BILL ANALYSIS Ó AB 1731 Page 1 Date of Hearing: April 17, 2012 ASSEMBLY COMMITTEE ON HEALTH William W. Monning, Chair AB 1731 (Block) - As Amended: April 9, 2012 SUBJECT : Newborn screening program: critical congenital heart disease. SUMMARY : Establishes the Newborn Critical Congenital Heart Disease (CCHD) Screening Program and requires hospitals to offer a pulse oximetry test for the identification of CCHD to parents of newborns prior to discharge. Specifically, this bill : 1)Applies the requirement to general acute care hospitals with licensed perinatal services. 2)Requires the hospital to use protocols approved by the Department of Health Care Services (DHCS). 3)Requires DHCS to begin phasing in implementation by hospitals on or after July 1, 2013 and requires 100% participation rate by 2016. 4)Requires hospitals to develop a screening program with the following elements: a) Competent CCHD screening; b) Appropriate staff and equipment; c) Referral of infants with abnormal screening results for appropriate care; d) Reporting and maintenance of data as required; and, e) Physician and family-parent education. 5)Requires the pulse oximetry test to be performed by a licensed physician, licensed registered nurse, or an appropriately trained individual who is supervised by a licensed health care professional. 6)Exempts a newborn if the parent or guardian objects on the grounds that the test is in violation of his or her beliefs. 7)Makes legislative findings and declarations regarding the incidence of CCHD, current methods of detection, and pulse oximetry. AB 1731 Page 2 EXISTING LAW : 1)Establishes the Newborn and Infant Hearing Screening, Tracking, and Intervention Act which requires every general acute care hospital with licensed perinatal services to offer every newborn a hearing screening test for the identification of hearing loss, as specified, and provide written information on the availability of community resources and services for children with hearing loss to the parents of those who are diagnosed with a hearing loss. 2)Requires the Department of Public Health (DPH) to establish a genetic disease unit to coordinate programs in the area of genetic disease and promote a statewide program of information, testing, and counseling services and to have the responsibility of designating test and regulations to be used in executing this Newborn Screening (NBS) Program. Under the Hereditary Disorders Act, declares the intent of the Legislature that the state's hereditary disorders program activities are to be fully supported by fees collected for services provided by the NBS Program, unless otherwise provided. FISCAL EFFECT : This bill has not been analyzed by a fiscal committee. COMMENTS : 1)PURPOSE OF THIS BILL . Congenital heart disease (CHD) involves defects of the walls, valves, arteries, or veins of the heart and occurs in seven to nine of every 1,000 live births in the United States. According to the author, this bill is designed to ensure that newborns are screened for CCHD, which is a subset of CHD. This bill accomplishes this purpose by requiring DHCS to establish statewide screening of newborns by means of pulse oximetry screening. The author explains that pulse oximetry screening is a test that occurs at the bedside and is a non-invasive test that estimates the percentage of hemoglobin in the blood that is saturated with oxygen. The author argues that many newborn lives could potentially be saved by earlier detection and treatment of CCHD if hospitals were required to perform this simple, noninvasive screening method. AB 1731 Page 3 2)BACKGROUND . CHD is an overarching term that describes clinical outcomes derived from a number of defects of the walls, valves, arteries, or veins of the heart. The disease is classified as critical or CCHD when it includes a group of seven defects that cause severe and life-threatening symptoms and requires intervention within the first days or first year of life. According to the Centers for Disease Control and Prevention (CDC), the incidence of CCHD in the United States is about 11.6 per 10,000 babies per year. Other heart defects can be just as severe, according to the CDC, and also require treatment soon after birth, however pulse oximetry may not detect these as consistently as those listed as CCHDs. Some babies born with a heart defect can appear healthy at first and may be sent home before the defect is detected. The CDC advises that pulse oximetry newborn screening, along with the physical examination, can identify some infants with a CCHD before they show signs of the condition. Once identified, babies with a CCHD can be seen by cardiologists and receive special care and treatment to prevent death or disability. According to the CDC, certain hospitals routinely screen all newborns using pulse oximetry screening. However, currently it is not included in most state newborn screening panels. 3)NEWBORN SCREENING. The Secretary of the federal Department of Health and Human Services (DHHS) Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) was chartered in February 2003 and is charged with making systematic evidence-based and peer-reviewed recommendations to advise the DHHS Secretary regarding the most appropriate application of universal newborn screening tests, technologies, policies, guidelines and standards for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. In 2010, the Secretary adopted the SACHDNC's Recommended Uniform Screening Panel (RUSP) as a national standard for newborn screening programs and to facilitate the adoption of the SACHDNC's RUSP by all state newborn screening programs. The RUSP included 29 core conditions and 25 secondary conditions which are disorders that can be detected in the differential diagnosis of a core disorder. At the same time, the Secretary adopted the recommendation to add Severe combined immunodeficiency (SCID) as a core condition and related T-cell lymphocycte deficiencies as a secondary condition to the RUSP. California is in the process of adding the SCID screening as directed by AB 695 (Pan), Chapter 461, Statutes of 2011, which AB 1731 Page 4 will conform California's NBS to the Secretary's recommendations. 4)CCHD PULSE OXIMETRY SCREENING . In April of 2011, the Secretary notified SACHDNC that its recommendations pertaining to the addition of CCHD screening to the RUSP were not yet ready for adoption primarily due to a number of identified evidence gaps. Since then a number of steps have been undertaken by the Secretary, SACHDNC, and other national public health agencies and advisory groups with regard to these identified issues. On September 21, 2011, the Secretary decided to adopt the SACHDNC recommendation to add CCHD to the RUSP. In addition, she requested that SACHDNC collaborate with the Health Resource and Services Administration (HRSA) to complete a thorough evaluation of the potential public health impact of universal screening for CCHD. One of the steps she had previously taken was to refer the recommendations to the Interagency Coordinating Committee on Screening in Newborns and Children (ICC) for additional review and input on implementation. She specifically requested the ICC to review the evidence gaps and propose a plan of action. The Secretary stated that the ICC Plan of Action and other reviewing entities had identified remaining evidence gaps and she concluded that these should receive closer attention as implementation occurs. As a consequence, a comprehensive Federal Plan of Action has been undertaken. This includes research by the National Institute of Health to determine the relationship of screening to outcomes of affected newborns and CDC surveillance and monitoring of the link to infant mortality and other health outcomes. HRSA will guide the development of screening standards and infrastructure needed for the implementation of a public health approach to point of service screening for CCHD and is funding the development of, in collaboration with public health and health care professionals and families, appropriate education and training materials for families and public health care professionals relevant to the screening and treatment of CCHD. 5)SCREENING PROTOCOLS . This bill requires hospitals to use protocols approved by DHCS. One of the identified evidence gaps is the lack of standardized screening protocols. Neonates with abnormal pulse oximetry screening results need confirmatory testing for the cause and immediate intervention. The Federal Plan of Action calls for HRSA to support the development, dissemination, and validations of screening AB 1731 Page 5 protocols and newborn screening infrastructure during 2011. HRSA is also in the process of awarding grants for a three-year demonstration program for this purpose. In addition the Federal Plan includes future guidance to state Medicaid directors for screening, follow-up and treatment that is medically necessary for children enrolled in Medicaid. 6)SUPPORT . The March of Dimes writes that it supports this bill because it will save lives. According to the March of Dimes, CCHD is a subgroup of CHD that affects approximately 4,800 babies born in the United States each year. In support, the March of Dimes states that a California study has shown that an estimated 30 babies die each year in California from undiagnosed CCHD, deaths that could be prevented if CCHD is detected and treated earlier. Babies with CCHD have a heart defect that requires intervention, such as surgery, in the first few hours, days, or months of life. March of Dimes points out that it has been instrumental in expanding newborn screening and is supportive where there is a documented medical benefit to early detection, a reliable screening test and early detection can be done through specific means, all of which exist for CCHD screening. The American Heart Association (AHA) also in support of this bill writes that some CCHD can cause severe and life-threatening symptoms that require intervention within the first days of life. In addition, AHA argues in support, the economic costs related to CHD are high. AHA states that when conducted on newborns at the time of delivery, pulse oximetry screening significantly improves the effectiveness and probability of detecting CCHD. AHA believes that by requiring pulse oximetry screening for all newborn babies, lives will be saved and the economic impact of CHD will be reduced. The Santa Clara Board of Supervisors writes in support that the Director of Neonatal Intensive Care (NICU) at the Santa Clara Valley Medical Center, Dr. Balaji Govindaswami, is a pioneer in this remarkable simple technique. According to this support, while pulse oximeters are routinely used as a screening tool, they are not typically used on newborns. Because they are common in the NICU setting however, Dr. Goindaswami has identified that their use on all newborns could identify otherwise completely unnoticed heart problems. AB 1731 Page 6 The American Congress of Obstetricians and Gynecologists (ACOG), District IX writes in support that the Secretary of the DHHS added screening for CCHD to the RUSP in September 2010. ACOG writes that there are now 31 core conditions and California requires screening for the 30 other conditions. ACOG points out that CCHD screening is done through a non-invasive pulse oximetry test, in which a sleeve is placed on the infant's foot to measure blood oxygen saturation, similar to the fingertip device used to measure an adult's blood oxygen and that detect CCHD before symptoms present themselves, allowing for the proper treatment to be given to prevent disability or death. 7)SUPPORT WITH AMENDMENTS . The Children's Specialty Care Coalition (CSCC) writes that while they support the general intent of this bill to institute newborn screening for CCHD, they have concerns. Specifically, in order to ensure that sick children receive appropriate and quality health care services they recommend that this bill include reference to the generally accepted screening protocols for CCHD that have been endorsed by the American Academy of Pediatrics, AHA and the SACHDNC's Expert Panels Workgroup's Preliminary Recommendations. CSCC further states in support of these amendments that pediatric cardiologists who have reviewed this bill, support moving forward with state screening of newborn for CCHD, but point out that it is essential to use generally accepted screening protocols in order to minimize the number of false positive results from the test. According to CSCC, large numbers of false positive results would lead to greater health care costs in the system because of the need for echocardiograms and referrals to specialists that would be necessary to confirm the diagnoses, unnecessary worry on the part of the parents and family members, and finally a large number of false positive results could overwhelm our network of pediatric cardiologists in the state with unnecessary referrals. 8)OPPOSITION . The California Hospital Association (CHA), in opposition to the bill, writes that in California, there are more than 500,000 babies born in hospitals each year. According to CHA, for each of those births, hospitals administer a hearing screening test for identification of hearing loss, as well as genetic disease testing as required by state law. These programs are administered and managed by the DHCS and the DPH, respectively. CHA writes that while AB 1731 Page 7 they appreciate the bill's intent to add testing for CCHD to the growing list of services provided to newborns prior to discharge from a hospital, they are mindful of the impact a new mandate has on hospitals, health care professionals, and our state's health oversight infrastructure and financing capacity. CHA argues that any new mandate for screening should be evidence-based and only be implemented once standard protocols have been tested and when it is established that actual benefits, in terms of improved patient outcomes, will result. According to their opposition, this bill fails to address many necessary and critical components of a screening program. In opposition, CHA raises the following issues: a) No statewide uniformity of protocol - each hospital is required to develop its own protocol and to submit it to the state for approval. This is contrary to how similar testing programs have been implemented in California. b) Data collection - no mechanism is established to collect, evaluate, and monitor data reported from hospitals for quality improvement tracking purposes. c) Reimbursement - hospitals will have to purchase specialty pediatric equipment and supplies to perform this test; incur labor costs to develop the protocol and training material for their staff; inventory, sterilize, store, and maintain the equipment; obtain consent and document the consent; document the test outcomes; and, educate physicians and family members, etc. The costs are extensive. How will these costs be reimbursed? d) RELATED LEGISLATION . SB 1072 (Strickland ) of 2012, requires DPH to expand statewide screening of newborns to include screening for the following types of lysosomal storage diseases: Fabry disease, Gaucher disease, Hurler syndrome, also known as mucopolysaccharidosis type I, Krabbe disease, Niemann-Pick disease, and Pompe disease. SB 1072 is pending in the Senate Health Committee. 9)PREVIOUS LEGISLATION . AB 1731 Page 8 a) AB 2651 (Jones), Chapter 335, Statutes of 2006, requires all licensed acute care hospitals with perinatal services to administer newborn hearing screening tests effective January 1, 2008. b) SB 1103 (Committee on Budget and Fiscal Review), Chapter 228, Statutes of 2004, expands statewide screening of newborns to include tandem mass spectrometry (TMS) screening for fatty acid oxidation, amino acid, organic acid disorders, and congenital adrenal hyperplasia and provided that if DPH was unable to provide this screening by July 1, 2005, requires screening for these disorders was to be obtained from one or more laboratories. c) AB 442 (Committee on Budget), Chapter 1161, Statutes of 2002, requires hospitals to collect fees associated with any tests conducted under the State's NBS Program and made an outreach and community awareness process for this program voluntary, versus mandatory. d) SB 148 (Alpert), Chapter 541, Statutes of 1999, requires health care service plans and specified disability insurers to provide coverage for the testing and treatment of PKU, a genetic disorder. e) 2780 (Gallegos, Ducheny, and Villaraigosa), Chapter 310, Statutes of 1998, requires every California Children's Services (CCS)-approved general acute care hospital with licensed perinatal services in this state to offer all parents of a newborn a hearing screening test, as specified. Requires the Department of Health Services (now DPH) to begin phasing in implementation of a comprehensive hearing screening program by CCS-approved general acute care hospitals with licensed perinatal services on or after July 1, 1999, and 100% participation by December 31, 2002. f) SB 537 (Greene), Chapter 1011, Statutes of 1998, creates a trial program for the use of TMS to screen for treatable genetic diseases under the NBS program funded by fees paid voluntarily into the Genetic Disease Testing Fund by the family. 10)POLICY COMMENT . a) Implementation Challenge . The primary method of AB 1731 Page 9 screening newborns for the other core conditions on the RUSP is by means a needle stick in the infant's heel. In California this is administered by the DPH NBS Program. Prior to leaving the hospital, a few drops of blood from the newborn's heel are collected on filter paper. Medi-Cal and most private insurance will pay for the test. The sample is sent to one of seven regional laboratories or to a centralized laboratory at DPH for testing. The results are sent to DPH for data collection and quality control. Parents obtain the test results from the baby's doctor or clinic. It takes about two weeks for the doctor to receive the written results. If the baby needs more tests, parents will get a letter or a phone call a few days after discharge from the hospital. Last session, testing for SCID was added to the NBS by AB 395 (Pan). Administratively, this addition was relatively straightforward as it merely required an addition of a new spot on the filter paper and did not require any new protocols or equipment at the hospital. In addition, DPH had been involved in a pilot study that ended in February 2012 to screen for SCID and found that it was far more common than previously estimated. As part of the pilot study, DPH also determined that because of the need for new testing equipment, relying on the regional laboratories would have required a significant fee increase. It was therefore determined to be more cost-effective to centralize the testing at the state laboratory. Because NBS is fully fee supported, a fee increase of $9.95 is required. Prior to this increase, the cost of the NBS test was $102.75. Unlike the blood test in the NBS program, this bill proposes a test with medical equipment in the hospital and requires immediate interpretation or analysis of the results. In that regard, it is more analogous to the Newborn and Infant Hearing Screening, Tracking, and Intervention Program which is administered by DHCS. In California, infants who do not pass the initial hearing screening in the hospital are referred for a rescreening which could be performed before one month of age. Infants who do not pass the rescreening are referred for a diagnostic hearing evaluation. Upon identification of hearing loss, infants and their families are referred to the local Early Start Program, a multi-agency effort by the Department of Developmental AB 1731 Page 10 Services and the California Department of Education for access to early intervention and related services. Even though this bill proposes a screening program analogous to the auditory screening program, implementation will require a number of new hospital protocols, state mandated activities, and follow-up. As Secretary Sibelius pointed out in her letter adopting the SACHDNC recommendations, it would be beneficial to states, health care facilities, and individual clinicians to have the SACHDNC and other public health experts, partner with HRSA to provide information about a number of issues, including but not limited to the following: i) What will be the impact on state health departments, including staffing needs, to implement this program? ii) What are the roles for the state health departments? iii) What capability is present to ensure that all babies are screened and their results are communicated to providers, including assuring that those not screened at birth receive a screen? As stated above, the various federal health and public health agencies have been tasked with filling these evidence gaps identified by the Secretary and others when this recommendation was considered. The author may wish to explain whether the timeline and implementation strategy envisioned by this bill is sufficiently consistent with the Federal Plan of Action in order to have these questions answered and assure that implementation is done appropriately. b) Recommended Amendment-Screening Protocol . Standardization of protocols has also been identified as an evidence gap. The author may wish to clarify that the protocols approved by DHCS are to be consistent with those generally accepted by nationally recognized medical professional associations, scientific experts, and national health and public health agencies. REGISTERED SUPPORT / OPPOSITION : Support AB 1731 Page 11 American Congress of Obstetricians and Gynecologists, District IX American Heart Association Association of Regional Center Agencies California Chapter of the American College of Cardiology March of Dimes MCAH Action Santa Clara County Board of Supervisors Opposition California Hospital Association Analysis Prepared by : Marjorie Swartz / HEALTH / (916) 319-2097