BILL ANALYSIS                                                                                                                                                                                                    Ó



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          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. 








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           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.









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           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 








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            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 








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            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.  










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            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 








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            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  . 









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             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 








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               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 








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               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 








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           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