Existing law requires that every patient who has blood drawn at a primary care clinic, as defined, and who has consented to the test to be offered an HIV test that is consistent with the United States Preventive Services Task Force recommendations for screening for HIV infection. Existing law specifies the manner in which the results of that test are provided.

This bill would create a pilot project, administered by the State Department of Public Health, to assess and make recommendations regarding the effectiveness of the routine offering of an HIV test in the emergency department of a hospital. The bill would require the department to select 4 hospitals, or fewer under specified circumstances, that have emergency departments to voluntarily participate in the pilot project. The bill would require the participating hospitals to offer an HIV test to any patient in the hospital emergency department, as provided, to collect specified information, and to report the information to the department. The pilot project would commence on March 1, 2017, and end on February 28, 2019. The bill would require the department, by December 1, 2019, to complete a report to the Legislature on the findings of the hospitals in the pilot project and make recommendations about routine HIV testing in hospital emergency departments.

This bill would require that these provisions be implemented only to the extent that the department identifies available funding for the purposes of these provisions.

Existing law requires that every patient who has blood drawn at a primary care clinic, as defined, and who has consented to the test to be offered an HIV test that is consistent with the United States Preventive Services Task Force recommendations for screening for HIV infection. Existing law specifies the manner in which the results of that test are provided.

This bill would create a pilot project, administered by the State Department of Public Health, to assess and make recommendations regarding the effectiveness of the routine offering of an HIV test in the emergency department of a hospital. The bill would require the department to select 4 hospitals, or fewer under specified circumstances, that have emergency departments to voluntarily participate in the pilot project. The bill would require the participating hospitals to offer an HIV test to any patient in the hospital emergency department, as provided, to collect specified information, and to report the information to the department. The pilot project would commence on March 1, 2017, and end on February 28, 2019. The bill would require the department, by December 1, 2019, to complete a report to the Legislature on the findings of the hospitals in the pilot project and make recommendations about routine HIV testing in hospital emergency departments.

This bill would require that these provisions be implemented only to the extent that the department identifies available funding for the purposes of these provisions.

Existing law requires that every patient who has blood drawn at a primary care clinic, as defined, and who has consented to the test to be offered an HIV test that is consistent with the United States Preventive Services Task Force recommendations for screening for HIV infection. Existing law specifies the manner in which the results of that test are provided.

This bill would create a pilot project, administered by the State Department of Public Health, to assess and make recommendations regarding the effectiveness of the routine offering of an HIV test in the emergency department of a hospital. The bill would require the department to select 4 hospitals, as provided, or fewer under specified circumstances, that have emergency departments to voluntarily participate in the pilot project. The bill would require the participating hospitals to offer an HIV test to any patient in the hospital emergency department, as provided, to collect specified information, and to report the information to the department. The pilot project would commence on March 1, 2017, and end on February 28, 2019. The bill would require the department, by July December 1, 2019, to complete a report to the Legislature on the findings of the 4 hospitals in the pilot project and make recommendations about routine HIV testing in hospital emergency departments.

Existing law requires that every patient who has blood drawn at a primary care clinic, as defined, and who has consented to the test to be offered an HIV test that is consistent with the United States Preventive Services Task Force recommendations for screening for HIV infection. Existing law specifies the manner in which the results of that test are provided.

This bill would create a pilot project, administered by the State Department of Public Health, to assess and make recommendations regarding the effectiveness of the routine offering of an HIV test in the emergency department of a hospital. The bill would require the department to select 4 hospitals, as provided, that have emergency departments to voluntarily participate in the pilot project. The bill would require the participating hospitals to offer an HIV test to any patient in the hospital emergency department, as provided, to collect specified information, and to report the information to the department. The pilot project would commence on March 1, 2017, and end on February 28, 2019. The bill would require the department, by July 1, 2019, to complete a report to the Legislature on the findings of the 4 hospitals in the pilot project and make recommendations about routine HIV testing in hospital emergency departments.

Existing law requires that every patient who has blood drawn at a primary care clinic, as defined, and who has consented to the test to be offered an HIV test that is consistent with the United States Preventive Services Task Force recommendations for screening for HIV infection. Existing law specifies the manner in which the results of that test are provided.

This bill would create a pilot project, administered by the State Department of Public Health, to assess and make recommendations regarding the effectiveness of the routine offering of an HIV test in the emergency department of a hospital. The bill would require the department to select 4 hospitals, as provided, that have emergency departments to voluntarily participate in the pilot project. The bill would require the participating hospitals to offer an HIV test to any patient in the hospital emergency department, as provided, to collect specified information, and to report the information to the department. The pilot project would commence on March 1, 2017, and end on February 28, 2019. The bill would require the department, by July 1, 2019, to complete a report to the Legislature on the findings of the 4 hospitals in the pilot project and make recommendations about routine HIV testing in hospital emergency departments.

Existing law requires that every patient who has blood drawn at a primary care clinic, as defined, and who has consented to the test to be offered an HIV test that is consistent with the United States Preventive Services Task Force recommendations for screening for HIV infection. Existing law specifies the manner in which the results of that test are provided.

This bill would create a pilot project, administered by the State Department of Public Health, to assess and make recommendations regarding the effectiveness of the routine offering of an HIV test in the emergency department of a hospital. The bill would require the department to select 4 hospitals, as provided, that have emergency departments to voluntarily participate in the pilot project. The bill would require the participating hospitals to offer an HIV test to any patient in the hospital emergency department, as provided, to collect specified information, and to report the information to the department. The pilot project would commence on March 1, 2017, and end on February 28, 2019. The bill would require the department, by July 1, 2019, to complete a report to the Legislature on the findings of the 4 hospitals in the pilot project and make recommendations about routine HIV testing in hospital emergency departments.

Existing law requires that every patient who has blood drawn at a primary care clinic, as defined, and who has consented to the test to be offered an HIV test that is consistent with the United States Preventive Services Task Force recommendations for screening for HIV infection. Existing law specifies the manner in which the results of that test are provided.

Existing law requires that every patient who has blood drawn at a primary care clinic, as defined, and who has consented to the test to be offered an HIV test that is consistent with the United States Preventive Services Task Force recommendations for screening for HIV infection. Existing law specifies the manner in which the results of that test are provided.

This bill would, additionally, apply those provisions to the emergency department of a general acute care hospital. The bill would authorize a hospital emergency department to comply with certain requirements to provide information, counseling, and advice to a patient after the results of an HIV test have been received by providing the patient with printed material that includes that information and advice. The bill would exempt a hospital emergency department from the testing requirements if the personnel in the emergency department determine that the person is being treated for a life-threatening emergency or if the person lacks the capacity to consent to an HIV test.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 2439

Author:(Nazarian)

As Amended Ver:August 15, 2016

Majority vote

Original Committee Reference: HEALTH

SUMMARY: Creates a pilot project to be administered by the Department of Public Health (DPH), in order to assess and make recommendations regarding the effectiveness of the routine offering of a human immunodeficiency virus (HIV) test in the emergency department (ED) of a hospital.

The Senate amendments:

1. Specify that if an ED physician at a hospital in the pilot determines that a patient is in significant pain or distress, including psychological distress, the hospital will not offer an HIV test to the patient, but that once an ED physician determines that the patient has stabilized and is no longer in significant pain or distress, the hospital will offer an HIV test to the patient.
2. Authorize DPH to select fewer hospitals to participate in the pilot if an insufficient number of hospitals express willingness to voluntarily participate.
3. Specify that data on the pilot collected by participating hospitals will be in a form, manner, and timeframe determined by DPH.
4. Change the due date of the report on the pilot required of DPH from July 1, 2019, to December 1, 2019.
5. Specify that this bill will be implemented only to the extent that DPH identifies available funding.

FISCAL EFFECT:

1. One-time costs of $305,000 in 2016-17 and $560,000 in 2017-18 for DPH to oversee the pilot project (General Fund (GF)).
2. By requiring hospitals to offer additional HIV testing to patients, the bill will increase the number of tests provided and the number of previously undiagnosed individuals who will be diagnosed with HIV, typically leading to treatment. The number of additional tests provided and the number of previously undiagnosed cases of HIV discovered through those tests is subject to uncertainty. Based on information developed by the Office of Statewide Planning and Development, there are about 14 million emergency department patient encounters per year. If 10% of the encounters in participating hospitals lead to an HIV test and the population accepting the test has roughly the same rate of undiagnosed HIV as the overall state population, there would be about 10-20 newly diagnosed cases of HIV identified per year. This would result in the following state costs:
   1. About $150,000 per year for additional HIV testing (including follow up testing for positive test results) by the Medi-Cal program (GF and federal funds).
   2. About $200,000 per year to provide medical care Medi-Cal enrollees newly diagnosed with HIV (GF and federal funds).
   3. About $50,000 per year to provide medical care to new Aids Drug Assistance Program enrollees (federal funds and drug rebate funds).
3. Unknown long-term cost savings to Medi-Cal due to earlier medical intervention for HIV-positive Medi-Cal enrollees. To the extent that HIV-positive Medi-Cal enrollees are diagnosed earlier and begin treatment earlier, it is likely that the long-term health status of those individuals will improve and some of the health effects of HIV will be delayed or avoided. There are indications that untreated HIV causes long-term health impacts such as elevated risk of diabetes and heart disease, even before the effects of compromised immune system function associated with HIV infection become evident. Earlier diagnosis and treatment for HIV-positive individuals may to reduce long-term Medi-Cal expenditures for those individuals. However, to some unknown extent the improvement in health status and reduction in health care needs will be offset by longer lifespans, potentially offsetting cost savings.
4. Unknown cost savings due to reduced HIV infections in the state, including amongst Medi-Cal beneficiaries. There are academic findings that diagnosis of HIV significantly reduces the likelihood that an HIV positive individual will infect others. This is due both to a reduction in risky behavior by those aware of their HIV positive status and reductions in viral loads in the blood due to antiretroviral treatments. To the extent that the bill results in new diagnoses of HIV and that newly diagnosed individuals are able to access appropriate medical care, the bill is likely to prevent future HIV infections.

COMMENTS: According to the author, over the past three decades, almost every imaginable location to provide routine HIV testing has been employed to capture as many people as possible who may have engaged in risk behaviors. The author contends we continue to come up short, in large part because HIV testing is occurring only sporadically in the ED, the last major health care institution in California where HIV testing does not occur routinely. The author states despite dramatic advances in treatment options, there are more than 5,000 new infections in California every year and according to DPH, 16% of Californians who are HIV-positive do not know they are HIV-positive and thus are not getting treatment and unwittingly exposing uninfected people to HIV, and that number jumps to 58% for young people under the age of 24. The author continues, despite the many successes, the failures of our testing protocols are most pronounced among young people and people of color, noting that the state's HIV demographics are trending younger, notably increasing in those aged 20 to 29, and climbing infection rates among Black and Latino Californians, especially Black women.

The California Office of AIDS estimates that approximately 126,000 Californians are living with HIV, and of these, 23,000 or 18% are unaware of their HIV status. An estimated 6,000 Californians are newly diagnosed with HIV each year. Gay, bisexual, and other men who have sex with men (MSM) continue to be the risk group most heavily affected by HIV in California, accounting for over 70% of all persons diagnosed with HIV in 2013.

Unlike national statistics, new HIV diagnoses among all MSM in California decreased by over 13% (from 3,789 to 3,281) from 2005 to 2013 (versus a national increase of 6%). White MSM in California account for this decline, with an almost 35% decrease in new diagnoses (versus a national decrease of 18%). Both Latino and Black MSM in California had a net zero change in new HIV diagnoses from 2005 to 2013 (versus national increases of 24% and 22%, respectively). Only "other" race/ethnicities in California that had an increase in new HIV diagnoses during this period (an increase of 30% from 2005 to 2013, driven primarily by a 73% increase among Asians). "Other" race/ethnicity includes American Indian/Alaska Native, Asian, Native Hawaiian/Pacific Islander, and multi-racial persons.

However, young MSM aged 13 to 24 years old in California had an overall increase of 27% in new HIV diagnoses from 2005 to 2013 (from 536 in 2005 to 680 in 2013). This increase was driven by young Hispanic MSM, whose numbers increased by 35% (from 246 to 333). Diagnoses among young Black MSM in California increased by 16% (from 124 to 144) during this period. Among young white MSM new diagnoses increased approximately 8% (from 130 to 140), compared to 56% nationally. New HIV diagnoses among young MSM of other race/ethnicities in California increased by an even higher percentage (75%) from 2005 to 2013, but there are relatively few cases in this group (36 in 2005 to 63 in 2013).

In September 2006, the Centers for Disease Control and Prevention (CDC) released, "Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings." These recommendations advise routine HIV screening of adults, adolescents, and pregnant women in health care settings in the United States. The CDC also recommends reducing barriers to HIV testing. In April 2013, the United States Preventive Services Task Force (USPSTF) issued similar recommendations. According to these recommendations, clinicians should routinely screen adolescents and adults ages 15 to 65 years for HIV infection. Younger adolescents and older adults who are at increased risk should also be screened. USPSTF also recommends screening all pregnant women for HIV, including those who present in labor whose HIV status is unknown.

Hospitals in two of California's largest urban settings, the Alameda County Medical Center (ACMC) and Los Angeles County + University of Southern California Medical Center (LAC+USC) have been successful in integrating routine HIV testing in their EDs, although neither facility has offered HIV testing to every patient receiving a blood draw as this bill would require. As an early adopter of HIV testing in their ED, ACMC utilized medical staff for the introduction and provision of HIV tests. Over a three year demonstration project (2010-12), ACMC identified 52 new HIV cases from 45,210 HIV tests conducted with a positivity yield of 0.1%. In 2005, LAC+USC utilized a rapid test approach, embedding test counselors to introduce and provide HIV tests, and identified 13 new cases of HIV among 1,713 patients tested yielding a positivity yield of 0.8%. In addition, a regional hospital, Desert Regional Medical Center in Palm Springs, has implemented HIV testing in its ED. In 2015, it tested 810 patients of which 17 were HIV positive for a positivity rate of 2%. These positivity yields meet the benchmark of 0.1% determined by the CDC to demonstrate cost effectiveness of HIV testing in healthcare settings.

The AIDS Healthcare Foundation (AHF) is the sponsor of this bill and states despite dramatic advances in treatment options, there are more than 5,000 new infections in California every year, and everyday more than a dozen Californians are being infected with HIV. AHF contends that while almost every imaginable location that provides routine HIV testing has been employed to capture as many people as possible who may have engaged in risk behaviors, we continue to come up short in large part because HIV testing is occurring only sporadically in hospital EDs, the last major health care institution where HIV testing does not occur routinely.

The California Chapter of the American College (Cal/ACEP) opposes this bill stating that the pilot project requires every patient in an ED to be offered an HIV test, whether they are having their blood drawn already or not, and as a practical matter, this means that a patient who is there for a broken foot, stiches, a concussion, or any other medical condition that does not require blood to be drawn, will have their blood drawn as a purely public health screening measure. Cal/ACEP notes that it is aware that the CDC has stated that hospitals with an AIDS diagnosis rate greater than one per 1,000 discharges should adopt a policy of offering HIV counseling and testing routinely to patients aged 15 to 54 years, however if ED prophylactically tested for all diseases with a 0.001% prevalence, life-saving care to acutely ill patients would come to a screeching halt.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0004123 0003258

 THIRD READING  

Bill No: AB 2439

Author:

:

Vote:

SENATE HEALTH COMMITTEE: 7-0, 6/29/16

AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Pan, Roth

NO VOTE RECORDED: Nielsen, Wolk

SENATE APPROPRIATIONS COMMITTEE: 5-2, 8/11/16

AYES: Lara, Beall, Hill, McGuire, Mendoza

NOES: Bates, Nielsen

ASSEMBLY FLOOR: 54-24, 6/2/16 - See last page for vote

SUBJECT:

SOURCE: AIDS Healthcare Foundation

DIGEST: This bill creates a pilot project, to be administered by the Department of Public Health (DPH), in order to assess and make recommendations regarding the effectiveness of the routine offering of an HIV test in the emergency department (ED) of a hospital. Requires DPH to select four hospitals that have EDs to voluntarily participate in the pilot project, as specified.

ANALYSIS:

Existing law:

1. Requires each patient who has blood drawn at a primary care clinic, and who has consented, to be offered an HIV test, consistent with the United States Preventive Services Task Force (USPSTF) recommendation for screening the HIV infection.
2. Requires a medical provider, prior to ordering an HIV test to inform the patient that the test is planned, provide information about the test, inform the patient that there are numerous treatment options available for a patient who tests positive for HIV and that a person who tests negative for HIV should continue to be routinely tested, and advise the patient that he or she has the right to decline the test. If a patient declines the test, the medical care provider is required to note that fact in the patient’s medical file. These provisions do not apply when a person independently requests an HIV test from a medical care provider.
3. Requires the medical provider or other person administering the test, after the results of an HIV test have been received, to ensure that the patient receives timely information and counseling, as appropriate, to explain the results and the implications for the patient’s health. If the patient tests positive for HIV infection, the medical provider or the person who administers the test is required to inform the patient that there are numerous treatment options available and identify follow-up testing and care that may be recommended, including contact information for medical and psychological services. If the patient tests negative but is known to be at high risk for HIV infection, the medical provider or the person who administers the test is required to advise the patient of the need for periodic retesting, explain the limitations of current testing technology and the current window period for verification of results, and is permitted offer prevention counseling or a referral to prevention counseling.

This bill:

1. Creates a pilot project, to be administered by DPH, in order to assess and make recommendations regarding the effectiveness of the routine offering of an HIV test in the ED of a hospital. Requires DPH to select four hospitals that have EDs to voluntarily participate in the pilot project, as follows:
   1. Two of the hospitals from large urban areas;
   2. One hospital from a small urban or suburban area; and,
   3. One hospital from a rural area.
2. Permits DPH to select fewer hospitals if an insufficient number of hospital express willingness to voluntarily participate.
3. Requires each hospital in the pilot project to offer an HIV test to any patient in the ED who has consented to the HIV test. Requires the ED to comply with existing law related to HIV testing, and permits the ED to comply either by using hospital personnel or engaging the services of an HIV organization that has experience in prevention counseling for persons at risk for HIV.
4. Prohibits a hospital in the pilot project from offering a test to any person who is being treated for a life-threatening emergency or who lacks the capacity to consent to an HIV test.
5. Requires a hospital in the pilot project to offer HIV tests to individuals between 15 and 65 years of age pursuant to USPSTF recommendations.
6. Authorizes a hospital in the pilot project to charge a patient for the cost of the HIV testing.
7. Requires a hospital in the pilot project to be directed by DPH, in a form, manner, and timeframe determined by DPH, to collect and report data on:
   1. The frequency of HIV test offers;
   2. The frequency of consent or non-consent to an HIV test and any reasons given by the patient for the consent or the non-consent;
   3. The time taken to offer an HIV test and secure consent from a patient and the time taken to provide information and counseling, as specified;
   4. The aggregate HIV positivity rate;
   5. The frequency with which patients agree to participate in a session to receive information and counseling pursuant to existing law related to HIV testing and the reasons that patients give for refusing to participate; and,
   6. The frequency of patients leaving the ED without receiving their test results.
8. Requires a hospital in the pilot project to provide information to DPH regarding its practices and protocols for implementing the offer of an HIV test and the required follow-up to the test, as well as an assessment of the effectiveness of those practices and protocols.
9. Commences the pilot project on March 1, 2017, and ends it on February 28, 2019.
10. Requires DPH, by December 1, 2019, to complete a report to the Legislature on the findings of the four hospitals in the pilot project and make recommendations about routine HIV testing in EDs, as specified. Requires DPH, in preparing the report to the Legislature, to solicit input from a broad range of HIV testing and hospital stakeholders. Makes this provision inoperative on July 1, 2023, as specified.
11. Requires this bill to be implemented only to the extent that DPH identifies available funding for its purposes. Permits DPH to seek or use private funding to cover the costs of administering the pilot project.

Background

According to a 2015 Centers for Disease Control and Prevention (CDC) report, an estimated 1,148,200 persons aged 13 years and older are living with HIV infection. Over the past decade, the number of people living with HIV has increased, while the annual number of new HIV infections has remained relatively stable. Still, the pace of new infections continues at far too high a level, particularly among certain groups. The estimated incidence of HIV has remained stable overall in recent years, at about 50,000 new HIV infections per year. Within the overall estimates, however, some groups are affected more than others. Men who have sex with men continue to bear the greatest burden of HIV infection, and among races/ethnicities, African Americans continue to be disproportionately affected. In 2013, an estimated 47,352 people were diagnosed with HIV infection in the United States. In that same year, an estimated 26,688 people were diagnosed with AIDS. Overall, an estimated 1,194,039 people in the United States have been diagnosed with AIDS. An estimated 13,712 people with an AIDS diagnosis died in 2012, and approximately 658,507 people in the United States with an AIDS diagnosis have died overall. The deaths of persons with an AIDS diagnosis can be due to any cause—that is, the death may or may not be related to AIDS.

1. HIV positive but unaware. According to the CDC, of the nearly 1.2 million people estimated to be living with HIV in the U.S., nearly one in seven (more than 168,000) do not know they are infected. According to the California Office of AIDS, as of the end of 2011, it is estimated that between 29,523 and 31,948 HIV-positive and unaware individuals reside in California. Because many new infections are transmitted by people who do not know they are infected, undiagnosed infection remains a significant factor fueling the HIV epidemic. According to the CDC, when HIV is diagnosed early, appropriately timed interventions, particularly highly active antiretroviral therapy, can lead to improved health outcomes, including slower clinical progression and reduced mortality. Additionally, HIV counseling with testing has been demonstrated to be an effective intervention for HIV-infected participants, who increased their safer behaviors and decreased risk behaviors.

Comments

Author’s statement. According to the author, the National Association of State and Territorial AIDS Directors declared in its most recent report that “hospital emergency rooms continue to play a critical role in the successful expansion of HIV testing.” Given that there are more than 5,000 new HIV infections in California every year, AB 2439 will bridge the gap in lack of HIV testing by requiring the four selected hospitals to offer an HIV test to patients that have been admitted via the ED. The emergency room trigger is key, as emergency rooms will continue to play a critical role in delivering primary care services to many new enrollees and to those who remain uninsured. AB 2439 recognizes that emergency rooms continue to play a vital role in helping to identify individuals with HIV.

FISCAL EFFECT: Appropriation: Fiscal Com.: Local:

According to the Senate Appropriations Committee:

1. One-time costs of $305,000 in 2016-17 and $560,000 in 2017-18 for the DPH to oversee the pilot project (General Fund).
2. By requiring hospitals to offer additional HIV testing to patients, the bill will increase the number of tests provided and the number of previously undiagnosed individuals who will be diagnosed with HIV, typically leading to treatment. The number of additional tests provided and the number of previously undiagnosed cases of HIV discovered through those tests is subject to uncertainty. Based on information developed by the Office of Statewide Planning and Development, there are about 14 million ED patient encounters per year. If 10% of the encounters in participating hospitals lead to an HIV test and the population accepting the test has roughly the same rate of undiagnosed HIV as the overall state population, there would be about 10-20 newly diagnosed cases of HIV identified per year. This would result in the following state costs:
   1. About $150,000 per year for additional HIV testing (including follow up testing for positive test results) by the Medi-Cal program (General Fund and federal funds).
   2. About $200,000 per year to provide medical care Medi-Cal enrollees newly diagnosed with HIV (General Fund and federal funds).
   3. About $50,000 per year to provide medical care to new AIDS Drug Assistance Program enrollees (federal funds and drug rebate funds).
3. Unknown long-term cost savings to Medi-Cal due to earlier medical intervention for HIV-positive Medi-Cal enrollees. To the extent that HIV-positive Medi-Cal enrollees are diagnosed earlier and begin treatment earlier, it is likely that the long-term health status of those individuals will improve and some of the health effects of HIV will be delayed or avoided. There are indications that untreated HIV causes long-term health impacts such as elevated risk of diabetes and heart disease, even before the effects of compromised immune system function associated with HIV infection become evident. Earlier diagnosis and treatment for HIV-positive individuals may to reduce long-term Medi-Cal expenditures for those individuals. However, to some unknown extent the improvement in health status and reduction in health care needs will be offset by longer lifespans, potentially offsetting cost savings.
4. Unknown cost savings due to reduced HIV infections in the state, including amongst Medi-Cal beneficiaries. There are academic findings that diagnosis of HIV significantly reduces the likelihood that an HIV positive individual will infect others. This is due both to a reduction in risky behavior by those aware of their HIV positive status and reductions in viral loads in the blood due to antiretroviral treatments. To the extent that the bill results in new diagnoses of HIV and that newly diagnosed individuals are able to access appropriate medical care, the bill is likely to prevent future HIV infections.

SUPPORT: (Verified 8/12/16)

AIDS Healthcare Foundation (source)

Beyond AIDS

City of West Hollywood

OPPOSITION: (Verified 8/12/16)

None received

ARGUMENTS IN SUPPORT: The AIDS Healthcare Foundation (AHF) is the sponsor of this bill and states despite dramatic advances in treatment options, there are more than 5,000 new infections in California every year, and everyday more than a dozen Californians are being infected with HIV. AHF contends that while almost every imaginable location that provides routine HIV testing has been employed to capture as many people as possible who may have engaged in risk behaviors, we continue to come up short in large part because HIV testing is occurring only sporadically in hospital EDs, the last major health care institution where HIV testing does not occur routinely.

ASSEMBLY FLOOR: 54-24, 6/2/16

AYES: Achadjian, Alejo, Atkins, Baker, Bloom, Bonilla, Bonta, Brown, Burke, Calderon, Campos, Chau, Chiu, Chu, Cooley, Cooper, Dababneh, Daly, Dodd, Eggman, Frazier, Cristina Garcia, Eduardo Garcia, Gipson, Gomez, Gonzalez, Hadley, Roger Hernández, Holden, Irwin, Jones-Sawyer, Levine, Linder, Lopez, Low, Maienschein, Mayes, McCarty, Mullin, Nazarian, O'Donnell, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Mark Stone, Thurmond, Ting, Waldron, Weber, Williams, Wood, Rendon

NOES: Travis Allen, Arambula, Bigelow, Brough, Chang, Chávez, Dahle, Beth Gaines, Gallagher, Gatto, Gray, Grove, Harper, Jones, Kim, Lackey, Mathis, Melendez, Obernolte, Olsen, Patterson, Steinorth, Wagner, Wilk

NO VOTE RECORDED: Gordon, Medina

Prepared by:

8/15/16 20:33:29

**** END ****

SENATE COMMITTEE ON

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

AB 2439 (Nazarian) - HIV testing

*********** ANALYSIS ADDENDUM – SUSPENSE FILE ***********

The following information is revised to reflect amendments

adopted by the committee on August 11, 2016

Bill Summary:

AB 2439 would create a pilot project to assess the effectiveness of routinely offering HIV tests in the emergency department of a hospital.

Fiscal Impact:

• One-time costs of $305,000 in 2016-17 and $560,000 in 2017-18 for the Department of Public Health to oversee the pilot project (General Fund).
• By requiring hospitals to offer additional HIV testing to patients, the bill will increase the number of tests provided and the number of previously undiagnosed individuals who will be diagnosed with HIV, typically leading to treatment. The number of additional tests provided and the number of previously undiagnosed cases of HIV discovered through those tests is subject to uncertainty. Based on information developed by the Office of Statewide Planning and Development, there are about 14 million emergency department patient encounters per year. If 10% of the encounters in participating hospitals lead to an HIV test and the population accepting the test has roughly the same rate of undiagnosed HIV as the overall state population, there would be about 10-20 newly diagnosed cases of HIV identified per year. This would result in the following state costs:
  • About $150,000 per year for additional HIV testing (including follow up testing for positive test results) by the Medi-Cal program (General Fund and federal funds).
  • About $200,000 per year to provide medical care Medi-Cal enrollees newly diagnosed with HIV (General Fund and federal funds).
  • About $50,000 per year to provide medical care to new Aids Drug Assistance Program enrollees (federal funds and drug rebate funds).
• Unknown long-term cost savings to Medi-Cal due to earlier medical intervention for HIV-positive Medi-Cal enrollees. To the extent that HIV-positive Medi-Cal enrollees are diagnosed earlier and begin treatment earlier, it is likely that the long-term health status of those individuals will improve and some of the health effects of HIV will be delayed or avoided. There are indications that untreated HIV causes long-term health impacts such as elevated risk of diabetes and heart disease, even before the effects of compromised immune system function associated with HIV infection become evident. Earlier diagnosis and treatment for HIV-positive individuals may to reduce long-term Medi-Cal expenditures for those individuals. However, to some unknown extent the improvement in health status and reduction in health care needs will be offset by longer lifespans, potentially offsetting cost savings.
• Unknown cost savings due to reduced HIV infections in the state, including amongst Medi-Cal beneficiaries. There are academic findings that diagnosis of HIV significantly reduces the likelihood that an HIV positive individual will infect others. This is due both to a reduction in risky behavior by those aware of their HIV positive status and reductions in viral loads in the blood due to antiretroviral treatments. To the extent that the bill results in new diagnoses of HIV and that newly diagnosed individuals are able to access appropriate medical care, the bill is likely to prevent future HIV infections.

Author Amendments:

Authorize the Department to select fewer than four hospitals, delay the reporting requirements, and make technical changes.

-- END --

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

AB 2439 (Nazarian) - HIV testing

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

AB 2439 would create a pilot project to assess the effectiveness of routinely offering HIV tests in the emergency department of a hospital.

Fiscal Impact:

• One-time costs of $305,000 in 2016-17 and $560,000 in 2017-18 for the Department of Public Health to oversee the pilot project (General Fund).
• By requiring hospitals to offer additional HIV testing to patients, the bill will increase the number of tests provided and the number of previously undiagnosed individuals who will be diagnosed with HIV, typically leading to treatment. The number of additional tests provided and the number of previously undiagnosed cases of HIV discovered through those tests is subject to uncertainty. Based on information developed by the Office of Statewide Planning and Development, there are about 14 million emergency department patient encounters per year. If 10% of the encounters in participating hospitals lead to an HIV test and the population accepting the test has roughly the same rate of undiagnosed HIV as the overall state population, there would be about 10-20 newly diagnosed cases of HIV identified per year. This would result in the following state costs:
  • About $150,000 per year for additional HIV testing (including follow up testing for positive test results) by the Medi-Cal program (General Fund and federal funds).
  • About $200,000 per year to provide medical care Medi-Cal enrollees newly diagnosed with HIV (General Fund and federal funds).
  • About $50,000 per year to provide medical care to new Aids Drug Assistance Program enrollees (federal funds and drug rebate funds).
• Unknown long-term cost savings to Medi-Cal due to earlier medical intervention for HIV-positive Medi-Cal enrollees. To the extent that HIV-positive Medi-Cal enrollees are diagnosed earlier and begin treatment earlier, it is likely that the long-term health status of those individuals will improve and some of the health effects of HIV will be delayed or avoided. There are indications that untreated HIV causes long-term health impacts such as elevated risk of diabetes and heart disease, even before the effects of compromised immune system function associated with HIV infection become evident. Earlier diagnosis and treatment for HIV-positive individuals may to reduce long-term Medi-Cal expenditures for those individuals. However, to some unknown extent the improvement in health status and reduction in health care needs will be offset by longer lifespans, potentially offsetting cost savings.
• Unknown cost savings due to reduced HIV infections in the state, including amongst Medi-Cal beneficiaries. There are academic findings that diagnosis of HIV significantly reduces the likelihood that an HIV positive individual will infect others. This is due both to a reduction in risky behavior by those aware of their HIV positive status and reductions in viral loads in the blood due to antiretroviral treatments. To the extent that the bill results in new diagnoses of HIV and that newly diagnosed individuals are able to access appropriate medical care, the bill is likely to prevent future HIV infections.

Background:

Under current law, patients who have blood drawn at primary care clinics must be offered an HIV test by the clinic.

Under state and federal law, the Department of Health Care Services operates the Medi-Cal program, which provides health care coverage to low income individuals, families, and children. Medi-Cal provides coverage to childless adults and parents with household incomes up to 138% of the federal poverty level and to children with household incomes up to 266% of the federal poverty level. The federal government provides matching funds that vary from 50% to 90% of expenditures depending on the category of beneficiary.

In addition, the Department of Public Health manages the Aids Drug Assistance Program which offers coverage for treatment of HIV to those who do not qualify for Medi-Cal.

Current law mandates that all individual and group health plans and insurance policies provide coverage for HIV testing.

Proposed Law:

AB 2439 would create a pilot project to assess the effectiveness of routinely offering HIV tests in the emergency department of a hospital.

Specific provisions of the bill would:

• Establish a pilot project to assess and make recommendations regarding the effectiveness of routinely offering an HIV test in the emergency department of a hospital;
• Require the Department of Public Health to administer the pilot project;
• Require the Department to select four hospitals to voluntarily participate;
• Require participating hospitals to offer an HIV test to any patient in the hospital emergency department who has consented to the test, with certain exceptions;
• Require participating hospitals to report specified data to the Department;
• Make the term of the pilot project March 1, 2017 to February 28, 2019;
• Require the Department to report to the Legislature by July 1, 2019 on the results of the pilot project;
• Authorize the Department to seek or use private funding to support the pilot project.

Related Legislation:

• AB 2640 (Gipson) would require a medical provider administering an HIV test to provide information on pre- and post-exposure prophylaxis to individuals with a negative result who are at high risk of HIV infection. That bill will be heard in this committee.
• AB 521 (Nazarian, 2015) would have required a general acute care hospital to offer an HIV test to any individual who has been admitted to the hospital through the emergency department and who has blood drawn after admission to the hospital. That bill was vetoed by Governor Brown.

Staff Comments:

Current law requires health plans and health insurers to cover HIV testing. However, the enrollee cost sharing for such testing will vary based on the individual’s plan and the network status of the hospital providing the HIV test. An individual with commercial health insurance may be required to pay a deductible or copay associated with the test required in the bill. In addition, if the hospital is not in the enrollee’s plan network, the enrollee may be required to cover a larger share of cost, potentially the entire cost of the test, depending on the terms of coverage.

The state’s Medi-Cal program covers HIV testing with no cost sharing for beneficiaries. Because HIV screening has been recommended for individuals between 15 and 65 years of age by the United States Preventative Services Taskforce, the Department of Health Care Services indicates that the cost of the screening provided under the bill would be covered by Medi-Cal.

This bill is narrower than AB 521, in that this bill would require a pilot project limited to four hospitals. However, under AB 521 an HIV test would have been offered only to an individual who was admitted to the hospital through the emergency department. This bill would require an HIV test to be offered as part of any encounter in an emergency department (with some limitations). Because a small portion of emergency department encounters lead to hospital admissions, staff estimates that the overall number of HIV tests that would be offered under this bill would be roughly 25% of those that would have been offered under AB 521.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 2439

SUBJECT: HIV testing

SUMMARY:

Creates a pilot project, to be administered by the Department of Public Health (DPH), in order to assess and make recommendations regarding the effectiveness of the routine offering of an HIV test in the emergency department (ED) of a hospital. Requires DPH to select four hospitals that have EDs to voluntarily participate in the pilot project, as specified.

Existing law:

1. Requires each patient who has blood drawn at a primary care clinic, and who has consented, to be offered an HIV test, consistent with the United States Preventive Services Task Force (USPSTF) recommendation for screening the HIV infection.
2. Requires a medical provider, prior to ordering an HIV test to inform the patient that the test is planned, provide information about the test, inform the patient that there are numerous treatment options available for a patient who tests positive for HIV and that a person who tests negative for HIV should continue to be routinely tested, and advise the patient that he or she has the right to decline the test. If a patient declines the test, the medical care provider is required to note that fact in the patient’s medical file. These provisions do not apply when a person independently requests an HIV test from a medical care provider.
3. Requires the medical provider or other person administering the test, after the results of an HIV test have been received, to ensure that the patient receives timely information and counseling, as appropriate, to explain the results and the implications for the patient’s health. If the patient tests positive for HIV infection, the medical provider or the person who administers the test is required to inform the patient that there are numerous treatment options available and identify follow-up testing and care that may be recommended, including contact information for medical and psychological services. If the patient tests negative but is known to be at high risk for HIV infection, the medical provider or the person who administers the test is required to advise the patient of the need for periodic retesting, explain the limitations of current testing technology and the current window period for verification of results, and is permitted offer prevention counseling or a referral to prevention counseling.

This bill:

1. Creates a pilot project, to be administered by DPH, in order to assess and make recommendations regarding the effectiveness of the routine offering of an HIV test in the ED of a hospital. Requires DPH to select four hospitals that have EDs to voluntarily participate in the pilot project, as follows:
   1. Two of the hospitals from large urban areas;
   2. One hospital from a small urban or suburban area; and,
   3. One hospital from a rural area.
2. Requires each hospital in the pilot project to offer an HIV test to any patient in the ED who has consented to the HIV test. Requires the ED to comply with existing law related to HIV testing, and permits the ED to comply either by using hospital personnel or engaging the services of an HIV organization that has experience in prevention counseling for persons at risk for HIV.
3. Prohibits a hospital in the pilot project from offering a test to any person who is being treated for a life-threatening emergency or who lacks the capacity to consent to an HIV test.
4. Requires a hospital in the pilot project to offer HIV tests to individuals between 15 and 65 years of age pursuant to USPSTF recommendations.
5. Authorizes a hospital in the pilot project to charge a patient for the cost of the HIV testing.
6. Requires a hospital in the pilot project to be directed by DPH to collect and report data on:
   1. The frequency of HIV test offers;
   2. The frequency of consent or non-consent to an HIV test and any reasons given by the patient for the consent or the non-consent;
   3. The time taken to offer an HIV test and secure consent from a patient and the time taken to provide information and counseling, as specified;
   4. The aggregate HIV positivity rate;
   5. The frequency with which patients agree to participate in a session to receive information and counseling pursuant to existing law related to HIV testing and the reasons that patients give for refusing to participate; and,
   6. The frequency of patients leaving the ED without receiving their test results.
7. Requires a hospital in the pilot project to provide information to DPH regarding its practices and protocols for implementing the offer of an HIV test and the required followup to the test, as well as an assessment of the effectiveness of those practices and protocols.
8. Commences the pilot project on March 1, 2017, and ends it on February 28, 2019.
9. Requires DPH, by July 1, 2019, to complete a report to the Legislature on the findings of the four hospitals in the pilot project and make recommendations about routine HIV testing in EDs, as specified. Requires DPH, in preparing the report to the Legislature, to solicit input from a broad range of HIV testing and hospital stakeholders. Makes this provision inoperative on July 1, 2023, as specified.
10. Permits DPH to seek or use private funding to cover the costs of administering the pilot project.

FISCAL EFFECT:

According to the Assembly Appropriations Committee:

1. Staff costs to DPH of $305,000 in fiscal year 2016-17, $550,000 in 2017-18, and $275,000 in 2018-19 to implement and manage the pilot project, collect data, and prepare a report (General Fund (GF) or private funds).
2. Cost pressure to provide funding for hospitals to participate in this project. Although they can be reimbursed for HIV testing, it is unclear whether hospitals would participate without funding for enhanced tracking and data collection efforts. A current Centers for Disease Control and Prevention (CDC) grant provides $270,000 per year to each hospital participating in a similar pilot project (GF or private funds).
3. Identifying more individuals with HIV could increase testing and treatment costs to Medi-Cal and the AIDS Drug Assistance Program, and potentially reduce long-term costs by identifying HIV infection and beginning treatment earlier before significant medical complications arise, as well as by potentially preventing additional transmission. The pilot project is relatively small and thus any fiscal impact to the state for additional treatment would be small. The net effect on costs is unknown.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, the National Association of State and Territorial AIDS Directors declared in its most recent report that “hospital emergency rooms continue to play a critical role in the successful expansion of HIV testing.” Given that there are more than 5,000 new HIV infections in California every year, AB 2439 will bridge the gap in lack of HIV testing by requiring the four selected hospitals to offer an HIV test to patients that have been admitted via the emergency department. The emergency room trigger is key, as emergency rooms will continue to play a critical role in delivering primary care services to many new enrollees and to those who remain uninsured. AB 2439 recognizes that emergency rooms continue to play a vital role in helping to identify individuals with HIV.
2. Background. According to a 2015 CDC report, an estimated 1,148,200 persons aged 13 years and older are living with HIV infection. Over the past decade, the number of people living with HIV has increased, while the annual number of new HIV infections has remained relatively stable. Still, the pace of new infections continues at far too high a level, particularly among certain groups. The estimated incidence of HIV has remained stable overall in recent years, at about 50,000 new HIV infections per year. Within the overall estimates, however, some groups are affected more than others. Men who have sex with men (MSM) continue to bear the greatest burden of HIV infection, and among races/ethnicities, African Americans continue to be disproportionately affected. In 2013, an estimated 47,352 people were diagnosed with HIV infection in the United States. In that same year, an estimated 26,688 people were diagnosed with AIDS. Overall, an estimated 1,194,039 people in the United States have been diagnosed with AIDS. An estimated 13,712 people with an AIDS diagnosis died in 2012, and approximately 658,507 people in the United States with an AIDS diagnosis have died overall. The deaths of persons with an AIDS diagnosis can be due to any cause—that is, the death may or may not be related to AIDS.
3. HIV positive but unaware. According to the CDC, of the nearly 1.2 million people estimated to be living with HIV in the US, nearly one in seven (more than 168,000) do not know they are infected. According to the California Office of AIDS, as of the end of 2011, it is estimated that between 29,523 and 31,948 HIV-positive and unaware individuals reside in California. Because many new infections are transmitted by people who do not know they are infected, undiagnosed infection remains a significant factor fueling the HIV epidemic. According to the CDC, when HIV is diagnosed early, appropriately timed interventions, particularly highly active antiretroviral therapy, can lead to improved health outcomes, including slower clinical progression and reduced mortality. Additionally, HIV counseling with testing has been demonstrated to be an effective intervention for HIV-infected participants, who increased their safer behaviors and decreased risk behaviors.
4. Related legislation. AB 2640 (Gipson) would require a medical care provider or person administering a test for HIV to inform individuals who test negative for HIV infection, yet are at high risk for HIV infection, of the effectiveness and safety of all federal Food and Drug Administration approved methods that prevent or reduce the risk of contracting HIV, including pre-exposure prophylaxis and post-exposure prophylaxis, consistent with guidance of the CDC. AB 2640 is set to the heard in the Senate Health Committee on June 29, 2016.
5. Prior legislation. AB 521 (Nazarian of 2015) would have required a patient admitted as an inpatient to a hospital through the ED that had blood drawn after being admitted to the hospital, and who consented, to be offered an HIV test. AB 521 was vetoed by the Governor, stating in part: "…hospitals are not appropriately staffed nor are they the place to provide counseling, routine preventive screenings, or follow-up care for sensitive HIV testing. Limited resources would be better spent supporting outreach and education activities by existing providers which have the staff and training for HIV testing and follow-up care."
6. Support. The AIDS Healthcare Foundation (AHF) is the sponsor of this bill and states despite dramatic advances in treatment options, there are more than 5,000 new infections in California every year, and everyday more than a dozen Californians are being infected with HIV. AHF contends that while almost every imaginable location that provides routine HIV testing has been employed to capture as many people as possible who may have engaged in risk behaviors, we continue to come up short in large part because HIV testing is occurring only sporadically in hospital EDs, the last major health care institution where HIV testing does not occur routinely.
7. Author’s amendments. The author requests that the Committee approve the following amendments respond to concerns about the offer of an HIV test when an ED patient is in too much pain or distress to give consent or when a minor patient does not feel free to make a decision about consent because of the presence of a parent or guardian.  

• 1. On page 2, between lines 24 and 25, insert:

(2) If an emergency department physician at a hospital in the pilot project determines that a patient is in significant pain or distress, including psychological distress, the hospital shall not offer a HIV test to the patient. Once an emergency department physician determines that the patient has stabilized and is no longer in significant pain or distress, including psychological distress, the hospital shall offer a HIV test to the patient.

• 1. On page 2, in line 28, after the period insert:

In order to protect the confidentiality and privacy interests of minors, the hospital shall not offer HIV test to individuals 15 to 17 years of age, inclusive, in the presence of their parent or legal guardian.

SUPPORT AND OPPOSITION:

Support: AIDS Healthcare Foundation (sponsor)

Beyond AIDS

City of West Hollywood

Oppose: None Received

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 2439

Author:(Nazarian)

As Amended Ver:May 31, 2016

Majority vote

SUMMARY: Creates a pilot project to be administered by the Department of Public Health (DPH), in order to assess and make recommendations regarding the effectiveness of the routine offering of a human immunodeficiency virus (HIV) test in the emergency department (ED) of a hospital. Specifically, this bill:

1. Requires DPH to select four hospitals that have EDs to voluntarily participate in the pilot project as follows:
   1. Two of the hospitals must be from large urban areas;
   2. One hospital must be from a small urban or suburban area;
   3. One hospital must be from a rural area;
   4. Each hospital in the pilot project must offer an HIV test to any patient in the ED who has consented to the HIV test. Specifies that the ED must comply with all existing notice and counseling requirements, and that the ED may comply with those requirements by either using ED or other hospital personnel or engaging the services of an HIV organization that has experience in prevention counseling for persons at risk for HIV;
   5. Specifies that a hospital in the pilot project must not offer a test to any person who is being treated for a life-threatening emergency or who lacks the capacity to consent to an HIV test;
   6. Requires a hospital in the pilot project to offer HIV tests to individuals between 15 and 65 years of age, inclusive, pursuant to the United States Preventive Services Task Force (USPSTF) recommendations;
   7. Authorizes a hospital in the pilot project to charge a patient for the cost of the HIV testing;
   8. Requires a hospital in the pilot project to collect and report data on the following topics to DPH:
      1. The frequency of HIV test offers;
      2. The frequency of consent or nonconsent to an HIV test and any reasons given by the patient for the consent or nonconsent;
      3. The time taken to offer an HIV test and secure consent from a patient and the time taken to provide information and counseling;
      4. The aggregate HIV positivity rate;
      5. The frequency with which patients agree information and counseling and the reasons that patients give for refusing counseling; and,
      6. The frequency of patients leaving the ED without receiving their test results.
2. Requires hospitals in the pilot project to provide information to DPH regarding the hospitals practices and protocols for implementing the offer of an HIV test; the required follow up to the test; as well as an assessment of the effectiveness of those practices and protocols.
3. Specifies that the pilot project must commence on March 1, 2017, and end on February 28, 2019.
4. Requires DPH, by July 1, 2019, to complete a report to the Legislature on the finding of the four hospitals in the pilot and make recommendations about routine HIV testing in hospital EDs. Requires DPH to solicit input form a broad range of HIV testing and hospital stakeholders when preparing the report.
5. Authorizes DPH to seek or use private funding to cover the costs of administering the pilot project.

FISCAL EFFECT: According to the Assembly Appropriations Committee:

1. Staff costs to DPH of $305,000 in fiscal year 2016-17, $550,000 in 2017-18, and $275,000 in 2018-19 to implement and manage the pilot project, collect data, and prepare a report (General Fund (GF)or private funds).
2. Cost pressure to provide funding for hospitals to participate in this project. Although they can be reimbursed for HIV testing, it is unclear whether hospitals would participate without funding for enhanced tracking and data collection efforts. A current Centers for Disease Control and Prevention (CDC) grant provides $270,000 per year to each hospital participating in a similar pilot project (GF or private funds).
3. Identifying more individuals with HIV could increase testing and treatment costs to Medi-Cal and the AIDS Drug Assistance Program, and potentially reduce long-term costs by identifying HIV infection and beginning treatment earlier before significant medical complications arise, as well as by potentially preventing additional transmission. The pilot project is relatively small and thus any fiscal impact to the state for additional treatment would be small. The net effect on costs is unknown.

COMMENTS: According to the author, over the past three decades, almost every imaginable location to provide routine HIV testing has been employed to capture as many people as possible who may have engaged in risk behaviors. The author contends we continue to come up short, in large part because HIV testing is occurring only sporadically in the ED, the last major health care institution in California where HIV testing does not occur routinely. The author states despite dramatic advances in treatment options, there are more than 5,000 new infections in California every year and according to DPH, 16% of Californians who are HIV-positive do not know they are HIV-positive and thus are not getting treatment and unwittingly exposing uninfected people to HIV, and that number jumps to 58% for young people under the age of 24. The author continues, despite the many successes, the failures of our testing protocols are most pronounced among young people and people of color, noting that the state's HIV demographics are trending younger, notably increasing in those aged 20 to 29, and climbing infection rates among Black and Latino Californians, especially Black women.

The California Office of AIDS estimates that approximately 126,000 Californians are living with HIV, and of these, 23,000 or 18% are unaware of their HIV status. An estimated 6,000 Californians are newly diagnosed with HIV each year. Gay, bisexual, and other men who have sex with men (MSM) continue to be the risk group most heavily affected by HIV in California, accounting for over 70% of all persons diagnosed with HIV in 2013.

Unlike national statistics, new HIV diagnoses among all MSM in California decreased by over 13% (from 3,789 to 3,281) from 2005 to 2013 (versus a national increase of 6%). White MSM in California account for this decline, with an almost 35% decrease in new diagnoses (versus a national decrease of 18%). Both Latino and Black MSM in California had a net zero change in new HIV diagnoses from 2005 to 2013 (versus national increases of 24% and 22%, respectively). Only "other" race/ethnicities in California that had an increase in new HIV diagnoses during this period (an increase of 30% from 2005 to 2013, driven primarily by a 73% increase among Asians). "Other" race/ethnicity includes American Indian/Alaska Native, Asian, Native Hawaiian/Pacific Islander, and multi-racial persons.

However, young MSM aged 13 to 24 years old in California had an overall increase of 27% in new HIV diagnoses from 2005 to 2013 (from 536 in 2005 to 680 in 2013). This increase was driven by young Hispanic MSM, whose numbers increased by 35% (from 246 to 333). Diagnoses among young Black MSM in California increased by 16% (from 124 to 144) during this period. Among young white MSM new diagnoses increased approximately 8% (from 130 to 140), compared to 56% nationally. New HIV diagnoses among young MSM of other race/ethnicities in California increased by an even higher percentage (75%) from 2005 to 2013, but there are relatively few cases in this group (36 in 2005 to 63 in 2013).

In September 2006, the CDC released, "Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings." These recommendations advise routine HIV screening of adults, adolescents, and pregnant women in health care settings in the United States. The CDC also recommends reducing barriers to HIV testing. In April 2013, the USPSTF issued similar recommendations. According to these recommendations, clinicians should routinely screen adolescents and adults ages 15 to 65 years for HIV infection. Younger adolescents and older adults who are at increased risk should also be screened. USPSTF also recommends screening all pregnant women for HIV, including those who present in labor whose HIV status is unknown.

According to a Kaiser Family Foundation report, as of 2012, more than half (54%) of U.S. adults, aged 18 to 64, reported ever having been tested for HIV, including 22% who reported being tested in the last year. The share of the public saying they have been tested for HIV at some point increased between 1997 and 2004, but has remained fairly steady since then. Of those U.S. adults, aged 18-64, who say they have never been tested for HIV, nearly six in 10 (57%) say it is because they do not see themselves as at risk. HIV testing varies by state, age, and race/ethnicity, for example, Blacks and Latinos are significantly more likely to report having been tested for HIV than whites.

Hospitals in two of California's largest urban settings, the Alameda County Medical Center (ACMC) and Los Angeles County + University of Southern California Medical Center (LAC+USC) have been successful in integrating routine HIV testing in their EDs, although neither facility has offered HIV testing to every patient receiving a blood draw as this bill would require. As an early adopter of HIV testing in their ED, ACMC utilized medical staff for the introduction and provision of HIV tests. Over a three year demonstration project (2010-12), ACMC identified 52 new HIV cases from 45,210 HIV tests conducted with a positivity yield of 0.1%. In 2005, LAC+USC utilized a rapid test approach, embedding test counselors to introduce and provide HIV tests, and identified 13 new cases of HIV among 1,713 patients tested yielding a positivity yield of 0.8%. In addition, a regional hospital, Desert Regional Medical Center in Palm Springs, has implemented HIV testing in its ED. In 2015, it tested 810 patients of which 17 were HIV positive for a positivity rate of 2%. These positivity yields meet the benchmark of 0.1% determined by the CDC to demonstrate cost effectiveness of HIV testing in healthcare settings.

The AIDS Healthcare Foundation (AHF) is the sponsor of this bill and states despite dramatic advances in treatment options, there are more than 5,000 new infections in California every year, and everyday more than a dozen Californians are being infected with HIV. AHF contends that while almost every imaginable location that provides routine HIV testing has been employed to capture as many people as possible who may have engaged in risk behaviors, we continue to come up short in large part because HIV testing is occurring only sporadically in hospital EDs, the last major health care institution where HIV testing does not occur routinely.

The California Chapter of the American College (Cal/ACEP) opposes this bill stating that the pilot project requires every patient in an ED to be offered an HIV test, whether they are having their blood drawn already or not, and as a practical matter, this means that a patient who is there for a broken foot, stiches, a concussion, or any other medical condition that does not require blood to be drawn, will have their blood drawn as a purely public health screening measure. Cal/ACEP notes that it is aware that the CDC has stated that hospitals with an AIDS diagnosis rate greater than one per 1,000 discharges should adopt a policy of offering HIV counseling and testing routinely to patients aged 15 to 54 years, however if ED prophylactically tested for all diseases with a 0.001% prevalence, life-saving care to acutely ill patients would come to a screeching halt.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0003258

Date of Hearing: May 4, 2016

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

ABPCA Bill Id:AB 2439

Author:(Nazarian) – As Amended Ver:April 21, 2016

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill requires the California Department of Public Health (CDPH) to administer and evaluate a pilot project whereby routine testing for human immunodeficiency virus (HIV) virus is conducted in four participating hospital emergency departments (EDs), as specified. It also:

1. Requires participating hospitals to submit specified data and information to CDPH.
2. Requires HIV tests to be offered to individuals between 15 and 65 years of age and to any patient in the hospital emergency department who has consented to the test.
3. Specifies the pilot project shall commence on March 1, 2017, and end on February 28, 2019.
4. Requires, by July 1, 2019, CDPH to submit a report to the Legislature on the findings of the four hospitals in the pilot project that includes recommendations about routine HIV testing in hospital emergency departments. Requires CDPH to solicit stakeholder input in preparing the report.

FISCAL EFFECT:

1. GF Staff costs to CDPH of $305,000 in fiscal year 2016-17, $550,000 in 2017-18, and $275,000 in 2018-19 to implement and manage the pilot project, collect data, and prepare a report.
2. GF cost pressure to provide funding for hospitals to participate in this project. Although they can be reimbursed for HIV testing, it is unclear whether hospitals would participate without funding for enhanced tracking and data collection efforts. A current CDC grant provides $270,000 per year to each hospital participating in a similar pilot project.
3. Identifying more individuals with HIV could increase testing and treatment costs to Medi-Cal and the AIDS Drug Assistance Program, and potentially reduce long-term costs by identifying HIV infection and beginning treatment earlier before significant medical complications arise, as well as by potentially preventing additional transmission.  The pilot project is relatively small and thus any fiscal impact to the state for additional treatment would be small. The net effect on costs is unknown.

COMMENTS:

1. Purpose. According to the author, California has led the way in identifying people living with HIV and linking them with care and treatment. The pilot project created by this bill will allow the department to test strategies in a variety of settings in order to inform development of best practices for hospital ED testing for HIV. This bill is sponsored by the AIDS Healthcare Foundation and, in its current form, has no known opposition.
2. Background. HIV destroys cells that are crucial to the normal function of the human immune system. Although a person infected with HIV may not show symptoms until several years later, the virus is active in the body and, if untreated, the HIV disease will progress to AIDS. An AIDS diagnosis is made when the count of CD4+, or T cells, falls below a certain level or when the person has a history of infections commonly associated with AIDS. HIV/AIDS can be treated with a complex regimen of antiretroviral medications. Although fewer people are dying from AIDS, the total number of HIV cases in California is still increasing every year because of new diagnoses, and because the mortality rate from AIDS has declined dramatically. There are around 5,000 new infections in California every year.
3. HIV Testing. Identifying those with HIV and linking them to treatment can allow them to live a normal life span, and also prevent the spread of the virus by suppressing their viral load. However, many HIV-positive people have not achieved viral suppression because many people do not know their status, and because some who do are not in care. Despite recommendations for universal testing, identifying those who are HIV-positive and do not know it has proven challenging. The challenges and opportunities of providing HIV testing in emergency departments have been well-documented in the public health literature. On one hand, testing is fairly efficient with high prevalence rates. Models for such testing appear to be public health department-driven, such as local collaborations with EDs where public health departments provide either direct funding or staffing to provide testing services within EDs, or provide technical assistance, training, free test kits, or other related services.
4. Current state efforts. CDPH Office of AIDS (OA) currently provides training and technical assistance (TA) to health care settings and emergency departments that want to provide routine HIV testing to their patients. CDPH states training and TA are critical to the integration of HIV testing in all health care settings. In 2008, OA received dedicated funding from CDC to assist three Bay Area EDs to implement and evaluate routine HIV testing.
5. Prior legislation. AB 521 (Nazarian) required hospitals to offer an HIV test to consenting patients who have blood drawn after being admitted through the emergency department. This bill was vetoed by Governor Brown, who was concerned about appropriateness of the demographics of the target population and the whether hospitals are appropriate places to provide counseling, routine preventive screenings, or follow-up care for sensitive HIV testing.

This bill does not mandate HIV testing, and the demographics of all ED patients as targeted by this bill provide a higher-risk population than those who are admitted, improving the cost-effectiveness of testing. This bill still requires HIV tests to be conducted in EDs, which the veto message implies are not an appropriate place to provide necessary follow-up counseling.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 19, 2016

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 2439

Author:(Nazarian) – As Amended Ver:April 12, 2016

SUBJECT: HIV testing.

SUMMARY: Creates a pilot project to be administered by the Department of Public Health (DPH), in order to assess and make recommendations regarding the effectiveness of the routine offering of a human immunodeficiency virus (HIV) test in the emergency department (ED) of a hospital. Specifically, this bill:

1. Requires DPH to select four hospitals that have EDs to participate in the pilot project as follows:
   1. Two of the hospitals must be from large urban areas;
   2. One hospital must be from a small urban or suburban area;
   3. One hospital must be from a rural area;
   4. Each hospital in the pilot project must offer an HIV test to any patient in the ED who has consented to the HIV test. Specifies that the ED must comply with all existing notice and counseling requirements, and that the ED may comply with those requirements by either using ED or other hospital personnel or engaging the services of an HIV organization that has experience in prevention counseling for persons at risk for HIV;
   5. Specifies that a hospital in the pilot project must not offer a test to any person who is being treated for a life-threatening emergency or who lacks the capacity to consent to an HIV test;
   6. Requires a hospital in the pilot project to comply with existing HIV testing requirements for testing a minor 12 years of age or older;
   7. Authorizes a hospital in the pilot project to charge a patient for the cost of the HIV testing;
   8. Requires a hospital in the pilot project to collect and report data on the following topics to DPH:
      1. The frequency of HIV test offers;
      2. The frequency of consent or nonconsent to an HIV test and any reasons given by the patient for the consent or nonconsent;
      3. The time taken to offer an HIV test and secure consent from a patient and the time taken to provide information and counseling;
      4. The aggregate HIV positivity rate;
      5. The frequency with which patients agree information and counseling and the reasons that patients give for refusing counseling; and,
      6. The frequency of patients leaving the ED without receiving their test results.
2. Requires hospitals in the pilot project to provide information to DPH regarding the hospitals practices and protocols for implementing the offer of an HIV test; the required follow up to the test; as well as an assessment of the effectiveness of those practices and protocols;
3. Specifies that the pilot project must commence on March 1, 2017, and end on February 28, 2019; and,
4. Requires DPH, by July 1, 2019, to complete a report to the Legislature on the finding of the four hospitals in the pilot and make recommendations about routine HIV testing in hospital EDs. Requires DPH to solicit input form a broad range of HIV testing and hospital stakeholders when preparing the report.

EXISTING LAW:

1. Requires each patient who has blood drawn at a primary care clinic, and who has consented, to be offered an HIV test, consistent with the U.S. Preventive Services Task Force (USPSTF) recommendation for screening HIV infection.
2. Requires a medical provider, prior to ordering an HIV test, to inform the patient that there are numerous treatment options available for a patient who tests positive for HIV and that a person who tests negative for HIV should continue to be routinely tested, and advise the patient that he or she has the right to decline the tests. Requires a medical provider, if a patient declines the test, to note that fact in the patient's medical file. Specifies that these provisions do not apply when a person independently requests an HIV test.
3. Prohibits an HIV test from being administered unless the person being tested, or his or her parent, guardian, or conservator has provided informed consent for the performance of the test. Specifies that informed consent may be provided orally or in writing, and must be noted in the client's medical record.
4. Requires, after the results of an HIV test have been received, that the medical care provider ensure that the patient receives timely information and counseling to explain the results and the implication for the patient's health. Requires the medical provider, if the patient tests positive, to inform the patient that there are numerous treatment options available and identify follow-up testing and care that may be recommended, including contact information for medical and psychological services.
5. Requires the medical care provider, if the patient tests negative for HIV infection and is known to be at high risk for HIV infection, to advise the patient of the need for periodic retesting, explain the limitations of current testing technology and the current window period for verification of results, and authorizes the medical care provider to offer prevention counseling or a referral to prevention counseling.

FISCAL EFFECT: This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, over the past three decades, almost every imaginable location to provide routine HIV testing has been employed to capture as many people as possible who may have engaged in risk behaviors. The author contends we continue to come up short, in large part because HIV testing is occurring only sporadically in the ED, the last major health care institution in California where HIV testing does not occur routinely. The author states despite dramatic advances in treatment options, there are more than 5,000 new infections in California every year and according to DPH, 16% of Californians who are HIV-positive do not know they are HIV-positive and thus are not getting treatment and unwittingly exposing uninfected people to HIV, and that number jumps to 58% for young people under the age of 24. The author continues, despite the many successes, the failures of our testing protocols are most pronounced among young people and people of color, noting that the state’s HIV demographics are trending younger, notably increasing in those aged 20 to 29, and climbing infection rates among Black and Latino Californians, especially Black women.
   
2. BACKGROUND. At the end of 2012, an estimated 1.2 million persons aged 13 and older were living with HIV infection in the United States, including 156,300 (12.8%) persons whose infections had not been diagnosed. The estimated incidence of HIV has remained stable overall in recent years, at about 50,000 new HIV infections per year.
   1. HIV in California. The California Office of AIDS (OA) estimates that approximately 126,000 Californians are living with HIV, and of these, 23,000 or 18% are unaware of their HIV status. An estimated 6,000 Californians are newly diagnosed with HIV each year. Gay, bisexual, and other men who have sex with men (MSM) continue to be the risk group most heavily affected by HIV in California, accounting for over 70% of all persons diagnosed with HIV in 2013.

Unlike national statistics, new HIV diagnoses among all MSM in California decreased by over 13% (from 3,789 to 3,281) from 2005 to 2013 (versus a national increase of 6%). White MSM in California account for this decline, with an almost 35% decrease in new diagnoses (versus a national decrease of 18%). Both Latino and Black MSM in California had a net zero change in new HIV diagnoses from 2005 to 2013 (versus national increases of 24% and 22%, respectively). Only "other" race/ethnicities in California that had an increase in new HIV diagnoses during this period (an increase of 30% from 2005 to 2013, driven primarily by a 73% increase among Asians). "Other" race/ethnicity includes American Indian/Alaska Native, Asian, Native Hawaiian/Pacific Islander, and multi-racial persons.

However, young MSM aged 13 to 24 years old in California had an overall increase of 27% in new HIV diagnoses from 2005 to 2013 (from 536 in 2005 to 680 in 2013). This increase was driven by young Hispanic MSM, whose numbers increased by 35% (from 246 to 333). Diagnoses among young Black MSM in California increased by 16% (from 124 to 144) during this period. Among young white MSM new diagnoses increased approximately 8% (from 130 to 140), compared to 56% nationally. New HIV diagnoses among young MSM of other race/ethnicities in California increased by an even higher percentage (75%) from 2005 to 2013, but there are relatively few cases in this group (36 in 2005 to 63 in 2013).

• 1. HIV screening recommendations. In September 2006, the Centers for Disease Control and Prevention (CDC) released, "Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings." These recommendations advise routine HIV screening of adults, adolescents, and pregnant women in health care settings in the United States. The CDC also recommends reducing barriers to HIV testing.

In April 2013, the USPSTF issued similar recommendations. According to these recommendations, clinicians should routinely screen adolescents and adults ages 15 to 65 years for HIV infection. Younger adolescents and older adults who are at increased risk should also be screened. USPSTF also recommends screening all pregnant women for HIV, including those who present in labor whose HIV status is unknown.

A general rule for those with risk factors is to get tested at least annually. Additionally, CDC has recently reported that sexually active gay and bisexual men may benefit from getting an HIV test more often, perhaps every three to six months.

New data from a National Institutes of Health sponsored trial indicates there is a clear personal advantage to achieving an HIV diagnosis and starting therapy in the early course of an infection. This new information further highlights the importance of routine HIV testing and the potential impact on better health outcomes.

• 1. Testing Statistics. According to a Kaiser Family Foundation report, as of 2012, more than half (54%) of U.S. adults, aged 18 to 64, reported ever having been tested for HIV, including 22% who reported being tested in the last year. The share of the public saying they have been tested for HIV at some point increased between 1997 and 2004, but has remained fairly steady since then. Of those U.S. adults, aged 18-64, who say they have never been tested for HIV, nearly six in 10 (57%) say it is because they do not see themselves as at risk. HIV testing varies by state, age, and race/ethnicity, for example, Blacks and Latinos are significantly more likely to report having been tested for HIV than whites.
  2. Insurance coverage of HIV testing. HIV testing that is “medically necessary” – recommended by a physician due to risk – is generally covered by insurance. For those without insurance, HIV testing can be obtained at little or no cost in some settings (e.g., stand-alone HIV testing sites, mobile testing clinics). In April 2013, the USPSTF gave routine HIV screening of all adolescents and adults, ages 15 to 65, an “A” rating – generally aligning the rating with the CDC’s HIV screening guidelines. This rating expanded the already existing “A” rating for people at increased risk for HIV (such as injection drug users and MSM), and for all pregnant women. The USPSTF ratings, developed by an independent panel of clinicians and scientists, are important because many private and public insurers link their coverage of preventive services to those rated “A” or “B” by the USPSTF. Moreover, the Patient Protection and Affordable Care Act (ACA), passed in 2010, requires or incentivizes insurers to cover preventive services rated “A” or “B” and do so without cost-sharing, as follows:
     1. Private Insurance: the ACA requires that all private plans (except those that are grandfathered, meaning they were in place before the ACA was passed and have made no significant changes to coverage) must cover routine HIV testing without cost-sharing;
     2. Medicaid (Medi-Cal in California): while all state Medicaid programs must cover “medically necessary” HIV testing, state coverage of “routine” HIV screening varies because it is an optional benefit under Medicaid. A recent analysis has found that more than two thirds of state Medicaid programs do cover routine HIV screening, including California; and,
     3. Medicare: In April 2015, the Centers for Medicare & Medicaid Services expanded Medicare coverage to include annual HIV testing for beneficiaries ages 15-65 regardless of risk, and those outside this age range at increased risk. Additionally, Medicare will cover up to three tests for pregnant beneficiaries.
  3. New York HIV testing in the ED. Effective September 1, 2010, the state of New York mandated numerous changes to its HIV testing requirements, including that all persons seeking care in the ED be offered a test. In 2012 the New York State Department of Health published a report evaluating the impact of the statute on the number of persons tested for HIV and the number of persons who access care and treatment. The review included a modeling prediction of the impact of the new law. Assuming the law is implemented as designed; the model predicts a reduction in the number of new infections as well as the proportion of undiagnosed cases. The model also predicts an initial surge in the annual number of newly diagnosed HIV infections followed by a decline, and a steady decline in the number of newly diagnosed AIDS cases, explained by the identification of persons earlier in the course of infection before progressing to late stage disease. The report concluded that the law was not expected to result in an increase in the number of persons newly linked to care per year.
     
  4. California HIV testing in the ED. In 2015, the DPH OA began funding three medical centers/hospitals within the California Project Area (all California counties excluding Los Angeles and San Francisco which receive direct federal funding) to provide HIV testing in their EDs: University of California at Irvine (UCI) Medical Center, Ventura County Medical Center, and Santa Paula Hospital. Combined, these three ED sites conducted 12,289 test events through the program in 2015, 16 of which were newly identified confirmed positive test events (0.13%) and 23 of which were previously identified confirmed positive test events (0.19%).

The UCI Medical Center ED conducted 4,544 test events through the program in 2015, 11 of which were newly-identified confirmed positive test events (0.24%) and five of which were previously-identified confirmed positive test events (0.11%). The Ventura County Medical Center ED conducted 5,604 test events through the program in 2015, four of which were newly-identified confirmed positive test events (0.07%) and 16 of which were previously-identified confirmed positive test events (0.29%). The Santa Paula Hospital ED conducted 2,141 test events through the program in 2015, one of which was a newly-identified confirmed positive test event (0.05%) and two of which were previously-identified confirmed positive test events (0.09%).

Hospitals in two of California’s largest urban settings, the Alameda County Medical Center (ACMC) and Los Angeles County + University of Southern California Medical Center (LAC+USC) have been successful in integrating routine HIV testing in their EDs, although neither facility has offered HIV testing to every patient receiving a blood draw as this bill would require. As an early adopter of HIV testing in their ED, ACMC utilized medical staff for the introduction and provision of HIV tests. Over a three year demonstration project (2010-2012), ACMC identified 52 new HIV cases from 45,210 HIV tests conducted with a positivity yield of 0.1%. In 2005, LAC+USC utilized a rapid test approach, embedding test counselors to introduce and provide HIV tests, and identified 13 new cases of HIV among 1,713 patients tested yielding a positivity yield of 0.8%. In addition, a regional hospital, Desert Regional Medical Center in Palm Springs, has implemented HIV testing in its ED. In 2015, it tested 810 patients of which 17 were HIV positive for a positivity rate of 2%. These positivity yields meet the benchmark of 0.1% determined by the CDC to demonstrate cost effectiveness of HIV testing in healthcare settings.

1. SUPPORT. The AIDS Healthcare Foundation (AHF) is the sponsor of this bill and states despite dramatic advances in treatment options, there are more than 5,000 new infections in California every year, and everyday more than a dozen Californians are being infected with HIV. AHF contends that while almost every imaginable location that provides routine HIV testing has been employed to capture as many people as possible who may have engaged in risk behaviors, we continue to come up short in large part because HIV testing is occurring only sporadically in hospital EDs, the last major health care institution where HIV testing does not occur routinely.
2. OPPOSITION. The California Chapter of the American College (Cal/ACEP) opposes this bill stating that the pilot project requires every patient in an ED to be offered an HIV test, whether they are having their blood drawn already or not, and as a practical matter, this means that a patient who is there for a broken foot, stiches, a concussion, or any other medical condition that does not require blood to be drawn, will have their blood drawn as a purely public health screening measure. Cal/ACEP notes that it is aware that the CDC has stated that hospitals with an AIDS diagnosis rate greater than one per 1,000 discharges should adopt a policy of offering HIV counseling and testing routinely to patients aged 15 to 54 years, however if ED prophylactically tested for all diseases with a .001% prevalence, life-saving care to acutely ill patients would come to a screeching halt.
   

The California Hospital Association (CHA) states that the pilot study does not attempt to address the significant requirements related to pre and post HIV testing, including: prior to ordering a test that identifies infection of a patient with HIV, a medical care provider must inform the patient that the test is planned, provide information about the test, inform the patient that there are numerous treatment options available for a patient who tests positive for HIV and that a person who tests negative for HIV should continue to be routinely tested, and advise the patient that he or she has the right to decline the test. CHA concludes that EDs are designed to address emergency issues, not to address population health management screenings in an efficient or cost-effective manner.

The California Medical Association (CMA) opposes this bill stating, currently, EDs suffer from overcrowding, lack of resources, and extremely low reimbursement rates as they are required to treat all individuals who enter the ED regardless of ability to pay. CMA notes this bill would require emergency physicians to devote time and resources away from other patients to offer HIV tests to patients who might be at an extremely low risk. CMA also notes concerns about false positives tests and requiring that counseling be provided within the ED, explaining that there are different types of tests for HIV and the ones that would presumably be done in the ED would be what are referred to as “rapid tests.” CMA says these tests look for HIV antibodies that an individual’s immune system would create if the virus was present and contends that false positives occur more frequently in these “rapid tests” and because the relationship between the emergency physician and the emergency patient is transient, there is no opportunity for follow up.

1. REQUESTED AMENDMENTS. A coalition of organizations which includes the American Civil Liberties Union of California, AIDS Project Los Angeles, and the Positive Women's Network had a position of oppose unless amended on the prior version of this bill. The coalition letter raises numerous concerns with the bill including, replacing in-person counseling with printed materials, confidentiality requirements (especially as they pertain to minors being treated in the ED), occupational exposures to HIV, and the exception for patients being treated for a life-threatening emergency. The coalition states that due to the sensitive environment of the ED, they would like the opportunity to discuss appropriate procedures before testing, including the information provided to the patient and how consent is obtained and documented, to ensure the patient's medical autonomy is protected and that the best foundation for an ongoing relationship with HIV medical care is created from the moment of testing.
   
2. RELATED LEGISLATION. AB 2640 (Gipson) requires a medical care provider or person administering a test for HIV to inform individuals who test negative for HIV infection, yet are at high risk for HIV infection, of the effectiveness and safety of all federal Food and Drug Administration approved methods that prevent or reduce the risk of contracting HIV, including pre-exposure prophylaxis and post-exposure prophylaxis, consistent with guidance of the CDC. AB 2640 is pending a hearing in Assembly Health Committee.
3. PREVIOUS LEGISLATION. AB 521 (Nazarian) of 2015 would have required a patient admitted as an inpatient to a hospital through the ED that had blood drawn after being admitted to the hospital, and who consented, to be offered an HIV test.
4. POLICY COMMENT. This bill is similar to AB 521 which was vetoed by the Governor, who indicated, in part that, "…hospitals are not appropriately staffed nor are they the place to provide counseling, routine preventive screenings, or follow-up care for sensitive HIV testing. Limited resources would be better spent supporting outreach and education activities by existing providers which have the staff and training for HIV testing and follow-up care." The Committee may wish to ask the author how he plans to address the Governor's veto.
5. SUGGESTED AMENDMENTS.
   1. As currently drafted this bill requires DPH to select four hospitals that have EDs to participate in the pilot project. The Committee may wish to amend the bill to clarify that participation in the pilot project is voluntary on the part of the hospitals.
   2. In order to address some of the privacy concerns raised by the opponents the author may wish to consider amending the bill to strike the provision requiring minors12 years of age and up be offered HIV tests, and instead mirror federal USPSTF recommendations for testing individuals between the ages of 15 and 65.
      
      
      
      

REGISTERED SUPPORT / OPPOSITION:

Support

AIDS Healthcare Foundation

Opposition

California Chapter of the American College of Emergency Physicians

California Hospital Association

California Medical Association

California Society of Pathologists

Keck Medical Center of USC

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097

Date of Hearing: April 12, 2016

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 2439

Author:(Nazarian) – As Introduced Ver:February 19, 2016

SUBJECT: HIV testing.

SUMMARY: Applies existing human immunodeficiency virus (HIV) testing requirement for primary care clinics to hospital emergency departments (EDs). Specifically, this bill:

1. Requires each patient in a hospital ED who has blood drawn and has given consent, to be offered a test for HIV.
2. Requires the ED clinician to offer the HIV test consistent with the United States Preventive Services Task Force (USPSTF) recommendation for screening HIV infection.
3. Specifies that a hospital ED is not required to offer the test if the ED has tested the patient for HIV or if the patient has been offered the HIV test and declined the test in the last 12 months.
4. Specifies that nothing prohibits a hospital ED from charging a patient to cover the cost of HIV testing, and that a hospital ED will be deemed in compliance with these provisions if an HIV test is offered.
5. Requires a hospital ED to attempt to provide test results to the patient before he or she leaves the facility. If that is not possible the facility may inform the patient who tests negative for HIV by letter or telephone.
6. Requires a hospital ED, to comply with existing requirements on providing timely information and counseling to patients, including treatment options, but deems a hospital ED to have complied with existing law if the ED provides printed material to the patient that includes the information and advice.
7. Specifies that a hospital ED is not required to test a person for HIV if medical personnel in the ED determine that the person is being treated for a life-threatening emergency or if they determine that the person lacks the capacity to consent to an HIV test.
8. Makes other technical and conforming changes, including applying existing requirements for minors to be tested.

EXISTING LAW

1. Requires each patient who has blood drawn at a primary care clinic, and who has consented, to be offered an HIV test, consistent with the USPSTF recommendation for screening HIV infection.
2. Requires a medical provider, prior to ordering an HIV test, to inform the patient that there are numerous treatment options available for a patient who tests positive for HIV and that a person who tests negative for HIV should continue to be routinely tested, and advise the patient that he or she has the right to decline the tests. Requires a medical provider, if a patient declines the test, to note that fact in the patient's medical file. Specifies that these provisions do not apply when a person independently requests an HIV test.
3. Prohibits an HIV test from being administered unless the person being tested, or his or her parent, guardian, or conservator has provided informed consent for the performance of the test. Specifies that informed consent may be provided orally or in writing, and must be noted in the client's medical record.
4. Requires, after the results of an HIV test have been received, that the medical care provider ensure that the patient receives timely information and counseling to explain the results and the implication for the patient's health. Requires the medical provider, if the patient tests positive, to inform the patient that there are numerous treatment options available and identify follow-up testing and care that may be recommended, including contact information for medical and psychological services.
5. Requires the medical care provider, if the patient tests negative for HIV infection and is known to be at high risk for HIV infection, to advise the patient of the need for periodic retesting, explain the limitations of current testing technology and the current window period for verification of results, and authorizes the medical care provider to offer prevention counseling or a referral to prevention counseling.

FISCAL EFFECT: This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, despite the enactment and implementation of the Patient Protection and Affordable Care Act (ACA), EDs continue to play a critical role in delivering primary care services to many new enrollees and to those who remain uninsured. The author contends that given that there are more than 5,000 new HIV infections in California every year, this bill will bridge the gap in lack of HIV testing by requiring EDs to uniformly provide HIV testing.
2. BACKGROUND. At the end of 2012, an estimated 1.2 million persons aged 13 and older were living with HIV infection in the United States, including 156,300 (12.8%) persons whose infections had not been diagnosed. The estimated incidence of HIV has remained stable overall in recent years, at about 50,000 new HIV infections per year.
   1. HIV in California. The California Office of AIDS (OA) estimates that approximately 126,000 Californians are living with HIV, and of these, 23,000 or 18% are unaware of their HIV status. An estimated 6,000 Californians are newly diagnosed with HIV each year. Gay, bisexual, and other men who have sex with men (MSM) continue to be the risk group most heavily affected by HIV in California, accounting for over 70% of all persons diagnosed with HIV in 2013.

Unlike national statistics, new HIV diagnoses among all MSM in California decreased by over 13% (from 3,789 to 3,281) from 2005 to 2013 (versus a national increase of 6%). White MSM in California account for this decline, with an almost 35% decrease in new diagnoses (versus a national decrease of 18%). Both Latino and Black MSM in California had a net zero change in new HIV diagnoses from 2005 to 2013 (versus national increases of 24% and 22%, respectively). Only "other" race/ethnicities in California that had an increase in new HIV diagnoses during this period (an increase of 30% from 2005 to 2013, driven primarily by a 73% increase among Asians). "Other" race/ethnicity includes American Indian/Alaska Native, Asian, Native Hawaiian/Pacific Islander, and multi-racial persons.

However, young MSM aged 13 to 24 years old in California had an overall increase of 27% in new HIV diagnoses from 2005 to 2013 (from 536 in 2005 to 680 in 2013). This increase was driven by young Hispanic MSM, whose numbers increased by 35% (from 246 to 333). Diagnoses among young Black MSM in California increased by 16% (from 124 to 144) during this period. Among young white MSM new diagnoses increased approximately 8% (from 130 to 140), compared to 56% nationally. New HIV diagnoses among young MSM of other race/ethnicities in California increased by an even higher percentage (75%) from 2005 to 2013, but there are relatively few cases in this group (36 in 2005 to 63 in 2013).

• 1. HIV screening recommendations. In September 2006, the Centers for Disease Control and Prevention (CDC) released, "Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings." These recommendations advise routine HIV screening of adults, adolescents, and pregnant women in health care settings in the United States. They also recommend reducing barriers to HIV testing.

In April 2013, the USPSTF issued similar recommendations. According to these recommendations, clinicians should routinely screen adolescents and adults ages 15 to 65 years for HIV infection. Younger adolescents and older adults who are at increased risk should also be screened. USPSTF also recommends screening all pregnant women for HIV, including those who present in labor whose HIV status is unknown.

A general rule for those with risk factors is to get tested at least annually. Additionally, CDC has recently reported that sexually active gay and bisexual men may benefit from getting an HIV test more often, perhaps every three to six months.

New data from a National Institutes of Health sponsored trial indicates there is a clear personal advantage to achieving an HIV diagnosis and starting therapy in the early course of an infection. This new information further highlights the importance of routine HIV testing and the potential impact on better health outcomes.

• 1. Testing Statistics. According to a Kaiser Family Foundation report, as of 2012, more than half (54%) of U.S. adults, aged 18 to 64, reported ever having been tested for HIV, including 22% who reported being tested in the last year. The share of the public saying they have been tested for HIV at some point increased between 1997 and 2004, but has remained fairly steady since then. Of those U.S. adults, aged 18-64, who say they have never been tested for HIV, nearly six in 10 (57%) say it is because they do not see themselves as at risk. HIV testing varies by state, age, and race/ethnicity, for example, Blacks and Latinos are significantly more likely to report having been tested for HIV than whites.
  2. Insurance coverage of HIV testing. HIV testing that is “medically necessary” – recommended by a physician due to risk – is generally covered by insurance. For those without insurance, HIV testing can be obtained at little or no cost in some settings (e.g., stand-alone HIV testing sites, mobile testing clinics). In April 2013 the USPSTF gave routine HIV screening of all adolescents and adults, ages 15 to 65, an “A” rating – generally aligning the rating with the CDC’s HIV screening guidelines. This rating expanded the already existing “A” rating for people at increased risk for HIV (such as injection drug users and MSM), and for all pregnant women. The USPSTF ratings, developed by an independent panel of clinicians and scientists, are important because many private and public insurers link their coverage of preventive services to those rated “A” or “B” by the USPSTF. Moreover, the ACA, passed in 2010, requires or incentivizes insurers to cover preventive services rated “A” or “B” and do so without cost-sharing, as follows:
     1. Private Insurance: the ACA requires that all private plans (except those that are grandfathered meaning they were in place before the ACA was passed and have made no significant changes to coverage) must cover routine HIV testing without cost-sharing;
     2. Medicaid (Medi-Cal in California): while all state Medicaid programs must cover “medically necessary” HIV testing, state coverage of “routine” HIV screening varies because it is an optional benefit under Medicaid. A recent analysis has found that more than two thirds of state Medicaid programs do cover routine HIV screening, including California; and,
     3. Medicare: In April 2015, the Centers for Medicare & Medicaid Services expanded Medicare coverage to include annual HIV testing for beneficiaries ages 15-65 regardless of risk, and those outside this age range at increased risk. Additionally, Medicare will cover up to three tests for pregnant beneficiaries.
  3. New York HIV testing in the ED. Effective September 1, 2010, the state of New York mandated numerous changes to its HIV testing requirements, including that all persons seeking care in the ED be offered a test. In 2012 the New York State Department of Health published a report evaluating the impact of the statute with respect to the number of persons tested for HIV and the number of persons who access care and treatment. The review included a modeling prediction of the impact of the new law. Assuming the law is implemented as designed; the model predicts a reduction in the number of new infections as well as the proportion of undiagnosed cases. The model also predicts an initial surge in the annual number of newly diagnosed HIV infections followed by a decline, and a steady decline in the number of newly diagnosed AIDS cases, explained by the identification of persons earlier in the course of infection before progressing to late stage disease. The report concluded that the law was not expected to result in an increase in the number of persons newly linked to care per year.
     
  4. California HIV testing in the ED. In 2015, OA began funding three medical centers/hospitals within the California Project Area (all California counties excluding Los Angeles and San Francisco which receive direct federal funding) to provide HIV testing in their EDs. University of California at Irvine (UCI) Medical Center, Ventura County Medical Center, and Santa Paula Hospital. Combined, these three ED sites conducted 12,289 test events through the program in 2015, 16 of which were newly-identified confirmed positive test events (0.13 percent) and 23 of which were previously-identified confirmed positive test events (0.19 percent).

The UCI Medical Center ED conducted 4,544 test events through the program in 2015, 11 of which were newly-identified confirmed positive test events (0.24 percent) and five of which were previously-identified confirmed positive test events (0.11 percent). The Ventura County Medical Center ED conducted 5,604 test events through the program in 2015, four of which were newly-identified confirmed positive test events (0.07 percent) and 16 of which were previously-identified confirmed positive test events (0.29 percent). The Santa Paula Hospital ED conducted 2,141 test events through the program in 2015, one of which was a newly-identified confirmed positive test event (0.05 percent) and two of which were previously-identified confirmed positive test events (0.09 percent).

Hospitals in two of California’s largest urban settings, Alameda County Medical Center (ACMC) and Los Angeles County + University of Southern California Medical Center (LAC) have been successful in integrating routine HIV testing in their EDs, although neither facility has offered HIV testing to every patient receiving a blood draw as this bill would require. As an early adopter of HIV testing in their ED, ACMC utilized medical staff for the introduction and provision of HIV tests. Over a three year demonstration project (2010-2012), ACMC identified 52 new HIV cases from 45,210 HIV tests conducted with a positivity yield of 0.1 percent. In 2005, LAC utilized a rapid test approach, embedding test counselors to introduce and provide HIV tests, and identified 13 new cases of HIV among 1,713 patients tested yielding a positivity yield of 0.8 percent. In addition, a regional hospital, Desert Regional Medical Center in Palm Springs, has implemented HIV testing their ED. In 2015, they tested 810 patients of which 17 were HIV positive for a positivity rate of 2 percent. These positivity yields meet the benchmark of 0.1 percent determined by the CDC to demonstrate cost effectiveness of HIV testing in healthcare settings.

1. SUPPORT. The AIDS Healthcare Foundation (AHF) is the sponsor of this bill and states despite dramatic advances in treatment options, there are more than 5,000 new infections in California every year, and everyday more than a dozen Californians are being infected with HIV. AHF contends that while almost every imaginable location that provides routine HIV testing has been employed to capture as many people as possible who may have engaged in risk behaviors, we continue to come up short in large part because HIV testing is occurring only sporadically in hospital EDs, the last major health care institution where HIV testing does not occur routinely.
2. OPPOSITION. The California Chapter of the American College (Cal/ACEP) opposes this bill stating that diagnosing and treating HIV is an important public health endeavor, but EDs are not the proper venue for a diagnostic public health campaign. Cal/ACEP also notes that this bill provides no funding for the test itself, thereby placing another unfunded mandate on EDs. Cal/ACEP concludes that between 2001 and 2010, California experienced a net loss of 21 hospitals, and when a hospital closes, it threatens access to emergency services for entire communities.
   

The California Hospital Association states that this bill would eliminate the physician's medical judgment as to what information or treatment is in the best interest of a particular patient, and under current practice, hospitals already offer HIV tests when the clinical judgement of the clinician determines an HIV test is needed.

The California Medical Association (CMA) opposes this bill stating, currently, EDs suffer from overcrowding, lack of resources, and extremely low reimbursement rates as they are required to treat all individuals who enter the ED regardless of ability to pay. CMA notes this bill would require emergency physicians to devote time and resources away from other patients to offer HIV tests to patients who might be at an extremely low risk. CMA also notes concerns about false positives tests and requiring that counseling be provided within the ED, explaining that there are different types of tests for HIV and the ones that would presumably be done in the ED would be what are referred to as “rapid tests.” CMA says these tests look for HIV antibodies that an individual’s immune system would create if the virus was present and contends that false positives occur more frequently in these “rapid tests” and because the relationship between the emergency physician and the emergency patient is transient, there is no opportunity for follow up.

1. REQUESTED AMENDMENTS. A coalition of organizations which includes the American Civil Liberties Union of California, AIDS Project Los Angeles, and the Positive Women's Network have a position of oppose unless amended on this bill. The coalition letter raises numerous concerns with the bill including, replacing in-person counseling with printed materials, confidentiality requirements (especially as they pertain to minors being treated in the ED), occupational exposures to HIV, and the exception for patients being treated for a life-threatening emergency. The coalition states that due to the sensitive environment of the ED, they would like the opportunity to discuss appropriate procedures before testing, including the information provided to the patient and how consent is obtained and documented, to ensure the patient's medical autonomy is protected and that the best foundation for an ongoing relationship with HIV medical care is created from the moment of testing.
   
2. RELATED LEGISLATION. AB 2640 (Gipson) requires a medical care provider or person administering a test for HIV to inform individuals who test negative for HIV infection, yet are at high risk for HIV infection, of the effectiveness and safety of all federal Food and Drug Administration –approved methods that prevent or reduce the risk of contracting HIV, including pre-exposure prophylaxis and post-exposure prophylaxis, consistent with guidance of the CDC. AB 2640 is pending a hearing in Assembly Health Committee.
3. PREVIOUS LEGISLATION. AB 521 (Nazarian) of 2015 would have required a patient admitted as an inpatient to a hospital through the ED that had blood drawn after being admitted to the hospital, and who consented, to be offered an HIV test. AB 521 was vetoed by the Governor, who stated, in part, "… hospitals are not appropriately staffed nor are they the place to provide counseling, routine preventive screenings, or follow-up care for sensitive HIV testing. Limited resources would be better spent supporting outreach and education activities by existing providers which have the staff and training for HIV testing and follow-up care."
4. POLICY COMMENT. This bill is similar to AB 521 which was vetoed by the Governor, who indicated, in part that, "…hospitals are not appropriately staffed nor are they the place to provide counseling, routine preventive screenings, or follow-up care for sensitive HIV testing. Limited resources would be better spent supporting outreach and education activities by existing providers which have the staff and training for HIV testing and follow-up care." The Committee may wish to ask the author how he plans to address the Governor's veto.
   

REGISTERED SUPPORT / OPPOSITION:

Support

AIDS Healthcare Foundation

Opposition

California Chapter of the American College of Emergency Physicians

California Hospital Association

California Medical Association

California Society of Pathologists

Keck Medical Center of USC

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097