Existing law requires the State Department of Public Health to establish a statewide program for the screening of newborns for specified genetic diseases. Existing law requires the department to establish a genetic disease unit to, among other things, evaluate and prepare recommendations on the implementation of tests for the detection of hereditary and congenital diseases. Existing law also requires the department to establish a statewide birth defects monitoring program.

Existing law, the Newborn and Infant Hearing Screening, Tracking and Intervention Act, requires a general acute care hospital with licensed perinatal services to administer to a newborn, upon birth admission, a hearing screening test for the identification of hearing loss, using protocols approved by the State Department of Health Care Services or its designee, unless the newborns parent or guardian objects to the test, as specified. Existing law requires the department to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss, as specified. Existing law authorizes the department to conduct a community outreach and awareness campaign to inform medical providers, pregnant women, and the families of newborns and infants about the newborn hearing screening program, as specified.

This bill would, until January 1, 2023, require the State Department of Health Care Services to establish a commission on Cytomegalovirus (CMV) Public Education and Testing. The bill would require the commission to examine research and data relating to congenital CMV, as specified. The bill would require the director of the department to appoint members to the commission, as specified. The bill would require the commission to submit a report to the Legislature on or before December 31, 2019, and an additional report on or before December 31, 2022, as specified.

Existing law requires the State Department of Public Health to establish a statewide program for the screening of newborns for specified genetic diseases. Existing law requires the department to establish a genetic disease unit to, among other things, evaluate and prepare recommendations on the implementation of tests for the detection of hereditary and congenital diseases. Existing law also requires the department to establish a statewide birth defects monitoring program.

Existing law, the Newborn and Infant Hearing Screening, Tracking and Intervention Act, requires a general acute care hospital with licensed perinatal services to administer to a newborn, upon birth admission, a hearing screening test for the identification of hearing loss, using protocols approved by the State Department of Health Care Services or its designee, unless the newborns parent or guardian objects to the test, as specified. Existing law requires the department to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss, as specified. Existing law authorizes the department to conduct a community outreach and awareness campaign to inform medical providers, pregnant women, and the families of newborns and infants about the newborn hearing screening program, as specified.

This bill would, until January 1, 2023, require the State Department of Health Care Services to establish a commission on Cytomegalovirus (CMV) Public Education and Testing. The bill would require the commission to examine research and data relating to congenital CMV, as specified. The bill would require the director of the department to appoint members to the commission, as specified. The bill would require the commission to submit a report to the Legislature on or before December 31, 2019, and an additional report on or before December 31, 2022, as specified.

Existing law requires the State Department of Public Health to establish a statewide program for the screening of newborns for specified genetic diseases. Existing law requires the department to establish a genetic disease unit to, among other things, evaluate and prepare recommendations on the implementation of tests for the detection of hereditary and congenital diseases. Existing law also requires the department to establish a statewide birth defects monitoring program.

Existing law, the Newborn and Infant Hearing Screening, Tracking and Intervention Act, requires a general acute care hospital with licensed perinatal services to administer to a newborn, upon birth admission, a hearing screening test for the identification of hearing loss, using protocols approved by the State Department of Health Care Services or its designee, unless the newborns parent or guardian objects to the test, as specified. Existing law requires the department to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss, as specified. Existing law authorizes the department to conduct a community outreach and awareness campaign to inform medical providers, pregnant women, and the families of newborns and infants about the newborn hearing screening program, as specified.

This bill would, until January 1, 2023, require the State Department of Health Care Services to establish a commission on Cytomegalovirus (CMV) Public Education and Testing. The bill would require the commission to examine research and data relating to congenital CMV, as specified. The bill would require the director of the department to appoint members to the commission, as specified. The bill would require the commission to submit a report to the Legislature on or before December 31, 2019, and annually thereafter for 3 years, an additional report on or before December 31, 2022, as specified.

Existing law requires the State Department of Public Health to establish a statewide program for the screening of newborns for specified genetic diseases. Existing law requires the department to establish a genetic disease unit to, among other things, evaluate and prepare recommendations on the implementation of tests for the detection of hereditary and congenital diseases. Existing law also requires the department to establish a statewide birth defects monitoring program.

Existing law, the Newborn and Infant Hearing Screening, Tracking and Intervention Act, requires a general acute care hospital with licensed perinatal services to administer to a newborn, upon birth admission, a hearing screening test for the identification of hearing loss, using protocols approved by the State Department of Health Care Services or its designee, unless the newborns parent or guardian objects to the test, as specified. Existing law requires the department to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss, as specified. Existing law authorizes the department to conduct a community outreach and awareness campaign to inform medical providers, pregnant women, and the families of newborns and infants about the newborn hearing screening program, as specified.

This bill would, until January 1, 2023, require the State Department of Health Care Services to establish a commission on Cytomegalovirus (CMV) Public Education and Testing. The bill would require the commission to examine research and data regarding congenital CMV and develop recommendations, relating to congenital CMV, as specified. The bill would require the director of the department to appoint members to the commission, as specified. The bill would require the commission to submit a report to the Legislature on or before December 31, 2019, and annually thereafter for 3 years, as specified.

Existing law requires the State Department of Public Health to establish a statewide program for the screening of newborns for specified genetic diseases. Existing law requires the department to establish a genetic disease unit to, among other things, evaluate and prepare recommendations on the implementation of tests for the detection of hereditary and congenital diseases. Existing law also requires the department to establish a statewide birth defects monitoring program.

Existing law, the Newborn and Infant Hearing Screening, Tracking and Intervention Act, requires a general acute care hospital with licensed perinatal services to administer to a newborn, upon birth admission, a hearing screening test for the identification of hearing loss, using protocols approved by the State Department of Health Care Services or its designee, unless the newborns parent or guardian objects to the test, as specified. Existing law requires the department to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss, as specified. Existing law authorizes the department to conduct a community outreach and awareness campaign to inform medical providers, pregnant women, and the families of newborns and infants about the newborn hearing screening program, as specified.

This bill would, until January 1, 2023, require the State Department of Health Care Services to establish a commission on Cytomegalovirus (CMV) Public Education and Testing. The bill would require the commission to address the issue of CMV public education and testing relating to CMV. examine research and data regarding congenital CMV and develop recommendations, as specified. The bill would require the director of the department to appoint members to the commission, as specified. The bill would require the commission to submit a report to the Legislature on or before December 31, 2019, and annually thereafter for 3 years, as specified.

Existing law requires the State Department of Public Health to establish a statewide program for the screening of newborns for specified genetic diseases. Existing law requires the department to establish a genetic disease unit to, among other things, evaluate and prepare recommendations on the implementation of tests for the detection of hereditary and congenital diseases. Existing law also requires the department to establish a statewide birth defects monitoring program.

Existing law, the Newborn and Infant Hearing Screening, Tracking and Intervention Act, requires a general acute care hospital with licensed perinatal services to administer to a newborn, upon birth admission, a hearing screening test for the identification of hearing loss, using protocols approved by the State Department of Health Care Services or its designee, unless the newborns parent or guardian objects to the test, as specified. Existing law requires the department to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss, as specified. Existing law authorizes the department to conduct a community outreach and awareness campaign to inform medical providers, pregnant women, and the families of newborns and infants about the newborn hearing screening program, as specified.

Existing law requires the State Department of Public Health to establish a statewide program for the screening of newborns for specified genetic diseases. Existing law requires the department to establish a genetic disease unit to, among other things, evaluate and prepare recommendations on the implementation of tests for the detection of hereditary and congenital diseases. Existing law also requires the department to establish a statewide birth defects monitoring program.

Existing law, the Newborn and Infant Hearing Screening, Tracking and Intervention Act, requires a general acute care hospital with licensed perinatal services to administer to a newborn, upon birth admission, a hearing screening test for the identification of hearing loss, using protocols approved by the State Department of Health Care Services or its designee, unless the newborns parent or guardian objects to the test, as specified. Existing law requires the department to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss, as specified. Existing law authorizes the department to conduct a community outreach and awareness campaign to inform medical providers, pregnant women, and the families of newborns and infants about the newborn hearing screening program, as specified.

This bill would require the State Department of Health Care Services, in consultation with the State Department of Public Health, to establish and conduct a public education program to inform pregnant women and women who may become pregnant about cytomegalovirus (CMV) using information about specified items, including birth defects caused by congenital CMV and available preventive measures to avoid CMV infection of those women. The bill would require the State Department of Health Care Services to make that information available on its Internet Web site and to provide the information to specified entities and individuals.

This bill would require the above-described general acute care hospital to provide the parent or legal guardian of the newborn with specified information relating to congenital CMV and to test the newborn for CMV before he or she is 21 days of age, unless the parent or legal guardian objects to the CMV test, as specified.

GOVERNOR'S VETO

GV Bill Id:AB 1801

Author:(Nazarian)

As Enrolled Ver:September 4, 2018

2/3 vote

Original Committee Reference: HEALTH

SUMMARY: Requires the California Department of Health Care Services (DHCS) to establish a Commission on cytomegalovirus (CMV) Public Education and Testing, as specified.

The Senate amendments make technical and clarifying amendments to the individuals that can serve on the Commission, and make changes to the reporting date by the Commission.

FISCAL EFFECT: According to the Senate Appropriations Committee, DHCS estimates the following:

1. DHCS costs of $217,000 total funds ($108,500 General Fund (GF), $108,500 federal funds) in fiscal year (FY) 2019-20 and $199,000 total funds ($99,500 GF, $99,500 federal funds) in FY 2020-21 and ongoing, for the department to establish a Commission on Cytomegalovirus Public Education and Testing; facilitate, at a minimum, bi-annual meetings; and, assist in the drafting of legislative reports. DHCS would need one full-time Associate Governmental Program Analyst for FY 2019-20 at $130,000 and FY 2020-21 and ongoing at $121,000 annually; and one Office Technician for FY 2019-20 at $87,000 and FY 2020-21 and ongoing at $78,000.
2. Minor and absorbable costs for the Department of Public Health (DPH) to be a member of the Commission.

COMMENTS: According to the author, CMV is a common virus that infects people of all ages. Most people infected with CMV show no signs or symptoms. The infection can cause serious health problems for babies infected with the virus before they are born. Congenital CMV is the leading cause of viral birth defects in newborns; it can lead to hearing loss, developmental disabilities, and other serious, long-term health problems. The author notes, public awareness of this preventable issue is abysmally low and most infants at risk for CMV-associated hearing loss are not identified early in life because of failure to test for the infection. The author concludes, by creating this Commission, California will gather the relevant data and information which can be used to make the appropriate policy recommendations in order to combat this serious virus.

CMV is a common virus that usually presents with no signs or symptoms for healthy children and adults. CMV can pose serious health issues for individuals with suppressed immune systems and fetuses. If a pregnant woman becomes infected with CMV during her pregnancy the infant can contract the virus which is called congenital CMV. According to the Centers for Disease Control and Prevention, one out of every 200 infants in the United States (U.S.) is born with congenital CMV and of these babies born with congenital CMV, one in five infants will have symptoms or lifelong complications, including, but not limited to: hearing loss, vision loss, intellectual disability, and seizures. Based on the average number of births in California, it is estimated that roughly 500 infants are born each year with congenital CMV that will suffer from these lifelong complications. It is important to note, there is no cure for CMV.

The U.S. Secretary of Health and Human Services recommends a list of disorders for the federal Recommended Uniform Screening Panel (RUSP). Disorders on the RUSP are selected based on evidence that supports the potential benefit of screening, the ability of states to screen for the disorder, and also the availability of effective treatments for the specific disorders. CMV is currently not recommended for the RUSP. Individuals and organizations have the option to nominate a condition to be considered for the RUSP. Based on communications with the sponsor of this bill, the National CMV Foundation will be nominating CMV by the end of 2018 to be included in the RUSP. In California, the Department of Public Health (DPH) oversees the Newborn Screening (NBS) program which requires all infants be screened shortly after birth for serious, but treatable genetic disorders. SB 1095 (Pan), Chapter 393, Statutes of 2016, requires DPH to align the NBS program with recommendations from the federal RUSP.

The National CMV Foundation, sponsor of this bill, writes that national awareness CMV is alarmingly low and the lack of screening-targeted or otherwise-leaves a significant number of infants with CMV to later develop long-term health complications. The National CMV Foundation notes by creating this Commission, California will gather relevant data and information which can be used to make the appropriate recommendations in order to combat this serious virus.

There is no known opposition to this bill.

GOVERNOR'S VETO MESSAGE:

This bill would require the Department of Health Care Services to establish a 13-member Commission to identify public educational resources for, and examine research and data relating to, Cytomegalovirus, a non-genetic virus which causes birth defects.

Researching, educating and testing for diseases in newborns is the function of the Department of Public Health's Newborn Screening program. I encourage the author to work with this department to review and assess this disease rather than create a new governmental body in a different department.

Analysis Prepared by: Monica Montano / HEALTH / (916) 319-2097 FN: 0005356

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 1801

Author:(Nazarian)

As Amended Ver:June 26, 2018

Majority vote

Original Committee Reference: HEALTH

SUMMARY: Requires the California Department of Health Care Services (DHCS) to establish a Commission on cytomegalovirus (CMV) Public Education and Testing, as specified.

The Senate amendments make technical and clarifying amendments to the individuals that can serve on the Commission, and make changes to the reporting date by the Commission.

FISCAL EFFECT: According to the Senate Appropriations Committee, DHCS estimates the following:

1. DHCS costs of $217,000 total funds ($108,500 General Fund (GF), $108,500 federal funds) in fiscal year (FY) 2019-20 and $199,000 total funds ($99,500 GF, $99,500 federal funds) in FY 2020-21 and ongoing, for the department to establish a Commission on Cytomegalovirus Public Education and Testing; facilitate, at a minimum, bi-annual meetings; and, assist in the drafting of legislative reports. DHCS would need one full-time Associate Governmental Program Analyst for FY 2019-20 at $130,000 and FY 2020-21 and ongoing at $121,000 annually; and one Office Technician for FY 2019-20 at $87,000 and FY 2020-21 and ongoing at $78,000.
2. Minor and absorbable costs for the Department of Public Health (DPH) to be a member of the Commission.

COMMENTS: According to the author, CMV is a common virus that infects people of all ages. Most people infected with CMV show no signs or symptoms. The infection can cause serious health problems for babies infected with the virus before they are born. Congenital CMV is the leading cause of viral birth defects in newborns; it can lead to hearing loss, developmental disabilities, and other serious, long-term health problems. The author notes, public awareness of this preventable issue is abysmally low and most infants at risk for CMV-associated hearing loss are not identified early in life because of failure to test for the infection. The author concludes, by creating this Commission, California will gather the relevant data and information which can be used to make the appropriate policy recommendations in order to combat this serious virus.

CMV is a common virus that usually presents with no signs or symptoms for healthy children and adults. CMV can pose serious health issues for individuals with suppressed immune systems and fetuses. If a pregnant woman becomes infected with CMV during her pregnancy the infant can contract the virus which is called congenital CMV. According to the Centers for Disease Control and Prevention, one out of every 200 infants in the United States (U.S.) is born with congenital CMV and of these babies born with congenital CMV, one in five infants will have symptoms or lifelong complications, including, but not limited to: hearing loss, vision loss, intellectual disability, and seizures. Based on the average number of births in California, it is estimated that roughly 500 infants are born each year with congenital CMV that will suffer from these lifelong complications. It is important to note, there is no cure for CMV.

The U.S. Secretary of Health and Human Services recommends a list of disorders for the federal Recommended Uniform Screening Panel (RUSP). Disorders on the RUSP are selected based on evidence that supports the potential benefit of screening, the ability of states to screen for the disorder, and also the availability of effective treatments for the specific disorders. CMV is currently not recommended for the RUSP. Individuals and organizations have the option to nominate a condition to be considered for the RUSP. Based on communications with the sponsor of this bill, the National CMV Foundation will be nominating CMV by the end of 2018 to be included in the RUSP. In California, the Department of Public Health (DPH) oversees the Newborn Screening (NBS) program which requires all infants be screened shortly after birth for serious, but treatable genetic disorders. SB 1095 (Pan), Chapter 393, Statutes of 2016, requires DPH to align the NBS program with recommendations from the federal RUSP.

The National CMV Foundation, sponsor of this bill, writes that national awareness CMV is alarmingly low and the lack of screening-targeted or otherwise-leaves a significant number of infants with CMV to later develop long-term health complications. The National CMV Foundation notes by creating this Commission, California will gather relevant data and information which can be used to make the appropriate recommendations in order to combat this serious virus.

There is no opposition to this bill.

Analysis Prepared by: Monica Montano / HEALTH / (916) 319-2097 FN: 00042650004265

 THIRD READING  

Bill No: AB 1801

Author: Nazarian (D)

Amended: 6/26/18 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 8-0, 6/20/18

AYES: Pan, Nguyen, Beall, Hernandez, Leyva, Mitchell, Monning, Roth

NO VOTE RECORDED: Nielsen

SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/16/18

AYES: Portantino, Bates, Beall, Bradford, Hill, Nielsen, Wiener

ASSEMBLY FLOOR: 71-0, 5/30/18 - See last page for vote

SUBJECT: Newborns: cytomegalovirus public education and testing

SOURCE: National CMV Foundation

DIGEST:

This bill requires the Department of Health Care Services to establish a Commission on Cytomegalovirus (CMV) Public Education and Testing (Commission) to examine research and data relating to CMV and to identify possible public educational resources to inform pregnant women and women who may become pregnant about CMV. Requires the Commission to report its findings to the Legislature, as specified. Sunsets this bill on January 1, 2023.

ANALYSIS:

Existing law:

1. Requires the Department of Health Care Services (DHCS) to establish a system to screen all newborns and infants for hearing loss, and create and maintain a system of assessment and follow-up services for newborns and infants identified by the screening, as specified. [HSC §123975]
2. Establishes the Newborn Hearing Screening Program (NHSP) within DHCS, which requires every general acute care hospital with licensed perinatal services in this state to administer to every newborn, prior to being discharged from the hospital nursery, a hearing screening test for the identification of hearing loss. Requires parents of all newborns and infants diagnosed with a hearing loss to be provided written information on the availability of community resources and services for children with hearing loss, as specified. [WIC §124115, et seq.]
3. Establishes the Department of Public Health (DPH) to be vested with all the duties, powers, purposes, functions, responsibilities, and jurisdiction as they relate to public health, as specified. [HSC §131050]
4. Establishes the Genetic Disease Unit within DPH to coordinate all programs in the area of genetic disease, including the Newborn Screening Program (NSP), to promote a statewide program of information, testing, and counseling services, as specified. [WIC §125000]

This bill:

1. Requires DHCS to establish a Commission on CMV to implement the provisions of this bill only to the extent funds are appropriated by the Legislature for these purposes.
2. Requires the Commission to consist of 13 members appointed by the Director of DHCS as follows:
3. An infectious disease specialist who has experience with CMV;
4. An obstetrician;
5. A family physician involved with management of pregnancy and delivery of newborns;
6. A labor and delivery nurse or nurse manager;
7. A parent of a child who has been affected with a birth defect resulting from infection with CMV;
8. A general pediatrician who practices primary care;
9. A person from DPH’s NSP;
10. A person from DHCS’s NHSP;
11. An audiologist;
12. A pediatric otolaryngologist;
13. A pediatric speech therapist;
14. A representative of health plans or insurers; and,
15. A representative of hospitals.
16. Requires DHCS to designate one member as the chair of the Commission. Requires all appointments to be made no later than January 31, 2019. Requires the chair to convene the initial meeting of the Commission within 15 days after all members have been appointed and for the Commission to meet at least once every six months.
17. Requires the Commission to examine research and data relating to, but not limited to, early identification, testing of congenital CMV, and appropriate treatment of birth defects caused by congenital CMV.
18. Requires the Commission to examine and identify possible public educational resources to inform pregnant women and women who may become pregnant that include, but are not limited to:
19. Information regarding the incidence of CMV;
20. The transmission of CMV during and before pregnancy;
21. Birth defects caused by congenital CMV;
22. Methods of diagnosing congenital CMV;
23. Available preventive measures; and,
24. Resources for the family of a child born with congenital CMV.
25. Requires the Commission to submit a report no later than December 31, 2019; an additional report no later than December 31, 2022; and any additional reports that include its findings. Permits the reports to include recommendations for possible legislation that are evidence-based and data driven. Requires the Commission to distribute its reports to the appropriate policy committees of the Legislature. Requires DHCS to make the reports publicly available on its Web site.
26. States legislative intent that the reports submitted be used to inform pregnant women and women who may become pregnant about CMV and to identify children born with CMV in order to improve their health and developmental outcomes.
27. Requires DHCS to provide or recommend necessary staffing services to the Commission including, but not limited to, staffing offered through the California Medical Association or the California Chapter of the American Academy of Pediatrics, to the extent permitted by law.
28. Sunsets this bill on January 1, 2023.

Comments

1. Author’s statement. According to the author, CMV is a common virus that infects people of all ages. Most people infected with CMV show no signs or symptoms. This infection can cause serious health problems for babies infected with the virus before they are born. Congenital CMV is the leading cause of viral birth defects in newborns. It can lead to hearing loss, vision loss, developmental disabilities, and other serious, long-term health problems. AB 1801 establishes a commission to review issues surrounding CMV exposure. Unfortunately, public awareness of this preventable virus is abysmally low. Additionally, most infants at risk for CMV-associated hearing loss are not identified early in life because of failure to test for the infection. Due to a lack of screening, targeted or otherwise, a significant number of infants with CMV who may later develop long-term health complications go unrecognized. As scientific evidence on testing and treatment continues to unfold, it is important for the state to consider means to best address this issue. By creating this Commission, California will gather the relevant data and information which can be used to make the appropriate recommendations in order to combat this serious virus.
2. CMV. According to the federal Centers for Disease Control and Prevention (CDC), CMV is a common virus that infects people of all ages. In the U.S., nearly one in three children are already infected with CMV by age five, and over half of adults by age 40 have been infected with CMV. Once it is in a person’s body, CMV stays there for life and can reactivate. A person can also be re-infected with a different strain of the virus. Most people infected with CMV show no sign or symptoms, as a healthy person’s immune system keeps the virus from causing illness. However, CMV can cause serious health problems for people with weakened immune systems, as well as babies infected with the virus before they are born (congenital CMV). According to the CDC, in some cases infection in healthy people can cause mild illness that may include fever, sore throat, fatigue, and swollen glands, and occasionally, CMV can cause mononucleosis or hepatitis. But people with weakened immune systems who get CMV can have more serious symptoms that affect the eyes, lungs, liver, esophagus, stomach, and intestines. People with CMV can pass on the virus in body fluids, such as urine, saliva, blood, tears, semen, and breast milk. Women infected with CMV can pass the virus to a developing baby during pregnancy. Blood tests can be used to diagnose CMV infections in people who have symptoms. The CDC states that healthy people who are infected with CMV usually do not require medical treatment. Medications are available to treat CMV infection in people with weakened immune systems.
3. Congenital CMV. About one out of every 200 babies are born with congenital CMV infection passed on through the mother while the baby is developing, although only about one in five babies with infection will be sick from the virus or will have long-term health problems. Most babies with congenital CMV never show signs or have health problems. Some babies may have health problems that are apparent at birth or may develop later during infancy or childhood. Some signs babies with congenital CMV may exhibit at birth include premature birth; liver, lung, and spleen problems; small size at birth; small head size; and seizures. Some long-term health problems that infected babies may experience include hearing and vision loss, intellectual disability, lack of coordination, and weakness or problems using muscles. Hearing loss may be present at birth or develop later in babies who pass their newborn hearing test. According to the CDC, congenital CMV can be diagnosed by testing a newborn baby’s saliva, urine, or blood, which must be collected for testing within two to three weeks after the baby is born in order to confirm a diagnosis. Medicines, such as antiretrovirals, may decrease the risk of health problems and hearing loss in some infected babies who show signs of infection at birth, though the CDC states that use of medications for treating babies with infection who have no signs at birth is not currently recommended. The CDC recommends that infected babies, with or without signs at birth, have regular hearing checks. The CDC also recommends women take steps to lessen their risk of getting CMV by reducing contact with saliva and urine from babies and young children, such as by kissing children on the cheek or head rather than the lips, and by washing their hands after changing diapers.

According to the National CMV Foundation, congenital CMV is the leading viral cause of congenital disabilities and the leading non-genetic cause of childhood hearing loss, though most adults have never heard of CMV. Approximately 30,000 babies are born with congenital CMV in the U.S. every year, and 6,000 will develop permanent disabilities. The National CMV Foundation states that CMV virus can live for up to 15 minutes on hands and plastic, and up to five minutes on crackers, while no viable virus survives after washing hands with water, soap, or sanitizer. The National CMV Foundation cites a study published in November 2016 in the Journal of Early Hearing Detection and Intervention, which found that CMV awareness is very low compared to other congenital and childhood conditions with lower incidence rates; women have an odds of awareness of one and a half to two times greater than men; Hispanics are less than half as likely to be aware of CMV than non-Hispanics; and the presence of a child ages zero to five in the household does not increase the chance that an adult in the household is aware of CMV.

1. NHSP. According to DHCS’s Web site, the California NHSP is a system of early identification, intervention, and support services for infants with hearing loss and their families. The goal of the program is to identify infants with a hearing loss prior to three months of age and to link infants with early intervention services by six months of age. Infants begin developing speech and language from the moment they are born, and studies show that hearing loss occurs in approximately two to four out of 1,000 babies. Without newborn hearing screening, hearing loss is often not identified until 18 months to three years of age when problems with speech are noted. If an infant has a hearing loss in one or both ears, early identification is crucial to preventing delayed speech and language development. There are two methods that may be used to screen a newborn’s hearing: Auditory Brainstem Response and/or Otoacoustic Emissions. These tests can be performed while the baby is asleep or quiet and does not require the infant’s participation. Sounds (tones or clicks) are played through small earphones and responses to the sounds are automatically measured. Both tests are quick, painless, and non-invasive. Infants who do not pass the initial hearing screening in the hospital are referred for a re-screening which should be performed before one month of age. Infants who do not pass the re-screening are referred for a diagnostic hearing evaluation. Upon identification of hearing loss, infants and their families are referred for access to early intervention and related services.
2. NSP. Since its creation in 1966, the NSP has been expanded several times as new discoveries are made and tests developed, and now screens for more than 80 disorders. Diseases have been added through regulation and legislation. According to DPH’s Web site, newborn screening is recognized nationally as an essential preventive health measure. All states in the nation and the District of Columbia have established newborn screening programs. Disorders screened for by the program have varying degrees of severity. If identified early, many conditions can be treated before they cause serious and sometimes life-threatening health problems. Over 99% of babies born in California are screened. The sample of newborn blood is obtained between 12 and 48 hours of life by a heel-stick and put on filter paper. Parents can get the test results from the baby’s doctor or clinic, which takes about two to three weeks. If the baby needs more tests, parents will be contacted by the provider. Medi-Cal, health plans, and most private insurance will pay for the test.

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

According to the Senate Appropriations Committee, DHCS and DPH estimate the following:

• DHCS costs of $217,000 total funds ($108,500 General Fund, $108,500 Federal Fund) in fiscal year (FY) 2019-20 and $199,000 total funds ($99,500 General Fund, $99,500 federal funds) in FY 2020-21 and ongoing, for the department to establish the Commission; facilitate, at a minimum, bi-annual meetings; and, assist in the drafting of legislative reports. DHCS would need one full-time Associate Governmental Program Analyst for FY 2019-20 at $130,000 and FY 2020-21 and ongoing at $121,000 annually; and one Office Technician for FY 2019-20 at $87,000 and FY 2020-21 and ongoing at $78,000.
• Minor and absorbable costs for DPH to be a member of the Commission.

SUPPORT: (Verified 8/15/18)

National CMV Foundation (source)

American Academy of Pediatrics, California

Association of Regional Center Agencies

California Academy of Audiology

California Hospital Association

California Optometric Association

California Speech-Language-Hearing Association

CCHAT Center

Center for Early Intervention on Deafness

John Tracy Clinic

Weingarten Children’s Center

OPPOSITION: (Verified 8/15/18)

None received

ARGUMENTS IN SUPPORT: The National CMV Foundation, the sponsor of this bill, and other supporters state that every year, in California, 3,000 children are born with CMV and may develop hearing and vision loss, cerebral palsy, mental and physical health disabilities, behavior issues, and seizures. The National CMV Foundation cites a 1990s study by the Institute of Medicine that estimated costs totaling $1.9 billion, with $300,000 per child ($450,000 adjusted for inflation). Supporters argue that studies confirm that CMV prevention education, when directed to pregnant patients, can decrease the incidence of children born with CMV and help improve the health and development outcomes of newborns with CMV. Supporters argue that national awareness of CMV is alarmingly low and needs to be addressed. Supporters further state that as CMV research continues and expands it is important for California to consider the means to best address this important public health issue, and the Commission proposed in this bill has the capacity to improve the long-term health of our state, both fiscally and that of children. The American Academy of Pediatrics, California, states that California pediatricians agree more needs to be done to identify and monitor infants infected with CMV who have acquired the infection during pregnancy from their mothers, and that this bill establishes a Commission to approach the need to strengthen CMV identification, monitoring, and care while adhering to evidence-based practices.

ASSEMBLY FLOOR: 71-0, 5/30/18

AYES: Acosta, Aguiar-Curry, Travis Allen, Arambula, Baker, Berman, Bigelow, Bloom, Bonta, Burke, Calderon, Carrillo, Cervantes, Chau, Chávez, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Dahle, Daly, Eggman, Flora, Frazier, Friedman, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gonzalez Fletcher, Gray, Grayson, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, McCarty, Medina, Mullin, Muratsuchi, Nazarian, Obernolte, O'Donnell, Quirk, Quirk-Silva, Reyes, Rodriguez, Rubio, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Voepel, Waldron, Weber, Wood, Rendon

NO VOTE RECORDED: Brough, Caballero, Fong, Harper, Mayes, Melendez, Patterson

Prepared by: Reyes Diaz / HEALTH / (916) 651-4111

8/18/18 13:45:43

**** END ****

SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2017 - 2018 Regular Session

AB 1801 (Nazarian) - Newborns: cytomegalovirus public education and testing

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

Bill Summary:

Requires the Department of Health Care Services (DHCS) to establish a commission on cytomegalovirus (CMV) public education and testing, and submit annual reports for three years beginning December 31, 2019. Sunsets the commission on January 1, 2023.

Fiscal Impact:

The Department of Health Care Services (DHCS) and Department of Public Health (CDPH) estimate the following:

• DHCS costs of $217,000 total funds ($108,500 General Fund, $108,500 Federal Fund) in fiscal year (FY) 2019-20 and $199,000 total funds ($99,500 General Fund, $99,500 federal funds) in FY 2020-21 and ongoing, for the department to establish a Commission on Cytomegalovirus Public Education and Testing; facilitate, at a minimum, bi-annual meetings; and, assist in the drafting of legislative reports. DHCS would need one full-time Associate Governmental Program Analyst for FY 2019-20 at $130,000 and FY 2020-21 and ongoing at $121,000 annually; and one Office Technician for FY 2019-20 at $87,000 and FY 2020-21 and ongoing at $78,000.
• Minor and absorbable costs for CDPH to be a member of the Commission.

Background:

According to the federal Centers for Disease Control and Prevention, one in every 200 infants in the U.S. is born with congenital CMV and one in 1,000 infants will have lifelong complications from the virus, including, but not limited to: hearing loss, vision loss, intellectual disability, and seizures. Based on the average number of births in California, it is estimated that roughly 500 infants are born each year with congenital CMV who will suffer from lifelong complications. There is no cure for CMV.

State genetic disease screening programs test babies for a number of rare and serious genetic conditions that are often otherwise undetectable. Typically, hospitals collect small blood spots on special paper by pricking a baby's heel. The specimens are sent to a laboratory for testing. The program currently tests for over 80 different genetic and congenital disorders. Nearly all babies are screened through the program.

A federal expert committee advises the Secretary of the U.S. Department of Health and Human Services on the most appropriate application of universal newborn screening standards. The Recommended Uniform Screening Panel (RUSP) is a list of disorders the federal HHS secretary recommends states screen for as part of their newborn screening programs. Disorders on the panel are chosen based on evidence that supports the potential net benefit of screening. Pursuant to SB 1095 (Pan), Chapter 393, Statutes of 2016, California is required to adopt statewide screening of any disease added to the federal panel within two years of its addition. CDPH’s Newborn Screening Program follows the guidance of RUSP. CMV is not currently included in the screening panel.

Proposed Law:

1. The bill includes the following provisions:

• Requires DHCS to establish a Commission on CMV to implement the provisions of this bill only to the extent funds are appropriated by the Legislature for these purposes.
• Requires the Commission to consist of 13 members appointed by the Director of DHCS as follows:
• An infectious disease specialist who has experience with CMV;
• An obstetrician;
• A family physician involved with management of pregnancy and delivery of newborns;
• A labor and delivery nurse or nurse manager;
• A parent of a child who has been affected with a birth defect resulting from infection with CMV;
• A general pediatrician who practices primary care;
• A person from DPH’s Newborn Screening Program;
• A person from DHCS’s Newborn Hearing Screening Program;
• An audiologist;
• A pediatric otolaryngologist;
• A pediatric speech therapist;
• A person from the California Association of Health Plans, the Association of California Life and Health Insurance Companies, or America’s Health Insurance Plans; and,
• A person from the California Hospitals Association.
• Requires DHCS to designate one member as the chair of the Commission. Requires all appointments to be made no later than January 31, 2019. Requires the chair to convene the initial meeting of the Commission within 15 days after all members have been appointed and for the Commission to meet at least once every six months.
• Requires the Commission to examine research and data relating to, but not limited to, early identification, testing of congenital CMV, and appropriate treatment of birth defects caused by congenital CMV.
• Requires the Commission to examine and identify possible public educational resources to inform pregnant women and women who may become pregnant that include, but are not limited to:
  • Information regarding the incidence of CMV;
  • The transmission of CMV during and before pregnancy;
  • Birth defects caused by congenital CMV;
  • Methods of diagnosing congenital CMV;
  • Available preventive measures; and,
  • Resources for the family of a child born with congenital CMV.
• Requires the Commission to submit a report no later than December 31, 2019; an additional report no later than December 31, 2022; and any additional reports that include its findings. Permits the reports to include recommendations for possible legislation that are evidence-based and data driven. Requires the Commission to distribute its reports to the appropriate policy committees of the Legislature. Requires DHCS to make the reports publicly available on its Web site.
• Requires DHCS to provide or recommend necessary staffing services to the Commission including, but not limited to, staffing offered through the California Medical Association or the California Chapter of the American Academy of Pediatrics, to the extent permitted by law.
• Sunsets the bill on January 1, 2023.

Related Legislation:

1. The Legislature recently deliberated similar policies, including:

• SB 1095 (Pan, Chapter 393, Statutes of 2016) requires CDPH to expand statewide screening of newborns to include screening for any disease that is detectable in blood samples as soon as practicable, but no later than two years after the disease is adopted by the federal Recommended Uniform Screening Panel (RUSP).
• AB 1559 (Pan, Chapter 565, Statutes of 2014) requires cDPH to expand a statewide screening of newborns to include screening for ALD when ALD is adopted by the RUSP.

Staff Comments:

Since its creation in 1966, the Newborn Screening Program has been expanded several times as new discoveries are made and tests developed, and now screens for more than 80 disorders. Diseases have been added through regulation and legislation. All states in the nation and the District of Columbia have established newborn screening programs. Over 99% of babies born in California are screened. The sample of newborn blood is obtained between 12 and 48 hours of life by a heel-stick and put on filter paper. Parents can get the test results from the baby’s doctor or clinic, which takes about two to three weeks. If the baby needs more tests, parents will be contacted by the provider. Medi-Cal, health plans, and most private insurance will pay for the test.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Dr. Richard Pan, Chair

BILL NO: AB 1801

SUBJECT: Newborns: cytomegalovirus public education and testing.

SUMMARY:

Requires the Department of Health Care Services to establish a Commission on Cytomegalovirus (CMV) Public Education and Testing (Commission) to examine research and data relating to CMV and to identify possible public educational resources to inform pregnant women and women who may become pregnant about CMV. Requires the Commission to report its findings to the Legislature, as specified. Sunsets this bill on January 1, 2023.

Existing law:

1. Requires DHCS to establish a system to screen all newborns and infants for hearing loss, and create and maintain a system of assessment and follow-up services for newborns and infants identified by the screening, as specified. [HSC §123975]
2. Establishes the Newborn Hearing Screening Program (NHSP) within Department of Health Care Services (DHCS), which requires every general acute care hospital with licensed perinatal services in this state to administer to every newborn, prior to being discharged from the hospital nursery, a hearing screening test for the identification of hearing loss. Requires parents of all newborns and infants diagnosed with a hearing loss to be provided written information on the availability of community resources and services for children with hearing loss, as specified. [WIC §124115, et seq.]
3. Establishes the Department of Public Health (DPH) to be vested with all the duties, powers, purposes, functions, responsibilities, and jurisdiction as they relate to public health, as specified. [HSC §131050]
4. Establishes the Genetic Disease Unit within DPH to coordinate all programs in the area of genetic disease, including the Newborn Screening Program (NSP), to promote a statewide program of information, testing, and counseling services, as specified. [WIC §125000]

This bill:

1. Requires DHCS to establish a Commission on CMV to implement the provisions of this bill only to the extent funds are appropriated by the Legislature for these purposes.
2. Requires the Commission to consist of 13 members appointed by the Director of DHCS as follows:
3. An infectious disease specialist who has experience with CMV;
4. An obstetrician;
5. A family physician involved with management of pregnancy and delivery of newborns;
6. A labor and delivery nurse or nurse manager;
7. A parent of a child who has been affected with a birth defect resulting from infection with CMV;
8. A general pediatrician who practices primary care;
9. A person from DPH’s Newborn Screening Program;
10. A person from DHCS’s Newborn Hearing Screening Program;
11. An audiologist;
12. A pediatric otolaryngologist;
13. A pediatric speech therapist;
14. A person from the California Association of Health Plans, the Association of California Life and Health Insurance Companies, or America’s Health Insurance Plans; and,
15. A person from the California Hospitals Association.
16. Requires DHCS to designate one member as the chair of the Commission. Requires all appointments to be made no later than January 31, 2019. Requires the chair to convene the initial meeting of the Commission within 15 days after all members have been appointed and for the Commission to meet at least once every six months.
17. Requires the Commission to examine research and data relating to, but not limited to, early identification, testing of congenital CMV, and appropriate treatment of birth defects caused by congenital CMV.
18. Requires the Commission to examine and identify possible public educational resources to inform pregnant women and women who may become pregnant that include, but are not limited to:
19. Information regarding the incidence of CMV;
20. The transmission of CMV during and before pregnancy;
21. Birth defects caused by congenital CMV;
22. Methods of diagnosing congenital CMV;
23. Available preventive measures; and,
24. Resources for the family of a child born with congenital CMV.
25. Requires the Commission to submit a report no later than December 31, 2019; an additional report no later than December 31, 2022; and any additional reports that include its findings. Permits the reports to include recommendations for possible legislation that are evidence-based and data driven. Requires the Commission to distribute its reports to the appropriate policy committees of the Legislature. Requires DHCS to make the reports publicly available on its Web site.
26. States Legislative intent that the reports submitted be used to inform pregnant women and women who may become pregnant about CMV and to identify children born with CMV in order to improve their health and developmental outcomes.
27. Requires DHCS to provide or recommend necessary staffing services to the Commission including, but not limited to, staffing offered through the California Medical Association or the California Chapter of the American Academy of Pediatrics, to the extent permitted by law.
28. Sunsets this bill on January 1, 2023.

FISCAL EFFECT:

According to the Assembly Appropriations Committee:

1. Estimated costs in the range of $100,000 to $200,000 General Fund (GF) annually for four years to staff the Commission and prepare the necessary reports.
2. Potential state cost pressure to develop screening and education programs, pursuant to Commission recommendations (GF/federal/special). The charge of the Commission suggests it is intended to develop recommendations for newborn screening for CMV and public education related to CMV.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, CMV is a common virus that infects people of all ages. Most people infected with CMV show no signs or symptoms. This infection can cause serious health problems for babies infected with the virus before they are born. Congenital CMV is the leading cause of viral birth defects in newborns. It can lead to hearing loss, vision loss, developmental disabilities, and other serious, long-term health problems. AB 1801 would establish a commission to review issues surrounding CMV exposure. Unfortunately, public awareness of this preventable virus is abysmally low. Additionally, most infants at risk for CMV-associated hearing loss are not identified early in life because of failure to test for the infection. Due to a lack of screening, targeted or otherwise, a significant number of infants with CMV who may later develop long-term health complications go unrecognized. As scientific evidence on testing and treatment continues to unfold, it is important for the state to consider means to best address this issue. By creating this Commission, California will gather the relevant data and information which can be used to make the appropriate recommendations in order to combat this serious virus.
2. CMV. According to the federal Centers for Disease Control and Prevention (CDC), CMV is a common virus that infects people of all ages. In the U.S., nearly one in three children are already infected with CMV by age five, and over half of adults by age 40 have been infected with CMV. Once it is in a person’s body, CMV stays there for life and can reactivate. A person can also be re-infected with a different strain of the virus. Most people infected with CMV show no sign or symptoms, as a healthy person’s immune system keeps the virus from causing illness. However, CMV can cause serious health problems for people with weakened immune systems, as well as babies infected with the virus before they are born (congenital CMV). According to the CDC, in some cases infection in healthy people can cause mild illness that may include fever, sore throat, fatigue, and swollen glands, and occasionally, CMV can cause mononucleosis or hepatitis. But people with weakened immune systems who get CMV can have more serious symptoms that affect the eyes, lungs, liver, esophagus, stomach, and intestines. People with CMV can pass on the virus in body fluids, such as urine, saliva, blood, tears, semen, and breast milk. Women infected with CMV can pass the virus to a developing baby during pregnancy. Blood tests can be used to diagnose CMV infections in people who have symptoms. The CDC states that healthy people who are infected with CMV usually do not require medical treatment. Medications are available to treat CMV infection in people with weakened immune systems.
3. Congenital CMV. About one out of every 200 babies are born with congenital CMV infection passed on through the mother while the baby is developing, although only about one in five babies with infection will be sick from the virus or will have long-term health problems. Most babies with congenital CMV never show signs or have health problems. Some babies may have health problems that are apparent at birth or may develop later during infancy or childhood. Some signs babies with congenital CMV may exhibit at birth include premature birth; liver, lung, and spleen problems; small size at birth; small head size; and seizures. Some long-term health problems that infected babies may experience include hearing and vision loss, intellectual disability, lack of coordination, and weakness or problems using muscles. Hearing loss may be present at birth or develop later in babies who pass their newborn hearing test. According to the CDC, congenital CMV can be diagnosed by testing a newborn baby’s saliva, urine, or blood, which must be collected for testing within two to three weeks after the baby is born in order to confirm a diagnosis. Medicines, such as antiretrovirals, may decrease the risk of health problems and hearing loss in some infected babies who show signs of infection at birth, though the CDC states that use of medications for treating babies with infection who have no signs at birth is not currently recommended. The CDC recommends that infected babies, with or without signs at birth, have regular hearing checks. The CDC also recommends women take steps to lessen their risk of getting CMV by reducing contact with saliva and urine from babies and young children, such as by kissing children on the cheek or head rather than the lips, and by washing their hands after changing diapers.

According to the National CMV Foundation, congenital CMV is the leading viral cause of congenital disabilities and the leading non-genetic cause of childhood hearing loss, though most adults have never heard of CMV. Approximately 30,000 babies are born with congenital CMV in the U.S. every year, and 6,000 will develop permanent disabilities. The National CMV Foundation states that CMV virus can live for up to 15 minutes on hands and plastic, and up to five minutes on crackers, while no viable virus survives after washing hands with water, soap, or sanitizer. The National CMV Foundation cites a study published in November 2016 in the Journal of Early Hearing Detection and Intervention, which found that CMV awareness is very low compared to other congenital and childhood conditions with lower incidence rates; women have an odds of awareness of one and a half to two times greater than men; Hispanics are less than half as likely to be aware of CMV than non-Hispanics; and the presence of a child ages zero to five in the household does not increase the chance that an adult in the household is aware of CMV.

1. NHSP. According to DHCS’s Web site, the California NHSP is a system of early identification, intervention, and support services for infants with hearing loss and their families. The goal of the program is to identify infants with a hearing loss prior to three months of age and to link infants with early intervention services by six months of age. Infants begin developing speech and language from the moment they are born, and studies show that hearing loss occurs in approximately two to four out of 1,000 babies. Without newborn hearing screening, hearing loss is often not identified until 18 months to three years of age when problems with speech are noted. If an infant has a hearing loss in one or both ears, early identification is crucial to preventing delayed speech and language development. There are two methods that may be used to screen a newborn’s hearing: Auditory Brainstem Response and/or Otoacoustic Emissions. These tests can be performed while the baby is asleep or quiet and does not require the infant’s participation. Sounds (tones or clicks) are played through small earphones and responses to the sounds are automatically measured. Both tests are quick, painless, and non-invasive. Infants who do not pass the initial hearing screening in the hospital are referred for a re-screening which should be performed before one month of age. Infants who do not pass the re-screening are referred for a diagnostic hearing evaluation. Upon identification of hearing loss, infants and their families are referred for access to early intervention and related services.
2. NSP. Since its creation in 1966, the NSP has been expanded several times as new discoveries are made and tests developed, and now screens for more than 80 disorders. Diseases have been added through regulation and legislation. According to DPH’s Web site, newborn screening is recognized nationally as an essential preventive health measure. All states in the nation and the District of Columbia have established newborn screening programs. Disorders screened for by the program have varying degrees of severity. If identified early, many conditions can be treated before they cause serious and sometimes life-threatening health problems. Over 99% of babies born in California are screened. The sample of newborn blood is obtained between 12 and 48 hours of life by a heel-stick and put on filter paper. Parents can get the test results from the baby’s doctor or clinic, which takes about two to three weeks. If the baby needs more tests, parents will be contacted by the provider. Medi-Cal, health plans, and most private insurance will pay for the test.
3. Related legislation. AB 612 (Rubio) amends the NHSP to require the use of an Internet Web-based, external data enabled, automated newborn and infant data management system to effect early detection of hearing loss, including tracking of children identified with potential hearing loss. AB 612 is pending in this Committee.
4. Prior legislation. SB 1095 (Pan, Chapter 393, Statutes of 2016) requires DPH to expand statewide screening of newborns to include screening for any disease that is detectable in blood samples as soon as practicable, but no later than two years after the disease is adopted by the federal Recommended Uniform Screening Panel (RUSP).

AB 1559 (Pan, Chapter 565, Statutes of 2014) requires DPH to expand a statewide screening of newborns to include screening for ALD when ALD is adopted by the RUSP.

1. Support. The National CMV Foundation, the sponsor of this bill, and other supporters state that every year in California 3,000 children are born with CMV and may develop hearing and vision loss, cerebral palsy, mental and physical health disabilities, behavior issues, and seizures. The National CMV Foundation cites a 1990s study by the Institute of Medicine that estimated costs totaling $1.9 billion, with $300,000 per child ($450,000 adjusted for inflation). Supporters argue that studies confirm that CMV prevention education, when directed to pregnant patients, can decrease the incidence of children born with CMV and help improve the health and development outcomes of newborns with CMV. Supporters argue that national awareness of CMV is alarmingly low and needs to be addressed. Supporters further state that as CMV research continues and expands it is important for California to consider the means to best address this important public health issue, and the Commission proposed in this bill has the capacity to improve the long-term health of our state, both fiscally and that of children. The American Academy of Pediatrics, California, states that California pediatricians agree more needs to be done to identify and monitor infants infected with CMV who have acquired the infection during pregnancy from their mothers, and that this bill establishes a Commission to approach the need to strengthen CMV identification, monitoring, and care while adhering to evidence-based practices.
2. Opposition. The California Medical Association (CMA) is opposed to this bill unless it is amended to address stakeholder concerns about the Commission members. CMA states that if the author takes the amendment, it would remove opposition to this bill. CMA states that it wants to ensure that the Commission does not come out in front of the science on CMV, harming patients or practitioners in the process.
3. Amendments. The author may wish to consider amendments related to the make-up of the Commission to make insurance and hospital representation consistent with other membership as follows:
   1. 124123.3. (a)

(12) One member from the California Association of Health Plans, the Association of California Life and Health Insurance Companies, or America’s Health Insurance Plans. who is a representative of health plans or insurers.

(13) One member from the California Hospitals Association. who is a representative of hospitals.

SUPPORT AND OPPOSITION:

Support: National CMV Foundation (sponsor)

American Academy of Pediatrics, California

Association of Regional Center Agencies

California Academy of Audiology

California Optometric Association

California Speech-Language-Hearing Association

CCHAT Center

Center for Early Intervention on Deafness

John Tracy Clinic

Weingarten Children’s Center

Oppose: California Medical Association (unless amended)

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 1801

Author:(Nazarian)

As Amended Ver:May 25, 2018

Majority vote

SUMMARY: Requires the State Department of Health Care Services (DHCS) to establish a Commission on cytomegalovirus (CMV) Public Education and Testing. Specifically, this bill:

1. Requires the Commission to submit an annual report, for three years, beginning on December 31, 2019 to the appropriate policy committees of the Legislature.
2. Requires DHCS to make the report, as specified in 1) above, publicly available on its Internet Web site.
3. Permits the Commission, when appropriate, to make recommendations, including, but not limited to, legislative recommendations, those recommendations must be evidence-based and data driven.
4. Requires the Commission to examine research and data relating to, but not limited to, early identification, testing of congenital CMV, and appropriate treatment of birth defects caused by congenital CMV.
5. Requires the Commission to examine and identify possible public educational resources to inform pregnant women and women who may become pregnant that include, but are not limited to:
   1. Information regarding the incidence of CMV;
   2. The transmission of CMV during and before pregnancy;
   3. Birth defects caused by congenital CMV;
   4. Methods of diagnosing congenital CMV;
   5. Available preventative measures; and,
   6. Resources for the family of a child born with congenital CMV.
6. Repeals the provisions of this bill on January 1, 2023.

FISCAL EFFECT: According to the Assembly Appropriations Committee:

1. Estimated costs in the range of $100,000 to $200,000 General Fund (GF) annually for four years to staff the commission and prepare the necessary reports.
2. Potential state cost pressure to develop screening and education programs, pursuant to commission recommendations (GF/federal/special). The charge of the commission suggests it is intended to develop recommendations for newborn screening for CMV and public education related to CMV.

COMMENTS: According to the author, CMV is a common virus that infects people of all ages. Most people infected with CMV show no signs or symptoms. The infection can cause serious health problems for babies infected with the virus before they are born. Congenital CMV is the leading cause of viral birth defects in newborns; it can lead to hearing loss, developmental disabilities, and other serious, long-term health problems. The author notes, public awareness of this preventable issue is abysmally low and most infants at risk for CMV-associated hearing loss are not identified early in life because of failure to test for the infection. The author concludes, by creating this Commission, California will gather the relevant data and information which can be used to make the appropriate policy recommendations in order to combat this serious virus.

CMV is a common virus that usually presents with no signs or symptoms for healthy children and adults. CMV can pose serious health issues for individuals with suppressed immune systems and fetuses. If a pregnant woman becomes infected with CMV during her pregnancy the infant can contract the virus which is called congenital CMV. According to the Centers for Disease Control and Prevention, one out of every 200 infants in the United States (U.S.) is born with congenital CMV and of these babies born with congenital CMV, one in five infants will have symptoms or lifelong complications, including, but not limited to: hearing loss, vision loss, intellectual disability, and seizures. Based on the average number of births in California, it is estimated that roughly 500 infants are born each year with congenital CMV that will suffer from these lifelong complications. It is important to note, there is no cure for CMV.

The U.S. Secretary of Health and Human Services recommends a list of disorders for the federal Recommended Uniform Screening Panel (RUSP). Disorders on the RUSP are selected based on evidence that supports the potential benefit of screening, the ability of states to screen for the disorder, and also the availability of effective treatments for the specific disorders. CMV is currently not recommended for the RUSP. Individuals and organizations have the option to nominate a condition to be considered for the RUSP. Based on communications with the sponsor of this bill, the National CMV Foundation will be nominating CMV by the end of 2018 to be included in the RUSP. In California, the Department of Public Health (DPH) oversees the Newborn Screening (NBS) program which requires all infants be screened shortly after birth for serious, but treatable genetic disorders. SB 1095 (Pan), Chapter 393, Statutes of 2016, requires DPH to align the NBS program with recommendations from the federal RUSP.

The National CMV Foundation, sponsor of this bill, writes that national awareness CMV is alarmingly low and the lack of screening-targeted or otherwise-leaves a significant number of infants with CMV to later develop long-term health complications. The National CMV Foundation notes by creating this Commission, California will gather relevant data and information which can be used to make the appropriate recommendations in order to combat this serious virus.

There is no opposition to this bill.

Analysis Prepared by: Monica Montano / HEALTH / (916) 319-2097 FN: 0003336

Date of Hearing: May 2, 2018

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez Fletcher, Chair

ABPCA Bill Id:AB 1801

Author:(Nazarian) – As Amended Ver:April 24, 2018

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

SUMMARY:

This bill requires the Department of Health Care Services (DHCS) to establish a commission on cytomegalovirus (CMV) public education and testing, and submit annual reports for three years beginning December 31, 2019. It also sunsets the commission January 1, 2023.

FISCAL EFFECT:

1. Estimated costs in the range of $100,000 to $200,000 GF annually for four years to staff the commission and prepare the necessary reports.
2. Potential state cost pressure to develop screening and education programs, pursuant to commission recommendations (GF/federal/special). The charge of the commission suggests it is intended to develop recommendations for newborn screening for CMV and public education related to CMV.

COMMENTS:

1. Purpose. By forming a commission, this bill seeks to gather and transmit information to inform the policy process with respect to newborn screening of, diagnosis of, and treatment for CMV, as well as public education about the virus.
2. CMV. According to the federal Centers for Disease Control and Prevention, one in every 200 infants in the U.S. is born with congenital CMV and one in 1,000 infants will have lifelong complications from the virus, including, but not limited to: hearing loss, vision loss, intellectual disability, and seizures. Based on the average number of births in California, it is estimated that roughly 500 infants are born each year with congenital CMV who will suffer from lifelong complications. There is no cure for CMV. Some studies suggest antiviral medication may be helpful to improve outcomes, but research is ongoing to monitor long-term improvements.
3. Newborn Screening. State genetic disease screening programs test babies for a number of rare and serious genetic conditions that are often otherwise undetectable. The goal of the program is to identify babies with these disorders and begin treatment as early as possible. Hospitals collect small blood spots on special paper by pricking a baby's heel. The specimens are sent to a laboratory for testing. The program currently tests for over 80 different genetic and congenital disorders Nearly all babies are screened through the program.

A federal expert committee advises the Secretary of the U.S. Department of Health and Human Services on the most appropriate application of universal newborn screening standards. The Recommended Uniform Screening Panel (panel) is a list of disorders the federal HHS secretary recommends states screen for as part of their newborn screening programs. Disorders on the panel are chosen based on evidence that supports the potential net benefit of screening. Pursuant to SB 1095 (Pan), Chapter 393, Statutes of 2016, California is required to adopt statewide screening of any disease added to the federal panel within two years of its addition.

When considering whether to include additional diseases in the panel, the federal advisory committee considers the reliability of the screening test, the availability of treatments, the benefits of early diagnosis, and the anticipated impact on health outcomes from additional screening, among other issues. As of now, CMV is not included in the panel.

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

Date of Hearing: April 17, 2018

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 1801

Author:(Nazarian) – As Amended Ver: April 10, 2018

SUBJECT: Newborns: cytomegalovirus public education and testing.

SUMMARY: Requires the State Department of Health Care Services (DHCS) to establish a Commission on cytomegalovirus (CMV) public education and testing. Specifically, this bill:

1. Requires the Commission to submit an annual report, for three years, beginning on December 31, 2019 to the appropriate legislative policy committees.
2. Requires DHCS to make the report, as specified in 1) above, publicly available on its Internet Website.
3. Requires the DHCS Director to appoint all 17 members of the Commission, as follows:
   1. An infectious diseases specialist;
   2. An obstetrician;
   3. A family physician and is involved with management of pregnancy and delivery of newborns;
   4. A nurse midwife;
   5. A labor and delivery nurse or nurse manager;
   6. A midwife who performs home births;
   7. A parent of a child affected with a birth defect resulting from infection with CMV;
   8. A neonatologist;
   9. A pediatrician;
   10. A member from the California Department of Public Health (DPH) newborn hearing screening;
   11. A member from DHCS early hearing detection and intervention program;
   12. An audiologist;
   13. A pediatric otolaryngologist;
   14. A pediatric speech therapist;
   15. A member from the California Association of Health Plans, the Association of California Life and Health Insurance Companies, or America’s Health Insurance Plans;
   16. A member from the California Hospitals Association; and,
   17. A member who is a CMV expert specialized in the diagnosis of newborns.
4. Requires the Commission to address the issue of CMV public education and testing in the state and develop solutions for newborns, including all of the following: newborn CMV screening; diagnosis of CMV infected newborns; and, treatment of CMV infected newborns.
5. Requires the Commission to identify the most effective public education resources to inform pregnant women and women who may become pregnant that include, but are not limited to:
   1. Information regarding the incidence of CMV;
   2. The transmission of CMV during and before pregnancy;
   3. Birth defects caused by congenital CMV;
   4. Methods of diagnosing congenital CMV;
   5. Available preventative measures; and,
   6. Resources for the family of a child born with congenital CMV.
6. Requires the Commission to work with DHCS to include congenital CMV infection on the list of reportable diseases.
7. Requires DHCS to provide or recommend necessary staffing services to the Commission, including, but not limited to, staffing offered through the California Medical Association or the California Chapter of the American Academy of Pediatrics.
8. Repeals the provisions of this bill on January 1, 2023.

EXISTING LAW:

1. Requires DPH to expand statewide screening of newborns to include screening for adrenoleukodystrophy (ALD) and any other diseases that is detectable in blood samples as soon as practicable, but no later than two years after the disease is adopted by the federal Recommended Uniform Screening Panel (RUSP).
2. Requires every licensed perinatal service to screen every newborn for hearing loss under the Newborn and Infant Hearing Screening, Tracking, and Intervention Act.
3. Requires DHCS to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss.

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

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, CMV is a common virus that infects people of all ages. Most people infected with CMV show no signs or symptoms. The infection can cause serious health problems for babies infected with the virus before they are born. Congenital CMV is the leading cause of viral birth defects in newborns; it can lead to hearing loss, developmental disabilities, and other serious, long-term health problems. The author states that, this bill would establish a Commission to review issues surrounding CMV exposure. The author notes, public awareness of this preventable issue is abysmally low and most infants at risk for CMV-associated hearing loss are not identified early in life because of failure to test for the infection. The author goes on to state, due to a lack of screening, a significant number of infants with CMV who may later develop long-term health complications go unrecognized. As scientific evidence on this issue unfolds, it is important for the state to consider means to best address this issue. The author concludes, by creating this Commission, California will gather the relevant data and information which can be used to make the appropriate policy recommendations in order to combat this serious virus.
2. BACKGROUND. CMV is a common virus that usually presents with no signs or symptoms for healthy children and adults. The Centers for Disease Control and Prevention (CDC) estimates that over half of adults by age 40 have been infected with CMV. Most individuals are unaware they may have been infected. CMV can pose serious health issues for individuals with suppressed immune systems and fetuses. If a pregnant woman becomes infected with CMV during her pregnancy the infant can contract the virus which is called congenital CMV. According to the CDC, one out of every 200 infants in the U.S. is born with congenital CMV and of these babies born with congenital CMV, one in five infants will have symptoms or lifelong complications, including, but not limited to: hearing loss, vision loss, intellectual disability, and seizures. Based on the average number of births in California, it is estimated that roughly 500 infants are born each year with congenital CMV that will suffer from these lifelong complications. It is important to note, there is no cure for CMV.
   1. Transmission. CMV is transmitted through bodily fluids and is found in higher rates in urine and saliva. Individuals, especially children, with CMV can easily spread the virus. Studies show that child care workers have a higher risk of CMV infection because they work closely with many young children. According to the CDC, avoiding contact with saliva and urine from young children might reduce the risk of CMV infection, although studies have not shown a clear effective manner in which one can completely eliminate the risk of contracting CMV.
   2. Symptoms. Approximately 10% of infants with congenital CMV will have signs at birth including, but not limited to: jaundice; small head size; or, liver, lung, and spleen problems. Congenital CMV can be diagnosed through testing a newborn’s saliva, urine, or blood. Testing a newborn’s saliva is the most reliable method for diagnosing congenital CMV and this must be done no later than three weeks after the child is born. As mentioned above, the majority of infants with congenital CMV will never present with symptoms or have health issues. However, for the 20% of infants with congenital CMV, 10% of those newborns will not have signs of congenital CMV at birth. This population of infants is at risk for developing hearing loss, one of the main symptoms of congenital CMV. There is no cure for congenital CMV and the use of antivirals may decrease the risk of health problems and hearing in loss in some of the infants with congenital CMV, but more research is necessary.
   3. RUSP. The Advisory Committee on Heritable Disorders in Newborns and Children (Advisory Committee) has the mission of reducing morbidity and mortality in newborns and children who have, or are at risk, for heritable disorders. The Advisory Committee advises the Secretary, U.S. Department of Health and Human Services (HHS) on the appropriate application of universal newborn screening test technologies, policies, guidelines, and standards. The Secretary of HHS then recommends a list of disorder for the RUSP. Disorders on the RUSP are selected based on evidence that supports the potential benefit of screening, the ability of states to screen for the disorder, and also the availability of effective treatments for the specific disorders. CMV is currently not recommended for the RUSP. Individuals and organizations have the option to nominate a condition for the Advisory Committee to consider for the RUSP. Through communications with the sponsor of this bill, the National CMV Foundation will be nominating CMV by the end of 2018 to the Advisory Committee. In California, DPH oversees the Newborn Screening (NBS) program which requires all infants be screened shortly after birth for serious, but treatable genetic disorders. The NBS follows the RUSP due to past legislation, SB 1095 (Pan), Chapter 393, Statutes of 2016, which requires DPH to follow the RUSP. The NBS program currently includes 80 different genetic and congenital disorders.
   4. Maine CMV Workgroup. Last year, the State Legislature of Maine convened a workgroup to provide the Maine Legislature with a report on the recommendations around how to prevent and identify CMV in Maine. The report was released at the beginning of 2018. The workgroup had several objectives such as, finding solutions for infants afflicted with CMV during and after birth and recommending the most effective public education resources to inform pregnant women and women who may become pregnant about information regarding the incidence of CMV. The workgroup had the following four recommendations:
      1. Provide education on the causes, symptoms and prevention of congenital CMV to all parents, caregivers, and providers working with children, infants, and pregnant women;
      2. Convene a workgroup to develop and disseminate education information and materials to key stakeholder groups;
      3. Require a targeted screening approach with the long-term goal of universal screening; and,
      4. Explore the option of utilizing bloodspot tests to screen for congenital CMV.
3. SUPPORT. The National CMV Foundation states this bill would require DHCS to establish a Commission to review congenital CMV. The National CMV Foundation goes onto note, national awareness is alarmingly low and the lack of screening-targeted or otherwise-leaves a significant number of infants with CMV to later develop long-term health complications. The National CMV Foundation notes by creating this Commission, California will gather relevant data and information which can be used to make the appropriate recommendations in order to combat this serious virus. The National CMV Foundation concludes this bill takes necessary steps to help alleviate the potentially devastating consequences of congenital CMV.
4. OPPOSITION. The California Hospital Association (CHA) believes the CDC and other nationally recognized professional organizations are in the best position to establish these standards. CHA notes that the Commission proposed would either confirm the existing national standard, in which case this section would be unnecessary, or create an alternative solution, which would differ from the national standard and confuse providers.
5. OPPOSE UNLESS AMENDED. The American Academy of Pediatrics, California (AAP-CA), opposes this bill unless amended. AAP-CA has significant concerns with the charge of the Commission as it is conceptualized in the current form. AAP-CA states the amended bill appears to presuppose what the outcomes of the dialogue among Commission members will be, i.e., that the Commission will call for legislation, and that such legislation will relate to “the most effective public education resources for pregnant women,” as well as the best ways to “identify children born with CMV.” AAP-CA notes it may be possible the Commission could make recommendations that do not require any legislative action/statutory change, yet the bill language does not allow for that possibility. AAP-CA concludes that in order for the Commission to have a productive and positive conversation that leads to improvements in care and outcomes for these children and their families, it is critically important that this be an evidence-based, open process.
6. PREVIOUS LEGISLATION.
   1. SB 1095 of 2016 requires DPH to expand disease screening of newborns to align with recommendations by the federal RUSP.
   2. AB 1559 (Pan), Chapter 565, Statutes of 2014, requires DPH to expand a statewide screening of newborns to include screening for ALD, when ALD is adopted by the federal Recommended Uniform Screening Panel.
   3. SB 1072 (Strickland) of 2012, would have required DPH to screen newborns for two additional inherited conditions, Hurler Syndrome and Krabbe disease. SB 1072 was placed on suspense in the Senate Appropriations Committee.
   4. AB 1731 (Block), Chapter 336, Statutes of 2012, requires a general acute care hospital that has a license perinatal service to offer to parents of a newborn, a pulse oximetry test for the identification of a critical congenital heart disease.
7. SUGGESTED AMENDMENTS.
   1. As the bill is written, the Commission would be required to work with DHCS on including congenital CMV on the list of reportable diseases. Under existing law, DPH not DHCS is required to list reportable communicable and noncommunicable diseases. There is no evidence to suggest congenital CMV should be added to the list of reportable disease, the Committee may wish to delete this provision from the bill.
   2. The Committee suggests minor and technical amendments to correct drafting errors.

REGISTERED SUPPORT / OPPOSITION:

Support

National CMV Foundation (sponsor)

American College of Surgeons- San Diego-Imperial Chapter (prior version)

Association of Regional Center Agencies

California Speech-Language Hearing Association

Children’s Choice for Hearing and Talking Center (prior version)

John Tracy Clinic (prior version)

North Los Angeles County Regional Center Board of Trustees (prior version)

The Arc and United Cerebral Palsy California Collaboration (prior version)

Weingarten Children’s Center (prior version)

Numerous individuals (prior version)

Opposition

America’s Health Insurance Plans (prior version)

American College of Obstetricians and Gynecologists District IX (prior version)

Association of California Life and Health Insurance Companies (prior version)

California Association of Health Plans (prior version)

California Hospital Association

Analysis Prepared by: Monica Montano / HEALTH / (916) 319-2097