B-318975

November 17, 2009

The Honorable Tom Harkin
Chairman
The Honorable Michael B. Enzi
Ranking Minority Member
Committee on Health, Education, Labor, and Pensions
United States Senate

The Honorable Henry A. Waxman
Chairman
The Honorable Joe L. Barton
Ranking Minority Member
Committee on Energy and Commerce
House of Representatives

Subject: Department ofHealth and Human Services, Centers for Disease Control and Prevention: MedicalExamination of Aliens--Removal of Human Immunodeficiency Virus (HIV) InfectionFrom Definition of Communicable Disease of Public Health Significance

Pursuant to section 801(a)(2)(A) of title 5, UnitedStates Code, this is our report on a major rule promulgated by the Departmentof Health and Human Services, Centers for Disease Control and Prevention (CDC),entitled Medical Examination of Aliens--Removal of Human ImmunodeficiencyVirus (HIV) Infection From Definition of Communicable Disease of Public HealthSignificance (RIN: 0920-AA26). Wereceived the rule on October 30, 2009.It was published in the FederalRegister as a final rule on November 2, 2009, with an effective date of January 4, 2010. 74 Fed. Reg. 56,547.

The finalrule removes HIV infection from thedefinition of communicable disease of public health significance and removes references to HIV from thescope of examinations for aliens because HIV infection does not represent acommunicable disease that is a significant threat to the general U.S.population. As a result of the finalrule, HIV infection will no longer be an inadmissible condition, and HIV testingwill no longer be required for those aliens who are required to undergo amedical examination for U.S. immigration purposes. As a result of this final rule, CDC has alsorevised the Technical Instructions provided to panel physicians and civilsurgeons to reflect the removal of the HIV testing requirement.

Prior to the enactment of the United StatesGlobal Leadership Against HIV/AIDS, Tuberculosis, and Malaria ReauthorizationAct of 2008, CDC was required by statute to list HIV infection as a communicabledisease of public health significance. Now that the statute provides discretion, CDC removed HIV infection from the definition to reflect current scientific knowledge andpublic health best practices, and to reduce stigmatization of people who areHIV infected. CDC also found itappropriate to remove HIV testing from the scope of examinations in theimmigration process, since HIV infection has been removed as a communicabledisease of public health significance. CDC notes that the regulationsfound at 42 C.F.R. part 34 do not specify testing for any illness that is notincluded in the definition of communicabledisease of public health significance.

Enclosed is our assessment of the CDCs compliance withthe procedural steps required by section 801(a)(1)(B)(i) through (iv) of title5 with respect to the rule. Our reviewof the procedural steps taken indicates that CDC complied with the applicablerequirements.

If you have any questions about this report or wish tocontact GAO officials responsible for the evaluation work relating to thesubject matter of the rule, please contact Shirley A. Jones, Assistant GeneralCounsel, at (202) 512-8156.

signed

Robert J. Cramer
Managing Associate General Counsel

Enclosure

cc: Vivian Stallion
Program Manager
Department of Health and
Human Services

ENCLOSURE

REPORT UNDER 5U.S.C. sect.801(a)(2)(A) ON A MAJOR RULE
ISSUED BY THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
CENTERS FOR DISEASE CONTROL AND PREVENTION
ENTITLED
"MEDICAL EXAMINATION OF ALIENS--REMOVAL OF
HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION
FROM DEFINITION OF COMMUNICABLE DISEASE
OF PUBLIC HEALTH SIGNIFICANCE"
(RIN: 0920-AA26)

(i) Cost-benefit analysis

CDC analyzedthe costs and benefits of the final rule. The benefits would allow roughly 4,275 persons to enter the United States annuallywho are otherwise admissible but are denied admission solely based on their HIVstatus, will bring family members together who had been barred from entry thusstrengthening families, permit HIV-infected immigrants with skills in highdemand to enter the U.S. to seek employment and contribute as productivemembers of U.S. society, remove stigmatization of HIV-infected people who havelong been denied entry into the U.S. based only on a treatable and preventablemedical condition, and bring the U.S. in line with current science andinternational standards of public health.The costs to the health care sector could range from an estimated $19million to $173 million in the first year, depending on annual cost oftreatment, available treatment options, and inclusion of direct medicalcosts. Though difficult to quantify withprecision, the CDC also noted there will likely be some additional cases of HIVinfection due to onward transmissions from HIV infected immigrants to others inthe United States who are not currently infected. The costs associated with onward transmissioninclude shortened lifespan and reduction in quality of life even with treatment,the health care costs associated with treating HIV infection, the costs ofsocial services when individuals are unable to fully support themselves becauseof their illness, and decreased productivity when individuals become too sickto work.

(ii) Agency actions relevant to the RegulatoryFlexibility Act, 5 U.S.C. sections603-605, 607, and 609

CDCcertifies that the rule will not have a significant impact on a substantialnumber of small entities and therefore did not provide an analysis under the Act.

(iii) Agency actionsrelevant to sections 202-205 of the Unfunded Mandates Reform Act of 1995, 2U.S.C. sections1532-1535

CDC states that the rule does not contain federal mandatesfor state, local, or tribal governments, nor for the private sector. CDC also states the rules provisions will not affect small governments.

(iv) Other relevant information or requirements underacts and executive orders

Administrative Procedure Act, 5 U.S.C. sections551 etseq.

Thefinal rule was issued using the notice and comment procedures found at 5 U.S.C.sect. 553. On July 2, 2009, CDC published anotice of proposed rulemaking to remove HIV infection from the definition of communicabledisease of public health significance and from the scope of examinationsfor immigration purposes. 74 Fed. Reg. 31,798. CDCreceived over 20,000 timely items of correspondence from the publicwhich are addressed in the final rule. 74Fed. Reg. 56,549.

Paperwork Reduction Act, 44 U.S.C. sections3501-3520

There are no new data collectionrequirements. The Act applies to thedata collection requirements found in 42 C.F.R. part 34. CDC states that currently, aliens determinedto have a communicable disease of public health significance may request awaiver from the Department of Homeland Security to enter the United Statesunder the Immigration and Nationality Act.8 U.S.C. sect. 1182(d)(3)(a), (g). CDChas approval from the Office of Management and Budget (OMB) to collect datapertaining to the waiver. CDC will discontinuethe use of this form, for a reduction of 67 burden hours for this approved datacollection.

Statutory authorization for the rule

CDCstates that the rule is promulgated under the authority of 42 U.S.C. sect. 252 and8U.S.C. sections 1182, 1222.

Executive Order No. 12,866 (Regulatory Planning and Review)

TheCDC states that the final rule is an economically significant action under theOrder.

Executive Order No. 13,132 (Federalism)

CDChas determined that this rule does not have sufficient federalism implicationsto warrant the preparation of a federalism summary impact statement.