PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following revised rule:
Proposed Action:
Amendment of Subpart 69-4 of Title 10 NYCRR.
Statutory authority:
Public Health Law, sections 2540 - 2559-b
Subject:
Early Intervention Program.
Purpose:
To make several changes to the standards for the provision of services in the Early Intervention Program.
Substance of revised rule:
A new subdivision (2)(iii) is added to section 69-4.1(l) creating a definition of "applied behavioral analysis." Subdivision (l) of section 69-4.1 is repealed and a new section is created and renumbered to be (m) to clarify several aspects of the duration of eligibility for children potentially eligible for the preschool special education program to conform with modifications to Public Health Law and Education Law enacted in 2003. This section is amended to clarify that "eligible child" also includes any infant or toddler with a disability who is an Indian child residing on a reservation located in the State; a homeless child or a ward of the State. These changes are needed to conform with modifications enacted as part of the reauthorization of the federal Individuals with Disabilities Education Act of 2004. Section 69-4.1(ak) is amended to revise the list of qualified personnel to reflect changes that have been made to teacher certifications and professional licenses. Optometrists and vision rehabilitation therapist are added to the list of qualified personnel.
Subdivision 69-4.3(b)(1) is amended to add that race and ethnicity can be included in a referral without parent consent to conform with federal requirements. Subdivision 69-4.3(c) is amended to add facsimile and secure web transmission to the list of ways referrals can be made. Subdivision 69-4.3(f) is amended to clarify certain items on the list of criteria that define children to be at risk of having a disability, including adding the presence of a genetic syndrome, modifying the definition of elevated blood levels, and adding indicated cases of child maltreatment.
A new section 69-4.3a is created establishing initial and continuing eligibility criteria for the program. For children with a delay only in the communication domain, the criteria are a score of 2.0 standard deviations below the mean in the area of communication. If no test is appropriate for the child, a delay in the area of communication is determined by qualitative criteria in clinical practice guidelines issued by the Department. Subdivision (b) of section 69-4.3a allows early intervention officials to require a determination be made of the child's continuing eligibility if there is an observable change in the child's developmental status. Continuing eligibility is be established by a multidisciplinary evaluation and can include a delay consistent with the criteria for initial eligibility, a delay in one or more domains such that the child is not within the normal range expected for his or her age, a score of 1.0 standard deviation below the mean in one or more domain; or the continuing presence of a diagnosed condition with a high probability of delay.
Section 69-4.5 is repealed and a new section 69-4.5 is created to establish enhanced standards for the approval of providers, including a requirement that agencies enroll as Medicaid providers and that they submit consolidated fiscal reports to the Department. For individual providers who are able to deliver services as independent contractors in the program, a minimum amount of past experience is required serving children under five years of age. Agency providers are required to submit a quality assurance plan for each service offered; employ a program director and a minimum of two qualified personnel; and employ professionals to oversee the quality assurance plan. The Commissioner would be authorized to require approved agencies and individuals to seek reapproval no sooner than five years after approval. Subsection 69-4.5(b) establishes criteria for the approval of agencies allowed to provide ABA intervention programs using paraprofessional aides. Subdivision 69-4.5(c) requires that an agency's approval in the program shall terminate upon the transfer of ten percent or more of an interest in the agency within the last five years. The new agency is required to apply for approval at least ninety days prior if it wishes to provide services in the program after such transfer. Subdivision 69-4.5(d) requires providers to communicate with parents and other service providers. Subdivision 69-4.5(e) requires providers to comply with marketing standards issued by the Department. Subdivision 69-4.5(f) requires approved individuals to notify the Department within two business days if his or her license is suspended, revoked, limited or annulled and subdivision (g) requires providers to comply with State and Federal non-discrimination provisions. Subdivision 69-4.5(l) requires providers who intend to cease providing services to submit written notice and a plan for transition of children not less than 90 days prior, and to collaborate to ensure a smooth transition of eligible children.
A new section 69-4.5a is added relating to proceedings involving the approval of providers. Subdivision (a) provides that a providers approval may be revoked, suspended, limited or annulled if the provider no longer meets one of the criteria for approval or reapproval; does not have current licensure, registration or certification; falsely represented or omits material in an application; has been excluded or suspended from any medical insurance program; has been the subject of actions taken against the provider by another State agency; has been convicted in an administrative or criminal proceeding; fails to provide access to facilities, child records, or other documents; fails to submit corrective action plans; fails to pay recoupment due, or implement any actions required on the basis of an audit; fails to pay fines or penalties assessed by the Department; has placed children, parents, or staff in danger; or has submitted improper or fraudulent claims.
Subdivision (b) of section 69-4.5a gives providers the right to be heard prior to actions being taken by the Department. Subdivision (c) provides that the Department may take a summary action prior to granting an opportunity to be heard for one hundred twenty days following a finding that the health or safety of a child, parents or staff of the agency or municipality is in imminent risk of danger. The provider is then granted an opportunity to be heard to contest the Department's findings.
A new subdivision (d) is added to section 69-4.6 requiring parents to provide information for claiming to third party payors in conformance with modifications enacted to Public Health Law in 2003.
Subdivision (a)(6)(i) of section 69-4.8 is repealed and replaced with a new subdivision that requires evaluators to use standardized instruments from a list of preferred tools developed by the Department. Evaluators are required to provide written justification if an instrument is used that is not on the list.
Section 69-4.9 is repealed and replaced with a new section 69-4.9. Subdivisions (c) and (d) clarify that municipalities and providers are required to comply with Department health and safety standards. Subdivision (g) requires providers to notify parents in a reasonable period of time prior to any inability to deliver a service due to illness, emergencies, hazardous weather, or other circumstances. Providers also are required to notify parents and service coordinator five days prior to any scheduled absences due to vacation, professional activities, or other circumstances, and notify parents, service coordinator and early intervention official at least thirty days prior to the date on which the provider intends to cease providing services to a child altogether. Subdivision (i) prohibits the use of aversives in the program, a definition of aversive interventions is included, and it is clarified that behavior management techniques are allowed to prevent a child from seriously injuring him/herself or others.
A new section 69-4.9a is added that creates standards for the use of paraprofessional aides in the delivery of Applied Behavioral Analysis (ABA) in the program. Subdivision (a)(1) requires agencies approved to deliver ABA services to coordinate all services in a child's IFSP. Subdivision (a)(2) requires agencies to assign each child to a team consisting of a supervisor, ABA aides and other qualified personnel. Subdivision (a)(3) requires ABA agencies to employ supervisory personnel and aides to implement ABA plans, and subdivision (a)(4) allows them to either employ or contract with other qualified personnel to participate in delivery of ABA plans or deliver other services in a child's IFSP. Subdivision (a)(5) requires the use of systematic measurement and data collection to monitor child progress. Subdivision (a)(6) requires ABA agencies to maintain and implement policies and procedures for the delivery of ABA services. Subdivision (a)(7) requires ABA agencies to ensure the training of supervisory personnel and ABA aides. Subdivisions (b), (c) and (d) establish the minimum requirements and responsibilities for supervisors of ABA aides, respectively. The supervision of ABA behavior aides must include a minimum of six hours per month in the first three months of employment, and a minimum of four hours per month thereafter, of direct on-site observation; and a minimum of two hours per month of indirect supervision. Supervisors are required to convene a minimum of two team meetings per month with all personnel delivering services to the child. Subdivision (e) and (f) establishes the minimum qualifications and allowable activities for ABA aides. Subdivision (g) establishes the requirements for other employed or contracted qualified personnel providing other services in a child's IFSP as part of a ABA services.
A new subdivision (a)(2)(ii)(a) is added to section 69-4.11 to allow early intervention officials to participate in IFSP meetings by phone. A new subdivision (a)(5)(i) is added to require that notice to parents of an IFSP meeting include that parents furnish social security numbers to facilitate claiming to third party payors. A new subdivision (a)(6)(i) is added to clarify that if parents refuse to provide social security numbers, services must still be provided. Subdivision (a)(10)(v) is amended to clarify the intent for frequency, intensity, length, duration, location and the method of delivering services. Subdivision (a)(10)(vi) is amended to clarify the requirements for the IFSP when services will not be provided in a natural environment. Subdivision (a)(10)(xiii) is amended to modify the requirements for the IFSP for transition of children out of the program who are potentially eligible for preschool special education. Subdivision (b) is amended to allow six month IFSP reviews to occur via conference call or record review; and to allow early intervention officials to require an additional evaluation be performed to assess the need for an increase in the frequency or duration of services.
Subdivision (a)(1)(i) of section 69-4.12 is amended and a new subdivision (a)(4)(x) is created to add verification of correction of non-compliance to the list of monitoring procedures consistent with new federal requirements.
Subdivisions (i)(4), and (i)(6) through (i)(10) of section 69-4.17 are repealed. Subdivision (i)(5) is renumbered to be (i)(4) and a new subdivision (i)(5) is added to clarify the requirements for complaint investigations performed by the Department.
A new section 69-4.17a is added clarifying the requirements for the content and retention of child records consistent with a guidance document previously issued by the Department. Subdivision (a) and (b) establish the requirements for municipalities and providers, respectively. Subdivision (c) establishes requirements for maintaining original signed and dated session notes.
Subdivision (b) of section 69-4.20 is amended to drop a requirement that parent's consent to notification and instead provide parents the opportunity to "opt-out" by providing their objection. This modification is needed to comply with an opinion from the U.S. Department of Education that requiring parents to affirmatively consent is in conflict with federal regulations. This subdivision is further modified to clarify that parents may decline transition conferences.
Subdivision (c)(1) of section 69-4.30 is amended to delete the requirement that early intervention officials notify the Department of additional screenings provided. A new subdivision (c)(13) is added establishing a price for services provided by an ABA intervention program aide to be billed in 60 minute increments.
Revised rule compared with proposed rule:
Substantial revisions were made in sections 69-4.1(ak), 69-4.5(a), (b), (d), 69-4.9(b), (g), (i), 69-4.9a(b), (e) and 69-4.20(b).
Text of revised proposed rule and any required statements and analyses may be obtained from
Katherine Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.state.ny.us
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
30 days after publication of this notice.
Regulatory Impact Statement, Regulatory Flexibility Analysis and Rural Area Flexibility Analysis
Changes made to the last published rule do not necessitate revision to the previously published RIS, RFA or RAFA.
Revised Job Impact Statement
Nature of Impact:
Three aspects of the proposed revisions to Part 69 have the potential to have an impact on jobs and employment opportunities. The proposal to allow paraprofessionals to deliver Applied Behavioral Analysis (ABA) to children in the Early Intervention Program with an autism spectrum disorder (ASD) or other appropriate condition will likely create additional job opportunities across the state. The proposed expansion of the list of qualified personnel who can deliver services in the program also will likely create additional jobs. Finally, the proposed enhanced standards for providers in the program has the potential to change the way that agency and individual providers are approved in the program, but it is not likely to result in a substantive decrease in jobs or employment opportunities.
The Department proposes to establish standards for behavioral aides, approval of providers, and paraprofessional reimbursement rates for delivery of intensive behavioral intervention services to children with ASD. This change is in response to the growing population of children with ASD in New York State. The number of children in the program with ASD has increased to nearly 4,000 in the 2007-08 program year, double the number of five years ago. Evidence indicates that the earlier children are diagnosed with ASD and can begin intensive intervention services, the better their chances for minimizing the symptoms and their impact on their lives.
In 2007, $100 million was expended for services to children with ASD in the program. The Department's evidence-based clinical practice guideline on ASD recommends ABA intervention programs for children with ASD at an average intensity of 20 hours per week (depending on the child's age, ability to tolerate the intervention, and other factors). Currently, these intervention programs are provided using licensed, registered, or certified professionals, when research shows these intervention programs can be successfully delivered using supervised and trained paraprofessional behavioral aides. In addition to cost savings, implementation of State standards for delivery of behavioral intervention programs will enhance the quality and availability of this intervention to children with ASD and other severe disabililities for which the treatment has been shown to be effective.
The list of qualified personnel in the program is proposed to expand to include optometrists and vision rehabilitation therapists to meet the need for services to children with vision impairments. These proposed changes will also have a positive impact on jobs and employment opportunities.
Finally, numerous additional enhanced standards are proposed for providers in the program, including new requirements that agencies enroll in the Medicaid program, and that individuals have a minimum number of hours of experience in the program before being able to be approved to serve as an independent contractor in the program. This last change is being made to assure that children receive services from professionals with an adequate level of experience serving young children. Individuals who lack the minimum level of experience are allowed to provide services to children in the program as employees of approved agencies rather than independent contractors, since this setting can better assure adequate oversight and mentoring while a new professional gains experience. These requirements may result in a shift in the relationship between agencies and some therapists to an employment rather than contracting model, but it should not result in a decline in jobs or employment opportunities.
Categories and Numbers Affected:
Currently, there are 22,402 approved providers in the program with approximately 2,000 of these agencies and the rest individual therapists. The individuals impacted include, but are not limited to speech language pathologists, physical and occupational therapists, and special education teachers with various certifications. The type of business entities includes a mix of business corporations, professional corporations, professional limited liability corporations and not-for-profit organizations. The number of individuals providing services in the program will likely increase as a result of the expansion of qualified personnel described above.
Regions of Adverse Impact:
This proposal will not disproportionately impact any region of the state.
Minimizing Adverse Impact:
These proposed revisions will likely create additional jobs and employment opportunities in New York State.
Assessment of Public Comment
Public comment was received from 129 commenters, including ten municipalities, ten parents, 109 providers, the Honorable Assemblywomen Glick and Russell, and the New York State Education Department (NYSED). To comply with federal requirements, the New York State Department of Health (Department) had a 60-day public comment period and convened public hearings in Albany, New York City and Rochester. The following is a summary of the assessment of public comment and response. The full text of the assessment of public comment is available at the following website: www.nyhealth.gov.
The New York State Association of Applied Behavior Analysts (NYSABA) and the NYSED commented on 69-4.1(k)(2)(iii), definition of ABA to the list of EI services. NYSABA recommended the definition be replaced. NYSED recommended an alternative definition to define ABA as an instructional method. As the definition of ABA proposed by NYSABA is widely recognized by behavior analysts, 69-4.1(k)(2)(iii) has been revised per NYSABA's recommendation.
NYSED expressed concern that 69-4.1(aj), defining "agency" and "individual" providers would authorize providers to provide a variety of professional services which may be inconsistent with Education Law. NYSED recommended that the definition of "individual" be revised to mean a person who is appropriately licensed by the State of New York in the area of professional practice.
No revisions have been made to this section. The Department approves applicants in accordance with applicable State laws and in a manner consistent with NYSED policies and practices. "Individual" means persons who hold a state approved or state-recognized certificate, license, or registration in the area in which they are providing services, ensuring that if such individual provides services in an area regulated by NYSED, the individual is required to obtain appropriate state credentials.
NYSED and Assemblywoman Glick opposed changes to 69-4.1(ak) to allow an individual to be qualified to deliver EI services when possessing only a credential issued by an entity other than NYSED. NYSED objected to 69-4.1(ak)(2) and (3), and (6)-(8) which would include as qualified personnel board certified behavior analysts and assistant analysts, and low vision specialists, orientation and mobility specialists, and vision rehabilitation therapists.
Section 69-4.1(ak) has been revised to respond to address these concerns. Two types of certifications have been removed from the list of qualified personnel; however, professionals who deliver vision services have been retained as they present no conflict with existing professional licensing, certification, or registration requirements and are used in other NYS service delivery systems.
Several commenters expressed concern about amendments to 69-4.3(f)(1)(xvii), to replace "suspected hearing impairment" with "failure of initial newborn infant hearing screening and the child is in need of follow-up screening". This provision has been broadened to include other risk factors for hearing loss. Children with suspected hearing impairment must be referred for a multidisciplinary evaluation (MDE) under existing regulation at 69-4.3(d) and (e).
Some commenters opposed the criteria set forth in 69-4.3a(a)(2)(iv), which eliminated the 33% delay criteria for children who have a delay only in the communication domain, arguing that it would exclude children with feeding/swallowing disabilities. Some strongly supported the proposed definition with revisions. Among supporters, recommended revisions included elimination of a diagnosis of specific language impairment as criteria for eligibility and edits to clarify the meaning of the rule.
A rigorous definition of communication delay is needed to ensure that the program serves children with communication delays who will not achieve normal development without intervention. National experts have called for states to discontinue the use of "percent delay" as criteria for program eligibility, in favor of rigorous definitions of developmental delay supported by standardized testing and clinical criteria.
The definition of communication delay in 69-4.3a(a)(2)(iv) has been retained with clarifying revisions and to remove the diagnosis of specific language impairment. Specific language impairment is best addressed as a diagnosed condition with a high probability of resulting in developmental delay.
In response to concerns that the definition would eliminate children with oral-motor feeding and swallowing disorders from EIP eligibility, 69-4.3a(a)(2) has been revised to clarify that the physical domain of development includes these disorders.
Comments were received stating that the proposed language in 69-4.3a(b) provides expansive authority to early intervention officials to question children's eligibility. This section has been revised to clarify that a determination of continuing eligibility can be required only if there is an observable change in the child's development that indicates a change in eligibility.
Commenters expressed concern about the burden that would be imposed by 69-4.5(a)(1) and (2), which require EIP approved providers to enroll in the Medicaid program and submit financial reports to the Department, respectively. Some commenters supported 69-4.5(a)(2).
Sections 69-4.5(a)(1) and (2) have been retained. To ensure the quality and integrity of services provided under both programs, it is imperative that providers enroll in and are accountable to the Medicaid program. Under the proposed regulations, providers will be required to enroll in the Medicaid program, but will not be required to bill Medicaid. Submission of fiscal reports will assist the Department in establishing EI reimbursement rates which are equitable, adequate, and cost-effective.
Commenters opposed minimum experience requirements proposed for individual providers in 69-4.5(a)(4)(iv) arguing that the requirement will prevent newly licensed professionals or those who have limited caseloads from providing services, particularly in rural communities. Some commenters supported this section with more stringent experience requirements.
After careful consideration, the Department amended proposed 69-4.5(a)(4)(iv) in response to these concerns. Individuals with 1,600 clock hours of experience delivering services to children under five at any time in their professional career, at least some of which must include direct experience with children with disabilities, will now meet this requirement. Relevant professions licensed, registered, or certified by NYSED require a minimum of 1,600 clock hours of clinical experience as a prerequisite for credentialing, and therefore this is a reasonable minimum standard for qualified personnel seeking to deliver EIP services.
Commenters opposed proposed requirements in 69-4.5(a)(4)(vii)(a)-(c) which require agency providers to employ a full time program director and a minimum of two qualified personnel, each of whom provides evaluations, service coordination, or early intervention services for a minimum of twenty hours per week. Assemblywoman Russell and others commented that a small agency in a rural area would not be able to meet the minimum service hours requirements for two employees. Some commenters were concerned that the requirements imposed hardship for agencies which focus on services to individuals with low-incidence disabilities, including vision impairment.
The Department has retained 69-4.5(a)(4)(vii)(a) as written. While the program director must be employed on a full-time basis, the program director may have duties within the agency associated with services other than EIP delivered by the agency.
Section 69-4.5(a)(4)(vii)(b) has been revised to allow agencies to count employment of service coordinators and credit delivery of services to any individual with disabilities toward the minimum twenty hour per week requirement.
NYSED commented that it does not support 69-4.5(a) which adds a requirement for reapproval of programs after five years, due to added responsibilities to NYSED for the reapproval of providers that also provide services under Education Law. Section 2550 of Public Health Law authorizes the Department to periodically reapprove providers. The vast majority of providers apply to the Department for approval and reapproval. To ensure the quality and safety of early intervention services, the requirement is retained, but revised to provide for approval for a minimum of five years and to require providers to apply for reapproval upon receipt of notice from the Department.
NYSED also objects to DOH approval of "ABA Intervention Programs", as in their view ABA is an instructional method. Many comments were received expressing concern that ABA services would no longer be able to be delivered by qualified personnel.
The proposed rule was not meant to establish a new ABA intervention program, or require that children in need of ABA services only receive services from agencies employing paraprofessionals. Qualified personnel may and are expected to continue to deliver ABA services under their current EI approval. The Department's intent is to enhance the capacity to provide ABA services by establishing rigorous standards for employment, supervision, and training of paraprofessionals. References to "ABA intervention program" have been revised to "ABA services" and "ABA intervention program aide" has been revised to "ABA aides".
Some commenters opposed 69-4.8(a)(6)(i), which requires evaluators, in conjunction with informed clinical opinion, to use standardized instruments on a list developed by the Department when conducting MDEs. Municipalities strongly supported this provision. The provision has been retained to ensure quality and consistency of MDEs. Requirements in regulation which require the use of non-discriminatory procedures in the conduct of MDEs, remain in effect.
Comments were received concerning notification requirements in 69-4.9(f)(2). Commenters opposed 69-4.9(f)(2)(i) requiring that parents be notified at least 24 hours prior to a scheduled service visit of any temporary inability to deliver services, because such circumstances are difficult to anticipate in advance. The Department has revised 69-4.9(f)(2)(i) to require notice within a reasonable period.
Providers and municipalities opposed the requirement in 69-4.9(f)(2)(ii) that providers notify the parent, service coordinator, and early intervention official, of planned absences, as notification of the parent and service coordinator is sufficient. Section 69-4.9(f)(2)(ii) has been modified accordingly.
NYSABA supported requirements in 69-4.9(h) prohibiting use of aversives during EIP service delivery; however, they expressed concern about the potential exclusion of planned restraint and contingent food programs under highly controlled conditions when necessary to prevent significant physical injury or harm to the child. Section 69-4.9(h)(9) has been revised based on NYSABA's recommendations.
Municipalities supported the need for behavior management techniques within the context of a behavior management plan, but recommended that such plans be developed external to the child's and family's individualized family service plan (IFSP). The Department has revised 69-4.9(h)(9) in response to this concern.
NYSED recommended that 69-4.9a(1) be revised to prohibit ABA aides from providing services that are within the scope of any profession licensed, certified, or registered by the State. The Department agrees and has revised this section accordingly.
In response to concerns expressed by numerous providers, 69-4.9a(b)(1) has been revised to include special education teachers among those professionals who may supervise ABA aides.
NYSED opposed board certified behavior analysts credentialed by the Behavior Analyst Certification Board as qualified to supervise ABA aides, unless such individuals are also credentialed by NYSED. NYSABA recommended adding speech language pathologists with appropriate training as potential supervisors. The Department concurs and has revised this provision accordingly.
NYSED recommended that the qualifications for ABA aides in 69-4.9a(d) mirror those of certified teaching assistants, arguing that ABA aides will be assisting in delivery of instructional services. The Department disagrees with NYSED's position that ABA aides will be assisting in instructional services. ABA aides will be assisting with EI services, which are designed to meet the developmental needs of the child and needs of the family in enhancing the child's development.
Some commenters were opposed to the amendment to 69-4.11(a)(2), which would allow the early intervention official to participate in IFSP meetings by conference call, arguing that IFSPs must be developed with all parties at the meeting, and service delivery will be delayed. The Department intends to monitor to ensure participation by telephone does not delay service delivery.
Many commenters opposed proposed amendments in 69-4.11(10)(xiii) and 69-4.20(b), which eliminate the requirement that parent consent be obtained prior to notification of the school districts when children are potentially eligible for preschool special education, and to instead allow parents to "opt out" of the federal notice requirement. Parents and advocates view this to be a diminution of parental rights. The Department has been notified by the U.S. Department of Education that New York must implement an "opt out" policy consistent with federal policies for continued receipt of funding. The proposed provisions are being retained.
NYSED and others opposed the elimination of required timeframes for notice to the school district's committee on preschool education of a child's the potential transition to preschool special education, as this would impede the smooth transition of children from EIP. The 120 day notice requirement has been retained.
