Expanding Screening to Save Lives

AHIP Coverage (January/February 2007)

Expanding Screening to Save Lives
Health plans prepare for universal HIV testing.
By Jay Greene

With the U.S. Centers for Disease Control and Prevention now advising providers to offer HIV tests in health care settings to everyone ages 13 to 64, clinicians and health insurance plans are evaluating what changes need to be made in their HIV testing and counseling protocols to encourage more widespread screening. The 1993 CDC guidelines suggested routine counseling and testing for all persons at high risk for HIV and for those in acute-care hospital settings in which HIV prevalence was greater than 1 percent, or AIDS diagnosis rates of 1 per 1,000 discharges.

Before the new policy was released in the center’s Sept. 22 Morbidity and Mortality Weekly Report, CDC also had recommended that individuals receive detailed HIV prevention counseling before testing and that they sign an informed consent form. Now the CDC says pre-test counseling is not needed and that providers should include HIV screening as part of lab tests when rendering routine medical care. Providers also should inform patients of the HIV testing component and allow them to opt out if they choose. Counseling is still recommended if patients test positive for HIV.

“Using risk-based testing to identify HIV-infected persons is not working anymore,” says Bernard Branson, M.D., associate director for laboratory diagnostics in the CDC’s National Center for HIV, STD, and TB Prevention, Atlanta. Part of that is because risk is more diffuse, but it’s also that non-risk-based testing simply may be more effective. “We hope the new recommendations will identify people earlier in the course of the disease, when they are in the position to benefit more from treatment, and we hope it will reduce the number of new infections from people who have HIV but don’t know it.”

Branson says health care providers are often too busy to offer HIV tests, garner informed consent signatures, and provide counseling. Moreover, some people who engage in high-risk behaviors may feel stigmatized by the test and refuse to take it.

“You used to have to admit to being part of a high-risk group to request the test, and that created a barrier,” Branson notes. “People avoided taking the test because they did not want a claim form sent in [to their insurance company] that might have suggested they were in a high-risk group. We want to remove these barriers.” But he says that the primary reason for the CDC’s near-universal HIV screening recommendation is the large number of people who have the AIDS virus but do not know it.

The CDC estimates that 25 percent of more than 1 million people living with HIV do not know they have the AIDS virus. At least 40,000 new infections occur each year, and approximately 40 percent of those are so-called “late testers,” or people who test positive for HIV and are diagnosed with AIDS within a year after the test, Branson says. “This means they have been living with HIV for a long time—up to 10 years. Early testing will get these people into treatment much quicker and reduce the spread of the disease to others.”

While health plan executives interviewed for this article recognize that current outreach strategies still leave too many people undetected, there may be barriers to implementing the CDC’s new HIV testing recommendations. Nine states, including Connecticut, Illinois, and Kentucky, require pre- and post-test counseling, and 14 states require specific written informed consent, says the American Hospital Association’s Health Research and Educational Trust. Some states also specify who can perform testing, counseling, and partner notification services, creating a patchwork of regulation across the country.

“The requirement for pre-test counseling can be a huge barrier for doctors because of the amount of information that needs to be provided to patients,” says Enid Eck, Kaiser Permanente’s regional director of infection prevention and control in Pasadena, California. “We have not revised our HIV policy because of restrictions in state laws. We would be willing to work with legislators to get the law changed [to be in sync with the CDC’s recommendations]. Once the laws change, we will go through a formal policy revision.”
The CDC’s recommendations also reiterate its policy that all pregnant women should be tested for the virus during each pregnancy unless they opt out. The new policy adds that pregnant women engaging in high-risk behavior, including injection drug users or commercial sex workers or those who live in a higher prevalence region, should be tested again in the third trimester.

Despite CDC’s recommendations to test high-risk pregnant women for HIV since 1995, studies show only about 70 percent of women pregnant during 2002 were tested, Branson says. Over the past 10 years, women have been one of the fastest-growing groups with new HIV diagnoses. An estimated 6,000–7,000 HIV-positive women give birth each year in the United States, says the U.S. Preventive Services Task Force (USPSTF). From 2000 to 2004, the estimated number of new AIDS cases increased 10 percent among females and 7 percent among males. However, due to new medications designed for HIV-positive pregnant women, the estimated number of babies born with HIV has declined to less than 240 each year from about 1,650 in 1991, the CDC says.

Notes Branson, “We hope the new recommendations will further increase testing of pregnant women and all high-risk groups because the stigma of taking an HIV test will be removed as it becomes a routine part of medical care.”

Insurers Respond
Health plan executives at Humana, Aetna, and Kaiser Permanente say they support the CDC’s new HIV testing and counseling recommendations. “Making HIV testing a routine part of [medical care] will bring HIV and AIDS back into people’s attention in a way it hasn’t been for multiple years, and we support it,” says Steve Goldberg, M.D., corporate medical director, clinical policy for Humana in Louisville, Kentucky. “Routine testing elevates the profile of the test and will result in more conversations, more risk-avoidance behavior, and more early detection.”

Kaiser’s Eck says the policy will encourage people to seek tests. “It is appropriate because we still are in an epidemic, and there are still a large number of people who don’t know they are infected and put many people at risk because of that,” Eck says. “The CDC is right; we need to make testing a part of routine care.…We need to figure out how to do it.”

Joanne Armstrong, M.D., Aetna’s senior medical director in Sugar Land, Texas, says the Hartford-based insurer supports the recommendations. “We have updated our Clinical Policy Bulletin to reflect the recent CDC recommendations,” she says. She adds that Aetna pays for HIV screening based on task force and CDC recommendations, noting that Aetna’s claim system does not edit out HIV testing for population groups.

During the first three months of 2007, Goldberg expects Humana to finalize its new HIV testing policy. “We will update our policy to provide coverage for ‘routine’ HIV screening and testing.”

An HIV rapid test costs $3 to $15, experts say. Because of the time it takes for conventional HIV test results to become available, the CDC says in its report that “the use of rapid HIV tests can substantially decrease the number of persons who fail to learn their test results and reduce the resources expended to locate persons identified as HIV infected.” However, positive rapid HIV test results are preliminary and must be confirmed before the diagnosis is established.

Eck says including HIV screening is not that expensive compared with other tests doctors order. “The cost is more for the pre- and post-test counseling because that takes time,” she says. Although pre-test counseling is no longer included in CDC recommendations, state laws vary. The counseling can take 15 to 20 minutes—longer if patients have questions. If the HIV test is positive, Eck says post-test counseling can take another 20 to 30 minutes or longer, and then referrals are made for additional clinical and support resources.

“When we had no treatment people perceived it as a death sentence and responded with suicide and massive depression,” she continues. “Now we have lots of treatment and medicines [that can prolong life and improve quality of life], and research shows that if people test positive they change their behavior and stop infecting others.”

A 2005 study in the Journal of Acquired Immune Deficiency Syndromes indicated that there was a 68 percent reduction in unprotected sex among those who knew they had the AIDS virus. Another policy question that looms for health plans is test frequency. New studies show cost-effectiveness for HIV screenings every three to five years.

“In all but the lowest-risk populations, routine, voluntary screening for HIV once every three to five years is justified on both clinical and cost-effectiveness grounds. One-time screening in the general population may also be cost-effective,” according to a study in the Feb. 10, 2005, New England Journal of Medicine.

To help providers, Branson says the CDC plans to publish HIV implementation guidance over the next six months. A full implementation report should be released by June 2007. “The question is how to do this in the emergency department and in different settings like primary care or correctional settings,” Branson explains.

For example, studies show that the prevalence of positive HIV diagnoses is highest in emergency departments, he points out. Some 27 percent of positive HIV tests are in hospitals and emergency departments, 21 percent in public community clinics, and 17 percent in private physician offices, the CDC indicates.

“In emergency departments, it probably make more sense to do rapid tests, and if there is a preliminary positive, then link patients to counseling,” he says. Rapid tests take about 20 minutes or less for results compared with one to two weeks for conventional tests. On the other hand, Branson says physicians in primary care settings could recommend that patients include HIV testing as part of routine medical care. If there were national standards as opposed to state-by-state requirements, “They could order the test and then provide the results by telephone.”

Differing Policies
The CDC’s HIV-testing recommendation departs somewhat from the U.S. Preventive Services Task Force (USPSTF) policy—the gold standard that many health plans and professional physician groups use when formulating their own policies, says Ned Calonge, M.D., chair of the task force, the leading independent panel of private-sector experts in prevention and primary care.

“Currently our recommendation and the CDC’s are not congruent,” says Calonge, who also is chief medical officer of the Colorado Department of Public Health and Environment in Denver. “The CDC, in making its recommendations, cited additional literature published since our 2005 update. We now feel compelled to look at that report,” Calonge says.

In July 2005, the USPSTF modified its HIV testing policy to recommend that all pregnant women be tested for HIV along with people in high-risk population groups. Since 1996, the USPSTF had recommended that pregnant women in certain high-risk categories be tested. “We are more in agreement than in conflict,” Branson says. “The difference is in the settings.”

Calonge says the CDC recommends testing for HIV in more health care settings than the USPSTF currently encourages. The CDC’s policy advises testing for HIV in health care settings that include hospital emergency departments, inpatient and primary care settings, urgent care clinics, public health clinics, and correctional health care facilities, unless prevalence of undiagnosed HIV infection in patients has been documented at less than 0.1 percent (1 in 1,000). USPSTF advises testing patients in hospital acute-care settings where the prevalence of HIV is greater than 1 percent. “Most people don’t even know what the prevalence rate is in their health care setting,” Branson says.

Calonge says the USPSTF did not recommend universal screening for HIV in all settings because it concluded that the “benefit of screening adolescents and adults without risk factors for HIV is too small to justify a general recommendation.” However, the CDC’s decision-making process included review of a 2005 meta-analysis study published in the Journal of Acquired Immune Deficiency Syndromes showing that HIV-infected persons reduced high-risk behavior substantially when they became aware of their infection.

“In theory, new sexual HIV infections could be reduced (by more than) 30 percent per year if all infected persons could learn their HIV status and adopt changes in behavior similar to those adopted by persons already aware of their infection,” the CDC’s Sept. 22 report notes. Calonge says the JAIDS study is one of several pieces of information that the task force did not have available to review when it approved its policy in July 2005, a month before the JAIDS study was published.

“There is a concern that people with risk factors aren’t getting tested because of the stigma that has evolved with the HIV infection since 1980,” Calonge says. “A universal recommendation could make testing more acceptable to a wider range of people and could enhance screening among those with risk factors. We are going to review this.”

Data show that while the HIV infection rate declined from 1994 to 1999, it stabilized between 1999 and 2004 “and we haven’t been able to move it down,” Calonge says. “CDC is interested in moving it down and their motivation is they want to decrease the burden of illness of HIV infection.”

While the annual number of AIDS cases has declined since peaking at 78,000 diagnosed cases in 1992 to about 40,000 annually since 1998, the CDC indicates that the annual number of cases among blacks, members of other racial/ethnic minority populations, and persons exposed through heterosexual contact has increased.

“I think they have done a great job putting HIV in the front of people’s minds,” says Larry Fields, M.D., board chair of the American Academy of Family Physicians (AAFP), Leawood, Kansas. “It hasn’t been at the forefront because we have been talking about other things. HIV in this country is a terrible disease and is widespread.” A recent Gallup poll shows that the percentage of Americans who identified AIDS as the most urgent health problem in 2006 is 6 percent, down from 33 percent in 1999 and an all-time high of 68 percent in 1987.

Fields says his organization’s HIV policy follows USPSTF recommendations. “AAFP suggests that everybody who is at high risk be tested along with pregnant women,” he says. “The CDC recommends that everybody be tested. It is a good public health idea. I am not sure the evidence would support that. We will not change our recommendations unless the USPSTF changes theirs, but we will not discourage our members from following the CDC.”

USPSTF met last November and discussed its current recommendations in light of the new CDC recommendations, but the task force had not made that review public at press time. George Isham, M.D., a task force member and chief health officer and medical director at HealthPartners, Minneapolis, says HealthPartners will continue to pay for HIV tests but will most likely not encourage practitioners to follow the CDC recommendations. “We will have internal committees look at our policies and make a decision about how to proceed.”

Aetna’s Armstrong says the company’s Clinical Policy Bulletin, which was updated in November, includes both the USPSTF and CDC recommendations. “To the extent that we have two policy recommendations, it is a challenge for doctors to determine which one to follow,” Armstrong admits. With Kaiser, its policy is much more expansive than what USPSTF currently recommends but not as inclusive as the CDC’s new policy, Eck says.

“I foresee HIV testing to be a routine question providers ask patients in the next two to three years,” she predicts. “We are working to get there, expanding the populations tested and making sure people get tested at least once. Depending on the risk factors, we may recommend testing every three years. We are moving in the right direction.”
Jay Greene is a freelance writer in St. Paul, Minnesota.

[Sidebar]
Revisions to CDC’s HIV Testing Guidelines
For patients in all health care settings:

HIV screening is recommended for patients in all health care settings after the patient is notified that testing will be performed unless the patient declines (opt-out screening).
Persons at high risk for HIV infection should be screened for HIV at least annually.
Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing.
Prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in health care settings.

For pregnant women:

HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women.
HIV screening is recommended after the patient is notified that testing will be performed unless the patient declines (opt-out screening).
Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing.
Repeat screening in the third trimester is recommended in certain jurisdictions with elevated rates of HIV infection among pregnant women.

[Sidebar]
Risk Factors Defined by the USPSTF
According to the USPSTF, a person is considered at increased risk for HIV infection (and thus should be offered HIV testing) if he or she reports one or more individual risk factors or receives health care in a high-prevalence or high-risk clinical setting where the prevalence of HIV is greater than 1 percent. Increased risk factors include the following:

men who have had sex with men after 1975;
men and women having unprotected sex with multiple partners;
past or present injection drug users;
men and women who exchange sex for money or drugs or have sex partners who do;
individuals whose past or present sex partners were HIV-infected, bisexual, or injection drug users;
persons being treated for sexually transmitted diseases; and
persons with a history of blood transfusion between 1978 and 1985.

Persons who request an HIV test despite reporting no individual risk factors may also be considered at increased risk, since this group is likely to include individuals unwilling to disclose high-risk behaviors, the USPSTF says.