Existing law requires a medical care provider or person administering a test for HIV to, after receiving results indicating no infection for a patient who is known to be at high risk for HIV infection, advise the patient of the need for periodic retesting and explain the limitations of current testing technology and the current window period for verification of results.

This bill would instead require a medical care provider or person administering a test for HIV to provide patients who test negative for HIV infection and are determined to be at high risk for HIV infection by the medical provider or person administering the test with the above-described information and information about methods that prevent or reduce the risk of contracting HIV, including preexposure prophylaxis and postexposure prophylaxis, as specified.

Existing law requires a medical care provider or person administering a test for HIV to, after receiving results indicating no infection for a patient who is known to be at high risk for HIV infection, advise the patient of the need for periodic retesting and explain the limitations of current testing technology and the current window period for verification of results.

This bill would instead require a medical care provider or person administering a test for HIV to provide patients who test negative for HIV infection and are determined to be at high risk for HIV infection by the medical provider or person administering the test with the above-described information and information about methods that prevent or reduce the risk of contracting HIV, including preexposure prophylaxis and postexposure prophylaxis, as specified.

Existing law requires a medical care provider or person administering a test for HIV to, after receiving results indicating no infection for a patient who is known to be at high risk for HIV infection, advise the patient of the need for periodic retesting and explain the limitations of current testing technology and the current window period for verification of results.

This bill would instead require a medical care provider or person administering a test for HIV to provide patients who test negative for HIV infection and are determined to be at a high risk for HIV infection by the medical provider or person administering the test with the above-described information and information about the effectiveness and safety of all methods that prevent or reduce the risk of contracting HIV, including preexposure prophylaxis and postexposure prophylaxis, as specified.

Existing law requires a medical care provider or person administering a test for HIV to, after receiving results indicating no infection for a patient who is known to be at high risk for HIV infection, advise the patient of the need for periodic retesting and explain the limitations of current testing technology and the current window period for verification of results.

This bill would additionally instead require a medical care provider or person administering a test for HIV to provide patients who test negative for HIV infection and are at high risk for HIV infection determined to be at a high risk for HIV infection by the medical provider or person administering the test with written information the above-described information and information about the effectiveness and safety of all methods that prevent or reduce the risk of contracting HIV, including preexposure prophylaxes prophylaxis and postexposure prophylaxes, prophylaxis, as specified.

Existing law requires a medical care provider or person administering a test for HIV to, after receiving results indicating no infection for a patient who is at high risk for HIV infection, advise the patient of the need for periodic retesting and explain the limitations of current testing technology and the current window period for verification of results.

This bill would additionally require a medical care provider or person administering a test for HIV to inform people provide patients who test negative for HIV infection and are at high risk for HIV infection of with written information about the effectiveness and safety of all federal Food and Drug Administration-approved methods that prevent or reduce the risk of contracting HIV, including preexposure prophylaxis prophylaxes and postexposure prophylaxis. prophylaxes, as specified.

Existing law, the Hepatitis C Education, Screening, and Treatment Act, sets forth provisions pertaining to education and outreach related to hepatitis C, as specified. Existing law sets forth the intent of the Legislature with regard to these provisions.

This bill would make technical, nonsubstantive changes to these provisions.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 2640

Author:(Gipson)

As Amended Ver:August 15, 2016

Majority vote

Original Committee Reference: HEALTH

SUMMARY: Requires a medical care provider or person administering a test for human immunodeficiency virus (HIV) to provide patients who test negative for HIV infection, and are determined to be at high risk for HIV infection by the medical provider or person administering the test, with information about methods that prevent or reduce the risk of contracting HIV, including, but not limited to, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), consistent with guidance of the federal Centers for Disease Control and Prevention (CDC).

The Senate amendments delete the requirement that the information be provided in writing and make other technical and clarifying changes.

FISCAL EFFECT:

1. Likely ongoing costs in the millions to low tens of millions to provide PrEP and PEP to high-risk individuals enrolled in Medi-Cal (General Fund and federal funds). Based on CDC estimates for the number of individuals at high risk for HIV infection, staff estimates that there are about 150,000 individuals in the state that would meet CDC guidelines for using PrEP or PEP. For each 1% of that population that elects to begin taking PrEP, the proportional cost to the Medi-Cal program to cover the cost of providing PrEP would be about $4 million per year. (Costs for PEP would be considerable lower, since it is only recommended for 28-day use, as opposed to ongoing use for PrEP.)
2. Unknown long-term savings to Medi-Cal and the Aids Drug Assistance Program due to lower HIV infection rates (General Fund and federal funds). To the extent that the bill does result in lower HIV infection rates, there would be cost savings to the Medi-Cal and Aids Drug Assistance Programs. However, there are some factors that limit the potential cost savings from the bill. First, it is not known how effective greater knowledge and use of PrEP and PEP are at the population level in reducing HIV infection. There are clinical studies that show a very dramatic decline in HIV infections amongst users of PrEP. Whether those findings would translate to the larger population not part of a research study is unknown. Second, the annual cost to provide PrEP is may not be substantially less than the current cost to provide treatment to HIV positive Medi-Cal beneficiaries. The cost that Medi-Cal would pay for PreP is not public information. However, the New York State Department of Public Health indicates that annual costs range from $8,000 to $14,000 per year. Even assuming that Medi-Cal receives significant discounts, the cost to provide PreP is likely to be in the thousands per patient per year. On the other hand, the current average annual cost of care for an HIV positive Medi-Cal beneficiary is about $15,000 per year.

COMMENTS: According to the author, this bill seeks to reduce the spread of HIV and save the lives of individuals at high risk of HIV exposure by providing them with information about preventive medications during HIV post-test counseling. The author notes that in 2013, California was second among the 50 states in the number of new HIV diagnoses, with approximately 5,000 new HIV diagnoses, and a 2015 survey of individuals at risk for HIV by the California HIV/AIDS Research Program found that only one in 10 respondents had ever used PrEP. The author concludes, considering the high volume of new HIV infections being diagnosed in the state of California and the low awareness of these medications, it is critical that those being tested are aware of PEP and PrEP medications.

Treatment as Prevention (TasP), PrEP, and PEP. In TasP, people living with HIV/AIDS use anti-retroviral (ARV) medications to reduce their viral load (the amount of HIV in the body) to undetectable levels. With an undetectable viral load, the amount of HIV in the body is so small it greatly reduces the likelihood of passing the virus to another person. Strict adherence to TasP reduces the likelihood of transmission by up to 96%. PrEP is a new intervention that uses an established ARV medication, Truvada to protect at-risk HIV-negative individuals from HIV infection. PrEP is different from PEP; the medication is taken before, not after possible exposure. Daily PrEP use can lower the risk of getting HIV from sex by more than 90% and from injection drug use by more than 70%. Missing doses reduces PrEP effectiveness. Truvada is currently the only FDA drug approved for HIV PrEP. PEP uses ARV medications to prevent HIV from replicating and spreading through the body after an exposure to the virus. PEP is a short-term (28-day) intervention and must be started within three days of an exposure – sooner, if possible – to be effective. PEP was originally developed for occupational exposures, such as needle-sticks in hospitals, but is also effective for sexual exposures.

In 2015, the CDC estimated that one in four sexually active gay and bisexual men, one in five people who inject drugs, and one in 200 sexually active heterosexual adults meet the criteria for PrEP. In 2015, the California HIV/AIDS Research Program conducted a survey of 602 young gay and bisexual men and found that only one in 10 had ever taken PrEP. Although awareness of the intervention was high among those who had never taken PrEP, awareness was significantly lower among Black and Latino respondents compared to white respondents. In addition, the large majority of respondents indicated they had never talked to their doctor or healthcare provider about PrEP.

In its November 24, 2015 Morbidity and Mortality Weekly Report, the CDC estimated that 1.2 million Americans could benefit from PrEP, including 492,000 men who have sex with men, 115,000 injection drug users, and 624,000 heterosexuals. The report concludes that clinical organizations, health departments, and community-based organizations should raise awareness of PrEP among persons with substantial risk for acquiring HIV infection and their health care providers.

AIDS Project Los Angeles and the Los Angeles LGBT (lesbian, gay, bisexual, transgender) Center are the cosponsors of this bill and they state that awareness and use of PrEP and PEP among Californians at risk for HIV remain extremely low. They conclude it remains vital to ensure that all individuals at risk for HIV receive accurate information about PrEP and PEP, particularly highly-impacted communities of color.

The AIDS Healthcare Foundation (AHF) states in opposition that HIV screening is intended to mirror other screening tests, which require simple consent only and which do not burden the process with additional activities that may or may not be necessary. AHF asserts that its experience as the largest private tester in the state is that the more time and demands placed on the person it is encouraging to be tested, the more likely the person is to decline.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0004124

 THIRD READING  

Bill No: AB 2640

Author: Gipson (D)

Amended: 8/15/16 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 7-1, 6/29/16

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

NOES: Nielsen

NO VOTE RECORDED: Wolk

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

AYES: Lara, Beall, Hill, McGuire, Mendoza

NOES: Bates, Nielsen

ASSEMBLY FLOOR: 57-20, 6/1/16 - See last page for vote

SUBJECT: Public health: HIV

SOURCE: AIDS Project Los Angeles

Los Angeles LGBT Center

DIGEST: This bill requires a medical provider or a person administering a HIV test, in the case that a patient that is known to be at high risk for HIV infection tests negative for HIV to provide written information about the methods that prevent or reduce the risk of contracting HIV, including, but not limited to, pre-exposure prophylaxes (PrEP) and post-exposure prophylaxes (PEP), consistent with guidance of the federal Centers for Disease Control and Prevention (CDC).

ANALYSIS: Existing law places certain requirements on the information shared by medical providers with patients for HIV testing, as specified. Requires the medical provider or other person performing a HIV test, after the results of a 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 for HIV infection and 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 may offer prevention counseling or a referral to prevention counseling.

This bill requires a medical provider or a person administering a HIV test, in the case that a patient that is known to be at high risk for HIV infection tests negative for HIV, to provide written information about the effectiveness and safety of all methods that prevent or reduce the risk of contracting HIV, including, but not limited to, PrEP and PEP, consistent with guidance of the CDC.

Comments

1. Author’s statement. According to the author, AB 2640 seeks to reduce the spread of HIV and save the lives of individuals at high risk of HIV exposure by providing them with information about preventive medications during HIV post-test counseling. In 2013, California was second among the 50 states in the number of new HIV diagnoses, with approximately 5,000 new HIV diagnoses. A 2015 survey of individuals at risk for HIV by the California HIV/AIDS Research Program found that only 1 in 10 respondents had ever used PrEP. Although awareness of the intervention was high among those who had never taken PrEP, awareness was significantly lower among Black and Latino respondents compared to white respondents. In addition, the large majority of respondents indicated they had never talked to their doctor or healthcare provider about PrEP. Considering the high volume of new HIV infections being diagnosed in the state of California and the low awareness of these medications, it is critical that those being tested are aware of PrEP and PEP medications.
2. Background. According to the CDC, more than 1.2 million people in the U.S. are living with HIV infection, and 13% are unaware of their infection. Gay, bisexual, and men who have sex with men (MSM), particularly young African American MSM, are most seriously affected by HIV. By race, African Americans face the most severe burden of HIV. 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. An estimated 13,712 people with an AIDS diagnosis died in 2012, and approximately 658,507 people in the U.S. with an AIDS diagnosis have died overall. The Department of Public Health’s (DPH) 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. People living with HIV/AIDS have an estimated life expectancy of 32 years after infection and that number is increasing. According to the OA, with treatment costs averaging around $23,000 per year, lifetime treatment is currently estimated at around $740,000 or more per person. With that estimate, the 6,000 new infections per year in California will cost an estimated $4.5 billion to treat.
3. PrEP and PEP. “Treatment as prevention” (TasP) refers to HIV prevention methods that use antiretroviral treatment to decrease the risk of HIV transmission. According to the World Health Organization, TasP needs to be considered as a key element of combination HIV prevention and as a major part of the solution to ending the HIV epidemic. Through TasP, people living with HIV/AIDS use anti-retroviral (ARV) medications to reduce their viral load (the amount of HIV in the body) to undetectable levels. With an undetectable viral load, the amount of HIV in the body is so small it greatly reduces the likelihood of passing the virus to another person. Strict adherence to TasP reduces the likelihood of transmission by up to 96%. PrEP is a new intervention that uses an established ARV medication, Truvada to protect at-risk HIV-negative individuals from HIV infection. PrEP is different from PEP; the medication is taken before possible exposure. Daily PrEP use can lower the risk of getting HIV from sex by more than 90% and from injection drug use by more than 70%. Missing doses reduces PrEP effectiveness. Truvada is currently the only FDA drug approved for HIV PrEP. PEP uses ARV medications to prevent HIV from replicating and spreading through the body after an exposure to the virus. PEP is a short-term (28-day) intervention and must be started within three days of an exposure – sooner, if possible – to be effective. PEP was originally developed for occupational exposures, such as needle-sticks in hospitals, but is also effective for sexual exposures.
   
4. Research supporting PrEP use. On May 14, 2014, the U.S. Public Health Service released the first comprehensive clinical practice guidelines for PrEP. This followed the earlier publication of brief interim guidelines that were based on findings from several large national and international clinical trials. Those trials evaluated PrEP among gay and bisexual men, heterosexual men and women, and injection drug users. All participants in the trials received pills containing either PrEP or placebo, along with intensive counseling on safe-sex behavior, regular testing for sexually transmitted diseases, and a regular supply of condoms. In all of the studies, the risk of getting HIV infection was lower—up to 92% lower—for participants who took the medicines consistently than for those who did not take the medicines.
5. CDC guidelines. The most recent federal guidelines for health care providers recommend that PrEP be considered for people who are HIV-negative and at substantial risk for HIV infection. For sexual transmission, this includes anyone who is in an ongoing relationship with an HIV-positive partner. It also includes anyone who is not in a mutually monogamous relationship with a partner who recently tested HIV-negative, and, is a gay or bisexual man who has had anal sex without a condom or been diagnosed with asexually transmitted disease in the past six months; or, a heterosexual man or woman who does not regularly use condoms during sex with partners of unknown HIV status who are at substantial risk of HIV infection (e.g., people who inject drugs or have bisexual male partners). For people who inject drugs, this includes those who have injected illicit drugs in past six months and who have shared injection equipment or been in drug treatment for injection drug use in the past six months. Health care providers should also discuss PrEP with heterosexual couples in which one partner is HIV-positive and the other is HIV-negative as one of several options to protect the partner who is HIV-negative during conception and pregnancy. The CDC is currently updating recommendations about use of PEP for HIV prevention.
   
6. DPH PrEP Navigator Services Program. In the 2015-2016 Budget Act, the California Legislature appropriated $2 million annually (General Fund, $1.764 million in local assistance, $236,000 for state support) to DPH to establish a PrEP Navigator Services Program to “…ensure access for and serve the most vulnerable Californians at high risk for HIV.” The primary client target for the PrEP Navigator Services Programs are gay, bisexual, transgender, or other MSM, transgender women who have sex with men, and partners of HIV-positive people with a detectable viral load and/or inconsistent antiretroviral use. Special emphasis is to be placed on young gay and bisexual men, young transgender women, and gay and bisexual men and transgender women of color. The PrEP Navigator Services Programs established through this funding are meant to identify, conduct outreach, and provide culturally competent services to target populations, provide assistance to participants allowing them to access, enroll in, and utilize insurance or patient assistance programs to pay for PrEP, link to PrEP providers, and support adherence to PrEP and PrEP-related follow-up participants.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Senate Appropriations Committee:

1. Likely ongoing costs in the millions to low tens of millions to provide PrEP and PEP to high-risk individuals enrolled in Medi-Cal (General Fund and federal funds). Based on CDC estimates for the number of individuals at high risk for HIV infection, Senate Appropriations staff estimates that there are about 150,000 individuals in the state that would meet CDC guidelines for using PrEP or PEP. For each 1% of that population that elects to begin taking PrEP, the proportional cost to the Medi-Cal program to cover the cost of providing PrEP would be about $4 million per year. (Costs for PEP would be considerable lower, since it is only recommended for 28-day use, as opposed to ongoing use for PrEP.)
2. Unknown long-term savings to Medi-Cal and the Aids Drug Assistance Program due to lower HIV infection rates (General Fund and federal funds). To the extent that the bill does result in lower HIV infection rates, there would be cost savings to the Medi-Cal and Aids Drug Assistance Programs. However, there are some factors that limit the potential cost savings from the bill. First, it is not known how effective greater knowledge and use of PrEP and PEP are at the population level in reducing HIV infection. There are clinical studies that show a very dramatic decline in HIV infections amongst users of PrEP. Whether those findings would translate to the larger population not part of a research study is unknown. Second, the annual cost to provide PrEP is may not be substantially less than the current cost to provide treatment to HIV positive Medi-Cal beneficiaries. The cost that Medi-Cal would pay for PreP is not public information. However, the New York State Department of Public Health indicates that annual costs range from $8,000 to $14,000 per year. Even assuming that Medi-Cal receives significant discounts, the cost to provide PreP is likely to be in the thousands per patient per year. On the other hand, the current average annual cost of care for an HIV positive Medi-Cal beneficiary is about $15,000 per year.

SUPPORT: (Verified 8/12/16)

AIDS Project Los Angeles (co-source)

Los Angeles LGBT Center (co-source)

Access Support Network

Bienestar Human Services, Inc.

Black AIDS Institute

California Health+ Advocates

California Life Sciences Association

City of West Hollywood

Community Clinic Association of Los Angeles County

Desert AIDS Project

Equality California

Free Speech Coalition

Friends Community Center

Gender Health Center

JWCH Institute, Inc.

Men’s Health Foundation

Our Family Coalition

Positive Women’s Network

Project Inform

San Diego LGBT Community Center

San Francisco AIDS Foundation

Tarzana Treatment Centers

Transgender Law Center

UCLA Center for Behavioral and Addiction Medicine

OPPOSITION: (Verified 8/15/16)

AIDS Healthcare Foundation

American College of Emergency Physicians, California Chapter

ARGUMENTS IN SUPPORT: AIDS Project Los Angeles and the Los Angeles LGBT Center are the co-sponsors of this bill and state that awareness and use of PrEP and PEP among Californians at risk for HIV remain extremely low. The sponsors note that in 2015 the California HIV/AIDS Research Program conducted a survey of young gay and bisexual men and found that only one in 10 had ever taken PrEP, and although awareness of the intervention was high overall, awareness was significantly lower among black and Latino respondents compared to white respondents. The sponsors also note the majority of respondents lacked the information needed to make a decision about using PrEP, did not know where to access PrEP, and that few respondents had ever talked to their doctor or healthcare provider about PrEP. They conclude it remains vital to ensure that all individuals at risk for HIV receive accurate information about PrEP and PEP, particularly highly-impacted communities of color. Numerous supporters state that roughly 4,700 individuals are newly diagnosed with HIV in California each year and PrEP/PEP are highly effective HIV prevention interventions that could dramatically reduce new infections. Supporters state that PrEP and PEP are key components of the National HIV/AIDS Strategy, but awareness and use of these interventions remain extremely low, and it is vital to increase awareness and use of PrEP and PEP among communities at risk for HIV. Equality California states that given the effectiveness of PrEP and PEP, it is now critically important to ensure that individuals receiving an HIV test are also provided with accurate information about the benefits of these interventions. Bienestar Human Services writes that this bill builds on AB 446, which established what information must be provided to individuals during HIV post-test counseling, including advising the individual of the need for periodic retesting and explaining the limitations of current testing technology. Bienstar states that given the effectiveness of PrEP and PEP, it is now critically important to ensure that individuals receiving an HIV test are also provided with accurate information about the benefits these interventions. California Health+ Advocates writes that California’s clinics are committed to keeping our patients healthy and this bill will assist in this mission.

ARGUMENTS IN OPPOSITION: The AIDS Healthcare Foundation (AHF) states that HIV screening is intended to mirror other screening tests, which require simple consent only and which do not burden the process with additional activities that may or may not be necessary. AHF also notes that guidelines for prevention and risk reduction are fluid, based on the most recent advice from the CDC and DPH, and that information to be shared must be dictated by the needs and circumstances of the person being tested. Finally, AHF contends that recent changes to California law that allowed for disclosure of a negative HIV test result on a secure Web site already minimizes the interaction between the tester and the test subject post-testing and makes the conveying of any more than the most basic information in current law less likely to be useful.

ASSEMBLY FLOOR: 57-20, 6/1/16

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

NOES: Achadjian, Arambula, Bigelow, Brough, Chávez, Dahle, Beth Gaines, Gallagher, Grove, Jones, Kim, Lackey, Linder, Mathis, Melendez, Obernolte, Olsen, Patterson, Steinorth, Wagner

NO VOTE RECORDED: Chang, Frazier, Hadley

Prepared by: Melanie Moreno / HEALTH / (916) 651-4111

8/15/16 20:22:28

**** END ****

SENATE COMMITTEE ON

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

AB 2640 (Gipson) - Public health: HIV

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

The following information is revised to reflect amendments

adopted by the committee on August 11, 2016

Bill Summary:

AB 2640 would require a health care provider administering an HIV test to provide information on preexposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) to a patient determined to be at high risk for HIV infection.

Fiscal Impact:

• Likely ongoing costs in the millions to low tens of millions to provide PrEP and PEP to high-risk individuals enrolled in Medi-Cal (General Fund and federal funds). Based on Centers for Disease Control and Prevention estimates for the number of individuals at high risk for HIV infection, staff estimates that there are about 150,000 individuals in the state that would meet CDC guidelines for using PrEP or PEP. For each 1% of that population that elects to begin taking PrEP, the proportional cost to the Medi-Cal program to cover the cost of providing PrEP would be about $4 million per year. (Costs for PEP would be considerable lower, since it is only recommended for 28-day use, as opposed to ongoing use for PrEP.)
• Unknown long-term savings to Medi-Cal and the Aids Drug Assistance Program due to lower HIV infection rates (General Fund and federal funds). To the extent that the bill does result in lower HIV infection rates, there would be cost savings to the Medi-Cal and Aids Drug Assistance Programs. However, there are some factors that limit the potential cost savings from the bill. First, it is not known how effective greater knowledge and use of PrEP and PEP are at the population level in reducing HIV infection. There are clinical studies that show a very dramatic decline in HIV infections amongst users of PrEP. Whether those findings would translate to the larger population not part of a research study is unknown. Second, the annual cost to provide PrEP is may not be substantially less than the current cost to provide treatment to HIV positive Medi-Cal beneficiaries. The cost that Medi-Cal would pay for PreP is not public information. However, the New York State Department of Public Health indicates that annual costs range from $8,000 to $14,000 per year. Even assuming that Medi-Cal receives significant discounts, the cost to provide PreP is likely to be in the thousands per patient per year. On the other hand, the current average annual cost of care for an HIV positive Medi-Cal beneficiary is about $15,000 per year.

Author Amendments:

Modify the information that must be provided to patients.

-- END --

SENATE COMMITTEE ON

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

AB 2640 (Gipson) - Public health: HIV

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

Bill Summary:

AB 2640 would require a health care provider administering an HIV test to provide information on preexposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) to a patient determined to be at high risk for HIV infection.

Fiscal Impact:

• Likely ongoing costs in the millions to low tens of millions to provide PrEP and PEP to high-risk individuals enrolled in Medi-Cal (General Fund and federal funds). Based on Centers for Disease Control and Prevention estimates for the number of individuals at high risk for HIV infection, staff estimates that there are about 150,000 individuals in the state that would meet CDC guidelines for using PrEP or PEP. For each 1% of that population that elects to begin taking PrEP, the proportional cost to the Medi-Cal program to cover the cost of providing PrEP would be about $4 million per year. (Costs for PEP would be considerable lower, since it is only recommended for 28-day use, as opposed to ongoing use for PrEP.)
• Unknown long-term savings to Medi-Cal and the Aids Drug Assistance Program due to lower HIV infection rates (General Fund and federal funds). To the extent that the bill does result in lower HIV infection rates, there would be cost savings to the Medi-Cal and Aids Drug Assistance Programs. However, there are some factors that limit the potential cost savings from the bill. First, it is not known how effective greater knowledge and use of PrEP and PEP are at the population level in reducing HIV infection. There are clinical studies that show a very dramatic decline in HIV infections amongst users of PrEP. Whether those findings would translate to the larger population not part of a research study is unknown. Second, the annual cost to provide PrEP is may not be substantially less than the current cost to provide treatment to HIV positive Medi-Cal beneficiaries. The cost that Medi-Cal would pay for PreP is not public information. However, the New York State Department of Public Health indicates that annual costs range from $8,000 to $14,000 per year. Even assuming that Medi-Cal receives significant discounts, the cost to provide PreP is likely to be in the thousands per patient per year. On the other hand, the current average annual cost of care for an HIV positive Medi-Cal beneficiary is about $15,000 per year.

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.

Under current law, specific information must be provided by a health care provider who is administering an HIV test, for both individuals testing positive and individuals testing negative who are at high risk for HIV infection.

Proposed Law:

AB 2640 would require a health care provider administering an HIV test to provide information on preexposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) to a patient who tests negative but is determined to be at high risk for HIV infection.

Related Legislation:

AB 2439 (Gipson) would create a pilot project to assess the effectiveness of routinely offering HIV tests in the emergency department of a hospital. That bill will be heard in this committee.

Staff Comments:

There is a great deal of uncertainty in how individuals at high risk of HIV infection will respond to receiving information about PrEP and PEP. Assuming even a small number of such individuals who test negative for HIV would seek PrEP, costs to the Medi-Cal program could be substantial. Of course, any action that reduces HIV infection would have substantial population health benefits and would lead to cost savings to Medi-Cal.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 2640

SUBJECT: Public health: HIV

SUMMARY:

Requires a medical provider or a person administering a HIV test, in the case that a patient that is known to be at high risk for HIV infection tests negative for HIV to provide written information about the effectiveness and safety of all methods that prevent or reduce the risk of contracting HIV, including, but not limited to, preexposure prophylaxes and postexposure prophylaxes, consistent with guidance of the federal Centers for Disease Control and Prevention.

Existing law:

1. Places certain requirements on the information shared by medical providers with patients for HIV testing, including informing the patient that the test is planned, providing information about the test, informing 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 advising the patient that he or she has the right to decline the test. If a patient declines the test, the medical care provider shall note that fact in the patient’s medical file.
2. Requires the medical provider or other person performing a HIV test, after the results of a 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 for HIV infection and 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 may offer prevention counseling or a referral to prevention counseling.

This bill: Requires a medical provider or a person administering a HIV test, in the case that a patient that is known to be at high risk for HIV infection tests negative for HIV to provide written information about the effectiveness and safety of all methods that prevent or reduce the risk of contracting HIV, including, but not limited to, preexposure prophylaxes (PrEP) and postexposure prophylaxes (PEP), consistent with guidance of the federal Centers for Disease Control and Prevention (CDC).

FISCAL EFFECT:

According to the Assembly Appropriations Committee, to the extent this bill raises awareness of drug therapy for people at high risk for HIV, this bill could potentially increase demand for and utilization of drug treatment for HIV prevention, particularly PrEP. According to the New York State Department of Health, Truvada, the drug used in PrEP therapy, costs between $8,000 and $14,000 per year. Medi-Cal prices for the drug are unknown, but even assuming significant discounts are available, costs to Medi-Cal could be in the millions annually if even a few hundreds more people a year take the medication (General Fund/federal). To the extent increased utilization with PrEP among high-risk populations reduces the number of HIV infections, there would be offsetting cost savings for less HIV/AIDS treatment in Medi-Cal and the AIDS Drug Assistance Program.

Costs to the California Department of Public Health (DPH) to produce updated written material, and to modify HIV counselor training, are minor and absorbable.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, AB 2640 seeks to reduce the spread of HIV and save the lives of individuals at high risk of HIV exposure by providing them with information about preventive medications during HIV post-test counseling. In 2013, California was second among the fifty states in the number of new HIV diagnoses, with approximately 5,000 new HIV diagnoses. A 2015 survey of individuals at risk for HIV by the California HIV/AIDS Research Program found that only 1 in 10 respondents had ever used PrEP. Although awareness of the intervention was high among those who had never taken PrEP, awareness was significantly lower among Black and Latino respondents compared to white respondents. In addition, the large majority of respondents indicated they had never talked to their doctor or healthcare provider about PrEP. Considering the high volume of new HIV infections being diagnosed in the state of California and the low awareness of these medications, it is critical that those being tested are aware of PrEP and PEP medications.
2. Background. According to the CDC, more than 1.2 million people in the U.S. are living with HIV infection, and 13% are unaware of their infection. Gay, bisexual, and men who have sex with men (MSM), particularly young African American MSM, are most seriously affected by HIV. By race, African Americans face the most severe burden of HIV. 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. An estimated 13,712 people with an AIDS diagnosis died in 2012, and approximately 658,507 people in the U.S. with an AIDS diagnosis have died overall. The 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. People living with HIV/AIDS have an estimated life expectancy of 32 years after infection and that number is increasing. According to DPH’s Office of AIDS (OA), with treatment costs averaging around $23,000 per year, lifetime treatment is currently estimated at around $740,000 or more per person. With that estimate, the 6,000 new infections per year in California will cost an estimated $4.5 billion to treat.
3. PrEP and PEP. “Treatment as prevention” (TasP) refers to HIV prevention methods that use antiretroviral treatment (ART) to decrease the risk of HIV transmission. According to the World Health Organization, TasP needs to be considered as a key element of combination HIV prevention and as a major part of the solution to ending the HIV epidemic. Through TasP, people living with HIV/AIDS use anti-retroviral (ARV) medications to reduce their viral load (the amount of HIV in the body) to undetectable levels. With an undetectable viral load, the amount of HIV in the body is so small it greatly reduces the likelihood of passing the virus to another person. Strict adherence to TasP reduces the likelihood of transmission by up to 96%.
   
   PrEP is a new intervention that uses an established ARV medication, Truvada to protect at-risk HIV-negative individuals from HIV infection. PrEP is different from PEP; the medication is taken before, not after possible exposure. Daily PrEP use can lower the risk of getting HIV from sex by more than 90% and from injection drug use by more than 70%. Missing doses reduces PrEP effectiveness. Truvada is currently the only FDA drug approved for HIV PrEP.
   
   PEP uses ARV medications to prevent HIV from replicating and spreading through the body after an exposure to the virus. PEP is a short-term (28-day) intervention and must be started within three days of an exposure – sooner, if possible – to be effective. PEP was originally developed for occupational exposures, such as needle-sticks in hospitals, but is also effective for sexual exposures.
   
4. Public awareness and use of PrEP. In 2015, the CDC estimated that one in four sexually active gay and bisexual men, one in five people who inject drugs, and one in 200 sexually active heterosexual adults meet the criteria for PrEP. In 2015, the California HIV/AIDS Research Program conducted a survey of 602 young gay and bisexual men and found that only one in 10 had ever taken PrEP. Although awareness of the intervention was high among those who had never taken PrEP, awareness was significantly lower among Black and Latino respondents compared to white respondents. In addition, the large majority of respondents indicated they had never talked to their doctor or healthcare provider about PrEP.
   
   Another recent study found that few doctors are prescribing PrEP to those who could benefit. The study found that out of more than 1,000 gay and bisexual men, only 83 reported using PrEP. The author of the study concluded, “The majority of gay men who are good candidates for PrEP are not on the medication, and many haven’t spoken to their medical providers about PrEP. We need to get conversations going, and in general promote more open dialogue between doctors and patients regarding sexual health.” The findings are from One Thousand Strong, a three-year observational study of a U.S. national sample of gay and bisexual men ages 18 to 80 that is now underway.
   
   In its November 24, 2015 Morbidity and Mortality Weekly Report, the CDC estimated that 1.2 million Americans could benefit from PrEP, including 492,000 men who have sex with men (MSM), 115,000 injection drug users, and 624,000 heterosexuals. The report concludes that clinical organizations, health departments, and community-based organizations should raise awareness of PrEP among persons with substantial risk for acquiring HIV infection and their health care providers.
5. Research supporting PrEP use. On May 14, 2014, the U.S. Public Health Service released the first comprehensive clinical practice guidelines for PrEP. This followed the earlier publication of brief interim guidelines that were based on findings from several large national and international clinical trials. Those trials evaluated PrEP among gay and bisexual men, heterosexual men and women, and injection drug users. All participants in the trials received pills containing either PrEP or placebo, along with intensive counseling on safe-sex behavior, regular testing for sexually transmitted diseases, and a regular supply of condoms. In all of the studies, the risk of getting HIV infection was lower—up to 92% lower—for participants who took the medicines consistently than for those who did not take the medicines.
6. CDC guidelines. The most recent federal guidelines for health care providers recommend that PrEP be considered for people who are HIV-negative and at substantial risk for HIV infection. For sexual transmission, this includes anyone who is in an ongoing relationship with an HIV-positive partner. It also includes anyone who is not in a mutually monogamous relationship with a partner who recently tested HIV-negative, and, is a gay or bisexual man who has had anal sex without a condom or been diagnosed with asexually transmitted disease in the past six months; or, a heterosexual man or woman who does not regularly use condoms during sex with partners of unknown HIV status who are at substantial risk of HIV infection (e.g., people who inject drugs or have bisexual male partners). For people who inject drugs, this includes those who have injected illicit drugs in past six months and who have shared injection equipment or been in drug treatment for injection drug use in the past six months. Health care providers should also discuss PrEP with heterosexual couples in which one partner is HIV-positive and the other is HIV-negative as one of several options to protect the partner who is HIV-negative during conception and pregnancy. The CDC is currently updating recommendations about use of PEP for HIV prevention.
   
7. Cost of PrEP and PEP. Costs for PrEP may include payment for the medication as well as payment for required medical visits and laboratory tests. While most public and private insurance companies cover PEP and PrEP prescriptions, there is high variability in out-of-pocket costs such as deductibles or co-pays. Some health plans cover PrEP at a lower, generic co-pay, while others place it in a specialty, or higher, more expensive tier. For individuals without any insurance coverage, the cost is approximately $12,000 - $15,000 per year. There are currently several payment assistance programs available through both the manufacturer and community groups that can help individuals without insurance, and those with high out-of-pocket costs through their insurance company.
8. DPH PrEP Navigator Services Program. In the 2015-2016 Budget Act, the California Legislature appropriated $2 million annually (General Fund, $1.764 million in local assistance, $236,000 for state support) to DPH to establish a PrEP Navigator Services Program to “…ensure access for and serve the most vulnerable Californians at high risk for HIV.” The primary client target for the PrEP Navigator Services Programs are gay, bisexual, transgender, or other MSM, transgender women who have sex with men, and partners of HIV-positive people with a detectable viral load and/or inconsistent antiretroviral use. Special emphasis is to be placed on young gay and bisexual men, young transgender women, and gay and bisexual men and transgender women of color. The PrEP Navigator Services programs established through this funding are meant to identify, conduct outreach, and provide culturally competent services to target populations, provide assistance to participants allowing them to access, enroll in, and utilize insurance or patient assistance programs to pay for PrEP, link to PrEP providers, and support adherence to PrEP and PrEP-related follow-up participants.
9. Related legislation. AB 2439 (Nazarian), would require every hospital emergency department, if it otherwise draws blood from a patient, to offer to test that blood for HIV with the patients consent. AB 2439 is set to be heard in this Committee on June 29, 2016.
10. Prior legislation. AB 446 (Mitchell, Chapter 589, Statutes of 2013), revised requirements related to information provided at the time an HIV test is administered and after the test results are received; requires informed consent, as specified, either orally or in writing, except when a person independently requests an HIV test from an HIV counseling and testing site, as specified; requires documentation of the person’s independent request for the test and exempts clinical laboratories from the informed consent requirements; requires every patient who has blood drawn at a primary care clinic, as defined, who has consented to the test, to be offered an HIV test; and, authorizes disclosure of HIV test results by Internet posting or other electronic means if the HIV test subject is anonymously tested.

AB 491 (Portantino of 2011), would have allocated state and federal funds to test persons for HIV, would have specified that an HIV counselor is a medical care provider, and would have authorized a clinical laboratory test result of a negative HIV antibody test to be posted on a secure website if specified conditions were met. AB 491 was amended to deal with a different subject matter.

AB 1894 (Krekorian, Chapter 631, Statutes of 2008), requires health care service plans and disability insurers selling health insurance to offer testing for HIV antibodies and AIDS, regardless of whether the testing is related to a primary diagnosis.

AB 682 (Berg, Chapter 550, Statutes of 2007), revises the written and informed consent standards associated with testing blood for HIV, including prenatal HIV testing, to no longer require affirmative approval prior to administering an HIV test. Establishes the new HIV testing consent standard as the right to decline the test, providing that medical care providers present specified information to the individual about treatment options and the individual's right to decline the test, and the medical care provider notes in the chart when the patient declines to be tested. Exempts HIV testing at an alternative test site, as part of an autopsy, or when part of scientific research from these provisions.

1. Support. AIDS Project Los Angeles and the Los Angeles LGBT Center are the cosponsors of this bill and state that awareness and use of PrEP and PEP among Californians at risk for HIV remain extremely low. The sponsors note that in 2015 the California HIV/AIDS Research Program conducted a survey of young gay and bisexual men and found that only one in 10 had ever taken PrEP, and although awareness of the intervention was high overall, awareness was significantly lower among black and Latino respondents compared to white respondents. The sponsors also note the majority of respondents lacked the information needed to make a decision about using PrEP, did not know where to access PrEP, and that few respondents had ever talked to their doctor or healthcare provider about PrEP. They conclude it remains vital to ensure that all individuals at risk for HIV receive accurate information about PrEP and PEP, particularly highly-impacted communities of color. Numerous supporters state that roughly 4,700 individuals are newly diagnosed with HIV in California each year and PrEP/PEP are highly effective HIV prevention interventions that could dramatically reduce new infections. Supporters state that PrEP and PEP are key components of the National HIV/AIDS Strategy, but awareness and use of these interventions remain extremely low, and it is vital to increase awareness and use of PrEP and PEP among communities at risk for HIV. Equality California states that given the effectiveness of PrEP and PEP, it is now critically important to ensure that individuals receiving an HIV test are also provided with accurate information about the benefits of these interventions. Bienestar Human Services writes that this bill builds on AB 446, which established what information must be provided to individuals during HIV post-test counseling, including advising the individual of the need for periodic retesting and explaining the limitations of current testing technology. Bienstar states that given the effectiveness of PrEP and PEP, it is now critically important to ensure that individuals receiving an HIV test are also provided with accurate information about the benefits these interventions. CaliforniaHealth+ Advocates writes that California’s clinics are committed to keeping our patients healthy and this bill will assist in this mission.
2. Opposition. The AIDS Healthcare Foundation (AHF) states that HIV screening is intended to mirror other screening tests, which require simple consent only and which do not burden the process with additional activities that may or may not be necessary. AHF also notes that guidelines for prevention and risk reduction are fluid, based on the most recent advice from the CDC and DPH, and that information to be shared must be dictated by the needs and circumstances of the person being tested. Finally, AHF contends that recent changes to California law that allowed for disclosure of a negative HIV test result on a secure website already minimizes the interaction between the tester and the test subject post-testing and makes the conveying of any more than the most basic information in current law less likely to be useful. The California Medical Association (CMA) states that increased awareness of preventative treatment options for HIV should be a public health goal, however, it is concerned that the increased medical resources required to accomplish the goal of this bill are not worth the benefit of the mandate. CMA also notes that a physician is already required to provide a patient who tests positive with treatment and counseling options as well as mandated to schedule follow up appointments with relevant specialists. CMA concludes, for patients who test negative for HIV, it believes it is best left to the physician's clinical judgment as to what preventative treatment options should be given to the patient. The California Hospital Association (CHA) opposes codifying standards of practice and interfering in the physician-patient relationship by legislating what information a physician should tell a patient. CHA states this bill would eliminate the physician's medical judgment as to what information or treatment is in the best interest of the patient.
3. Author’s amendments. The author requests the Committee approve the following amendment to clarify that information about PrEP and PEP can be provided orally or in writing:

On page 3, line 33:

“…period for verification of results, provide written information about…”

SUPPORT AND OPPOSITION:

Support: AIDS Project Los Angeles (sponsor)

Access Support Network

Black AIDS Institute

Bienestar Human Services, Inc.

California Health+ Advocates

California Life Sciences Association

City of West Hollywood

Community Clinic Association of Los Angeles County

Desert AIDS Project

Free Speech Coalition

Friends Community Center

Gender Health Center

JWCH Institute, Inc.

Men’s Health Foundation

Our Family Coalition

Positive Women’s Network

Project Inform

San Diego LGBT Community Center

San Francisco AIDS Foundation

Tarzana Treatment Centers

Transgender Law Center

UCLA Center for Behavioral and Addiction Medicine

California Life Sciences Association

Oppose: AIDS Healthcare Foundation

American College of Emergency Physicians, California Chapter

California Hospital Association

California Medical Association

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 2640

Author:(Gipson)

As Amended Ver:

Majority vote

SUMMARY: Requires a medical care provider or person administering a test for human immunodeficiency virus (HIV) to provide patients who test negative for HIV infection, yet are at high risk for HIV infection, with written information about the effectiveness and safety of all methods that prevent or reduce the risk of contracting HIV, including, but not limited to, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), consistent with guidance of the federal Centers for Disease Control and Prevention (CDC).

FISCAL EFFECT: According to the Assembly Appropriations Committee, to the extent this bill raises awareness of drug therapy for people at high risk for HIV, this bill could potentially increase demand for and utilization of drug treatment for HIV prevention, particularly PrEP. According to the New York State Department of Health, Truvada, the drug used in PrEP therapy, costs between $8,000 and $14,000 per year. Medi-Cal prices for the drug are unknown, but even assuming significant discounts are available, costs to Medi-Cal could be in the millions annually if even a few hundreds more people a year take the medication (General Fund/federal). To the extent increased utilization with PrEP among high-risk populations reduces the number of HIV infections, there would be offsetting cost savings for less HIV/AIDS treatment in Medi-Cal and the AIDS Drug Assistance Program.

Costs to the California Department of Public Health to produce updated written material, and to modify HIV counselor training, are minor and absorbable.

COMMENTS: According to the author, this bill seeks to reduce the spread of HIV and save the lives of individuals at high risk of HIV exposure by providing them with information about preventive medications during HIV post-test counseling. The author notes that in 2013, California was second among the 50 states in the number of new HIV diagnoses, with approximately 5,000 new HIV diagnoses, and a 2015 survey of individuals at risk for HIV by the California HIV/AIDS Research Program found that only one in 10 respondents had ever used PrEP. The author concludes, considering the high volume of new HIV infections being diagnosed in the state of California and the low awareness of these medications, it is critical that those being tested are aware of PEP and PrEP medications.

Treatment as Prevention (TasP), PrEP, and PEP. In TasP, people living with HIV/AIDS use anti-retroviral (ARV) medications to reduce their viral load (the amount of HIV in the body) to undetectable levels. With an undetectable viral load, the amount of HIV in the body is so small it greatly reduces the likelihood of passing the virus to another person. Strict adherence to TasP reduces the likelihood of transmission by up to 96%. PrEP is a new intervention that uses an established ARV medication, Truvada to protect at-risk HIV-negative individuals from HIV infection. PrEP is different from PEP; the medication is taken before, not after possible exposure. Daily PrEP use can lower the risk of getting HIV from sex by more than 90% and from injection drug use by more than 70%. Missing doses reduces PrEP effectiveness. Truvada is currently the only FDA drug approved for HIV PrEP. PEP uses ARV medications to prevent HIV from replicating and spreading through the body after an exposure to the virus. PEP is a short-term (28-day) intervention and must be started within three days of an exposure – sooner, if possible – to be effective. PEP was originally developed for occupational exposures, such as needle-sticks in hospitals, but is also effective for sexual exposures.

In 2015, the CDC estimated that one in four sexually active gay and bisexual men, one in five people who inject drugs, and one in 200 sexually active heterosexual adults meet the criteria for PrEP. In 2015, the California HIV/AIDS Research Program conducted a survey of 602 young gay and bisexual men and found that only one in 10 had ever taken PrEP. Although awareness of the intervention was high among those who had never taken PrEP, awareness was significantly lower among Black and Latino respondents compared to white respondents. In addition, the large majority of respondents indicated they had never talked to their doctor or healthcare provider about PrEP.

In its November 24, 2015 Morbidity and Mortality Weekly Report, the CDC estimated that 1.2 million Americans could benefit from PrEP, including 492,000 men who have sex with men, 115,000 injection drug users, and 624,000 heterosexuals. The report concludes that clinical organizations, health departments, and community-based organizations should raise awareness of PrEP among persons with substantial risk for acquiring HIV infection and their health care providers.

AIDS Project Los Angeles and the Los Angeles LGBT Center are the cosponsors of this bill and they state that awareness and use of PrEP and PEP among Californians at risk for HIV remain extremely low. They conclude it remains vital to ensure that all individuals at risk for HIV receive accurate information about PrEP and PEP, particularly highly-impacted communities of color.

The AIDS Healthcare Foundation (AHF) states in opposition that HIV screening is intended to mirror other screening tests, which require simple consent only and which do not burden the process with additional activities that may or may not be necessary. AHF asserts that its experience as the largest private tester in the state is that the more time and demands placed on the person it is encouraging to be tested, the more likely the person is to decline. The California Medical Association (CMA) is opposed to this bill stating, increased awareness of preventative treatment options for HIV should be a public health goal, however, it is concerned that the increased medical resources required to accomplish the goal of this bill are not worth the benefit of the mandate. CMA notes that many preventative treatment options are not appropriate for every patient, and this bill would require a physician to inform the patient of a treatment option the physician might actually recommend against.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0003267

Date of Hearing: May 4, 2016

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

ABPCA Bill Id:AB 2640

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

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

SUMMARY:

This bill requires, after a patient known to be at high risk for human immunodeficiency virus (HIV) infection tests negative for HIV, the medical provider or the person who administers the test to provide written information about the effectiveness and safety of all methods that prevent or reduce the risk of contracting HIV, including, but not limited to, preexposure prophylaxes (PrEP) and postexposure prophylaxes (PEP), consistent with guidance of the federal Centers for Disease Control and Prevention (CDC).

FISCAL EFFECT:

1. To the extent this bill raises awareness of drug therapy for people at high risk for HIV, this bill could potentially increase demand for and utilization of drug treatment for HIV prevention, particularly PrEP. According to the New York State Department of Health, Truvada®, the drug used in PrEP therapy, costs between $8,000 and $14,000 per year. Medi-Cal prices for the drug are unknown, but even assuming significant discounts are available, costs to Medi-Cal could be in the millions annually if even a few hundreds more people a year take the medication (GF/federal). PrEP must be taken every day while the person remains high-risk to prevent infection.
2. To the extent increased utilization with PrEP among high-risk populations reduces the number of HIV infections, there would be offsetting cost savings for less HIV/AIDS treatment in Medi-Cal and the AIDS Drug Assistance Program (ADAP).
3. Costs to the California Department of Public Health (CDPH) to produce updated written material, and to modify HIV counselor training, are minor and absorbable.

COMMENTS:

1. Purpose. According to the author, this bill seeks to reduce the spread of HIV and save the lives of individuals at high risk of HIV exposure, by providing them with information about preventive medications during HIV post-test counseling.
2. PrEP. According to CDPH, PrEP, is an important HIV prevention option in which persons who are uninfected, but at significant risk for acquiring HIV, take one pill a day to prevent acquiring HIV. The medication currently approved by the federal Food and Drug Administration for PrEP is co-formulated emtricitabine/tenofovir (Truvada®). The pill can reduce the risk of HIV infection by up to 92% when consistently taken once a day as prescribed. PrEP does not replace other risk reduction options such as reducing the number of risk exposures, consistent use of condoms, and suppressing viral load through use of HIV medication among those who are HIV infected.
3. PEP. These medications are used to prevent HIV from replicating and spreading through the body after an exposure to the virus. PEP is a short-term (28-day) intervention and must be started within three days of an exposure – sooner, if possible – to be effective. PEP was originally developed for occupational exposures, such as needle-sticks in hospitals, but is also effective for sexual exposures.
4. Related Budget Action. In the 2015-2016 Budget Act, the California Legislature appropriated $2 million annually (General Fund, $1.764 million in local assistance, $236,000 for state support) to DPH to establish a PrEP Navigator Services Program to “…ensure access for and serve the most vulnerable Californians at high risk for HIV.” The primary client target for the PrEP Navigator Services Programs are gay, bisexual, transgender, or other MSM, transgender women who have sex with men, and partners of HIV-positive people with a detectable viral load and/or inconsistent antiretroviral use. On March 3, 2016 OA announced nine applicants that were selected to receive funding for the PrEP Navigator Services.
5. Support. AIDS Project Los Angeles and the Los Angeles LGBT Center are the cosponsors of this bill and they state that awareness and use of PrEP and PEP among Californians at risk for HIV remain extremely low. They conclude it remains vital to ensure that all individuals at risk for HIV receive accurate information about PrEP and PEP, particularly highly-impacted communities of color. A number of other advocacy groups for HIV-infected individuals as well as advocates for low-income and minority communities support this bill.
6. Opposition. The AIDS Healthcare Foundation (AHF) writes in opposition that HIV screening should be convenient and not be burdened with additional activities that may not be necessary. AHF asserts that the more time and demands are placed on the person it is encouraging to be tested, the more likely the person is to decline. AHF also notes that guidelines for prevention and risk reduction are fluid, based on the most recent advice from the CDC and CDPH, and that information to be shared must be dictated by the needs and circumstances of the person being tested. AHF also cites concern about inappropriate use of PrEP among low-risk individuals. Finally, AHF asserts the current language governing testing has been carefully negotiated in prior years to minimize burdensome requirements and avoid providing specific direction to medical providers and HIV testers.

The California Hospital Association (CHA) also opposes this bill, citing interference with the physician-patient relationship and opposition to codifying standards of practice. The California Medical Association stated similar concerns about a prior version of this bill; CMA's position is unknown.

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 2640

Author:(Gipson) – As Amended Ver:March 16, 2016

SUBJECT: Public Health: HIV.

SUMMARY: Requires a medical care provider or person administering a test for human immunodeficiency virus (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 (FDA) –approved methods that prevent or reduce the risk of contracting HIV, including pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), consistent with guidance of the federal Centers for Disease Control and Prevention (CDC).

EXISTING LAW:

1. Requires a medical provider or person administering a test for HIV, after receiving results indicating no infection for a patient who is at high risk for HIV infection, to advise the patient of the need for periodic retesting and explain the limitations of current testing technology and the current window period for verification of results.
2. Establishes the Office of AIDS (OA) within the Department of Public Health (DPH), to coordinate state programs, services, and activities related to HIV/acquired immune deficiency syndrome (AIDS).
3. Establishes the AIDS Drug Assistance Program within DPH to subsidize the cost of AIDS drugs for persons who do not have private health coverage, are not eligible for Medi-Cal, or cannot afford to purchase the drug privately. Indicates that the subsidy program is to be funded by state and federal sources.

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

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, this bill seeks to reduce the spread of HIV and save the lives of individuals at high risk of HIV exposure by providing them with information about preventive medications during HIV post-test counseling. The author notes that in 2013, California was second among the 50 states in the number of new HIV diagnoses, with approximately 5,000 new HIV diagnoses, and a 2015 survey of individuals at risk for HIV by the California HIV/AIDS Research Program found that only one in 10 respondents had ever used PrEP. The author concludes, considering the high volume of new HIV infections being diagnosed in the state of California and the low awareness of these medications, it is critical that those being tested are aware of PEP and PrEP medications.
2. BACKGROUND.
   
   1. Treatment as Prevention (TasP), PrEP, and PEP. In TasP, people living with HIV/AIDS use anti-retroviral (ARV) medications to reduce their viral load (the amount of HIV in the body) to undetectable levels. With an undetectable viral load, the amount of HIV in the body is so small it greatly reduces the likelihood of passing the virus to another person. Strict adherence to TasP reduces the likelihood of transmission by up to 96%.
      
      PrEP is a new intervention that uses an established ARV medication, Truvada to protect at-risk HIV-negative individuals from HIV infection. PrEP is different from PEP; the medication is taken before, not after possible exposure. Daily PrEP use can lower the risk of getting HIV from sex by more than 90% and from injection drug use by more than 70%. Missing doses reduces PrEP effectiveness. Truvada is currently the only FDA drug approved for HIV PrEP.
      
      PEP uses ARV medications to prevent HIV from replicating and spreading through the body after an exposure to the virus. PEP is a short-term (28-day) intervention and must be started within three days of an exposure – sooner, if possible – to be effective. PEP was originally developed for occupational exposures, such as needle-sticks in hospitals, but is also effective for sexual exposures.
      
   2. Public awareness and use of PrEP. In 2015, the CDC estimated that one in four sexually active gay and bisexual men, one in five people who inject drugs, and one in 200 sexually active heterosexual adults meet the criteria for PrEP. In 2015, the California HIV/AIDS Research Program conducted a survey of 602 young gay and bisexual men and found that only one in 10 had ever taken PrEP. Although awareness of the intervention was high among those who had never taken PrEP, awareness was significantly lower among Black and Latino respondents compared to white respondents. In addition, the large majority of respondents indicated they had never talked to their doctor or healthcare provider about PrEP.
      
      Another recent study found that few doctors are prescribing PrEP to those who could benefit. The study found that out of more than 1,000 gay and bisexual men, only 83 reported using PrEP. The author of the study concluded, “The majority of gay men who are good candidates for PrEP are not on the medication, and many haven’t spoken to their medical providers about PrEP. We need to get conversations going, and in general promote more open dialogue between doctors and patients regarding sexual health.” The findings are from One Thousand Strong, a three-year observational study of a U.S. national sample of gay and bisexual men ages 18 to 80 that is now underway.
      
      In its November 24, 2015 Morbidity and Mortality Weekly Report, the CDC estimated that 1.2 million Americans could benefit from PrEP, including 492,000 men who have sex with men (MSM), 115,000 injection drug users, and 624,000 heterosexuals. The report concludes that clinical organizations, health departments, and community-based organizations should raise awareness of PrEP among persons with substantial risk for acquiring HIV infection and their health care providers.
      
      The FDA first approved the use of ARVs as a form of HIV prevention for at-risk, HIV-negative individuals in 2012. Various studies have since demonstrated the efficacy of PrEP among different populations, however, African American MSM lag behind in PrEP use despite their disproportionate HIV incidence and prevalence.
      
   3. HIV in America. More than 1.2 million people in the United States are living with HIV infection, and almost one in eight (12.8%) are unaware of their infection. Gay, bisexual, and other MSM, particularly young African American MSM, are most seriously affected by HIV. By race, African Americans face the most severe burden of HIV.
      
      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.
      
      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.
      
      The 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.
      
      People living with HIV/AIDS have an estimated life expectancy of 32 years after infection and that number is increasing. According to OA, with treatment costs averaging around $23,000 per year, lifetime treatment is currently estimated at around $740,000 or more per person. With that estimate, the 6,000 new infections per year in California will cost an estimated $4.5 billion to treat.
      
   4. Research supporting PrEP use. On May 14, 2014, the U.S. Public Health Service released the first comprehensive clinical practice guidelines for PrEP. This followed the earlier publication of brief interim guidelines that were based on findings from several large national and international clinical trials. Those trials evaluated PrEP among gay and bisexual men, heterosexual men and women, and injection drug users. All participants in the trials received pills containing either PrEP or placebo, along with intensive counseling on safe-sex behavior, regular testing for sexually transmitted diseases, and a regular supply of condoms. In all of the studies, the risk of getting HIV infection was lower—up to 92% lower—for participants who took the medicines consistently than for those who did not take the medicines.
      
   5. CDC guidelines on PrEP. The most recent federal guidelines for health care providers recommend that PrEP be considered for people who are HIV-negative and at substantial risk for HIV infection. For sexual transmission, this includes anyone who is in an ongoing relationship with an HIV-positive partner. It also includes anyone who is not in a mutually monogamous relationship with a partner who recently tested HIV-negative, and, is a gay or bisexual man who has had anal sex without a condom or been diagnosed with asexually transmitted disease in the past six months; or, a heterosexual man or woman who does not regularly use condoms during sex with partners of unknown HIV status who are at substantial risk of HIV infection (e.g., people who inject drugs or have bisexual male partners).
      
      For people who inject drugs, this includes those who have injected illicit drugs in past six months and who have shared injection equipment or been in drug treatment for injection drug use in the past six months. Health care providers should also discuss PrEP with heterosexual couples in which one partner is HIV-positive and the other is HIV-negative as one of several options to protect the partner who is HIV-negative during conception and pregnancy.
      
      The CDC is currently updating recommendations about use of PEP for HIV prevention.
      
   6. Cost of PrEP and PEP. Costs for PrEP may include payment for the medication as well as payment for required medical visits and laboratory tests. While most public and private insurance companies cover PEP and PrEP prescriptions, there is high variability in out-of-pocket costs such as deductibles or co-pays. Some health plans cover PrEP at a lower, generic co-pay, while others place it in a specialty, or higher, more expensive tier. For individuals without any insurance coverage, the cost is approximately $12,000 - $15,000 per year. There are currently several payment assistance programs available through both the manufacturer and community groups that can help individuals without insurance, and those with high out-of-pocket costs through their insurance company.
      
   7. DPH PrEP Navigator Services Program. In the 2015-2016 Budget Act, the California Legislature appropriated $2 million annually (General Fund, $1.764 million in local assistance, $236,000 for state support) to DPH to establish a PrEP Navigator Services Program to “…ensure access for and serve the most vulnerable Californians at high risk for HIV.” The primary client target for the PrEP Navigator Services Programs are gay, bisexual, transgender, or other MSM, transgender women who have sex with men, and partners of HIV-positive people with a detectable viral load and/or inconsistent antiretroviral use. Special emphasis is to be placed on young gay and bisexual men, young transgender women, and gay and bisexual men and transgender women of color.
      
      The PrEP Navigator Services programs established through this funding are meant to identify, conduct outreach, and provide culturally competent services to target populations, provide assistance to participants allowing them to access, enroll in, and utilize insurance or patient assistance programs to pay for PrEP, link to PrEP providers, and support adherence to PrEP and PrEP-related follow-up participants.
      
      As a result of a statewide request for applications, on March 3, 2016 OA announced the nine applicants that were selected to receive funding for the PrEP Navigator Services Program are as follows:
      
      1. AltaMed Health Services Corporation;
      2. Asian Health Services;
      3. Desert AIDS Project;
      4. Friends Research Institute, Inc.;
      5. Humboldt County Department of Health and Human Services;
      6. Kern County Public Health Services Department;
      7. La Clinica de la Raza, Inc.;
      8. Alta Bates Summit Medical Center; and,
      9. Tarzana Treatment Centers.
3. SUPPORT. AIDS Project Los Angeles and the Los Angeles LGBT Center are the cosponsors of this bill and they state that awareness and use of PrEP and PEP among Californians at risk for HIV remain extremely low. They note that in 2015 the California HIV/AIDS Research Program conducted a survey of young gay and bisexual men and found that only one in 10 had ever taken PrEP, and although awareness of the intervention was high overall, awareness was significantly lower among black and Latino respondents compared to white respondents. The proponents also note the majority of respondents lacked the information needed to make a decision about using PrEP, did not know where to access PrEP, and that few respondents had ever talked to their doctor or healthcare provider about PrEP. They conclude it remains vital to ensure that all individuals at risk for HIV receive accurate information about PrEP and PEP, particularly highly-impacted communities of color.
   
   Equality California states that given the effectiveness of PrEP and PEP, it is now critically important to ensure that individuals receiving an HIV test are also provided with accurate information about the benefits of these interventions.
4. OPPOSITION. The AIDS Healthcare Foundation (AHF) states that HIV screening is intended to mirror other screening tests, which require simple consent only and which do not burden the process with additional activities that may or may not be necessary. AHF asserts that its experience as the largest private tester in the state is that the more time and demands placed on the person it is encouraging to be tested, the more likely the person is to decline. AHF also notes that guidelines for prevention and risk reduction are fluid, based on the most recent advice from the CDC and DPH, and that information to be shared must be dictated by the needs and circumstances of the person being tested. Finally, AHF contends that recent changes to California law that allowed for disclosure of a negative HIV test result on a secure website already minimizes the interaction between the tester and the test subject post-testing and makes the conveying of any more than the most basic information in current law less likely to be useful.
   
   The California Medical Association (CMA) is opposed to this bill stating, increased awareness of preventative treatment options for HIV should be a public health goal, however, it is concerned that the increased medical resources required to accomplish the goal of this bill are not worth the benefit of the mandate. CMA notes that many preventative treatment options are not appropriate for every patient, and this bill would require a physician to inform the patient of a treatment option the physician might actually recommend against. CMA also notes that a physician is already required to provide a patient who tests positive with treatment and counseling options as well as mandated to schedule follow up appointments with relevant specialists. CMA concludes, for patients who test negative for HIV, it believes it is best left to the physician's clinical judgment as to what preventative treatment options should be given to the patient.
   
   The California Hospital Association (CHA) opposes codifying standards of practice and interfering in the physician-patient relationship by legislating what information a physician should tell a patient. CHA states this bill would eliminate the physician's medical judgment as to what information or treatment is in the best interest of the patient. CHA also contends that this bill would eliminate the medical provider's option to refer the patient to another, more appropriate physician for prevention counseling and explains, the option to refer the patient to another physician is very important – many physicians who may order an HIV test, such as hospital emergency physicians and psychiatrists, do not routinely treat infectious disease patients as part of their practice. They instead refer such patients to internal medicine physicians or infectious disease specialist who keep themselves up-to-date on the most recent pronouncements and guidance from the FDA and the CDC. CHA concludes that medical discussion should be between the patient and the physician.
5. RELATED LEGISLATION. AB 2439 (Nazarian) would require every hospital emergency department, if it otherwise draws blood from a patient, to offer to test that blood for HIV with the patients consent. AB 2439 is pending in the Assembly Health Committee.
6. PREVIOUS LEGISLATION.
   1. AB 446 (Mitchell), Chapter 589, Statutes of 2013, revises requirements related to information provided at the time an HIV test is administered and after the test results are received; requires informed consent, as specified, either orally or in writing, except when a person independently requests an HIV test from an HIV counseling and testing site, as specified; requires documentation of the person’s independent request for the test and exempts clinical laboratories from the informed consent requirements; requires every patient who has blood drawn at a primary care clinic, as defined, who has consented to the test, to be offered an HIV test; and, authorizes disclosure of HIV test results by Internet posting or other electronic means if the HIV test subject is anonymously tested.
   2. AB 491 (Portantino) of 2011 would have allocated state and federal funds to test persons for HIV, would have specified that an HIV counselor is a medical care provider, and would have authorized a clinical laboratory test result of a negative HIV antibody test to be posted on a secure website if specified conditions were met. AB 491 was amended to deal with a different subject matter.
   3. AB 1894 (Krekorian), Chapter 631, Statutes of 2008, requires health care service plans and disability insurers selling health insurance to offer testing for HIV antibodies and AIDS, regardless of whether the testing is related to a primary diagnosis.
   4. AB 682 (Berg), Chapter 550, Statutes of 2007, revises the written and informed consent standards associated with testing blood for HIV, including prenatal HIV testing, to no longer require affirmative approval prior to administering an HIV test. Establishes the new HIV testing consent standard as the right to decline the test, providing that medical care providers present specified information to the individual about treatment options and the individual's right to decline the test, and the medical care provider notes in the chart when the patient declines to be tested. Exempts HIV testing at an alternative test site, as part of an autopsy, or when part of scientific research from these provisions.
      
7. SUGGESTED AMENDMENT. As currently drafted, this bill requires the medical provider or person who administers an HIV test to provide a patient who tests negative for HIV with information on the effectiveness and safety of all FDA approved methods that prevent or reduce the risk of contracting HIV, including PrEP and PEP. While it is a valid goal to improve awareness and use of PrEP and PEP, that treatment may not be appropriate for every patient. The Committee may wish to amend this bill to instead require that written information be provided to all persons who test negative regarding all methods that prevent or reduce the risk of contracting HIV, including, but not limited to, PrEP and PEP.

REGISTERED SUPPORT / OPPOSITION:

Support

AIDS Project Los Angeles (cosponsor)
Los Angeles LGBT Center (cosponsor)
Access Support Network
Bienestar Human Services, Inc.
Black AIDS Institute
California Primary Care Association
Community Clinic Association of Los Angeles County
Desert AIDS Project
Equality California
Free Speech Coalition
Friends Community Center
Gender Health Center
JWCH Institute
Our Family Coalition
Positive Women's Network
Project Inform
San Francisco AIDS Foundation
Tarzana Treatment Centers, Inc.
UCLA Center for Behavioral and Addiction Medicine

Opposition

AIDS Healthcare Foundation
California Hospital Association
California Medical Association

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

Date of Hearing: April 5, 2016

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 2640

Author:(Gipson) – As Amended Ver:March 16, 2016

SUBJECT: Public Health: HIV.

SUMMARY: Requires a medical care provider or person administering a test for human immunodeficiency virus (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 (FDA) methods that prevent or reduce the risk of contracting HIV, including pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), consistent with guidance of the federal Centers for Disease Control and Prevention (CDC).

EXISTING LAW:

1. Requires a medical provider or person administering a test for HIV, after receiving results indicating no infection for a patient who is at high risk for HIV infection, to advise the patient of the need for periodic retesting and explain the limitations of current testing technology and the current window period for verification of results.
2. Establishes the Office of AIDS within the Department of Public Health (DPH), to coordinate state programs, services, and activities related to HIV/acquired immune deficiency syndrome (AIDS).
3. Establishes the AIDS Drug Assistance Program (ADAP) within DPH to subsidize the cost of AIDS drugs for persons who do not have private health coverage, are not eligible for Medi-Cal, or cannot afford to purchase the drug privately. Indicates that the subsidy program is to be funded though state and federal sources.

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

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, this bill seeks to reduce the spread of HIV and save the lives of individuals at high risk of HIV exposure by providing them with information about preventive medications during HIV post-test counseling. The author notes that in 2013, California was second among the 50 states in the number of new HIV diagnoses, with approximately 5,000 new HIV diagnoses, and a 2015 survey of individuals at risk for HIV by the California HIV/AIDS Research Program found that only one in 10 respondents had ever used PrEP. The author concludes, considering the high volume of new HIV infections being diagnosed in the state of California and the low awareness of these medications, it is critical that those being tested are aware of PEP and PrEP medications.
2. BACKGROUND.
   
   1. Treatment as Prevention (TasP), PrEP, and PEP. In TasP, people living with HIV/AIDS use anti-retroviral (ARV) medications to reduce their viral load (the amount of HIV in the body) to undetectable levels. With an undetectable viral load, the amount of HIV in the body is so small it greatly reduces the likelihood of passing the virus on to another person. Strict adherence to TasP reduces the likelihood of transmission by up to 96%.

PrEP is a new intervention that uses an established ARV medication, Truvada to protect at-risk HIV-negative individuals from HIV infection. PrEP is different from PEP; the medication is taken before, not after possible exposure. Daily PrEP use can lower the risk of getting HIV from sex by more than 90% and from injection drug use by more than 70%. Missing doses reduces PrEP effectiveness. Truvada is currently the only FDA drug approved for HIV PrEP.

PEP uses ARV medications to prevent HIV from replicating and spreading through the body after an exposure to the virus. PEP is a short-term (28-day) intervention and must be started within three days of an exposure – sooner, if possible – to be effective. PEP was originally developed for occupational exposures, such as needle-sticks in hospitals, but is also effective for sexual exposures.

• 1. Public awareness of PrEP. In 2015, the CDC estimated that one in four sexually active gay and bisexual men, one in five people who inject drugs, and one in 200 sexually active heterosexual adults meet the criteria for PrEP. In 2015, the California HIV/AIDS Research Program (CHRP) conducted a survey of 602 young gay and bisexual men and found that only one in 10 had ever taken PrEP. Although awareness of the intervention was high among those who had never taken PrEP, awareness was significantly lower among Black and Latino respondents compared to white respondents. In addition, the large majority of respondents indicated they had never talked to their doctor or healthcare provider about PrEP.
     
     In its November 24, 2015 Morbidity and Mortality Weekly Report, the CDC estimated that 1.2 million Americans could benefit from PrEP, including 492,000 men who have sex with men (MSM), 115,000 injection drug users, and 624,000 heterosexuals. The report concludes that clinical organizations, health departments, and community-based organizations should raise awareness of PrEP among persons with substantial risk for acquiring HIV infection and their health care providers.

The FDA first approved the use of ARVs as a form of HIV prevention for at-risk, HIV-negative individuals in 2012. Various studies have since demonstrated the efficacy of PrEP among different populations, however, African American MSM lag behind in PrEP use despite their disproportionate HIV incidence and prevalence.

• 1. HIV in America. More than 1.2 million people in the United States are living with HIV infection, and almost one in eight (12.8%) are unaware of their infection. Gay, bisexual, and other MSM, particularly young African American MSM, are most seriously affected by HIV. By race, African Americans face the most severe burden of HIV.

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.

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.

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.

People living with HIV/AIDS have an estimated life expectancy of 32 years after infection and that number is increasing. With treatment costs averaging around $23,000 per year, lifetime treatment is currently estimated at around $740,000 or more per person. With that estimate, the 6,000 new infections per year in California will cost an estimated $4.5 billion to treat.

• 1. Research supporting PrEP use. On May 14, 2014, the U.S. Public Health Service released the first comprehensive clinical practice guidelines for PrEP. This followed the earlier publication of brief interim guidelines that were based on findings from several large national and international clinical trials. Those trials evaluated PrEP among gay and

bisexual men, heterosexual men and women, and injection drug users. All participants in the trials received pills containing either PrEP or placebo, along with intensive counseling on safe-sex behavior, regular testing for sexually transmitted diseases, and a regular supply of condoms. In all of the studies, the risk of getting HIV infection was lower—up to 92% lower—for participants who took the medicines consistently than for those who did not take the medicines.

• 1. CDC guidelines. The most recent federal guidelines for health care providers recommend that PrEP be considered for people who are HIV-negative and at substantial risk for HIV infection. For sexual transmission, this includes anyone who is in an ongoing relationship with an HIV-positive partner. It also includes anyone who, is not in a mutually monogamous relationship with a partner who recently tested HIV-negative, and, is a gay or bisexual man who has had anal sex without a condom or been diagnosed with asexually transmitted disease in the past six months; or a heterosexual man or woman who does not regularly use condoms during sex with partners of unknown HIV status who are at substantial risk of HIV infection (e.g., people who inject drugs or have bisexual male partners).
     

For people who inject drugs, this includes those who have injected illicit drugs in past six months and who have shared injection equipment or been in drug treatment for injection drug use in the past six months. Health care providers should also discuss PrEP with heterosexual couples in which one partner is HIV-positive and the other is HIV-negative as one of several options to protect the partner who is HIV-negative during conception and pregnancy.

The CDC is currently updating recommendations about use of PEP for HIV prevention.

• 1. Cost of PrEP and PEP. Costs for PrEP may include payment for the medication as well as payment for required medical visits and laboratory tests. While most public and private insurance companies cover PEP and PrEP prescriptions, there is high variability in out-of-pocket costs such as deductibles or co-pays. Some health plans cover PrEP at a lower, generic co-pay, while others place it in a specialty, or higher, more expensive tier. For individuals without any insurance coverage, the cost is approximately $12,000 - $15,000 per year. There are currently several payment assistance programs available through both the manufacturer and community groups that can help individuals without insurance, and those with high out-of-pocket costs through their insurance company.
     

1. SUPPORT. AIDS Project Los Angeles and the Los Angeles LGBT Center are the cosponsors of this bill and they state that awareness and use of PrEP and PEP among Californians at risk for HIV remain extremely low. They note that in 2015 the California HIV/AIDS Research Program conducted a survey of young gay and bisexual men and found that only one in 10 had ever taken PrEP, and although awareness of the intervention was high overall, awareness was significantly lower among black and Latino respondents compared to white respondents. The proponents also note the majority of respondents lacked the information needed to make a decision about using PrEP, did not know where to access PrEP, and that few respondents had ever talked to their doctor or healthcare provider about PrEP. They conclude it remains vital to ensure that all individuals at risk for HIV receive accurate information about PrEP and PEP, particularly highly-impacted communities of color.
   
   Equality California supports this bill, stating that given the effectiveness of PrEP and PEP, it is now critically important to ensure that individuals receiving an HIV test are also provided with accurate information about the benefits of these interventions.
2. OPPOSITION. The AIDS Healthcare Foundation (AHF) is opposed to this bill and states, HIV screening is intended to mirror other screening tests, which require simple consent only and which do not burden the process with additional activities that may or may not be necessary. AHF asserts that their experience as the largest private tester in the state is that the more time and demands placed on the person they are encouraging to be tested, the more likely the person is to decline. AHF also notes that guidelines for prevention and risk reduction are fluid, based on the most recent advice from the CDC and DPH, and that information to be shared must be dictated by the needs and circumstances of the person being tested. Finally, AHF contends that recent changes to California law that allowed for disclosure of a negative HIV test result on a secure website already minimizes the interaction between the tester and the test subject post-testing and makes the conveying of any more than the most basic information in current law less likely to be useful.
   
   The California Medical Association (CMA) is opposed to this bill stating, increased awareness of preventative treatment options for HIV should be a public health goal, however, their concern is that the increased medical resources required to accomplish the goal of this bill are not worth the benefit of the mandate. CMA notes that many preventative treatment options are not appropriate for every patient, and this bill would require a physician to inform the patient of a treatment option the physician might actually recommend against. CMA also notes that a physician is already required to provide a patient who tests positive with treatment and counseling options as well as mandated to schedule follow up appointments with relevant specialists. CMA concludes, for patients who test negative for HIV, they believe it is best left to the physician's clinical judgment as to what preventative treatment options should be given to the patient.
   
   The California Hospital Association (CHA) opposes this bill stating that they oppose codifying standards of practice and interfering in the physician-patient relationship by legislating what information a physician should tell a patient. CHA states this would eliminate the physician's medical judgment as to what information or treatment is in the best interest of the patient. CHA also contends that this bill would eliminate the medical provider's option to refer the patient to another, more appropriate physician for prevention counseling and explains, the option to refer the patient to another physician is very important – many physicians who may order an HIV test, such as hospital emergency physicians and psychiatrists, do not routinely treat infectious disease patients as part of their practice. They instead refer such patients to internal medicine physicians or infectious disease specialist who keep themselves up-to-date on the most recent pronouncements and guidance from the FDA and the CDC. CHA concludes that medical discussion should be between the patient and the physician.
3. RELATED LEGISLATION. AB 2439 (Nazarian) would require every hospital emergency department, if it otherwise draws blood from a patient, to offer to test that blood for HIV with the patients consent. AB 2439 is pending in the Assembly Health Committee.
4. PREVIOUS LEGISLATION.
   1. AB 446 (Mitchell), Chapter 589, Statutes of 2013, revises requirements related to information provided at the time an HIV test is administered and after the test results are received; requires informed consent, as specified, either orally or in writing, except when a person independently requests an HIV test from an HIV counseling and testing site, as specified; requires documentation of the person’s independent request for the test and exempts clinical laboratories from the informed consent requirements; requires every patient who has blood drawn at a primary care clinic, as defined, who has consented to the test, to be offered an HIV test; and authorizes disclosure of HIV test results by Internet posting or other electronic means if the HIV test subject is anonymously tested.
   2. AB 491 (Portantino) of 2011 would have allocated state and federal funds to test persons for HIV, would have specified that an HIV counselor is a medical care provider, and would have authorized a clinical laboratory test result of a negative HIV antibody test to be posted on a secure website if specified conditions were met. AB 491 was amended to deal with a different subject matter.
   3. AB 1894 (Krekorian), Chapter 631, Statutes of 2008, requires health care service plans and disability insurers selling health insurance to offer testing for HIV antibodies and AIDS, regardless of whether the testing is related to a primary diagnosis.
   4. AB 682 (Berg), Chapter 550, Statutes of 2007, revises the written and informed consent standards associated with testing blood for HIV, including prenatal HIV testing, to no longer require affirmative approval prior to administering an HIV test. Establishes the new HIV testing consent standard as the right to decline the test, providing that medical care providers present specified information to the individual about treatment options and the individual's right to decline the test, and the medical care provider notes in the chart when the patient declines to be tested. Exempts HIV testing at an alternative test site, as part of an autopsy, or when part of scientific research from these provisions.

REGISTERED SUPPORT / OPPOSITION:

Support

AIDS Project Los Angeles (cosponsor)
Los Angeles LGBT Center (cosponsor)
Access Support Network
Bienestar Human Services, Inc.
California Primary Care Association
Community Clinic Association of Los Angeles County
Desert AIDS Project
Equality California
Community Clinic Association of Los Angeles County
Positive Women's Network
Project Inform
San Francisco AIDS Foundation

Opposition

AIDS Healthcare Foundation
California Hospital Association
California Medical Association

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