining whether HIV should
remain in the definition of
communicable disease of public health
significance provided for in 42 CFR
34.2(b). Tom Lantos and Henry Hyde
United States Global Leadership Against
HIV/AIDS, Tuberculosis, and Malaria
Reauthorization Act of 2008, Public Law
110–293, section 305, 122 Stat. 2963
(July 30, 2008). In this Notice of
Proposed Rulemaking, HHS/CDC is
proposing this action to remove HIV
infection from the definition of
communicable disease of public health
significance. While HIV infection is a
serious health condition, it does not
represent a communicable disease that
is a significant threat for introduction,
transmission, and spread to the United
States population through casual
contact. An arriving alien with HIV
infection does not pose a public health
risk to the general population through
casual contact.
iii. Immigration to the U.S. and Relevant
Visa Categories
Annually, the U.S. Government
admits more than 1,000,000 immigrants
and refugees to reside permanently in
this country.
Foreign citizens who wish to live
permanently in the United States must
comply with U.S. immigration law and
specific procedures for applying for an
immigrant visa or adjustment of status.
The four main immigrant visa
classifications are: (1) Immediate
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relatives, that is, the spouse, child
(unmarried and under 21 years of age)
or parent of a U.S. citizen (a citizen
must be at least 21 years old to file a
petition for a parent); (2) Family-Based
immigrants (adult sons or daughters of
citizens, the siblings of citizens who are
at least 21 years old, and the spouse,
child, or adult sons or daughters of
lawful permanent residents); (3)
Employment-Based immigrants; and (4)
immigrant visas available to ‘‘Diversity’’
immigrants who obtain by lottery the
ability to seek one of these visas. The
immigration of immediate relatives is
not subject to numerical restrictions;
thus, an immigrant visa is available to
a qualified immediate relative upon
approval of the citizen relative’s visa
petition. Each month, the U.S.
Department of State (DoS) publishes a
Visa Bulletin, indicating the availability
of Family-Based, Employment-Based,
and Diversity immigrant visas for the
next month. The monthly Visa Bulletin
is available on the Department of State’s
Web site (https://travel.state.gov).
Aliens who are already in the United
States may apply to adjust to permanent
resident status pursuant to the familybased and employment-based categories
described above, as well as several other
statutorily-eligible adjustment
categories. See INA section 245; 8 U.S.C.
1255. Refugees and aslyees may also
apply to adjust to permanent resident
status from inside the United States. See
INA section 209; 8 U.S.C. 1159.
An alien seeking permanent
residence, whether through an
immigrant or refugee visa or through an
adjustment of status, must undergo a
medical examination to determine
whether the alien is inadmissible on
medical grounds. Overseas
examinations are conducted by panel
physicians designated by the
Department of State. Applicants for
adjustment of status to lawful
permanent resident are required to have
a medical examination conducted by a
civil surgeon designated by U.S.
Citizenship and Immigration Services.
Under the proposed rule, testing for HIV
infection would be eliminated from
these medical examinations.
Additionally, Temporary Protected
Status (TPS) is another immigration
mechanism for eligible aliens who are in
the United States and whose countries
have been designated for TPS due to
ongoing armed conflict, natural
disasters, or certain other extraordinary
and temporary conditions. INA section
244; 8 U.S.C. 1255a; 8 CFR Part 244.
TPS applicants are also subject to the
medical grounds of inadmissibility.
Currently, if a TPS applicant is infected
with HIV, DHS requires that the
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applicant be granted a waiver of
inadmissibility before TPS can be
granted.
Section 101(a)(42)(A) of the INA
generally defines refugees as persons
who cannot return to their country
because of persecution or the well
founded fear of persecution based on
race, religion, nationality, membership
in a particular social group, or political
opinion. An applicant is preliminarily
approved for refugee status overseas, but
is admitted as a refugee upon admission
to the U.S. at a port of entry. A refugee
is also subject to the medical grounds of
inadmissibility and the medical
examination requirements. See INA
section 207; 8 U.S.C. 1157; 8 CFR Part
207.
vi. Current Scientific Knowledge for HIV
Transmission
While HIV infection is a serious
health condition, it does not represent a
communicable disease that is a
significant threat for introduction,
transmission, and spread to the United
States population through casual
contact as is the case with other serious
conditions such as tuberculosis. An
arriving alien with HIV infection does
not pose a public health risk to the
general population through casual
contact.
CDC has determined that HIV
infection is transmitted among
individuals in the United States almost
exclusively by the following
mechanisms: Unprotected sexual
intercourse with an HIV-infected
person, sharing needles or syringes
contaminated with HIV, and mother-tochild transmission of HIV before or
during birth or through breast feeding.
Additionally, HIV can be transmitted
through transfusion of blood or blood
products infected with HIV. However,
there has been continuous screening for
HIV in all donated blood since 1985.
Therefore, the risk for HIV infection
through transfusion is extremely low.
The U.S. blood supply is considered
among the safest in the world.
Interventions have been successful at
mitigating exposure to and transmission
of HIV.
v. Global Context
In 2004, the Joint United Nations
Programme on HIV/AIDS (UNAIDS) and
the International Organization for
Migration (IOM) issued the ‘‘UNAIDS/
IOM Statement on HIV/AIDS-related
travel restrictions’’ which provides
guidance to governments regarding
addressing the public health, economic,
and human rights concerns involved in
HIV-related travel restrictions. This
document concludes that HIV-related
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travel restrictions have no public health
justification.
There are a dozen countries that deny
entry if a person has HIV. These
countries are: Armenia, Brunei, Iraq,
Libya, Moldova, Oman, Qatar, the
Russian Federation, Saudi Arabia, South
Korea, Sudan, and the United States.
This proposed rule will remove the
United States from the list of countries
that continue to have entry restrictions
for HIV-infected individuals.
III. Summary of Proposed Changes to
42 CFR Part 34
This proposed rule removes HIV
infection from the definition of
communicable diseases of public health
significance as defined in 42 CFR
34.2(b) and scope of examinations in 42
CFR 34.3.
Section 34.2(b) Communicable
Diseases of Public Health Significance
This provision defines communicable
disease of public health significance as
both a specific list of diseases and
categories of diseases for which all
aliens are inadmissible to the United
States. HHS/CDC is proposing to remove
human immunodeficiency virus (HIV)
infection from the specific list of
communicable disease of public health
significance as provided for in 42 CFR
34.2(b).
As described above, inclusion of HIV
in this definition is no longer statutorily
mandated. As a result, the Secretary of
HHS has the discretion to determine
whether to leave HIV infection in the
definition or remove it.
In consideration of epidemiologic
principles and current medical
knowledge regarding the mode of HIV
transmission, HHS/CDC is proposing to
remove HIV infection from 42 CFR part
34 because HIV infection does not
represent a communicable disease of
public health significance. HIV is not a
significant threat for introduction and
spread through casual contact to the
general U.S. population, where HIV
infection already exists among the U.S.
population as an endemic disease.
Under current regulatory
requirements, aliens who test positive
for HIV infection can apply for a waiver
from DHS and, if granted such a waiver,
are allowed admission into the United
States or to adjust status.
Diseases transmissible through
aerosol or respiratory droplets such as
tuberculosis pose a much greater risk
due to casual contact for introduction
and spread in the U.S. population.
While HIV infection continues to be a
disease of public health concern
throughout the world, HIV infection is
preventable by avoiding high risk sexual
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contact or needle-sharing with HIVinfected persons. Interventions have
been successful at mitigating exposure
to and transmission of HIV.
The rationale for maintaining HIV
infection as an excludable condition is
no longer valid based on current
medical knowledge and practice,
scientific knowledge, and experience
which has informed us on
characteristics of the virus, the modes of
transmission of HIV, and interventions
for prevention and further spread of the
virus. Indeed, HIV infection is not
spread by casual contact, through the
air, or from food, water or other objects.
An HIV-infected person in a common
public setting will not place another
individual at risk. HIV is a fragile virus
and cannot live for very long outside the
body. The virus is not transmitted by
mosquitoes, or through day-to-day
activities such as shaking hands,
hugging, or a casual kiss. HIV infection
cannot be acquired from a toilet seat,
drinking fountain, doorknob, eating
utensils, drinking glasses, food, or pets.
Section 34.3 Scope of Examinations
HHS/CDC is also proposing to remove
all references to serologic testing for HIV
infection in 42 CFR 34.3 which is
entitled ‘‘Scope of examinations’’. This
section applies to those aliens who are
required to undergo a medical
examination for U.S. immigration
purposes. The scope of examinations
outlines those matters that relate to the
inadmissible health-related conditions.
This section provides specific screening
and testing requirements for those
diseases that meet the current definition
of communicable disease of public
health significance and directly relates
to the diseases list in Section 34.2 (b) of
42 CFR Part 34. It does not provide
specific testing requirements for other
health-related conditions which are not
included in the current definition of
communicable disease of public health
significance. Therefore, HHS/CDC is
proposing to remove the specific testing
requirements for HIV infection in 42
CFR 34.3.
IV. Required Regulatory Analyses
Under Executive Order 12866
HHS/CDC has examined the impacts
of the proposed rule under Executive
Order 12866 and the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act
(Pub. L. 104–4). Executive Order 12866
directs agencies to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
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environmental, public health and safety,
and other advantages; distributive
impacts; and equity). The agency
believes that this proposed rule may be
an economically significant action
under the Executive Order.
In the analysis that follows, we assess
the potential impacts of removing HIV
from the list of specific communicable
disease of public health significance and
removing the HIV testing requirement in
the medical examination for aliens who
are applying for adjustment of their
status to that of a lawful permanent
resident. We are seeking comments on
this preliminary regulatory impact
analysis, including the identification of
potential data sources that would allow
us to more appropriately characterize
and estimate the impact of the proposed
rule.
A. Objectives and Basis for the Action
Prior to the enactment of the United
States Global Leadership Against HIV/
AIDS, Tuberculosis, and Malaria
Reauthorization Act of 2008, HHS/CDC
was required by statute to list HIV as a
‘‘communicable disease of public health
significance.’’ Now that the statute
provides discretion, HHS/CDC is
proposing to take this action to reflect
current scientific knowledge and public
health best practices, and to reduce
stigmatization of and discrimination
against people who are HIV-infected.
This proposed rule is not intended to
correct any market failure, but to
remove a government-imposed barrier
that does not appear to provide a
significant public health benefit and is
at odds with human rights
considerations.
B. Alternatives
HHS/CDC examined three regulatory
approaches.
1. The first approach is to maintain
HIV infection on the list of
communicable disease of public health
significance, i.e., to keep the disease as
an excludable condition for entry into
the U.S. This means that visa applicants
seeking permanent residency would
continue to undergo testing for HIV
infection as part of the application
process. Those applicants testing
positive for HIV, if eligible, would still
be required to apply for and obtain a
waiver from DHS prior to coming to the
U.S. There are several disadvantages to
this approach. As stated previously,
while HIV infection is a serious health
condition, it does not represent a
communicable disease that is a
significant threat for introduction,
transmission, and spread to the U.S.
population through casual contact.
Currently, there are already roughly 1
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million persons in the United States
living with HIV [1]. Thus, maintaining
HIV infection on the list of excludable
conditions for entry into the U.S. would
not result in significant public health
benefits. Further, this approach is not in
line with current international public
health practice. This approach
continues discriminatory practices and
contributes toward the stigmatization of
HIV-infected persons. HHS/CDC did not
select this approach.
2. The second approach is to remove
HIV infection from the list of
communicable diseases of public health
significance, i.e. remove it as a ground
of inadmissibility into the U.S., but
continue mandatory HIV testing for all
immigrant applicants similar to an
approach followed by some countries.
Under this approach, all those aliens
who test positive for HIV infection
could be informed of their HIV status,
counseled regarding their condition, the
need for appropriate treatment, and the
steps that should be taken to minimize
the risk of onward transmission.
There are potential public health
benefits to a mandatory testing
approach. The medical examination
offers a unique opportunity to both
inform immigrants of their HIV status
and link them with care. Through
screening, HIV-infected aliens who are
potentially unaware of their HIV status
would become aware of their status and
could be linked with prevention, care
and treatment options in the United
States. Early diagnosis and treatment of
HIV-infected persons can increase life
expectancy and may improve the
quality of life. Additionally, knowing
one’s HIV status decreases the
likelihood of onward transmission [2,
3]. These public health benefits are the
basis for the HHS/CDC’s ‘‘Revised
Recommendations for HIV Testing of
Adults, Adolescents, and Pregnant
Women in Health-Care Settings,’’ which
states that the characteristics of HIV
infection are consistent with all
generally accepted criteria that justify
voluntary screening [4]. However,
mandatory HIV testing is limited to
certain infrequent cases such as blood
and organ donors.
There are also disadvantages to
continued mandatory testing if HIV
infection is removed from the definition
of a communicable disease of public
health significance. Mandatory testing
for other serious health-related
conditions that are not inadmissible
health conditions, (e.g., infectious
diseases, such as hepatitis, malaria, and
West Nile virus and chronic conditions
such as diabetes and heart conditions),
are not required as part of this medical
examination. Thus, continued
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mandatory HIV testing would
differentiate HIV from other serious
health-related conditions. Second,
although the purpose of the medical
examination is to identify health
conditions considered inadmissible on
public health grounds, the results of
exams conducted by panel physicians in
the immigrant’s home country might not
be kept confidential because of
requirements in the country of origin
making it necessary to report HIV
results to local authorities. DHS would
also know an applicant’s HIV status
(while not necessarily other serious
health conditions) due to this
information being included on medical
notification form and could be used by
DHS in evaluating the possibility of the
alien becoming a public charge. 42 CFR
34.3(b)(ii)(5). These results may be
counter to HHS/CDC objectives of
reflecting current scientific knowledge
and public health best practices, and
reducing stigmatization of and
discrimination against people who are
HIV-infected. Therefore, as discussed
below in the 3rd approach, HIV testing,
consistent with CDC’s recommendations
for general screening, would be
available.
Although the approach of removing
HIV from the definition of
communicable disease of public health
significance but maintaining the
mandatory testing component of the
medical examination was not selected
for this proposal, HHS/CDC welcomes
public comment on the advantages and
disadvantages of this or alternative
approaches, such as (non-mandatory)
testing (i.e., opt out/opt in approach).
3. The third approach is to remove
HIV infection from the definition of
communicable disease of public health
significance and as a requirement in the
medical examination. This means that
mandatory testing for HIV infection
would no longer be required and DHS
would allow HIV-infected persons to
enter into the U.S. (or to adjust to
permanent resident status) if they meet
all other conditions of admissibility.
This is the regulatory approach that
HHS/CDC selected. Along with this
approach, all immigrants, refugees and
status adjusters would still have the
opportunity to receive information
about HIV testing and to be tested in the
United States as recommended by the
CDC guidelines [4]. The discussion of
the potential impacts of the rule that
follow relate to this approach.
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C. Baseline and Incremental Analysis
The baseline for this analysis assumes
no change in the current regulation. In
other words, all applicants for
admission into the U.S. as legal
permanent residents and those already
within the U.S. seeking adjustment to
permanent resident status are currently
tested for HIV during the immigration
medical exam. Those who are HIVinfected and are not granted a waiver by
the Department of Homeland Security
are refused lawful permanent resident
status in the United States.
Currently, refugees who are HIVinfected must be granted a waiver by the
Department of Homeland Security
before entering the U.S. Subsequently,
refugees infected with HIV who are
present in the U.S. and apply for
adjustment to permanent resident status
must be re-examined and granted
another waiver from DHS at that time
(i.e., the grant of waivers permits these
individuals to obtain refugee status, and
later, permanent resident status despite
being HIV-infected, which would
otherwise render them inadmissible).
We have not explicitly included
refugees and TPS-turned permanent
residents in our analysis, however,
because: (i) These persons, compared to
the other immigrants, enter the U.S.
under extraordinary circumstances; (ii)
the numbers are relatively small; and,
(iii) the proposed change in regulations
is not likely to have a significant impact
on the annual number of HIV-infected
refugees admitted to the U.S. and who
later become permanent residents
because such persons generally receive
a waiver of inadmissibility for HIV
infection under current procedures.
Thus, the numbers of admitted HIVinfected refugees who are subsequently
granted permanent resident status are
likely to stay the same, regardless of
regulations in place. That is, the HIVinfected refugees-turned-permanent
residents are part of the baseline
scenario.
Furthermore, though this policy
would increase the total number of
people who may be eligible to be
admitted, we assume that the total
number of immigrants who are annually
admitted into the United States is fixed
over time. Thus, the incremental input
to the rule is a calculation of the
additional costs due to HIV-infected
immigrants above the costs of non-HIVinfected immigrants. In general, given
that the total number of immigrants is
not likely to change and the share of
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HIV-infected immigrants is likely to be
relatively small, the rule will not likely
have an appreciable impact on the
economy in terms of wages,
productivity, or prices of goods and
services.
D. Defining the Population Affected
The affected population is defined as
the number of new HIV-infected lawful
permanent residents entering the United
States each year and those individuals
already in the United States seeking to
adjust their immigration status to that of
a lawful permanent resident. The
proposed changes in the medical
examination of aliens regulations affect
all foreign nationals entering the U.S.
who are infected with HIV. Although
HIV testing is not routinely required for
entrance into the U.S. except for those
aliens who are seeking to become lawful
permanent residents, visitors who are
infected with HIV are currently required
to request waivers to obtain entrance. If
this rule is finalized, that waiver process
will no longer be necessary. Data on the
number of waivers granted annually
based on HIV status are not available
but costs to obtain waivers are thought
to be minimal. For example, in Fiscal
Year 2007, the Department of State
reported that its consular officers found
746 immigrants ineligible for admission
to the U.S. under the communicable
disease grounds of INA 212(a)(1)(A)(i).
Of those immigrants 327 overcame the
initial finding. What portion of those
who tested positive for HIV infection is
unknown. This analysis is limited to
aliens seeking to become lawful
permanent residents who are required to
have a medical examination to
determine admissibility. Because
visitors, refugees and TPS applicants
have historically had the option of
obtaining a waiver to enter and remain
in the U.S., these groups are not
included in this analysis.
Based on the estimated distribution of
HIV/AIDS cases in each of the regions
in the world and weighted by the
number of immigrants entering the
United States from each region, we
estimate that approximately 4.06
immigrants per 1000 immigrants that
would be likely to enter the U.S. under
the proposed rule would be infected
with HIV (see Table 1 for the summary
of regional estimates and weights and
Technical Appendix II, Table 1:
Summary of Model, HIVEcon, Inputs
and Assumptions for Primary, Lower
and Upper Bound Analyses [5]).
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TABLE 1—REGIONAL POPULATION, IMMIGRATION AND HIV ESTIMATES USED TO CALCULATE THE WEIGHTED REGIONAL
RATE ESTIMATES
Legal
permanent
residents
(2007) [6]
Estimate of HIV rate per 1,000
(based on 2006 regional
population estimates [7] and
2007 HIV regional estimates [8])
Estimated number of HIV
infected immigrants
Primary
Primary
Low
Low
High
High
Africa* ...............................................................................
Asia ..................................................................................
Europe ..............................................................................
N. America .......................................................................
Oceania ............................................................................
S. America .......................................................................
96,105
383,508
120,821
339,355
6,101
106,525
18.05
1.29
3.23
3.84
2.19
3.20
16.70
1.05
2.46
1.42
1.55
2.81
19.57
1.63
4.38
5.61
3.50
3.79
1,735
494
390
1,302
13
341
1,605
403
297
481
9
300
1,880
624
529
1,903
21
404
Total ..........................................................................
1,052,415
4.98
4.35
5.73
................
................
................
4.06
‡ 2.94
‡ 5.09
4,275
3,096
5,361
HIV positive Rate per 1,000 U.S. immigrants †
* In this case, Africa includes North Africa, the Middle East and Unknowns.
** Total number of adults and children living with HIV in the region (see Technical Appendix II for more detail [5]).
† Based on weighted regional estimates. The assumption is that prevalence of HIV amongst immigrants to the U.S. mirrors that of the immigrant’s native regions and is adjusted for the number of immigrants coming to the U.S. from each region.
‡ Note: These estimates represent the 5th and 95th percentiles based on regional weight estimates. Due to concern that immigrants may not
be representative of the typcial country level estimates and thus may be outside the confidence interval, for purposes of this analyses we expanded our confidence interval to 25% to 150% of the Primary estimate (i.e. 1.02 to 6.09 HIV+ immigrants per 1,000 immigrants).
The numbers of HIV/AIDS persons in
each region of the world were taken
from the 2007 AIDS Epidemic Update:
Global Overview issued by the Joint
United Nations Programme on HIV/
AIDS (UNAIDS)[8]. HHS/CDC used
regional data and rates that were
determined using the regional
population data from 2006 published by
the Population Division of the
Department of Economic and Social
Affairs of the United Nations Secretariat
[7]. After examining the immigration
data, by region, from the Yearbook of
Immigration Statistics: 2007 Immigrants
[6], we assigned regional weights
according to the number of aliens
coming to the United States from each
region.
The 2007 Immigration Statistics [6, 9]
indicate that 1,052,415 persons became
permanent residents in 2007.
Multiplying this number by our
prevalence estimate of 4.06 HIV-infected
immigrants per 1000 immigrants yields
an estimated 4,275 HIV-infected
immigrants who would enter into the
United States each year.
However, we note that there are
significant uncertainties in this estimate
since no specific data exist on the HIV
prevalence of persons seeking to
immigrate to the United States. We do
not have a basis to judge whether these
immigrants who qualify for permanent
residence differ from the general
regional population in terms of HIV
prevalence; thus, for the purposes of
this analysis we assumed that it would
be equivalent to the regional HIV
prevalence rates. We used regional HIV
prevalence rates rather than HIV rates
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for specific countries to allow for year
to year variations in the number of
aliens entering the U.S. from specific
countries.
There are several possible reasons as
to why the proportion of HIV-infected
immigrants could be less or more than
the prevalence of HIV-infected persons
in the region of origin. For example, the
cost of adequate medical care in the U.S.
may make HIV-infected individuals
reluctant to immigrate to this country.
With the increase in the availability of
appropriate HIV treatments in many
parts of the world, adequate treatment is
often cheaper outside of the U.S.
Conversely, in regions or specific
countries where appropriate treatment
is less readily available, the portion of
HIV-infected immigrants from those
regions could be higher than the
prevalence of HIV-infected persons in
that region. We are seeking comments
on these assumptions and data that
would further allow us to refine our
estimates.
However, we also conducted
sensitivity analyses to assess the impact
of altering this assumption. We used a
range of 1.02 to 6.09 HIV-infected
persons per 1,000 immigrants based on
25% and 150% of the mean weighted
average, 4.06 per 1,000 immigrants (high
and low estimates) of the number of
estimated HIV-infected persons in each
region but weighted by the number of
lawful permanent residents who entered
the U.S. in 2007. This range yields a
lower bound estimate of 1,073 and an
upper bound estimate of 6,409 HIVinfected persons entering the United
States annually (see Technical
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Appendix II [5]). Because the impact of
the proposed rule change is highly
sensitive to HIV prevalence in aliens
entering the U.S., we are seeking
comment on these assumptions.
E. Benefits
HHS/CDC is proposing to remove HIV
infection from the definition of
communicable disease of public health
significance contained in 42 CFR 34.2(b)
and scope of examination, 42 CFR 34.3
because HIV infection does not
represent a communicable disease that
is a significant threat to the general U.S.
population. The rationale for
maintaining HIV infection as an
excludable condition is no longer valid
based on current medical knowledge
and public health practice, scientific
knowledge, and experience which has
informed us on the characteristics of the
virus, the modes of transmission of HIV,
and the effective interventions to
prevent further spread of the virus.
The benefits from this action are
difficult to quantify. Based on the
estimate above, this rule would allow
perhaps roughly 4,000 persons to enter
the United States annually who are
otherwise admissible but are denied
admission solely based on their HIV
status. The rule will bring family
members together who had been barred
from entry, thus strengthening families.
Also, HIV-infected immigrants with
skills in high demand would be
permitted to enter the U.S. to seek
employment and contribute as
productive members of U.S. society.
Depending on the region of the world
from which a person emigrates,
admittance to the U.S. may afford
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greater opportunity, better health care,
and education and training programs
than those available in the immigrant’s
home country. These HIV-infected
individuals, compared to those who do
not receive appropriate multi-drug antiretroviral therapy for HIV treatment,
could survive an additional 13 years,
with an average life expectancy of
approximately 29 years (to age 49 years)
[10]. This increased life expectancy
allows the opportunity for longer and
improved productivity.
Further, this proposed rule to remove
HIV infection from the list of
communicable disease of public health
significance and from the scope of
examinations will remove
stigmatization of and discrimination
against HIV-infected people who have
long been denied entry into the U.S.
based only on a treatable and
preventable medical condition. This
proposed rule will bring the U.S. in line
with current science and international
standards of public health and human
rights practice.
Though this rule is assumed to not
have an impact on the total number
immigrants annually admitted as legal
permanent residents, we note that
immigration, in general, produces net
economic gains for the United States.
Overall, an NRC study estimated that
immigrants, in general, create an annual
economic impact of between $1 billion
to $10 billion [11].
HHS/CDC welcomes comments on
these and other benefits associated with
the proposed regulatory change.
F. Costs
To the extent the proposed rule will
result in an increased number of HIVinfected immigrants to the U.S. each
year, there will be quantifiable impacts.
We have made our best attempt to
capture the likely effects of the rule, but
there are significant uncertainties in this
estimation effort. HHS/CDC encourages
public comment on costs associated
with this rulemaking and, in particular,
additional information that would
provide a basis for more robust
qualitative discussion or quantitative
estimates.
Impact on Health Care Expenditures
As previously discussed, the
incremental impacts of the rule should
be a comparison between the arrival of
an HIV-infected immigrant and the
arrival of an HIV-negative immigrant.
Presumably, HIV-related healthcare
expenditures will be different, but there
are a variety of health expenditures that
the HIV-infected immigrant may not
incur that other immigrants may incur
(e.g., certain types of cancer, diabetes,
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heart disease). It is not clear that, over
the course of a lifetime, on net an HIVinfected immigrant would consume
more health care resources than other
immigrants. Furthermore, HIV treatment
yields benefits that offset the
expenditures, including increased life
expectancy and productivity.
However, given that health care
expenditures associated with treatment
of HIV infection can be substantial and
may result in some fiscal impacts (as
discussed below), we developed a
model (HIVEcon) to estimate these
potential effects of the rule. A complete
description of the model including
assumptions, results and limitations is
available for comment [5]. The
spreadsheet model itself is also
available for download so that the
reader can determine the relative impact
of altering almost any input value,
individually or several simultaneously
[12].
The model, HIVEcon, examines the
treatment costs as estimated by
Schackman et al. [13] associated with
newly identified persons infected with
HIV regardless of payer, following the
2004 standards of care. The annual
treatment cost is estimated to be $25,200
in 2004 dollars, with a range of $19,466
to $30,954. However, significant
advances in the treatment of HIV have
been made since 2004 [14], and are
likely to continue to be made. Thus, the
expenditure estimates could be an
underestimate since as treatment
options increase, the benefits such as
quality of life and lifespan will increase
but so will costs. However, these
expenditures may be overestimates
since it is not clear to what extent
immigrants will seek and receive even
the 2004 standard of care.
Therefore, assuming 0% onwards
transmission from HIV-infected
immigrants entering at an average age of
20 years, an average annual medical
expenditures of $25,200 annually, an
HIV prevalence rate among immigrants
of 4.06 per 1,000, and a 3% annual
discount rate, the primary estimate of
the present value of lifetime medical
costs for persons identified as HIVinfected in Year One is $94 million in
the first year. The absolute lower bound
estimate is $19 million in the first year
(decreasing the prevalence rate to 1.02
HIV+ immigrants per 1,000 immigrants
and the average annual medical
expenditures to $19,466). The maximum
upper bound estimate is $173 million
(increasing the prevalence rate to 6.09
HIV+ immigrants among 1,000
immigrants, and the average annual
medical expenses to $30,954 per
immigrant). In the HIVEcon model, in
Year Two following the change in
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regulations, as the cumulative number
of HIV-infected immigrants almost
doubles, so will these health
expenditures. Likewise in the third year,
the expenditures will be equivalent to
three years’ worth of immigrants
(excluding those who have passed
away) and so on until the HIV-infected
immigrants reach their life expectancy
(e.g., in the model, an HIV-infected
person at age 30 has an average life
expectancy of 24.7 years).
Comparison With Congressional Budget
Office Analysis
The Congressional Budget Office
(CBO) estimated the cost to the federal
government of Section 305 of PL 110–
293 prior to the law’s enactment. The
analysis included increases in direct
spending related to provision of health
care and other benefits paid for by the
federal government. Specifically, those
benefits include Medicaid,
Supplemental Security Income, Food
Stamps, and nutritional programs. In
total, CBO estimated that providing
these benefits to HIV-infected
immigrants and their citizen children
will increase spending by less than
$500,000 in 2010 and $83 million over
the 2010–2018 period, primarily for
Medicaid.
The CBO analysis was done for the
purpose of estimating the impact of PL
110–293 on the federal budget. This
analysis was done to comply with
Executive Order 12866, which directs
agencies to assess all costs of available
regulatory alternatives, including, but
not limited to, those costs incurred by
the federal government. The economic
analysis for this regulation differs from
the CBO analysis for PL 110–293 in four
major areas: (1) The CBO analysis
assumed that the HIV prevalence rate
would be equal to half of the weightedaverage HIV prevalence rate for the
immigrants’ country of origin, whereas
this analysis assumed that the HIV
prevalence rate would be equal to the
weighted-average rate of the immigrants’
region of origin; (2) the number of
immigrants was increased by 5% each
year in the CBO analysis while this
analysis did not include growth in the
annual number; (3) the CBO analysis
only examined health care costs paid for
by Medicaid whereas this analysis
included all health care costs including
those paid for by the Ryan White
Program; and (4) the CBO analysis
included costs of federal disability and
nutrition benefits, whereas this analysis
did not include those costs.
By the year 2013, the number of HIVinfected immigrants entering the U.S.
projected by the CBO analysis is roughly
equivalent to that projected by this
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analysis (analytical differences in
prevalence and growth rates cancel out).
By 2018, the number of HIV-infected
immigrants projected by the CBO
analysis exceeds projections in this
analysis. The health care costs in this
analysis exceed that of CBO’s analysis
because the former included all federal
and nonfederal costs including those
costs paid for through the federallyfunded Ryan White Program. This
analysis did not include non-healthcare
costs.
We are seeking comments on these
assumptions and data that would
further allow us to refine our estimates.
We welcome comment on the estimated
prevalence of HIV among those likely to
immigrate based on, for example,
humanitarian waivers or other sources
of available data.
Potential Fiscal Impacts
As previously discussed, even if HIVrelated health restrictions are removed
as a barrier to admission for immigrants,
all immigrants still must meet other
admission requirements. In the United
States, under the Federal Personal
Responsibility Work and Opportunity
Reconciliation Act (PRWORA) of 1996,
most immigrants are not eligible to
receive means-tested public benefits for
five years after their entry into the U.S.
[15, 16]. Federal means-tested public
benefits include Supplemental Security
Income (SSI), cash Temporary
Assistance for Needy Families (TANF),
Medicaid, and food stamps [15, 17].
State and local means-tested benefits are
determined at the state or local level
and vary by jurisdiction. We have no
data to assume that HIV-infected
immigrants will seek, five years after
being admitted to the U.S., such benefits
at rates different from non HIV-infected
immigrants.
In addition, PRWORA placed other
limitations on aliens’ access to public
benefits, making them more difficult for
aliens to obtain such benefits in the first
place. For example, the income and
resources of the sponsor of a familybased immigrant or permanent resident
are deemed to be available to that alien
if he/she should apply for certain
means-tested public benefits. See 8
U.S.C. 1631, 1632. Since a sponsor must
first prove to DHS that he/she is able to
provide support to the sponsored alien
at an annual income that is at least
125% above the federal poverty level
before the alien’s immigration
application will be approved, it is
unlikely that the alien will be able to
show that his/her available resources
fall beneath the low income eligibility
thresholds required for many means-
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tested public benefits. See INA
§ 213A(a)(1)(A).
However, some immigrants may be
eligible for certain assistance through
the Ryan White HIV/AIDS Program—a
federally-funded program that provides
HIV-related health services. Funds are
awarded to agencies located around the
country, which in turn deliver care to
eligible individuals. Since the program
is administered through different
grantees using different eligibility
criteria, it is difficult to assess to what
extent the HIV-infected immigrants will
be eligible for assistance through this
program. However, given that the
estimated number of new HIV-infected
immigrants entering the United States as
a result of this rule are relatively small
(around 4,000 annually) compared to
the total number of persons currently
assisted by the funding (roughly half a
million), the overall impact on the
program is likely small.
Onward Transmission
Though difficult to quantify with
precision, there will likely be some
additional cases of HIV due to onward
transmission from HIV-infected
immigrants to others in the United
States who are not currently infected.
The costs associated with onward
transmission include:
• Shortened lifespan and reduction in
quality of life even with treatment,
• The health care costs associated
with treating HIV infection,
• The costs of social services when
individuals are unable to fully support
themselves because of their illness, and
• Decreased productivity when
individuals become too sick to work.
Because health care costs are
substantial and other costs listed above
are difficult to quantify, the analysis in
the HIVEcon model is limited to health
care costs associated with treatment of
HIV infection.
In the model, the number of estimated
HIV-infected cases due to onward
transmission (in Year t) is calculated as:
[(Number of HIV-infected immigrants
entering in Year t + Number of HIVinfected immigrants surviving from
previous years that survive to Year t +
additional persons previously infected
by onward transmission from HIVinfected immigrants that survive to Year
t) × onward transmission rate].
A 1.51% onward transmission rate
was used in the HIVEcon model to
represent the annual estimated number
of new infections caused by HIVinfected immigrants to the U.S., or
caused by U.S. person infected by HIVinfected immigrants (i.e., annually every
100 HIV-infected persons infect an
additional 1.51 persons). The most
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31805
recent estimate of average onward
transmission, when limited to sexual
transmission, in the United States is
3.02 per 100 HIV positive immigrants
[18]. In 2006, the overall rate for onward
transmission of HIV in the U.S. from all
causes, was 5 new infections per 100
HIV-infected persons [19]. Results from
published research indicate that
immigrants to the United States,
regardless of their race or ethnicity,
often have an initial better health profile
than native-born Americans across
diverse health behaviors and outcomes;
however, this health advantage declines
as length of residence in the United
States and degree of acculturation
increase [20–26]. Specifically, studies of
HIV risk behavior among immigrant
populations, upon arrival in the U.S.,
indicate that these behaviors are
influenced by a number of factors
including the demographic
characteristics of the migrants
(especially sex, social class, relationship
status and education); the purpose of
immigration; the type and location of
their receiving community and the
existing supports; discrepancy between
pre-immigration expectations and postimmigration experiences; and
transnational movement between the
U.S. and their home countries [27–31].
These multiple factors result in
heterogeneity in HIV risk between
migrant communities, with some being
at lower, and others higher risk, than
their U.S. counterparts. There is no
evidence to suggest immigration to the
U.S. significantly affects HIV incidence
in this country in one direction or the
other. Thus, it is not unreasonable to
assume that onward transmission rates
amongst HIV-infected immigrants will
be lower than among HIV-infected
persons born in the U.S.
For this analysis, we assumed that the
onward transmission rate for
immigrants, and those that they infect,
would be fifty percent of the average
U.S. rate for sexual transmission (i.e.,
rate of onward transmission from HIVinfected immigrants is assumed, in the
baseline case, to be 1.51 per 100).
Because data supporting this
assumption are limited, this assumption
was tested in sensitivity analysis. We
used 0% transmission as our lower
bound estimate and a transmission rate
of 4.53 per 100 HIV-infected
immigrants, and those that they infect,
as our upper bound estimate. The upper
bound transmission rate is a fifty
percent increase in the average annual
onward transmission rate of 3.02%.
Assuming 4,275 HIV-infected
immigrants enter in the first year, there
will be 65 new HIV infections due to
onward transmission, assuming an
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onward transmission rate of 1.51 per
100 HIV, with a range of 0 to 261
(assuming onward transmission of 0 and
4.53 per 100 HIV-infected immigrants,
respectively). These estimates imply
treatment costs, for those infected via
onward transmission only, in the first
year of $1.6 million in the primary
estimate and a range of $0 to $8.1
million [5].
For the purposes of calculating new
HIV infections associated with HIVinfected immigrants in the U.S.,
HIVEcon adds persons infected by HIVinfected immigrants to the cohort of
projected HIV-infected immigrants. This
modeling technique represents the
chain of onward transmission after
initial transmission from an HIVinfected immigrant. Thus, in the next
year, though the cumulative number of
HIV-infected immigrants essentially
doubles, the number of new HIV cases
(as well as the associated treatment
costs) will be slightly more than double
the previous year.
This modeling approach assumes that
those people infected by HIV-infected
immigrants would never have become
infected with HIV were it not for the
arrival in the U.S. of HIV-infected
immigrants. This could be unrealistic
since U.S. persons who are infected by
HIV-infected immigrants may engage in
behaviors that lead them to activities
that expose them to HIV infections,
regardless of the source of infection. An
alternative interpretation may be that at
least some of the additional infections
are occurring earlier than they otherwise
would have. Thus, these shifts in the
timing of infection will increase the
total number of new cases in any one
year, but the true incremental impact
may be the implications of becoming
infected earlier.
Furthermore, the model treats the
onward transmission rate as fixed over
time. However, data shows that onward
transmission has declined over time
[19]. If we assume that transmission
rates will continue to decrease in the
future, it is possible that the model may
overestimate the number of HIVinfected individuals due to onward
transmission as we project impacts into
the future.
G. Summary of Impacts
The HIVEcon model projects potential
impacts out to 50 years after the rules
go into effect. However, many of the key
inputs to the model may be significantly
different even ten years from now given
the rapid pace of change in HIV
treatment, HIV prevalence in other
countries, as well as potential changes
in the overall immigration policy. It may
not be inconceivable that there would
be an HIV vaccine in the next decade or
two. Given these uncertainties, Table 2
provides a summary of the potential
effects of the rule five years after
implementation.
TABLE 2—SUMMARY OF IMPACTS (YEAR FIVE AFTER IMPLEMENTATION), ASSUMING THE AVERAGE AGE OF ENTRY IS 30
YEARS AND THE ANNUAL DISCOUNT RATE IS 3%
Primary
Estimate
(4.06 HIV+
immigrants
per 1,000
immigrants)
Category
Low
Estimate
(1.02 HIV+
immigrants
per 1,000
immigrants)
High
Estimate
(6.09 HIV+
immigrants
per 1,000
immigrants)
HIV-POSITIVE IMMIGRANTS AT YEAR 5 (EXCLUDING ONWARD TRANSMISSION)
Total number of HIV-Positive Immigrants present in the U.S ............................................
15,755 ..............
3,956 ................
23,622.
Annualized Monetized Healthcare Expenditures ................................................................
$342 million ......
$86 million ........
$513 million.
Benefits (Qualitative) ..........................................................................................................
1. Reduce stigmatization of and discrimination
against HIV-infected people.
2. Compared to those who don’t receive appropriate
multi-drug anti-retroviral therapy, survive an additional 13 years, with an average life expectancy of
approximately 29 years (to age 49 years) [10].
This increased life expectancy allows opportunity
for longer and improved productivity.
HIV-POSITIVE CASES AT YEAR 5 DUE TO 1.51% ONWARD TRANSMISSION
Total number of HIV-Positive cases due to 1.51% onward transmission connected with
U.S. Immigrants.
676 ...................
170 ...................
1,014.
Annualized Monetized Healthcare Expenditures ................................................................
$96 million ........
$24 million ........
$145 million.
TRANSFERS
Federal Annualized Monetized ...........................................................................................
Notes: Source of estimates—see Figures 1,
3, and 4 in Technical Appendix II [5].
In the context of the U.S. HIV/AIDS
prevalence, currently estimated at
roughly 1 million persons [1] the 4,275
HIV-infected immigrants represents
only 0.4% of the national total of
persons living with HIV/AIDS. In the
context of the new U.S. incidence of
HIV, currently estimated at roughly
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Depends upon assumptions of who pays annualized
monetized medical costs.
56,000 [32], the onward transmission of
272 by year five represents only 0.5% of
the new cases.
In the primary estimate, the
monetized costs, mainly the treatment
cost of the onward transmission cases
are relatively modest. In terms of health
care expenditures for immigrants, by
Year Five there will be a cumulative
total of 15,755 HIV-infected immigrants
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living in the U.S., with another 676
cases occurring due to onward
transmission (total: 16,431) (Table 2)
These cases will incur $438 million of
medical expenses in Year Five.
We conclude that while we do not
believe HIV is a ‘‘communicable disease
of public health significance’’ for the
purposes of admissibility
determinations, the rule may be
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economically significant. However, due
to all of the uncertainties previously
discussed, we solicit comments on this
tentative conclusion.
H. Literature Cited
1. CDC, HIV prevalence estimates—United
States, 2006. MMWR Morb Mortal Wkly Rep,
2008. 57(39): p. 1073–6.
2. Marks, G., N. Crepaz, and R.S. Janssen,
Estimating sexual transmission of HIV from
persons aware and unaware that they are
infected with the virus in the USA. AIDS,
2006. 20(10): p. 1447–50.
3. Marks, G., et al., Meta-analysis of highrisk sexual behavior in persons aware and
unaware they are infected with HIV in the
United States: implications for HIV
prevention programs. J Acquir Immune Defic
Syndr, 2005. 39(4): p. 446–53.
4. Branson, B.M., et al., Revised
recommendations for HIV testing of adults,
adolescents, and pregnant women in healthcare settings. MMWR Recomm Rep, 2006.
55(RR–14): p. 1–17; quiz CE1–4.
5. CDC, Technical Appendix II: HIVEcon:
Additional notes and data on model inputs
and outputs. 2009. Available from: https://
www.cdc.gov/ncidod/dq.
6. DHS, Yearbook of Immigration
Statistics: 2007 Immigrants. Table 3: Persons
Obtaining Legal Permanent Resident Status
by Region and Country of Birth: Fiscal Years
1998 to 2007. 2007. Available from: https://
www.dhs.gov/xlibrary/assets/statistics/
yearbook/2007/table03d.xls.
7. UN, World Population Prospects: The
2006 Revision. Population Division of the
Department of Economic and Social Affairs
of the United Nations Secretariat, 2007.
Available from: https://www.un.org/esa/
population/publications/wpp2006/
wpp2006.htm.
8. UNAIDS, 2007 AIDS Epidemic Update.
WHO Library Cataloguing-in-Publication
Data: UNAIDS/07.27E/JC1322E, 2007.
Available from: https://data.unaids.org/pub/
EPISlides/2007/2007_epiupdate_en.pdf.
9. DHS, Yearbook of Immigration
Statistics: 2007 Immigrants. Table 8: Persons
Obtaining Legal Permanent Resident Status
by Gender, Age, Marital Status, and
Occupation: Fiscal Year 2007. 2007.
Available from: https://www.dhs.gov/xlibrary/
assets/statistics/yearbook/2007/table08.xls.
10. Life expectancy of individuals on
combination antiretroviral therapy in highincome countries: a collaborative analysis of
14 cohort studies. Lancet, 2008. 372(9635): p.
293–9.
11. PDEII, et al., The New Americans:
Economic, Demographic, and Fiscal Effects
of Immigration. Panel on the Demographic
and Economic Impacts of Immigration,
National Research Council, Commission on
Behavioral and Social Sciences and
Education, ed. J.R. Smith and B. Edmonston.
1997: National Academies Press.
12. Borse, R.H. and M.I. Meltzer, Technical
Appendix I: HIVEcon: A model to estimate
the economic costs of immigrants who are
HIV-positive. 2009. Available from: https://
www.cdc.gov/ncidod/dq.
13. Schackman, B.R., et al., The lifetime
cost of current human immunodeficiency
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virus care in the United States. Med Care,
2006. 44(11): p. 990–7.
14. PAGAA, Guidelines for the Use of
Antiretroviral Agents in HIV–1–Infected
Adults and Adolescents. DHHS Panel on
Antiretroviral Guidelines for Adults and
Adolescents (PAGAA)—A Working Group of
the Office of AIDS Research Advisory
Council (OARAC), 2008: p. 1–139. Available
from: https://aidsinfo.nih.gov/contentfiles/
AdultandAdolescentGL.pdf.
15. USCIS, Interoffice memorandum:
Consolidation of Policy Regarding USCIS
Form I–864, Affidavit of Support (AFM
Update AD06–20). 2006. Available from:
https://www.uscis.gov/files/pressrelease/
AffSuppAFM062706.pdf.
16. USDA, Public Law 104–193–Aug.22,
1996. 1996. Available from: https://
www.fns.usda.gov/snap/rules/Legislation/
pdfs/PL_104–193.pdf.
17. USCIS, A quick guide to public charge
and receipt to public benefits. U.S.
Department of Homeland Security, 1999.
Available from: https://www.uscis.gov/files/
article/Public.pdf.
18. Pinkerton, S.D., How many sexuallyacquired HIV infections in the USA are due
to acute-phase HIV transmission? AIDS,
2007. 21(12): p. 1625–9.
19. CDC, HIV/AIDS Transmission Rates in
the United States. CDC HIV/AIDS Facts,
2008. Available from: https://www.cdc.gov/
Hiv/topics/surveillance/resources/factsheets/
pdf/transmission.pdf.
20. Lucas, J.W., D.J. Barr-Anderson, and
R.S. Kington, Health status, health insurance,
and health care utilization patterns of
immigrant Black men. Am J Public Health,
2003. 93(10): p. 1740–7. Available from:
https://www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&dopt=
Citation&list_uids=14534231.
21. Kenya, S., et al., Effects of immigration
on selected health risk behaviors of Black
college students. J Am Coll Health, 2003.
52(3): p. 113–20. Available from: https://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&dopt=
Citation&list_uids=14992296.
22. Newcomb, M.D., et al., Acculturation,
sexual risk taking, and HIV health promotion
among Latinas. Journal of Counseling
Psychology, 1998. 45: p. 454–467.
23. Hines, A.M. and R. Caetano, Alcohol
and AIDS-related sexual behavior among
Hispanics: acculturation and gender
differences. AIDS Educ Prev, 1998. 10(6): p.
533–47. Available from: https://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&dopt=
Citation&list_uids=9883288.
24. Shedlin, M.G., C.U. Decena, and D.
Oliver-Velez, Initial acculturation and HIV
risk among new Hispanic immigrants. J Natl
Med Assoc, 2005. 97(7 Suppl): p. 32S–37S.
Available from: https://www.ncbi.nlm.nih.gov
/entrez/query.fcgi?cmd=
Retrieve&db=PubMed&dopt=
Citation&list_uids=16080455.
25. Hoffman, S., et al., HIV and sexually
transmitted infection risk behaviors and
beliefs among Black West Indian immigrants
and US-born Blacks. Am J Public Health,
2008. 98(11): p. 2042–50. Available from:
https://www.ncbi.nlm.nih.gov/entrez/
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query.fcgi?cmd=Retrieve&db=PubMed&dopt=
Citation&list_uids=18309140.
26. McDonald, J.A., J. Manlove, and E.N.
Ikramullah, Immigration measures and
reproductive health among Hispanic youth:
findings from the national longitudinal
survey of youth, 1997–2003. J Adolesc
Health, 2009. 44(1): p. 14–24. Available from:
https://www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&dopt=
Citation&list_uids=19101454.
27. Lassetter, J.H. and L.C. Callister, The
impact of migration on the health of
voluntary migrants in western societies. J
Transcult Nurs, 2009. 20(1): p. 93–104.
Available from: https://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&dopt=
Citation&list_uids=18840884.
28. Shedlin, M.G., et al., Immigration and
HIV/AIDS in the New York Metropolitan
Area. J Urban Health, 2006. 83(1): p. 43–58.
Available from: https://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&dopt=
Citation&list_uids=16736354.
29. Harawa, N.T., et al., HIV prevalence
among foreign- and US-born clients of public
STD clinics. Am J Public Health, 2002.
92(12): p. 1958–63. Available from: https://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&dopt=
Citation&list_uids=12453816.
30. Marin, B.V., et al., Acculturation and
gender differences in sexual attitudes and
behaviors: Hispanic vs non-Hispanic white
unmarried adults. Am J Public Health, 1993.
83(12): p. 1759–61. Available from: https://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&dopt=
Citation&list_uids=8259813.
31. UNAIDS and IOM, Migration and
AIDS. Int Migr, 1998. 36(4): p. 445–68.
Available from: https://
www.ncbi.nlm.nih.gov/entrez/
query.fcgi?cmd=Retrieve&db=PubMed&dopt=
Citation&list_uids=12295093.
32. CDC, HIV Incidence. 2008 (accessed
May 25, 2009). Available from: https://
www.cdc.gov/hiv/topics/surveillance/
incidence.htm.
V. Regulatory Flexibility Analysis
HHS/CDC has considered the
proposed rule’s effects on small entities,
as required by the Regulatory Flexibility
Act (RFA) (5 U.S.C. 601 et seq., Pub. L.
96–354) as amended by the Small
Business Regulatory Enforcement
Fairness Act of 1996 (SBREFA) (Pub. L.
104–121). The RFA establishes, as a
principle of regulation, that agencies
should tailor regulatory and
informational requirements to the size
of the entities, consistent with the
objectives of a particular regulation and
applicable statutes.
The objective of this analysis was to
compare the benefits and the costs of a
change in legislation that currently
prohibits HIV-infected immigrants from
entering the United States. HHS/CDC
carefully considered several other
alternatives, but they were either not
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logistically feasible or inconsistent with
current public health practice. This
analysis appears in the ‘Alternatives’
section.
HHS/CDC certifies the proposed rule
will not have a significant impact on a
substantial number of small entities as
defined in the statute.
VI. Other Administrative Requirements
A. The Unfunded Mandates Reform Act
HHS/CDC evaluated the rule
requirements for compliance with the
Unfunded Mandates Reform Act
(UMRA) of 1995. This rule does not
contain Federal mandates under the
regulatory provisions of Title II of the
UMRA for State, local, or Tribal
Governments, nor for the private sector.
The rule’s provisions will not affect
small Governments.
B. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
Executive Order 13045 requires HHS/
CDC to determine whether the rule is
economically significant. The Executive
Order further requires HHS to determine
whether the rule would create an
environmental health or safety risk
disproportionately affecting children.
HHS/CDC has determined that this rule
of general applicability is consistent
with these principles.
C. Paperwork Reduction Act of 1995
The Paperwork Reduction Act applies
to the data collection requirements
found in 42 CFR part 34. Currently,
aliens determined to have a
communicable disease of public health
significance may request a waiver from
DHS to enter the United States under
sections 212(d)(3)(a) and 212(g) of the
INA (8 U.S.C. 1182(d)(3)(a) and 1182(g)).
HHS/CDC has approval from the Office
of Management and Budget (OMB)
under OMB Control No. 0920–0006:
Statements in Support of Application
for Waiver of Inadmissibility under the
Immigration and Nationality Act
(expiration date December 31, 2011) to
collect data pertaining to the waiver.
CDC Form 4.422–1b is the form that is
required in support of a waiver of
inadmissibility for HIV infection. If the
proposed change is finalized, infection
with HIV would no longer be grounds
for an alien to apply for a waiver and
HHS/CDC would discontinue the use of
CDC form 4.422–1b, for a reduction of
67 burden hours for this approved data
collection.
D. Environmental Impact
HHS has determined that provisions
to amend 42 CFR part 34.2(b) will not
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have a significant impact on the human
environment.
E. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
Executive Order 13175, entitled
‘‘Consultation and Coordination with
Indian Tribal Governments’’ (65 FR
67249, September 9, 2000), requires
agencies to develop an accountable
process to ensure ‘‘meaningful and
timely input by tribal officials in the
development of regulatory policies that
have tribal implications.’’ The Executive
Order defines the phrase ‘‘policies that
have tribal implications’’ to include
regulations and other policy statements
or actions that have ‘‘substantial direct
effects on one or more Indian tribes, on
the relationship between the Federal
government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
government and Indian tribes.’’
HHS/CDC has determined that
provisions to amend 42 CFR Part 34 will
not have tribal implications.
F. Executive Order 12630: Governmental
Actions and Interference With
Constitutionally Protected Property
Rights
Under Executive Order 12630, if the
contemplated rule would require a
Federal taking of private property, then
a takings analysis is required. Since the
proposed rule does not require a Federal
taking of private property, the
provisions in the Executive Order are
not applicable.
G. Federalism
Under Executive Order 13132, if the
proposed rule would limit or preempt
State authorities, then a Federalism
analysis is required. The agency must
consult with State and local officials to
determine whether the rule would have
a substantial direct effect on State or
local Governments, as well as whether
it would either preempt State law or
impose a substantial direct cost of
compliance on them.
HHS/CDC determines that this
proposed rule does not have sufficient
federalism implications to warrant the
preparation of a federalism summary
impact statement.
H. Executive Order 13211: Energy
Effects
Executive Order 13211 requires HHS/
CDC to produce a statement of energy
effects if the proposed rule is significant
or economically significant and likely to
have a significant adverse effect on the
supply, distribution, or use of energy.
HHS/CDC has determined that the
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proposed rule does not have that effect
and that a statement of energy is not
required.
I. National Technology Transfer and
Advancement Act
This act, 15 U.S.C. 272, requires the
adoption of technical standards
developed or adopted by voluntary
consensus standards bodies in rules
promulgated by HHS. No voluntary
consensus standards are applicable and
feasible with regard to the proposed
rule.
J. Assessment of Federal Regulations
and Policies on Families
Title 5 U.S.C.A. 601 (note) requires
agencies to assess the impact of a
proposed action to determine whether
such an action would affect family wellbeing. HHS/CDC has assessed the
impact of this proposed regulation and
determines that it would not negatively
affect family well-being.
K. Executive Order 12988: Civil Justice
Reform
HHS/CDC has reviewed this rule
under Executive Order 12988, on Civil
Justice Reform and determines that the
proposed rule meets the standard in the
Executive Order.
L. Plain Language in Government
Writing
Under 63 FR 31883 (June 10, 1998),
Executive Departments and Agencies
are required to use plain language in all
proposed and final rules. HHS/CDC has
attempted to use plain language in
promulgating the proposed rule and
would welcome any comment from the
public in this regard.
List of Subjects in 42 CFR 34
Aliens, Health care, Scope of
examination, Passports and visas, Public
health.
For the reasons stated in the
preamble, the Centers for Disease
Control and Prevention, within the U.S.
Department of Health and Human
Services, proposes to amend 42 CFR
part 34 as follows:
PART 34—MEDICAL EXAMINATION OF
ALIENS
1. The authority citation for part 34
continues to read as follows:
Authority: 42 U.S.C. 252; 8 U.S.C. 1182
and 1222.
§ 34.2
[Amended]
2. Amend § 34.2 by removing
paragraph (b)(6) and redesignating
paragraphs (b)(7) through (10) (b)(6)
through (9), respectively.
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3. Amend § 34.3 by revising
paragraphs (b)(1)(i), (e)(1) introductory
text, (e)(2)(iii), (e)(2)(iv), (e)(5), and
(e)(6) to read as follows:
§ 34.3
Scope of examinations.
*
*
*
*
**
(b) * * *
(1) * * *
(i) A general physical examination
and medical history, evaluation for
tuberculosis, and serologic testing for
syphilis.
*
*
*
*
*
(e) * * *
(1) As provided in paragraph (e)(2) of
this section, a chest x-ray examination
and serologic testing for syphilis shall
be required as part of the examination
of the following:
*
*
*
*
*
(2) * * *
(iii) For applicants 15 years of age and
older, serologic testing for syphilis.
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(iv) Exceptions. Serologic testing for
syphilis shall not be required if the alien
is under the age of 15, unless there is
reason to suspect infection with
syphilis. An alien, regardless of age, in
the United States, who applies for
adjustment of status to lawful
permanent resident shall not be
required to have a chest x-ray
examination unless their tuberculin skin
test, or an equivalent test for showing an
immune response to Mycobacterium
tuberculosis antigens, is positive. HHS/
CDC may authorize exceptions to the
requirement for a tuberculin skin test,
an equivalent test for showing an
immune response to Mycobacterium
tuberculosis antigens, or chest x-ray
examination for good cause, upon
application approved by the Director.
*
*
*
*
*
(5) How and where performed. All
chest radiograph images used in
medical examinations performed under
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31809
the regulations to this part shall be large
enough to encompass the entire chest
(approximately 14 x 17 inches; 35.6 x
32.2 cm).
(6) Chest x-ray, laboratory, and
treatment reports. The chest radiograph
reading and serologic test results for
syphilis shall be included in the
medical notification. When the medical
examiner’s conclusions are based on a
study of more than one chest x-ray
image, the medical notification shall
include at least a summary statement of
findings of the earlier images, followed
by a complete reading of the last image,
and dates and details of any laboratory
tests and treatment for tuberculosis.
*
*
*
*
*
Dated: June 30, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9–15814 Filed 6–30–09; 4:15 pm]
BILLING CODE P
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]]>Agencies
[Federal Register Volume 74, Number 126 (Thursday, July 2, 2009)]
[Proposed Rules]
[Pages 31798-31809]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-15814]
[[Page 31797]]
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Part II
Department of Health and Human Services
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Centers for Disease Control and Prevention
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42 CFR Part 34
Medical Examination of Aliens--Removal of Human Immunodeficiency Virus
(HIV) Infection From Definition of Communicable Disease of Public
Health Significance; Proposed Rule
Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 /
Proposed Rules
[[Page 31798]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
42 CFR Part 34
[Docket No. CDC-2008-0001]
RIN 0920-AA26
Medical Examination of Aliens--Removal of Human Immunodeficiency
Virus (HIV) Infection From Definition of Communicable Disease of Public
Health Significance
AGENCY: Centers for Disease Control and Prevention (CDC), U.S.
Department of Health and Human Services (HHS).
ACTION: Notice of Proposed Rulemaking (NPRM).
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), within
the U.S. Department of Health and Human Services (HHS), is proposing to
revise the Part 34 regulation to remove ``Human Immunodeficiency Virus
(HIV) infection'' from the definition of ``communicable disease of
public health significance.'' HHS/CDC is also proposing to remove
references to ``HIV'' from the scope of examinations in its
regulations. Aliens infected with a ``communicable disease of public
health significance'' are inadmissible into the United States under the
Immigration and Nationality Act (INA).
The Tom Lantos and Henry Hyde United States Global Leadership
Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008
(the July 2008 legislation reauthorizing the President's Emergency Plan
for AIDS Relief (PEPFAR)) removed language from the INA which had
previously mandated that HIV be on the list of diseases that can bar
entry to the U.S. This legislative change allowed HHS/CDC to reassess
whether HIV infection should be retained or removed from regulations
based on sound public health science and current understanding of HIV
epidemiology. There are other diseases, including sexually transmitted
diseases, which CDC may remove from the definition of ``communicable
disease of public health significance'' through future rulemaking after
scientific review.
While HIV infection is a serious health condition, it does not
represent a communicable disease that is a significant threat for
introduction, transmission, and spread to the U.S. population through
casual contact. As a result of these proposed regulatory changes,
aliens would no longer be inadmissible into the United States based
solely on the grounds they are infected with HIV and they would no
longer undergo HIV testing as part of the routine medical examination.
DATES: Written comments must be received on or before August 17, 2009.
Comments received after August 17, 2009 will be considered to the
extent possible.
ADDRESSES: You may submit written comments, identified by Docket No.
CDC-2008-0001 to the following address: Division of Global Migration
and Quarantine, Centers for Disease Control and Prevention, U.S.
Department of Health and Human Services, Attn: Part 34 NPRM Comments,
1600 Clifton Road, NE., MS E-03, Atlanta, Georgia 30333. You may also
submit written comments electronically via the Internet at the
following Address: https://regulations.gov, or via e-mail to
Part34HIVcomments@cdc.gov.
Comments will be available for public inspection from Monday
through Friday, except for legal holidays, from 9 a.m. until 5 p.m.,
Eastern Time, at 1600 Clifton Road, NE., Atlanta, Georgia 30333. Please
call ahead to 1-404-498-1600, and ask for a representative in the
Division of Global Migration and Quarantine to schedule your visit.
Comments will also be available for viewing at the following
Internet address: https://www.cdc.gov//ncidod/dq. To download an
electronic version of the NPRM, please go to the following Internet
address: https://regulations.gov.
FOR FURTHER INFORMATION CONTACT: Stacy M. Howard, Division of Global
Migration and Quarantine, Centers for Disease Control and Prevention,
U.S. Department of Health and Human Services, 1600 Clifton Road, NE.,
MS E-03, Atlanta, Georgia 30333; telephone 1-404-498-1600.
SUPPLEMENTARY INFORMATION:
The NPRM is organized as follows:
I. Legal Authority
II. Background
i. Inadmissibility and the Medical Examination
ii. Legislative and Regulatory History
iii. Immigration and Relevant Visa Categories
iv. Current Scientific Knowledge for HIV Transmission
v. Global Context
III. Summary of Proposed Changes to 42 CFR part 34
IV. Required Regulatory Analyses Under Executive Order 12866
V. Regulatory Flexibility Analysis
VI. Other Administrative Requirements
I. Legal Authority
HHS/CDC is promulgating this rule under the authority of 42 U.S.C.
252 and 8 U.S.C. 1182 and 1222.
II. Background
i. Inadmissibility and the Medical Examination
Under section 212(a)(1) of the Immigration and Nationality Act
(INA) (8 U.S.C. 1182(a)(1)), any alien who is determined to have a
communicable disease of public health significance is inadmissible to
the United States. Those aliens outside the United States with a
communicable disease of public health significance (see below) are
ineligible to receive a visa and ineligible for admission into the
United States. The grounds of inadmissibility for specified health-
related grounds also pertain to aliens in the United States who are
applying for adjustment of their status to that of a lawful permanent
resident.
In addition to other potential grounds of inadmissibility, aliens
are inadmissible if they are determined: (1) To have a communicable
disease of public health significance (as currently defined by
regulations); (2) to have a physical or mental disorder and behavior
associated with that disorder that may pose, or has posed, a threat to
the property, safety, or welfare of the alien or others; (3) to have
had a physical or mental disorder and a history of behavior associated
with the disorder, which has posed a threat to the property, safety, or
welfare of the alien or others and which is likely to recur or lead to
other harmful behavior; or (4) to be a drug abuser or addict. Further,
except for certain adopted children 10 years of age or younger, any
alien who seeks admission as an immigrant, or seeks adjustment of their
immigration status to that of a lawful permanent resident, is
inadmissible if the alien fails to present documentation of having
received vaccination against vaccine-preventable diseases, including
mumps, measles, rubella, polio, tetanus and diphtheria toxoids,
pertussis, Haemophilus influenzae type B, hepatitis B, and any other
vaccination against vaccine-preventable disease recommended by the
Advisory Committee for Immunization Practices (ACIP).
Medical examinations, including a physical and mental evaluation,
to determine whether an alien could have such a health-related
condition, are authorized under section 232 of the INA. (8 U.S.C. 1222)
Under sections 212(a)(1) and 232 of the INA, and section 325 of the
Public Health Service Act (42 U.S.C. 252), the Secretary of
[[Page 31799]]
Health and Human Services (HHS) promulgates regulations establishing
the requirements for the medical examination and lists the health-
related conditions that make aliens ineligible for admission into the
United States. The regulations, administered by the HHS/Centers for
Disease Control and Prevention (CDC), are promulgated at 42 CFR part
34.
The provisions in part 34 apply to the medical examination of: (1)
Aliens outside the United States who are applying for a visa at an
embassy or consulate of the United States; (2) aliens arriving in the
United States; and (3) aliens required by the U.S. Department of
Homeland Security (DHS) to have a medical examination in connection
with determination of their admissibility into the United States; and
(4) aliens who apply for adjustment of their immigration status to that
of lawful permanent resident.
While 42 CFR part 34 can apply to individuals who wish to come to
the United States on a temporary basis, such as leisure or business
travelers, a medical examination is not routinely required as a
condition for issuance of non-immigrant visas or entry into the United
States.
On October 6, 2008, HHS/CDC revised 42 CFR part 34 to amend the
definition of communicable disease of public health significance and
revise the scope of the medical examination. This update addressed
emerging and reemerging diseases in immigrant or refugee populations
who are bound for the United States. See 73 FR 58047 and 73 FR 62210.
The current definition of communicable disease of public health
significance contained in 42 CFR 34.2(b) includes: active tuberculosis,
infectious syphilis, gonorrhea, infectious leprosy, chancroid,
lymphogranuloma venereum, granuloma inguinale, and HIV infection;
quarantinable diseases designated by Presidential Executive Order; and
a communicable disease that may pose a public health emergency of
international concern in accordance with the International Health
Regulations of 2005, provided it meets specified criteria.
Panel physicians, designated by Department of State (DoS) consular
officers, perform medical examinations on refugees and/or persons
living outside of the United States who are seeking to immigrate to the
United States, and civil surgeons, designated by U.S. Citizenship and
Immigration Services within DHS, perform medical examinations for
aliens who are already present in the United States seeking a change of
status. Aliens determined to have a communicable disease of public
health significance may request a waiver of inadmissibility to enter
the United States under sections 207(c)(3), 212(d)(3)(A) and 212(g) of
the INA (8 U.S.C. 1157(c)(3), 1182(d)(3)(A) and 1182(g)).
HHS/CDC issues Technical Instructions and provides the technical
consultation and guidance to panel physicians and civil surgeons who
conduct the medical examinations of aliens. The CDC Technical
Instructions for Medical Examination of Aliens, including the most
current updates, which panel physicians and civil surgeons must follow
in accordance with these regulations, are available to the public on
the CDC Web site, located at the following Internet address: https://www.cdc.gov/ncidod/dq/technica.htm.
ii. Legislative and Regulatory History
Beginning in 1952, the INA mandated that aliens ``who are afflicted
with any dangerous contagious disease'' are ineligible to receive a
visa and are to be excluded from admission into the United States. In
April, 1986, prior to the recent developments in medicine and
epidemiologic principles, HHS proposed to include acquired
immunodeficiency syndrome (AIDS) as a dangerous contagious disease and
in June, 1987 issued a final rule adopting the proposal. 51 FR 15354
(April 23, 1986); 52 FR 21532 (June 8, 1987). Separately, HHS proposed
to substitute HIV infection for AIDS on the list of dangerous
contagious diseases since individuals who are so infected, but do not
actually have AIDS, are also contagious. 52 FR 21607 (June 8, 1987).
While the proposed rule was pending for public comment, Congress added
HIV infection to the list of dangerous contagious diseases. Public Law
100-71, section 518, 101 Stat. 475 (July 11, 1987). HHS issued final
regulations in August of that year complying with the congressional
mandate. 52 FR 32540 (August 28, 1987). Accordingly and immediately,
aliens infected with HIV became ineligible to receive visas and were
excluded from admission into the United States because of infection
with a dangerous contagious disease. See INA section 212(a)(6), 8
U.S.C. 1182(a)(6)(1988).
In 1990, Congress amended the INA by revising the classes of
excludable aliens to provide that an alien who is determined (in
accordance with regulation prescribed by the Secretary of Health and
Human Services) to have a communicable disease of public health
significance is excludable from the United States. Immigration Act of
1990, Public Law 101-649, section 601, 104 Stat. 4978 January 23, 1990;
INA section 212(a)(1)(A)(i), 8 U.S.C. 1182(a)(1)(A)(i) (effective June
1, 1991). HHS/CDC subsequently published a proposed rule that would
have removed from the list all diseases, including HIV infection,
except for infectious tuberculosis. 56 FR 2484 (January 23, 1991).
Based on comments received and reconsideration of the issues, HHS
published an interim final rule retaining all diseases on the list,
including HIV infection, and committing its initial proposal for
further study. 56 FR 25000 (May 31, 1991). Congress subsequently
amended INA section 212(a)(1) to specify that ``infection with the
etiologic agent for acquired immune deficiency syndrome'' is a
communicable disease of public health significance, thereby making
explicit in the INA that aliens with HIV are ineligible for admission
into the United States. National Institutes of Health Revitalization
Act of 1993, Public Law 103-43, section 2007, 107 Stat. 122 (June 10,
1993).
In the summer of 2008, Congress amended the INA by striking ``which
shall include infection with the etiologic agent for acquired immune
deficiency syndrome,'' thereby leaving to the Secretary of HHS the
discretion for determining whether HIV should remain in the definition
of communicable disease of public health significance provided for in
42 CFR 34.2(b). Tom Lantos and Henry Hyde United States Global
Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization
Act of 2008, Public Law 110-293, section 305, 122 Stat. 2963 (July 30,
2008). In this Notice of Proposed Rulemaking, HHS/CDC is proposing this
action to remove HIV infection from the definition of communicable
disease of public health significance. While HIV infection is a serious
health condition, it does not represent a communicable disease that is
a significant threat for introduction, transmission, and spread to the
United States population through casual contact. An arriving alien with
HIV infection does not pose a public health risk to the general
population through casual contact.
iii. Immigration to the U.S. and Relevant Visa Categories
Annually, the U.S. Government admits more than 1,000,000 immigrants
and refugees to reside permanently in this country.
Foreign citizens who wish to live permanently in the United States
must comply with U.S. immigration law and specific procedures for
applying for an immigrant visa or adjustment of status. The four main
immigrant visa classifications are: (1) Immediate
[[Page 31800]]
relatives, that is, the spouse, child (unmarried and under 21 years of
age) or parent of a U.S. citizen (a citizen must be at least 21 years
old to file a petition for a parent); (2) Family-Based immigrants
(adult sons or daughters of citizens, the siblings of citizens who are
at least 21 years old, and the spouse, child, or adult sons or
daughters of lawful permanent residents); (3) Employment-Based
immigrants; and (4) immigrant visas available to ``Diversity''
immigrants who obtain by lottery the ability to seek one of these
visas. The immigration of immediate relatives is not subject to
numerical restrictions; thus, an immigrant visa is available to a
qualified immediate relative upon approval of the citizen relative's
visa petition. Each month, the U.S. Department of State (DoS) publishes
a Visa Bulletin, indicating the availability of Family-Based,
Employment-Based, and Diversity immigrant visas for the next month. The
monthly Visa Bulletin is available on the Department of State's Web
site (https://travel.state.gov).
Aliens who are already in the United States may apply to adjust to
permanent resident status pursuant to the family-based and employment-
based categories described above, as well as several other statutorily-
eligible adjustment categories. See INA section 245; 8 U.S.C. 1255.
Refugees and aslyees may also apply to adjust to permanent resident
status from inside the United States. See INA section 209; 8 U.S.C.
1159.
An alien seeking permanent residence, whether through an immigrant
or refugee visa or through an adjustment of status, must undergo a
medical examination to determine whether the alien is inadmissible on
medical grounds. Overseas examinations are conducted by panel
physicians designated by the Department of State. Applicants for
adjustment of status to lawful permanent resident are required to have
a medical examination conducted by a civil surgeon designated by U.S.
Citizenship and Immigration Services. Under the proposed rule, testing
for HIV infection would be eliminated from these medical examinations.
Additionally, Temporary Protected Status (TPS) is another
immigration mechanism for eligible aliens who are in the United States
and whose countries have been designated for TPS due to ongoing armed
conflict, natural disasters, or certain other extraordinary and
temporary conditions. INA section 244; 8 U.S.C. 1255a; 8 CFR Part 244.
TPS applicants are also subject to the medical grounds of
inadmissibility. Currently, if a TPS applicant is infected with HIV,
DHS requires that the applicant be granted a waiver of inadmissibility
before TPS can be granted.
Section 101(a)(42)(A) of the INA generally defines refugees as
persons who cannot return to their country because of persecution or
the well founded fear of persecution based on race, religion,
nationality, membership in a particular social group, or political
opinion. An applicant is preliminarily approved for refugee status
overseas, but is admitted as a refugee upon admission to the U.S. at a
port of entry. A refugee is also subject to the medical grounds of
inadmissibility and the medical examination requirements. See INA
section 207; 8 U.S.C. 1157; 8 CFR Part 207.
vi. Current Scientific Knowledge for HIV Transmission
While HIV infection is a serious health condition, it does not
represent a communicable disease that is a significant threat for
introduction, transmission, and spread to the United States population
through casual contact as is the case with other serious conditions
such as tuberculosis. An arriving alien with HIV infection does not
pose a public health risk to the general population through casual
contact.
CDC has determined that HIV infection is transmitted among
individuals in the United States almost exclusively by the following
mechanisms: Unprotected sexual intercourse with an HIV-infected person,
sharing needles or syringes contaminated with HIV, and mother-to-child
transmission of HIV before or during birth or through breast feeding.
Additionally, HIV can be transmitted through transfusion of blood or
blood products infected with HIV. However, there has been continuous
screening for HIV in all donated blood since 1985. Therefore, the risk
for HIV infection through transfusion is extremely low. The U.S. blood
supply is considered among the safest in the world. Interventions have
been successful at mitigating exposure to and transmission of HIV.
v. Global Context
In 2004, the Joint United Nations Programme on HIV/AIDS (UNAIDS)
and the International Organization for Migration (IOM) issued the
``UNAIDS/IOM Statement on HIV/AIDS-related travel restrictions'' which
provides guidance to governments regarding addressing the public
health, economic, and human rights concerns involved in HIV-related
travel restrictions. This document concludes that HIV-related travel
restrictions have no public health justification.
There are a dozen countries that deny entry if a person has HIV.
These countries are: Armenia, Brunei, Iraq, Libya, Moldova, Oman,
Qatar, the Russian Federation, Saudi Arabia, South Korea, Sudan, and
the United States.
This proposed rule will remove the United States from the list of
countries that continue to have entry restrictions for HIV-infected
individuals.
III. Summary of Proposed Changes to 42 CFR Part 34
This proposed rule removes HIV infection from the definition of
communicable diseases of public health significance as defined in 42
CFR 34.2(b) and scope of examinations in 42 CFR 34.3.
Section 34.2(b) Communicable Diseases of Public Health Significance
This provision defines communicable disease of public health
significance as both a specific list of diseases and categories of
diseases for which all aliens are inadmissible to the United States.
HHS/CDC is proposing to remove human immunodeficiency virus (HIV)
infection from the specific list of communicable disease of public
health significance as provided for in 42 CFR 34.2(b).
As described above, inclusion of HIV in this definition is no
longer statutorily mandated. As a result, the Secretary of HHS has the
discretion to determine whether to leave HIV infection in the
definition or remove it.
In consideration of epidemiologic principles and current medical
knowledge regarding the mode of HIV transmission, HHS/CDC is proposing
to remove HIV infection from 42 CFR part 34 because HIV infection does
not represent a communicable disease of public health significance. HIV
is not a significant threat for introduction and spread through casual
contact to the general U.S. population, where HIV infection already
exists among the U.S. population as an endemic disease.
Under current regulatory requirements, aliens who test positive for
HIV infection can apply for a waiver from DHS and, if granted such a
waiver, are allowed admission into the United States or to adjust
status.
Diseases transmissible through aerosol or respiratory droplets such
as tuberculosis pose a much greater risk due to casual contact for
introduction and spread in the U.S. population. While HIV infection
continues to be a disease of public health concern throughout the
world, HIV infection is preventable by avoiding high risk sexual
[[Page 31801]]
contact or needle-sharing with HIV-infected persons. Interventions have
been successful at mitigating exposure to and transmission of HIV.
The rationale for maintaining HIV infection as an excludable
condition is no longer valid based on current medical knowledge and
practice, scientific knowledge, and experience which has informed us on
characteristics of the virus, the modes of transmission of HIV, and
interventions for prevention and further spread of the virus. Indeed,
HIV infection is not spread by casual contact, through the air, or from
food, water or other objects. An HIV-infected person in a common public
setting will not place another individual at risk. HIV is a fragile
virus and cannot live for very long outside the body. The virus is not
transmitted by mosquitoes, or through day-to-day activities such as
shaking hands, hugging, or a casual kiss. HIV infection cannot be
acquired from a toilet seat, drinking fountain, doorknob, eating
utensils, drinking glasses, food, or pets.
Section 34.3 Scope of Examinations
HHS/CDC is also proposing to remove all references to serologic
testing for HIV infection in 42 CFR 34.3 which is entitled ``Scope of
examinations''. This section applies to those aliens who are required
to undergo a medical examination for U.S. immigration purposes. The
scope of examinations outlines those matters that relate to the
inadmissible health-related conditions. This section provides specific
screening and testing requirements for those diseases that meet the
current definition of communicable disease of public health
significance and directly relates to the diseases list in Section 34.2
(b) of 42 CFR Part 34. It does not provide specific testing
requirements for other health-related conditions which are not included
in the current definition of communicable disease of public health
significance. Therefore, HHS/CDC is proposing to remove the specific
testing requirements for HIV infection in 42 CFR 34.3.
IV. Required Regulatory Analyses Under Executive Order 12866
HHS/CDC has examined the impacts of the proposed rule under
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act (Pub. L. 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule may be an economically significant action under the
Executive Order.
In the analysis that follows, we assess the potential impacts of
removing HIV from the list of specific communicable disease of public
health significance and removing the HIV testing requirement in the
medical examination for aliens who are applying for adjustment of their
status to that of a lawful permanent resident. We are seeking comments
on this preliminary regulatory impact analysis, including the
identification of potential data sources that would allow us to more
appropriately characterize and estimate the impact of the proposed
rule.
A. Objectives and Basis for the Action
Prior to the enactment of the United States Global Leadership
Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of
2008, HHS/CDC was required by statute to list HIV as a ``communicable
disease of public health significance.'' Now that the statute provides
discretion, HHS/CDC is proposing to take this action to reflect current
scientific knowledge and public health best practices, and to reduce
stigmatization of and discrimination against people who are HIV-
infected. This proposed rule is not intended to correct any market
failure, but to remove a government-imposed barrier that does not
appear to provide a significant public health benefit and is at odds
with human rights considerations.
B. Alternatives
HHS/CDC examined three regulatory approaches.
1. The first approach is to maintain HIV infection on the list of
communicable disease of public health significance, i.e., to keep the
disease as an excludable condition for entry into the U.S. This means
that visa applicants seeking permanent residency would continue to
undergo testing for HIV infection as part of the application process.
Those applicants testing positive for HIV, if eligible, would still be
required to apply for and obtain a waiver from DHS prior to coming to
the U.S. There are several disadvantages to this approach. As stated
previously, while HIV infection is a serious health condition, it does
not represent a communicable disease that is a significant threat for
introduction, transmission, and spread to the U.S. population through
casual contact. Currently, there are already roughly 1 million persons
in the United States living with HIV [1]. Thus, maintaining HIV
infection on the list of excludable conditions for entry into the U.S.
would not result in significant public health benefits. Further, this
approach is not in line with current international public health
practice. This approach continues discriminatory practices and
contributes toward the stigmatization of HIV-infected persons. HHS/CDC
did not select this approach.
2. The second approach is to remove HIV infection from the list of
communicable diseases of public health significance, i.e. remove it as
a ground of inadmissibility into the U.S., but continue mandatory HIV
testing for all immigrant applicants similar to an approach followed by
some countries. Under this approach, all those aliens who test positive
for HIV infection could be informed of their HIV status, counseled
regarding their condition, the need for appropriate treatment, and the
steps that should be taken to minimize the risk of onward transmission.
There are potential public health benefits to a mandatory testing
approach. The medical examination offers a unique opportunity to both
inform immigrants of their HIV status and link them with care. Through
screening, HIV-infected aliens who are potentially unaware of their HIV
status would become aware of their status and could be linked with
prevention, care and treatment options in the United States. Early
diagnosis and treatment of HIV-infected persons can increase life
expectancy and may improve the quality of life. Additionally, knowing
one's HIV status decreases the likelihood of onward transmission [2,
3]. These public health benefits are the basis for the HHS/CDC's
``Revised Recommendations for HIV Testing of Adults, Adolescents, and
Pregnant Women in Health-Care Settings,'' which states that the
characteristics of HIV infection are consistent with all generally
accepted criteria that justify voluntary screening [4]. However,
mandatory HIV testing is limited to certain infrequent cases such as
blood and organ donors.
There are also disadvantages to continued mandatory testing if HIV
infection is removed from the definition of a communicable disease of
public health significance. Mandatory testing for other serious health-
related conditions that are not inadmissible health conditions, (e.g.,
infectious diseases, such as hepatitis, malaria, and West Nile virus
and chronic conditions such as diabetes and heart conditions), are not
required as part of this medical examination. Thus, continued
[[Page 31802]]
mandatory HIV testing would differentiate HIV from other serious
health-related conditions. Second, although the purpose of the medical
examination is to identify health conditions considered inadmissible on
public health grounds, the results of exams conducted by panel
physicians in the immigrant's home country might not be kept
confidential because of requirements in the country of origin making it
necessary to report HIV results to local authorities. DHS would also
know an applicant's HIV status (while not necessarily other serious
health conditions) due to this information being included on medical
notification form and could be used by DHS in evaluating the
possibility of the alien becoming a public charge. 42 CFR
34.3(b)(ii)(5). These results may be counter to HHS/CDC objectives of
reflecting current scientific knowledge and public health best
practices, and reducing stigmatization of and discrimination against
people who are HIV-infected. Therefore, as discussed below in the 3rd
approach, HIV testing, consistent with CDC's recommendations for
general screening, would be available.
Although the approach of removing HIV from the definition of
communicable disease of public health significance but maintaining the
mandatory testing component of the medical examination was not selected
for this proposal, HHS/CDC welcomes public comment on the advantages
and disadvantages of this or alternative approaches, such as (non-
mandatory) testing (i.e., opt out/opt in approach).
3. The third approach is to remove HIV infection from the
definition of communicable disease of public health significance and as
a requirement in the medical examination. This means that mandatory
testing for HIV infection would no longer be required and DHS would
allow HIV-infected persons to enter into the U.S. (or to adjust to
permanent resident status) if they meet all other conditions of
admissibility. This is the regulatory approach that HHS/CDC selected.
Along with this approach, all immigrants, refugees and status adjusters
would still have the opportunity to receive information about HIV
testing and to be tested in the United States as recommended by the CDC
guidelines [4]. The discussion of the potential impacts of the rule
that follow relate to this approach.
C. Baseline and Incremental Analysis
The baseline for this analysis assumes no change in the current
regulation. In other words, all applicants for admission into the U.S.
as legal permanent residents and those already within the U.S. seeking
adjustment to permanent resident status are currently tested for HIV
during the immigration medical exam. Those who are HIV-infected and are
not granted a waiver by the Department of Homeland Security are refused
lawful permanent resident status in the United States.
Currently, refugees who are HIV-infected must be granted a waiver
by the Department of Homeland Security before entering the U.S.
Subsequently, refugees infected with HIV who are present in the U.S.
and apply for adjustment to permanent resident status must be re-
examined and granted another waiver from DHS at that time (i.e., the
grant of waivers permits these individuals to obtain refugee status,
and later, permanent resident status despite being HIV-infected, which
would otherwise render them inadmissible). We have not explicitly
included refugees and TPS-turned permanent residents in our analysis,
however, because: (i) These persons, compared to the other immigrants,
enter the U.S. under extraordinary circumstances; (ii) the numbers are
relatively small; and, (iii) the proposed change in regulations is not
likely to have a significant impact on the annual number of HIV-
infected refugees admitted to the U.S. and who later become permanent
residents because such persons generally receive a waiver of
inadmissibility for HIV infection under current procedures. Thus, the
numbers of admitted HIV-infected refugees who are subsequently granted
permanent resident status are likely to stay the same, regardless of
regulations in place. That is, the HIV-infected refugees-turned-
permanent residents are part of the baseline scenario.
Furthermore, though this policy would increase the total number of
people who may be eligible to be admitted, we assume that the total
number of immigrants who are annually admitted into the United States
is fixed over time. Thus, the incremental input to the rule is a
calculation of the additional costs due to HIV-infected immigrants
above the costs of non-HIV-infected immigrants. In general, given that
the total number of immigrants is not likely to change and the share of
HIV-infected immigrants is likely to be relatively small, the rule will
not likely have an appreciable impact on the economy in terms of wages,
productivity, or prices of goods and services.
D. Defining the Population Affected
The affected population is defined as the number of new HIV-
infected lawful permanent residents entering the United States each
year and those individuals already in the United States seeking to
adjust their immigration status to that of a lawful permanent resident.
The proposed changes in the medical examination of aliens regulations
affect all foreign nationals entering the U.S. who are infected with
HIV. Although HIV testing is not routinely required for entrance into
the U.S. except for those aliens who are seeking to become lawful
permanent residents, visitors who are infected with HIV are currently
required to request waivers to obtain entrance. If this rule is
finalized, that waiver process will no longer be necessary. Data on the
number of waivers granted annually based on HIV status are not
available but costs to obtain waivers are thought to be minimal. For
example, in Fiscal Year 2007, the Department of State reported that its
consular officers found 746 immigrants ineligible for admission to the
U.S. under the communicable disease grounds of INA 212(a)(1)(A)(i). Of
those immigrants 327 overcame the initial finding. What portion of
those who tested positive for HIV infection is unknown. This analysis
is limited to aliens seeking to become lawful permanent residents who
are required to have a medical examination to determine admissibility.
Because visitors, refugees and TPS applicants have historically had the
option of obtaining a waiver to enter and remain in the U.S., these
groups are not included in this analysis.
Based on the estimated distribution of HIV/AIDS cases in each of
the regions in the world and weighted by the number of immigrants
entering the United States from each region, we estimate that
approximately 4.06 immigrants per 1000 immigrants that would be likely
to enter the U.S. under the proposed rule would be infected with HIV
(see Table 1 for the summary of regional estimates and weights and
Technical Appendix II, Table 1: Summary of Model, HIVEcon, Inputs and
Assumptions for Primary, Lower and Upper Bound Analyses [5]).
[[Page 31803]]
Table 1--Regional Population, Immigration and HIV Estimates Used To Calculate the Weighted Regional Rate
Estimates
----------------------------------------------------------------------------------------------------------------
Estimate of HIV rate per 1,000 Estimated number of HIV
(based on 2006 regional infected immigrants
Legal population estimates [7] and --------------------------------
permanent 2007 HIV regional estimates
residents [8])
(2007) [6] --------------------------------- Primary Low High
Primary Low High
----------------------------------------------------------------------------------------------------------------
Africa*.......................... 96,105 18.05 16.70 19.57 1,735 1,605 1,880
Asia............................. 383,508 1.29 1.05 1.63 494 403 624
Europe........................... 120,821 3.23 2.46 4.38 390 297 529
N. America....................... 339,355 3.84 1.42 5.61 1,302 481 1,903
Oceania.......................... 6,101 2.19 1.55 3.50 13 9 21
S. America....................... 106,525 3.20 2.81 3.79 341 300 404
------------------------------------------------------------------------------
Total........................ 1,052,415 4.98 4.35 5.73 ......... ......... .........
================================================================================================================
HIV positive Rate per 1,000 U.S. immigrants 4.06 [Dagger] [Dagger] 4,275 3,096 5,361
[dagger] 2.94 5.09
----------------------------------------------------------------------------------------------------------------
* In this case, Africa includes North Africa, the Middle East and Unknowns.
** Total number of adults and children living with HIV in the region (see Technical Appendix II for more detail
[5]).
[dagger] Based on weighted regional estimates. The assumption is that prevalence of HIV amongst immigrants to
the U.S. mirrors that of the immigrant's native regions and is adjusted for the number of immigrants coming to
the U.S. from each region.
[Dagger] Note: These estimates represent the 5th and 95th percentiles based on regional weight estimates. Due to
concern that immigrants may not be representative of the typcial country level estimates and thus may be
outside the confidence interval, for purposes of this analyses we expanded our confidence interval to 25% to
150% of the Primary estimate (i.e. 1.02 to 6.09 HIV+ immigrants per 1,000 immigrants).
The numbers of HIV/AIDS persons in each region of the world were
taken from the 2007 AIDS Epidemic Update: Global Overview issued by the
Joint United Nations Programme on HIV/AIDS (UNAIDS)[8]. HHS/CDC used
regional data and rates that were determined using the regional
population data from 2006 published by the Population Division of the
Department of Economic and Social Affairs of the United Nations
Secretariat [7]. After examining the immigration data, by region, from
the Yearbook of Immigration Statistics: 2007 Immigrants [6], we
assigned regional weights according to the number of aliens coming to
the United States from each region.
The 2007 Immigration Statistics [6, 9] indicate that 1,052,415
persons became permanent residents in 2007. Multiplying this number by
our prevalence estimate of 4.06 HIV-infected immigrants per 1000
immigrants yields an estimated 4,275 HIV-infected immigrants who would
enter into the United States each year.
However, we note that there are significant uncertainties in this
estimate since no specific data exist on the HIV prevalence of persons
seeking to immigrate to the United States. We do not have a basis to
judge whether these immigrants who qualify for permanent residence
differ from the general regional population in terms of HIV prevalence;
thus, for the purposes of this analysis we assumed that it would be
equivalent to the regional HIV prevalence rates. We used regional HIV
prevalence rates rather than HIV rates for specific countries to allow
for year to year variations in the number of aliens entering the U.S.
from specific countries.
There are several possible reasons as to why the proportion of HIV-
infected immigrants could be less or more than the prevalence of HIV-
infected persons in the region of origin. For example, the cost of
adequate medical care in the U.S. may make HIV-infected individuals
reluctant to immigrate to this country. With the increase in the
availability of appropriate HIV treatments in many parts of the world,
adequate treatment is often cheaper outside of the U.S. Conversely, in
regions or specific countries where appropriate treatment is less
readily available, the portion of HIV-infected immigrants from those
regions could be higher than the prevalence of HIV-infected persons in
that region. We are seeking comments on these assumptions and data that
would further allow us to refine our estimates.
However, we also conducted sensitivity analyses to assess the
impact of altering this assumption. We used a range of 1.02 to 6.09
HIV-infected persons per 1,000 immigrants based on 25% and 150% of the
mean weighted average, 4.06 per 1,000 immigrants (high and low
estimates) of the number of estimated HIV-infected persons in each
region but weighted by the number of lawful permanent residents who
entered the U.S. in 2007. This range yields a lower bound estimate of
1,073 and an upper bound estimate of 6,409 HIV-infected persons
entering the United States annually (see Technical Appendix II [5]).
Because the impact of the proposed rule change is highly sensitive to
HIV prevalence in aliens entering the U.S., we are seeking comment on
these assumptions.
E. Benefits
HHS/CDC is proposing to remove HIV infection from the definition of
communicable disease of public health significance contained in 42 CFR
34.2(b) and scope of examination, 42 CFR 34.3 because HIV infection
does not represent a communicable disease that is a significant threat
to the general U.S. population. The rationale for maintaining HIV
infection as an excludable condition is no longer valid based on
current medical knowledge and public health practice, scientific
knowledge, and experience which has informed us on the characteristics
of the virus, the modes of transmission of HIV, and the effective
interventions to prevent further spread of the virus.
The benefits from this action are difficult to quantify. Based on
the estimate above, this rule would allow perhaps roughly 4,000 persons
to enter the United States annually who are otherwise admissible but
are denied admission solely based on their HIV status. The rule will
bring family members together who had been barred from entry, thus
strengthening families. Also, HIV-infected immigrants with skills in
high demand would be permitted to enter the U.S. to seek employment and
contribute as productive members of U.S. society. Depending on the
region of the world from which a person emigrates, admittance to the
U.S. may afford
[[Page 31804]]
greater opportunity, better health care, and education and training
programs than those available in the immigrant's home country. These
HIV-infected individuals, compared to those who do not receive
appropriate multi-drug anti-retroviral therapy for HIV treatment, could
survive an additional 13 years, with an average life expectancy of
approximately 29 years (to age 49 years) [10]. This increased life
expectancy allows the opportunity for longer and improved productivity.
Further, this proposed rule to remove HIV infection from the list
of communicable disease of public health significance and from the
scope of examinations will remove stigmatization of and discrimination
against HIV-infected people who have long been denied entry into the
U.S. based only on a treatable and preventable medical condition. This
proposed rule will bring the U.S. in line with current science and
international standards of public health and human rights practice.
Though this rule is assumed to not have an impact on the total
number immigrants annually admitted as legal permanent residents, we
note that immigration, in general, produces net economic gains for the
United States. Overall, an NRC study estimated that immigrants, in
general, create an annual economic impact of between $1 billion to $10
billion [11].
HHS/CDC welcomes comments on these and other benefits associated
with the proposed regulatory change.
F. Costs
To the extent the proposed rule will result in an increased number
of HIV-infected immigrants to the U.S. each year, there will be
quantifiable impacts. We have made our best attempt to capture the
likely effects of the rule, but there are significant uncertainties in
this estimation effort. HHS/CDC encourages public comment on costs
associated with this rulemaking and, in particular, additional
information that would provide a basis for more robust qualitative
discussion or quantitative estimates.
Impact on Health Care Expenditures
As previously discussed, the incremental impacts of the rule should
be a comparison between the arrival of an HIV-infected immigrant and
the arrival of an HIV-negative immigrant. Presumably, HIV-related
healthcare expenditures will be different, but there are a variety of
health expenditures that the HIV-infected immigrant may not incur that
other immigrants may incur (e.g., certain types of cancer, diabetes,
heart disease). It is not clear that, over the course of a lifetime, on
net an HIV-infected immigrant would consume more health care resources
than other immigrants. Furthermore, HIV treatment yields benefits that
offset the expenditures, including increased life expectancy and
productivity.
However, given that health care expenditures associated with
treatment of HIV infection can be substantial and may result in some
fiscal impacts (as discussed below), we developed a model (HIVEcon) to
estimate these potential effects of the rule. A complete description of
the model including assumptions, results and limitations is available
for comment [5]. The spreadsheet model itself is also available for
download so that the reader can determine the relative impact of
altering almost any input value, individually or several simultaneously
[12].
The model, HIVEcon, examines the treatment costs as estimated by
Schackman et al. [13] associated with newly identified persons infected
with HIV regardless of payer, following the 2004 standards of care. The
annual treatment cost is estimated to be $25,200 in 2004 dollars, with
a range of $19,466 to $30,954. However, significant advances in the
treatment of HIV have been made since 2004 [14], and are likely to
continue to be made. Thus, the expenditure estimates could be an
underestimate since as treatment options increase, the benefits such as
quality of life and lifespan will increase but so will costs. However,
these expenditures may be overestimates since it is not clear to what
extent immigrants will seek and receive even the 2004 standard of care.
Therefore, assuming 0% onwards transmission from HIV-infected
immigrants entering at an average age of 20 years, an average annual
medical expenditures of $25,200 annually, an HIV prevalence rate among
immigrants of 4.06 per 1,000, and a 3% annual discount rate, the
primary estimate of the present value of lifetime medical costs for
persons identified as HIV-infected in Year One is $94 million in the
first year. The absolute lower bound estimate is $19 million in the
first year (decreasing the prevalence rate to 1.02 HIV+ immigrants per
1,000 immigrants and the average annual medical expenditures to
$19,466). The maximum upper bound estimate is $173 million (increasing
the prevalence rate to 6.09 HIV+ immigrants among 1,000 immigrants, and
the average annual medical expenses to $30,954 per immigrant). In the
HIVEcon model, in Year Two following the change in regulations, as the
cumulative number of HIV-infected immigrants almost doubles, so will
these health expenditures. Likewise in the third year, the expenditures
will be equivalent to three years' worth of immigrants (excluding those
who have passed away) and so on until the HIV-infected immigrants reach
their life expectancy (e.g., in the model, an HIV-infected person at
age 30 has an average life expectancy of 24.7 years).
Comparison With Congressional Budget Office Analysis
The Congressional Budget Office (CBO) estimated the cost to the
federal government of Section 305 of PL 110-293 prior to the law's
enactment. The analysis included increases in direct spending related
to provision of health care and other benefits paid for by the federal
government. Specifically, those benefits include Medicaid, Supplemental
Security Income, Food Stamps, and nutritional programs. In total, CBO
estimated that providing these benefits to HIV-infected immigrants and
their citizen children will increase spending by less than $500,000 in
2010 and $83 million over the 2010-2018 period, primarily for Medicaid.
The CBO analysis was done for the purpose of estimating the impact
of PL 110-293 on the federal budget. This analysis was done to comply
with Executive Order 12866, which directs agencies to assess all costs
of available regulatory alternatives, including, but not limited to,
those costs incurred by the federal government. The economic analysis
for this regulation differs from the CBO analysis for PL 110-293 in
four major areas: (1) The CBO analysis assumed that the HIV prevalence
rate would be equal to half of the weighted-average HIV prevalence rate
for the immigrants' country of origin, whereas this analysis assumed
that the HIV prevalence rate would be equal to the weighted-average
rate of the immigrants' region of origin; (2) the number of immigrants
was increased by 5% each year in the CBO analysis while this analysis
did not include growth in the annual number; (3) the CBO analysis only
examined health care costs paid for by Medicaid whereas this analysis
included all health care costs including those paid for by the Ryan
White Program; and (4) the CBO analysis included costs of federal
disability and nutrition benefits, whereas this analysis did not
include those costs.
By the year 2013, the number of HIV-infected immigrants entering
the U.S. projected by the CBO analysis is roughly equivalent to that
projected by this
[[Page 31805]]
analysis (analytical differences in prevalence and growth rates cancel
out). By 2018, the number of HIV-infected immigrants projected by the
CBO analysis exceeds projections in this analysis. The health care
costs in this analysis exceed that of CBO's analysis because the former
included all federal and nonfederal costs including those costs paid
for through the federally-funded Ryan White Program. This analysis did
not include non-healthcare costs.
We are seeking comments on these assumptions and data that would
further allow us to refine our estimates. We welcome comment on the
estimated prevalence of HIV among those likely to immigrate based on,
for example, humanitarian waivers or other sources of available data.
Potential Fiscal Impacts
As previously discussed, even if HIV-related health restrictions
are removed as a barrier to admission for immigrants, all immigrants
still must meet other admission requirements. In the United States,
under the Federal Personal Responsibility Work and Opportunity
Reconciliation Act (PRWORA) of 1996, most immigrants are not eligible
to receive means-tested public benefits for five years after their
entry into the U.S. [15, 16]. Federal means-tested public benefits
include Supplemental Security Income (SSI), cash Temporary Assistance
for Needy Families (TANF), Medicaid, and food stamps [15, 17]. State
and local means-tested benefits are determined at the state or local
level and vary by jurisdiction. We have no data to assume that HIV-
infected immigrants will seek, five years after being admitted to the
U.S., such benefits at rates different from non HIV-infected
immigrants.
In addition, PRWORA placed other limitations on aliens' access to
public benefits, making them more difficult for aliens to obtain such
benefits in the first place. For example, the income and resources of
the sponsor of a family-based immigrant or permanent resident are
deemed to be available to that alien if he/she should apply for certain
means-tested public benefits. See 8 U.S.C. 1631, 1632. Since a sponsor
must first prove to DHS that he/she is able to provide support to the
sponsored alien at an annual income that is at least 125% above the
federal poverty level before the alien's immigration application will
be approved, it is unlikely that the alien will be able to show that
his/her available resources fall beneath the low income eligibility
thresholds required for many means-tested public benefits. See INA
Sec. 213A(a)(1)(A).
However, some immigrants may be eligible for certain assistance
through the Ryan White HIV/AIDS Program--a federally-funded program
that provides HIV-related health services. Funds are awarded to
agencies located around the country, which in turn deliver care to
eligible individuals. Since the program is administered through
different grantees using different eligibility criteria, it is
difficult to assess to what extent the HIV-infected immigrants will be
eligible for assistance through this program. However, given that the
estimated number of new HIV-infected immigrants entering the United
States as a result of this rule are relatively small (around 4,000
annually) compared to the total number of persons currently assisted by
the funding (roughly half a million), the overall impact on the program
is likely small.
Onward Transmission
Though difficult to quantify with precision, there will likely be
some additional cases of HIV due to onward transmission from HIV-
infected immigrants to others in the United States who are not
currently infected. The costs associated with onward transmission
include:
Shortened lifespan and reduction in quality of life even
with treatment,
The health care costs associated with treating HIV
infection,
The costs of social services when individuals are unable
to fully support themselves because of their illness, and
Decreased productivity when individuals become too sick to
work.
Because health care costs are substantial and other costs listed
above are difficult to quantify, the analysis in the HIVEcon model is
limited to health care costs associated with treatment of HIV
infection.
In the model, the number of estimated HIV-infected cases due to
onward transmission (in Year t) is calculated as: [(Number of HIV-
infected immigrants entering in Year t + Number of HIV-infected
immigrants surviving from previous years that survive to Year t +
additional persons previously infected by onward transmission from HIV-
infected immigrants that survive to Year t) x onward transmission
rate].
A 1.51% onward transmission rate was used in the HIVEcon model to
represent the annual estimated number of new infections caused by HIV-
infected immigrants to the U.S., or caused by U.S. person infected by
HIV-infected immigrants (i.e., annually every 100 HIV-infected persons
infect an additional 1.51 persons). The most recent estimate of average
onward transmission, when limited to sexual transmission, in the United
States is 3.02 per 100 HIV positive immigrants [18]. In 2006, the
overall rate for onward transmission of HIV in the U.S. from all
causes, was 5 new infections per 100 HIV-infected persons [19]. Results
from published research indicate that immigrants to the United States,
regardless of their race or ethnicity, often have an initial better
health profile than native-born Americans across diverse health
behaviors and outcomes; however, this health advantage declines as
length of residence in the United States and degree of acculturation
increase [20-26]. Specifically, studies of HIV risk behavior among
immigrant populations, upon arrival in the U.S., indicate that these
behaviors are influenced by a number of factors including the
demographic characteristics of the migrants (especially sex, social
class, relationship status and education); the purpose of immigration;
the type and location of their receiving community and the existing
supports; discrepancy between pre-immigration expectations and post-
immigration experiences; and transnational movement between the U.S.
and their home countries [27-31]. These multiple factors result in
heterogeneity in HIV risk between migrant communities, with some being
at lower, and others higher risk, than their U.S. counterparts. There
is no evidence to suggest immigration to the U.S. significantly affects
HIV incidence in this country in one direction or the other. Thus, it
is not unreasonable to assume that onward transmission rates amongst
HIV-infected immigrants will be lower than among HIV-infected persons
born in the U.S.
For this analysis, we assumed that the onward transmission rate for
immigrants, and those that they infect, would be fifty percent of the
average U.S. rate for sexual transmission (i.e., rate of onward
transmission from HIV-infected immigrants is assumed, in the baseline
case, to be 1.51 per 100). Because data supporting this assumption are
limited, this assumption was tested in sensitivity analysis. We used 0%
transmission as our lower bound estimate and a transmission rate of
4.53 per 100 HIV-infected immigrants, and those that they infect, as
our upper bound estimate. The upper bound transmission rate is a fifty
percent increase in the average annual onward transmission rate of
3.02%.
Assuming 4,275 HIV-infected immigrants enter in the first year,
there will be 65 new HIV infections due to onward transmission,
assuming an
[[Page 31806]]
onward transmission rate of 1.51 per 100 HIV, with a range of 0 to 261
(assuming onward transmission of 0 and 4.53 per 100 HIV-infected
immigrants, respectively). These estimates imply treatment costs, for
those infected via onward transmission only, in the first year of $1.6
million in the primary estimate and a range of $0 to $8.1 million [5].
For the purposes of calculating new HIV infections associated with
HIV-infected immigrants in the U.S., HIVEcon adds persons infected by
HIV-infected immigrants to the cohort of projected HIV-infected
immigrants. This modeling technique represents the chain of onward
transmission after initial transmission from an HIV-infected immigrant.
Thus, in the next year, though the cumulative number of HIV-infected
immigrants essentially doubles, the number of new HIV cases (as well as
the associated treatment costs) will be slightly more than double the
previous year.
This modeling approach assumes that those people infected by HIV-
infected immigrants would never have become infected with HIV were it
not for the arrival in the U.S. of HIV-infected immigrants. This could
be unrealistic since U.S. persons who are infected by HIV-infected
immigrants may engage in behaviors that lead them to activities that
expose them to HIV infections, regardless of the source of infection.
An alternative interpretation may be that at least some of the
additional infections are occurring earlier than they otherwise would
have. Thus, these shifts in the timing of infection will increase the
total number of new cases in any one year, but the true incremental
impact may be the implications of becoming infected earlier.
Furthermore, the model treats the onward transmission rate as fixed
over time. However, data shows that onward transmission has declined
over time [19]. If we assume that transmission rates will continue to
decrease in the future, it is possible that the model may overestimate
the number of HIV-infected individuals due to onward transmission as we
project impacts into the future.
G. Summary of Impacts
The HIVEcon model projects potential impacts out to 50 years after
the rules go into effect. However, many of the key inputs to the model
may be significantly different even ten years from now given the rapid
pace of change in HIV treatment, HIV prevalence in other countries, as
well as potential changes in the overall immigration policy. It may not
be inconceivable that there would be an HIV vaccine in the next decade
or two. Given these uncertainties, Table 2 provides a summary of the
potential effects of the rule five years after implementation.
Table 2--Summary of Impacts (Year Five After Implementation), Assuming The Average Age of Entry Is 30 Years and
The Annual Discount Rate Is 3%
----------------------------------------------------------------------------------------------------------------
Primary Estimate (4.06 Low Estimate (1.02 High Estimate (6.09
Category HIV+ immigrants per HIV+ immigrants per HIV+ immigrants per
1,000 immigrants) 1,000 immigrants) 1,000 immigrants)
----------------------------------------------------------------------------------------------------------------
HIV-POSITIVE IMMIGRANTS AT YEAR 5 (EXCLUDING ONWARD TRANSMISSION)
----------------------------------------------------------------------------------------------------------------
Total number of HIV-Positive 15,755................... 3,956................... 23,622.
Immigrants present in the U.S.
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Healthcare $342 million............. $86 million............. $513 million.
Expenditures.
----------------------------------------------------------------------------------------------------------------
Benefits (Qualitative)........... 1. Reduce stigmatization of and discrimination against HIV-infected people.
2. Compared to those who don't receive appropriate multi-drug anti-retroviral
therapy, survive an additional 13 years, with an average life expectancy of
approximately 29 years (to age 49 years) [10]. This increased life
expectancy allows opportunity for longer and improved productivity.
----------------------------------------------------------------------------------------------------------------
HIV-POSITIVE CASES AT YEAR 5 DUE TO 1.51% ONWARD TRANSMISSION
-----
