Home » 2016 Issues » May 25, 2016 » HLT-08-15-00003-A Supplementary Reports of Certain Birth Defects for Epidemiological Surveillance; Filing
HLT-08-15-00003-A Supplementary Reports of Certain Birth Defects for Epidemiological Surveillance; Filing
5/25/16 N.Y. St. Reg. HLT-08-15-00003-A
NEW YORK STATE REGISTER
VOLUME XXXVIII, ISSUE 21
May 25, 2016
RULE MAKING ACTIVITIES
DEPARTMENT OF HEALTH
NOTICE OF ADOPTION
I.D No. HLT-08-15-00003-A
Filing No. 472
Filing Date. May. 04, 2016
Effective Date. May. 25, 2016
Supplementary Reports of Certain Birth Defects for Epidemiological Surveillance; Filing
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of sections 22.3 and 22.9 of Title 10 NYCRR.
Statutory authority:
Public Health Law, sections 206(1)(d), 225(5)(t) and 2733
Subject:
Supplementary Reports of Certain Birth Defects for Epidemiological Surveillance; Filing.
Purpose:
To increase maximum age of reporting certain birth defects to the Birth Defect Registry.
Text or summary was published
in the February 25, 2015 issue of the Register, I.D. No. HLT-08-15-00003-P.
Final rule as compared with last published rule:
No changes.
Revised rule making(s) were previously published in the State Register on
February 17, 2016.
Text of rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.ny.gov
Summary of Revised Regulatory Impact Statement
Statutory Authority:
Section 206(1)(d) of the Public Health Law (PHL) authorizes the Commissioner to investigate the causes of diseases, epidemics, and the sources of mortality in New York State. PHL § 225(5)(t) provides that the State Sanitary Code may facilitate epidemiological research into the prevention of environmentally related diseases and require reporting of such diseases by physicians, medical facilities and clinical laboratories. PHL § 2733 requires that birth defects and genetic diseases be reported by physicians, hospitals, and persons in attendance at birth in a manner prescribed by the Commissioner. Information collected pursuant to such reports shall be kept confidential pursuant to the Personal Privacy Protection Act.
Legislative Objectives:
PHL § 206(1)(d) established the Commissioner’s broad authority to investigate the causes of disease in New York State. As reflected in the Declaration of Policy, the Legislature enacted PHL § 2733 and related statutes to ensure that the Department maintains a central and comprehensive responsibility for developing and administering the State's policy with respect to scientific investigations and research concerning the causes, prevention, treatment and cure of birth defects and genetic and allied diseases. Finally, in enacting PHL § 225(5)(t), the Legislature directed that the State Sanitary Code contain regulations that facilitate epidemiological research into the prevention of environmental diseases, by pathological conditions of the body or mind resulting from contact with toxins, mutagens or teratogens and by requiring the reporting of such diseases or suspected cases of such diseases to the Department.
To these ends, the Department maintains the Congenital Malformation Registry (CMR) and has issued regulations requiring the reporting of structural, functional or biochemical abnormalities determined genetically or induced during gestation, and which are not due to birthing events.
Needs and Benefits:
The Department’s proposal seeks to extend the case capture periods for certain diseases. Currently, health regulations require physicians and hospitals to report birth defects that are diagnosed within two years of a child’s birth, yet many birth defects are not diagnosed until after age two. By extending the capture period for certain diseases listed below, the Department’s proposal will enhance its epidemiologic surveillance and advance its understanding of birth defects and their environmental causes.
Fetal alcohol syndrome (FAS) is a serious but preventable birth defect that results from heavy maternal intake of alcohol during pregnancy. FAS is not uncommon, with national estimates of 5-20 cases per 10,000 live births. The annual prevalence of FAS reported by the CMR is about 10-fold less than national estimates. Studies indicate that FAS is more easily diagnosed from ages two to ten years.
Hereditary muscular dystrophies and other myopathies are a family of diseases that cause progressive and steady muscle weakness and wasting. The most common muscular dystrophy is Duchenne MD, followed by Becker MD. A recent US study indicated the prevalence of boys age 5 to 24 with Duchenne and Becker MD was 1.3 to 1.8 per 10,000 males. However, the CMR indicated an annual birth prevalence of only 0.08 per 10,000 live births. One study reported a mean age of diagnosis of 5 years for boys with Duchenne MD.
Congenital heart defects (CHDs) are the most common organ system malformations, and they remain the leading cause of infant deaths from birth defects. Approximately 1 out of every 115 to 150 babies is born with a heart defect. Minor defects are often not detected until later in life and can have serious consequences. One study indicates that 3% of children with CHDs are diagnosed from ages three to ten years old.
Genetic and Chromosomal Anomalies. The CMR was established prior to the sequencing of the human genome and the associated advances in the scientific community’s understanding of the role genetics plays in causing birth defects. Because the field of genetics and birth defects is so new, there is little or no documentation about diagnostic timing for many of these syndromes. However, genetic and chromosomal anomalies are often not recognized until after two years of age, because it can require several years to observe a child prior to diagnosis.
The Department’s proposal would also require reporting of birth defects diagnosed or identified during pregnancy. This reporting requirement is important due to the increase in routine prenatal screening. For many diseases, the CMR data suggests a prevalence rate in New York that is far below the expected range.
The proposed amendment also allows reporting by qualified health care professionals other than physicians—specifically, nurse practitioners and physician assistants. Over the past several years, a growing number of national, state and specialty-specific studies indicate that the physician workforce in the United States is facing current and future shortages. Moreover, the shortage of family physicians will be most acute in rural and underserved populations. These trends highlight the need to allow reporting by nurse practitioners and physician assistants. Indeed, anecdotal reports indicate that nurse practitioners and physician assistants are already filling this role because of the burden on physicians.
The regulation would also clarify the requirement that clinical laboratories performing diagnostic testing for birth defects must report to the CMR. This requirement is not new. In 1978, Commissioner Whalen issued a blanket order directing that all laboratories report birth defects to the Department pursuant to PHL § 2733. However, many clinical laboratories are not aware of the reporting requirement.
The Department’s proposal adds granularity to the list of reportable diseases. Many diseases currently reported fall under broad categories, thereby limiting the Department’s ability to receive information concerning the individual diseases within the category. For example, congenital leukemia and lymphangiomas are both currently reported under the broad classification of “congenital anomalies of the circulatory system.” The Department’s proposal lists these and other defects as separate reportable conditions.
Finally, the proposal replaces the term “congenital malformation” in favor of the term “birth defect” and renames the CMR the “New York Birth Defects Monitoring Program.” In a nationally representative survey conducted in 2007, respondents were asked what their first choice would be to describe problems at birth that can result in physical or mental disabilities. The preferred term was “birth defects”. This term was chosen over congenital malformations and congenital anomalies, among other choices. Using the term that is preferred by the public will enable positive engagement with affected families and improve the Department’s communication with the public.
Costs to Regulated Parties:
The Department anticipates that, for the entire State, the regulatory changes will require annual reporting of an approximate additional 900 live born children by physicians, nurse practitioners, physician assistants, midwives, and hospitals (FAS: 100-200 cases; muscular dystrophy: 100 cases; cardiac heart defects in children past age two: 200 cases; genetic or chromosomal anomalies: 400 cases).
Approximately 160 New York hospitals and their associated physicians, nurse practitioners, physician assistants and midwives will be affected by this change. The Department anticipates that the costs to these parties will be minimal, primarily because the number of additional birth defects to be reported annually through hospitals (five to six cases per year, on average) will be small, relative to the number or reports already being submitted. Hospitals already report cases to the CMR electronically. The additional hospital staff time to enter six to seven additional cases per year may require 20-30 minutes annually. Alternatively, a hospital can incorporate the additional diagnoses into a monthly batch file. Hospitals are already familiar with the process of modifying batch files.
Reporting by smaller, community-based health care facilities and individual providers will result in some costs primarily because, while physicians have always been required to report birth defects, this requirement has not been enforced for providers who are not associated with New York hospitals. The Department has minimized the administrative costs associated with the reporting requirement by integrating the reporting process with technologies that healthcare providers already utilize. Healthcare providers currently rely on the Department’s Health Commerce System (HCS) for communication and reporting to the Department. Within the HCS, the Department is implementing a comprehensive web-based reporting system known as the Child Health Information Integration (CHI2) project to be used as the central website to report and track newborn screening, immunizations, lead and newborn hearing screening. Reporting of birth defects will become a component of the CHI2 system in order to reduce the reporting burden of community-based healthcare facilities and providers.
Providers will be required to spend 3-5 minutes entering case information for each child or fetus diagnosed with a birth defect that is newly reportable under the updated CMR regulations. Statistically, this should involve very few cases for such providers. Because most providers already use and have free access to the online electronic reporting system, the proposed regulation will not impose any additional equipment or technology costs. The only costs will be in the amount of time required to use the CHI2 to report additional birth defects, which is expected to be negligible. The Department will assist any providers that currently do not have access to the web based reporting system.
With regards to extending the CMR reporting requirements to nurse practitioners, physician assistants and midwives, the Department does not expect that regulated parties will incur any associated direct costs. Rather, the Department expects that this change will relieve physicians and hospitals from being the only classes of healthcare providers authorized to submit a report when a child is diagnosed with a birth defect.
For clinical laboratories, the Department anticipates the regulatory change will require annual reporting of approximately 6,600 additional genetic or chromosomal anomalies recognized during pregnancy, and approximately 400 reports related to children diagnosed between the ages of 2 and 10 years old, for a total of 7,000 additional reports annually. The Department anticipates the ongoing costs to the roughly 50 clinical cytogenetic laboratories providing diagnostic testing for genetic and chromosomal anomalies to be minimal because these laboratories will report using the Electronic Clinical Laboratory Reporting System (ECLRS) as many already do. The Department estimates that the additional number of reports that these labs will make to ECLRS will cost approximately $1,400. Clinical laboratories may experience a one-time expense related to modifying the laboratory’s software to identify the additional cases that must be reported, which the Department estimates will require a maximum of 16 hours of work by a computer specialist at an estimated rate of pay of $100/hour.
Costs to the Regulatory Agency:
The Department has been using a web-based electronic reporting system in place since 2006. Currently, the CMR receives and processes about 12,000 reports annually. Thus, annual cost to DOH to receive and process the additional 1,000-1,200 cases will be minimal.
Costs to the State Government:
There will be no costs to state government. For the last ten years, reporting to the CMR has been conducted electronically. Currently, the Department uses the Health Commerce System to receive CMR reports. Reporters upload cases individually or in batch reports. The electronic reporting system already includes automated processes to match and combine reports for the same child, to ensure de-duplication of data reported from multiple reporters. Additional data quality control processes are built into the system.
Costs to Local Government:
Hospitals owned by local governments would be affected but, as discussed above, the costs will be minimal because the additional reporting requirement is relatively small.
Local Government Mandates:
There are no mandates on local governments, other than the additional reporting requirements that would apply to hospitals owned by a local government.
Paperwork:
This change will generate very little physical paperwork because reporting will be performed electronically as is described under “Costs to Regulated Parties.”
Duplication:
This change does not involve any duplication in laws. In terms of duplication of effort, the reporting software will prevent the repeated reporting of the same birth defect for a particular child.
Alternatives:
If no changes are made to this regulation, the Department will continue to collect incomplete reporting for birth defects, and prevalence estimates will remain inaccurate. This will impede the Department’s ability to detect and quantify environmental exposures that negatively impact the health of embryos and fetuses in New York State.
Concerning FAS, in particular, failure to change the reporting requirement will hamper prevention efforts and may cost New York more in the long-term. One study placed the nationwide annual cost of treating birth defects associated with FAS at $1.6 billion. Another study used a societal perspective and generated nationwide cost estimates of $9.69 billion. These costs included estimates of the value of productivity lost as a result of cognitive disabilities, as well as the cost of treatment and residential care. In addition to improving outcomes for affected children, early diagnosis and appropriate interventions are likely to generate significant costs savings over time.
Federal Standards:
There are no federal mandates for state-level reporting of birth defects. However, several of the 36 state birth defect surveillance programs require reporting of these birth defects past the age of 2 years, including Hawaii, Texas, Washington State and Colorado. At least eleven states receive reports of birth defects that occur during pregnancy.
Compliance Schedule:
Regulations will take effect immediately upon filing. The Department will continue its efforts to make reporting easier and more efficient, while simultaneously conducting outreach to understand and address any concerns that may arise.
Revised Regulatory Flexibility Analysis
Effect of Rule:
This amended rule will have limited impact on small businesses providing health care because many of these businesses are affiliated with a general hospital. These small businesses include community-based healthcare providers (pediatricians, family practitioners and maternal-fetal medicine specialists) and some laboratories with small offices.
The amended rule will have a small impact on those healthcare facilities that are owned by local governments and that also diagnose birth defects and genetic diseases. These healthcare facilities will be required to make additional reports to the CMR based on the updated list of reportable birth defects and genetic diseases. Although the Department does not maintain a listing of local government-owned facilities that would be required to report, the Greater NY Hospital Association estimated that the number is relatively few. Further, the Department reasonably expects the burden on such facilities to be small—only 3-5 minutes per additional case. The number of cases will vary depending on the size of the facility, but the Department estimates that such facilities will report an average of 5-6 newly reportable cases per year, per facility.
Compliance Requirements:
Because healthcare providers and facilities are transitioning to electronic record-keeping systems, reporting and record keeping are expected to be simple and require very little time. The Department publishes a CMR guide to assist hospitals with reporting. A guide will also be developed for other healthcare providers as well as clinical laboratories.
Professional Services:
No additional professional services are required under the amended rule.
Compliance Costs:
Staff working in small community-based healthcare providers and small clinical laboratories will need to learn how to report with the updated CMR requirements.
Economic and Technological Feasibility:
The amended rule is economically and technologically feasible because local governments and small businesses that are affected will continue submitting reports using their free access to the Department’s electronic reporting system.
Minimizing Adverse Impact:
By offering free access to the electronic reporting system, the Department has minimized the costs and impact on local governments and small businesses operating in New York State.
Small Business and Local Government Participation:
The Department has reached out to the healthcare community to gather feedback on the proposed amended rule. Those contacted include: NYS American Academy of Pediatrics, NYS Academy of Family Physicians, Nurse Practitioner Association of NYS, NYS Nurses Association, NYS Society of Physician Assistants, NY Health Information Management Association, Greater NY Hospital Association, Healthcare Association of NYS, NYS March of Dimes, NYS Clinical Geneticists, Genetic Counselors, Midwives, Neurologists, Neuromuscular Specialists, and Pediatric Cardiologists. Additionally, the Department contacted other NYS agencies and programs which provide services to children affected by these birth defects, specifically fetal alcohol syndrome.
The Department received comments from two organizations that represent health care providers. The President of the New York State Society of Physician Assistants stated, “After soliciting input from our leadership, we wholeheartedly support this suggested regulatory change.” No concern was expressed about costs. Greater New York Hospital Association (GNYHA), representing nearly 150 voluntary, not-for-profit, and public hospitals expressed concern that “raising the maximum reporting age to 10 … could potentially create an administrative burden for health care providers … already contending with a wide range of such requirements.” GNYHA strongly recommended that the DOH work closely with providers to develop and implement a reporting system that places the least possible amount of administrative burden on those impacted by this potential regulatory change.
The Department also received positive support for these regulatory changes from non-profit organizations and other State agencies, including the NYS Council on Children and Families, the NYS Office of Alcoholism and Substance Abuse Services, the NY State Education Department’s Office of Special Education, and the Long Island Council on Alcoholism and Drug Dependence. These organizations view the proposed regulatory change as positive steps for meeting the needs of children and families affected by these devastating birth defects.
The Department asked several maternal-fetal medicine practices for input concerning the proposed changes and received replies from three practices (Hudson Valley Perinatal Consulting, Harrison, NY; University GYN/OB, Inc, at Women and Children’s Hospital of Buffalo, Buffalo, NY; and Fetal Testing Unit of Mercy Hospital Buffalo South, Buffalo, NY). As for access to the Department’s web based reporting system, one had access, one did not, and the third was uncertain. All three expressed concerns about time required to report and assurances of patient confidentiality.
The Department reached out to the NYS Association of Licensed Midwives, who supported the amendment. In a survey sent to midwives, all respondents supported the regulatory amendment. The most common concern was the time required to comply, which the Department will minimize through its electronic reporting.
Public Health Law § 206(1)(j) ensures that diagnoses reported to the New York Birth Defects Monitoring Program shall be kept confidential and shall be used solely for the purposes of the Department’s scientific research. The statute further provides that such records are not admissible as evidence in a court of law. Regarding time to report, the Department expects that some of these practices may not actually have to report separately but that their associated institution or hospital will be able to assume that responsibility, thus reducing the anticipated burden.
The Department is committed to minimizing the administrative burden of these new reporting requirements. By using the CHI2 system as a reporting tool, the administrative burden will not be significant.
The Department will continue to communicate with stakeholders throughout the regulatory process. Prior to adoption of the rule, all amendments will appear in the New York State Register for public comment.
