Existing law, the Hepatitis C Education, Screening, and Treatment Act, sets forth provisions pertaining to education and outreach related to hepatitis C, as specified. The act sets forth findings, declarations, and the intent of the Legislature with regard to these provisions, and requires the Director of Public Health to, among other things, develop and implement a public education and outreach program to raise awareness of the hepatitis C virus aimed at high-risk groups, physicians offices, health care workers, and health care facilities.

This bill would would, until January 1, 2023, require a primary care clinic to offer each patient who receives primary care services in the clinic, and conduct upon agreement, a hepatitis C screening or diagnostic test, as specified, and would specify the manner in which the results of that test are provided. These requirements would not apply if the patient has taken a hepatitis C screening or diagnostic test, if the patient has been offered a hepatitis C screening or diagnostic test and declined the test within the primary care clinic within the previous 12 months, or to an individual receiving primary care services in a hospital or emergency room setting. The bill would add additional findings and declarations, including that hepatitis C is the most common bloodborne pathogen in the United States, and is a leading cause of complications from chronic liver disease.

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 The act sets forth findings, declarations, and the intent of the Legislature with regard to these provisions. provisions, and requires the Director of Public Health to, among other things, develop and implement a public education and outreach program to raise awareness of the hepatitis C virus aimed at high-risk groups, physicians offices, health care workers, and health care facilities.

This bill would make technical, nonsubstantive changes to these provisions. require a primary care clinic to offer each patient who receives primary care services in the clinic, and conduct upon agreement, a hepatitis C screening or diagnostic test, as specified, and would specify the manner in which the results of that test are provided. These requirements would not apply if the patient has taken a hepatitis C screening or diagnostic test, if the patient has been offered a hepatitis C screening or diagnostic test and declined the test within the primary care clinic within the previous 12 months, or to an individual receiving primary care services in a hospital or emergency room setting. The bill would add additional findings and declarations, including that hepatitis C is the most common bloodborne pathogen in the United States, and is a leading cause of complications from chronic liver disease.

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.

Date of Hearing: May 13, 2015

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Jimmy Gomez, Chair

ABPCA Bill Id:AB 383

Author:(Gipson) – As Amended Ver:April 30, 2015

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

SUMMARY:

This bill requires a primary care clinic (PCC) to offer specified patients receiving services a hepatitis C virus (HCV) screening or diagnostic test.

FISCAL EFFECT:

Based on conservative assumptions that this bill results in identification of 30,000 individuals affected by HCV in the first year:

1. Indirect cost pressure of $4.5 million (GF/federal) to Medi-Cal associated with increased testing in PCC clinics. Because clinics are reimbursed on a per-visit basis and the HCV test would likely be offered in combination with other services, testing cost would not be separately reimbursed.

2. For individuals who are diagnosed, counseling and follow-up care would result in increased visits costing Medi-Cal $1-2 million (GF/federal), depending on intensity of such care.

3. Cost pressure to Medi-Cal for increased drug treatment of HCV of $340 million (GF/federal), based on 38% of identified cases being among Medi-Cal eligible patients, and 75% of patients being linked to treatment at a one-time treatment cost of $40,000.

These estimates are based on general public health surveillance data and data on clinic encounters reported by the Office of Statewide Health Planning and Development and is subject to significant uncertainty. Similar costs would be incurred in future years, although would taper off year by year as more people infected with HCV would be identified. Although HCV is the most common bloodborne pathogen among Americans, the infection is not rapidly spreading and thus widespread one-time testing would likely yield fewer and fewer positive results in each subsequent year.

COMMENTS:

1. Purpose. According to the author, between 2.7 million and 3.9 million U.S. residents are infected with HCV and 500,000 Californians are living with the virus. Nevertheless, there is a significant lack of awareness of HCV, the threat that it poses to the public health, and current opportunities to control it. The author states this bill seeks to ensure that primary care clinics are proactive in testing high risk and baby boomer patients for HCV to increase community awareness.

2. Hepatitis C. Hepatitis is a virus, or infection, that causes liver disease and inflammation of the liver. Acute hepatitis C is a short-term infection with the hepatitis C virus. Symptoms can last up to six months. In about 15% of cases, the body is able to fight off the infection and get rid of the virus. Chronic hepatitis C is a long-lasting infection. Chronic hepatitis C occurs when the body can’t get rid of the hepatitis C virus. People can become infected through sharing needles, needle-stick injuries in health care settings, or being born to a mother who has HCV. Receipt of donated blood and organs was once a common means of transmission as well, but modern screening has virtually eliminated this. According to the CDC, millions of Americans have HCV, but most don’t know it, because people often have no symptoms and can live with an infection for decades without feeling sick. HCV is a leading cause of liver cancer and the leading cause of liver transplants.

3. Who is screened? This bill requires screening tests consistent with the United States Preventive Services Task Force (USPSTF) recommendations for screening and any federal Centers for Disease Control and Prevention (CDC) algorithms. The USPSTF and CDC recommend screening for HCV in persons at high risk for infection and 1-time screening for adults born between 1945 and 1965, who account for 75% of individuals infected with HCV.

4. Treatment. Treatment for Hepatitis C has evolved rapidly in recent years. According to the Centers for Disease Control and Prevention, prior to 2013, medication was given for 24-48 weeks and cured 50%–80% of patients, sometimes with significant side effects. In late 2013, the federal Food and Drug Administration approved two new antiviral drugs, Sofosbuvir (Sovaldi) and Simeprevir (Olysio) to treat chronic HCV infection. Clinical trials have shown that these new "breakthrough" medications cure 80%-95% of patients after 12-24 weeks of treatment with fewer side effects. However, Gilead Sciences, the manufacturer of Sovaldi, has come under heavy fire for the price of the drug treatment; the 12-week treatment regimen has a retail price of $84,000. Gilead Sciences reported sales of $10.3 billion for Sovaldi in 2014. After a year of market exclusivity for Sovaldi, Abbvie gained FDA approval to market rival HCV treatment Viekira Pak in late 2014. Pharmacy benefit managers (PBMs), like ExpressScripts and CVS Caremark quickly signed deals that agreed to exclusive coverage for specific brand drugs, in return for a hefty price discount on the drug. Other competitor drugs are currently in final stages of clinical trials and could be on the market in the near future, and increased competition in the market is expected to bring costs down significantly. In early 2015, Gilead announced it would be offering rebates of up to 46% on Sovaldi now that multiple rival drugs have entered the market.

5. Related Legislation. AB 521 (Nazarian) requires patients who have blood drawn at a general acute care hospital emergency room to be offered an HIV test.

6. Previous Legislation.

1. SB 1303 (Torres) of 2013 required every "qualifying individual" who receives medical care to be offered a HCV test. SB 1303 was held in the Senate Health Committee.

2. AB 446 (Mitchell), Chapter 589, Statutes of 2013, among other provisions, requires a patient between 12 and 65 years of age who has blood drawn at a primary care clinic to be offered an HIV test.

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

Date of Hearing: April 28, 2015

ASSEMBLY COMMITTEE ON HEALTH

Rob Bonta, Chair

ABPCA Bill Id:AB 383

Author:(Gipson) – As Amended Ver:March 26, 2015

SUBJECT: Public health: hepatitis C.

SUMMARY: Requires a primary care clinic (PCC) to offer every patient receiving services a hepatitis C virus (HCV) screening or diagnostic test. Specifically, this bill:

1. Requires the HCV screening or diagnostic test to be done with the patient's consent and in a manner consistent with the United States Preventative Services Talk Force (USPSTF) recommendations and Centers for Disease Control and Prevention (CDC) algorithms.

2. Specifies that screening is not required to be offered if the patient has already taken a HCV screening or diagnostic test, or if the patient has been offered screening or a test within the last 12 months.

3. Specifies that the provisions of this bill do not prohibit a PCC from charging a patient to cover the cost of the HCV screening or test, and that a PCC is deemed to be in compliance if a HCV screening or diagnostic test is offered.

4. Requires a PCC to attempt to provide test results to the patient before they leave the facility, and if that is not possible, allows the facility to inform a patient with negative test results by telephone, and a patient with positive test results in a manner consistent with current law.

5. Clarifies that these provisions do not apply to an individual receiving primary care services in a hospital or emergency room setting.

6. Makes various findings and declarations regarding HCV screening.

EXISTING LAW:

1. Requires the Department of Public Health (DPH) to make available protocols and guidelines developed by the National Institutes of Health (NIH), the University of California at San Francisco, and California legislative advisory committees on HCV for educating physicians and health professionals and training community service providers on the most recent scientific and medical information on HCV detection, transmission, diagnosis, treatment, and therapeutic decision making.

2. Requires a patient who has blood drawn at a primary care clinic and who has consented, as specified, to be offered a human immunodeficiency virus (HIV) test, unless the clinic has tested the patient for HIV within the previous 12 months. Requires the primary care clinician to offer an HIV test consistent with USPSTF recommendations for screening HIV infection.
   
   

3. Requires a patient that has received an HIV or HCV test to be informed if the preliminary result of the test indicates the likelihood of HIV infection or HCV exposure and that the result must be confirmed by an additional more specific test.

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

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, between 2.7 million and 3.9 million U.S. residents are infected with HCV and 500,000 Californians are living with the virus. Nevertheless, there is a significant lack of awareness of HCV, the threat that it poses to the public health and current opportunities to control it. The author states this bill seeks to ensure that primary care clinics are proactive in testing high risk and baby boomer patients for HCV to increase community awareness.

2. BACKGROUND.

   1. Hepatitis C. Hepatitis is a virus, or infection, that causes liver disease and inflammation of the liver. Acute hepatitis C is a short-term infection with the hepatitis C virus. Symptoms can last up to six months. The infection sometimes clears up because the body is able to fight off the infection and get rid of the virus. Chronic hepatitis C is a long-lasting infection. Chronic hepatitis C occurs when the body can’t get rid of the hepatitis C virus. People can become infected through sharing needles, needle-stick injuries in health care settings, or being born to a mother who has HCV.

According to the CDC, millions of Americans have HCV, but most don’t know it, because people often have no symptoms and can live with an infection for decades without feeling sick. About 80% who have HCV develop a chronic or lifelong infection. HCV is a leading cause of liver cancer and the leading cause of liver transplants.

2. USPSTF recommendations. Created in 1984, the USPSTF is an independent group of national experts in prevention and evidence-based medicine that works to improve the health of all Americans by making evidence-based recommendations about clinical preventive services such as screenings, counseling services, or preventive medications. The USPSTF is made up of 16 volunteer members who come from the fields of preventive medicine and primary care, including internal medicine, family medicine, pediatrics, behavioral health, obstetrics/gynecology, and nursing. All members volunteer their time to serve on the USPSTF, and most are practicing clinicians.

In June 2013 the USPSTF released recommendations for HCV infection screening. These recommendations apply to all asymptomatic adults without known liver disease or functional abnormalities. Persons born between 1945 and 1965 are more likely to be diagnosed with HCV infection, possibly because they received blood transfusions before the introduction of screening in 1992 or have a history of other risk factors for exposure decades earlier. The recommendations state that a risk-based approach may miss detection of a substantial proportion of HCV infected persons in the birth cohort because of a lack of patient disclosure or knowledge about prior risk status. As a result, one-time screening for HCV infection in the birth cohort may identify infected patients at earlier stages of disease who could benefit from treatment before developing complications from liver damage.

The USPSTF believes that screening should be voluntary and undertaken only with the patient's knowledge and understanding that HCV testing is planned. Patients should be informed orally or in writing that HCV testing will be performed unless they decline. The USPSTF further believes that before screening, patients should receive an explanation of the HCV infection, how it can (and cannot) be acquired, the meaning of positive and negative test results, and the benefits and harms of treatment. Patients should also be offered the opportunity to ask questions and to decline testing.

3. Treatment. HCV is usually not treated unless it becomes chronic. Until recently, chronic HCV was most often treated with a medicine combination that attacks the virus, and treatment lasted from 24 to 48 weeks. In December 2013, the federal Food and Drug Administration (FDA) approved a drug produced by Gilead Sciences called Sovaldi for the treatment of HCV. Sovaldi represents a significant advance in therapy for HCV as it provides a higher cure rate, allows for a shorter duration of treatment, has fewer adverse effects, and opens up treatment options for individuals with comorbid conditions for which traditional treatments are contraindicated.

While the drug has been found to be remarkably effective (curing 90% or more patients over the course of 12 weeks, according to the FDA), Gilead Sciences has come under heavy fire for the price of the drug treatment. Sovaldi is priced at $1,000 per pill, which brings the cost associated with a 12-week treatment regimen to $84,000. Gilead Sciences reported sales of $10.3 billion for Sovaldi in 2014 alone.

After a year of market exclusivity for Sovaldi, Abbvie gained FDA approval to market rival HCV treatment Viekira Pak in late 2014. Pharmacy benefit managers (PBMs), like ExpressScripts and CVS Caremark quickly signed deals that agreed to exclusive coverage for specific brand drugs on its formulary, in return for a hefty price discount on the drug. A few other competitor drugs are currently in final stages of clinical trials and could be on the market in the near future, and increased competition in the market is expected to bring costs down significantly. In early 2015, Gilead announced it would be offering rebates of up to 46% on Sovaldi now that multiple rival drugs have entered the market.

3. SUPPORT. The Wall las Memorias Project is the sponsor of this bill and states while still passionately focused on their mission to end the HIV/AIDS epidemic, they acknowledge the importance of bringing attention to another health concern that effect many of their community members – hepatitis C. The sponsors note the bill will ensure that primary care clinics are proactive in testing high risk patients for HCV to increase community awareness.

Numerous health and wellness non-profit organizations serving the Latino and LGBTQ communities including Bienestar Human Services, Inc., El Centro Del Pueblo, and Jovenes Inc., support this bill because it is estimated that one-time testing may prevent more than 120,000 deaths amongst the 500,000 Californians that are estimated to be living with the virus. Quest Diagnostics also supports this bill because, although they believe all physicians should screen their patients, they acknowledge that primary care clinics most likely serve high-risk, under-represented populations, and knowledge of the infection will help reduce the rate of transmission, which in turn could reduce the government's cost of treatment and prevent death.

4. RELATED LEGISLATION. AB 521 (Nazarian) requires that every patient who has blood drawn at a general acute care hospital emergency room, and who has consented to the test to be offered an HIV test, consistent with the USPSTF recommendations for screening.

5. PREVIOUS LEGISLATION.

   1. SB 1303 (Torres) of 2013 would have required every qualifying individual, as defined, who receives medical care from a health care practitioner to be offered a HCV screening test or diagnostic test. SB 1303 was held in the Senate Health Committee.

2. AB 446 (Mitchell), Chapter 589, Statutes of 2013, among other provisions, requires a patient between 12 and 65 years of age who has blood drawn at a primary care clinic, and who has consented to the HIV test to be offered an HIV test. Requires subsequent testing of a patient who has been tested by the primary care clinic to be consistent with the most recent guidelines issued by the CDC and the USPSTF.
   
   
   

1. SUGGESTED AMENDMENTS.
   
   
   

   1. Given that the treatment options for treating HCV are rapidly changing, and requiring annual screening might not be necessary in the near future, the Committee may wish to amend the bill to sunset these provisions in seven years.
      
      
      

   2. As currently drafted the bill requires patients with a positive test result to be notified in a manner consistent with state law. In order to ensure that PCCs know exactly which state law, the Committee may wish to amend the bill as follows:

On page 4, line 18, strike, "state law." and insert: Section 120917.

REGISTERED SUPPORT / OPPOSITION:

Support
The Wall las Memorias (sponsor)
Bienestar Human Services, Inc.
California Chronic Care Coalition
California Healthcare Institute
California Hepatitis Alliance
C.O.R.E. Medical Clinic, Inc.
El Centro Del Pueblo
Jovenes, Inc.
Project Inform
Quest Diagnostics
One individual

Opposition
None on file.

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