August 30, 2010

Medical Examination of Aliens

Proposed Rule
Summary

Score: 28 / 60

Additional details
Agency
Department of Health and Human Services
Regulatory Identification Number
0920-AA26
Agency Name
Department of Health and Human Services
Rule Publication Date
07/02/2009
Comment Closing Date
08/17/2009

RULE 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.

METHODOLOGY

There are twelve criteria within our evaluation within three broad categories: Openness, Analysis and Use. For each criterion, the evaluators assign a score ranging from 0 (no useful content) to 5 (comprehensive analysis with potential best practices). Thus, each analysis has the opportunity to earn between 0 and 60 points.

Criterion Score

Openness

1. How easily were the RIA , the proposed rule, and any supplementary materials found online?
0920-AA26 can be found on regulations.gov using the RIN and a keyword search. The Department of Health and Human Service's website is very difficult to navigate, and does not contain helpful links to this regulation. The best we could do is go to the aids.gov sub-website and find the final rule by searching using the keywords "HIV" and "immigration."
3/5
2. How verifiable are the data used in the analysis?
Sources for number of legal permanent residents and incidence of HIV in immigrants are provided. Numerous other data sources are provided, with links, in a section titled "Literature Cited."
4/5
3. How verifiable are the models and assumptions used in the analysis?
The spreadsheet model used to calculate costs is available for download. Some assumptions seem pulled out of thin air, but the RIA says it did this due to lack of data, acknowledged uncertainty, and included sensitivity analysis. For other assumptions and theories underlying the decision, the RIA cites a substantial amount of scholarly literature, providing references and links. A key analytical conclusion underpinning the decision—that HIV is not spread through casual contact—is repeatedly asserted with no evidence cited in support.
3/5
4. Was the analysis comprehensible to an informed layperson?
The analysis is clear, understandable, well organized, and easy to follow. An economist would understand all of it, but some technical jargon is used (especially in the discussion of costs).
4/5

Analysis

5. How well does the analysis identify the desired outcomes and demonstrate that the regulation will achieve them?
3/5
Does the analysis clearly identify ultimate outcomes that affect citizens’ quality of life?
The purpose is removal of a regulation that arguably encourages discrimination and/or violates human rights without improving public health. The analysis states that benefits will accrue to aliens with HIV who wish to enter the United States. Roughly 4,000 persons will be afforded the social, psychological, and financial benefits of U.S. citizenship (through greater opportunity, better health care, education, improved life expectancy, etc.). In total, these results affect the quality of immigrants' lives and may affect overall U.S. welfare as well. All of these factors are mentioned, but not tied together as strongly as they could be.
4/5
Does the analysis identify how these outcomes are to be measured?
Benefits are not really measured. One figure in the RIA that could be used as a measure would be the number of HIV-infected immmigrants currently denied permanent resident status; this would measure the number of people no longer discriminated against as a result of the proposed change. The RIA estimates this but does not explicitly offer it as a measure of outcomes.
2/5
Does the analysis provide a coherent and testable theory showing how the regulation will produce the desired outcomes?
Removal of the restriction would not change the number of immigrants, but would increase the percent with HIV. This is a desired outcome because these individuals were previously discriminated against and because of the additional benefits outlined under 5A.
4/5
Does the analysis present credible empirical support for the theory?
Obviously removal of the restriction allows these immigrants to come in. It would have been helpful to cite evidence of positive results for HIV-infected immigrants who enter countries that do not have this restriction.
2/5
Does the analysis adequately assess uncertainty about the outcomes?
The RIA notes that there is substantial uncertainty surrounding its calculation of the number of HIV-infected immigrants who are currently denied permanent resident status, and it conducts a sensitivity analysis.
3/5
6. How well does the analysis identify and demonstrate the existence of a market failure or other systemic problem the regulation is supposed to solve?
3/5
Does the analysis identify a market failure or other systemic problem?
The analysis notes that "The 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." Thus, it presents an example of a government policy that needs to be updated in light of new information. The proposal argues that there is no systemic problem that justifies the regulation it removes.
5/5
Does the analysis outline a coherent and testable theory that explains why the problem (associated with the outcome above) is systemic rather than anecdotal?
The proposal states, "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." This reflects the Center for Disease Control's judgment. The proposal explains the ways people can get infected with HIV, noting that none of them involve casual contact.
4/5
Does the analysis present credible empirical support for the theory?
The information reflects the CDC's judgment and a UN finding, but no emprical evidence is cited.The analysis would be improved if more discussion of the "current scientific knolwedge and public health best practices" that underpin the argument to remove HIV from the significant communicable disease list were described.
1/5
Does the analysis adequately assess uncertainty about the existence or size of the problem?
Public health findings are presented as a certainty. The analysis notes uncertainties about how many HIV-infected immigrants are kept out by the current regulation.
2/5
7. How well does the analysis assess the effectiveness of alternative approaches?
3/5
Does the analysis enumerate other alternatives to address the problem?
Three alternatives considered: keep the existing regulation, continue mandatory HIV testing but allow entry, or make testing voluntary and allow entry (the proposed rule).
4/5
Is the range of alternatives considered narrow (e.g., some exemptions to a regulation) or broad (e.g., performance-based regulation vs. command and control, market mechanisms, nonbinding guidance, information disclosure, addressing any government failures that caused the original problem)?
This scope of alternatives varies from prohibition to no prohibition. Still, it seems other options could have been considered, such as aggressive promotion of voluntary testing along with education about treatment, or require testing but allow entry with proof of treatment.
3/5
Does the analysis evaluate how alternative approaches would affect the amount of the outcome achieved?
The current regulation is the baseline. The benefits and costs of the chosen alternative are evaluated relative to this baseline. Results of the middle alternative—mandatory testing but allow HIV-infected immigrants to become legal residents—are not calculated, but HHS qualitatively discusses some advantages and disadvantages. For instance, under option 2) the analysis notes that removing the HIV from the communicable disease list while still requiring HIV testing offers a unique opportunity to both "inform immigrants of their HIV status and link them with care." This section of the analysis could be improved if more careful analysis of the incremental effect of the alternatives were quantitatively asessed.
2/5
Does the analysis adequately address the baseline? That is, what the state of the world is likely to be in the absence of federal intervention not just now but in the future?
The current regulation, which prohibits entry of people infected with HIV, is the baseline. Since the analysis is confined to immigrants seeking to become permanent residents, this seems like a reasonable baseline. Still, more discussion about the state of the world in the future in the absence of these proposed changes would improve this section.
3/5
8. How well does the analysis assess costs and benefits?
3/5
Does the analysis identify and quantify incremental costs of all alternatives considered?
The RIA calculates HIV treatment costs associated with HIV-infected legal residents. It also discusses a Congressional Budget Office cost estimate that includes some other federal expenditures, such as Food Stamps and Supplemental Security Income. Costs are calculated only for the option chosen.
3/5
Does the analysis identify all expenditures likely to arise as a result of the regulation?
The costs seem pretty thorough. In its Impact on Health Care Expenditures section of the analysis, a model (HIVcon) is used to examine treatment costs associated with newly identified persons infected with HIV regardless of payer following the 2004 standards of care. Given certain limitations, the estimates of the present value of lifetime medical costs for persons identified as HIV infected for a three year period are given.
4/5
Does the analysis identify how the regulation would likely affect the prices of goods and services?
The analysis states that, 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 . . . prices of goods and services."
3/5
Does the analysis examine costs that stem from changes in human behavior as consumers and producers respond to the regulation?
The RIA presents a variety of estimates of how many immigrants with HIV might enter the country if the regualtion is lifted, and these drive the cost calculations. No secondary behavioral effects are considered.
4/5
If costs are uncertain, does the analysis present a range of estimates and/or perform a sensitivity analysis?
The analysis notes that costs are uncertain, and HIV-infected immigrants may not have some other types of health care costs, so it is not even clear if the net cost figure would be positive or negative. Sensitivity analyses are performed to determine a range of estimates of the number of HIV-infected persons entering the U.S. annually and to determine the onward transmission rate of HIV for immigrants to assess health costs.
4/5
Does the analysis identify the alternative that maximizes net benefits?
Since the range of alternatives considered is narrow and benefits are not quantified, it is hard to determine from the analysis if this proposal maximizes net benefits. However, the RIA's qualitative description of benefits of the proposed changes is convincing. More description of the recent scientific knowledge and public health best practices would be helpful.
2/5
Does the analysis identify the cost-effectiveness of each alternative considered?
Since benefits are not estimated, cost-effectiveness is not calculated.
0/5
Does the analysis identify all parties who would bear costs and assess the incidence of costs?
It is not always clear who bears the "medical costs" associated with the HIV cases. Budgetary costs calculated by CBO are presumably borne by the federal government.
2/5
Does the analysis identify all parties who would receive benefits and assess the incidence of benefits?
Immigrants receive the most direct benefits, and the analysis hints there might be some indirect benefits for the nation as a whole, but these are not calculated or apportioned out.
1/5

Use

9. Does the proposed rule or the RIA present evidence that the agency used the analysis?
The actual RIA appears to have been developed after the fact to justify a decision reached for other reasons. A big part of the other reasons would be research that finds HIV is not spread through casual contact. However, this is merely asserted, without research cited to back it up.
1/5
10. Did the agency maximize net benefits or explain why it chose another alternative?
The RIA calculates the number of beneficiaries, but not total benefits or net benefits. Knowing the number of immigrants who would benefit could be the first step toward calculating net benefits. In some sense, HHS presents the net benefit decision as a "no brainer," since in thier view the current regulation imposes costs and generates no public health benefits.
1/5
11. Does the proposed rule establish measures and goals that can be used to track the regulation's results in the future?
No measures or goals are established, and the RIA is not complete enough to derive measures or goals.
0/5
12. Did the agency indicate what data it will use to assess the regulation's performance in the future and establish provisions for doing so?
Since the proposal eliminates mandatory HIV testing for immigrants seeking permanent resident status, it is difficult to see how HHS could even gather data that would measure how many immigrants benefit from the rule change in the future.
0/5
 
Total 28 / 60