[33 Pa.B. 1051]
[Continued from previous Web Page] Section 4226.12. Waiver funds (redesignated as ''Medicaid waiver funds'').
Four commentators stated that counties do not have complete control over whether waiver funds can be expended because use of waiver funds depends on eligible children being identified and their parents agreeing to participate in the waiver. They recommended clarifying the counties' obligation by adding language at the end of the paragraph such as ''to the extent that eligible services and eligible children can be identified, and the children's parents consent to participate in the waiver.'' One commentator suggested that because the waiver is a limited funding source, this section should be deleted.
Response
The Department concurs with the first comment and made the recommended change. The Department agrees that this is a limited funding source. Throughout the development of the waiver program, however, the Department received input recommending that the final-form rulemaking specify the availability of this funding source. In addition, the Department believes that the obligation of the counties to use waiver funds when those funds are available should be set forth in final-form rulemaking so that those funds are used to the maximum possible extent. Therefore, the Department retained this section.
The Department made a technical change by deleting the phrase ''allocate and'' because the Department, not the county MH/MR programs, allocates funding. The Department also added the word ''Medicaid'' to the heading of this section to avoid confusion in light of the addition of § 4226.6 (relating to waiver of regulations). The Department made other technical changes to conform this section to other changes made in the final-form rulemaking.
Section 4226.13(a). Nonsubstitution of funds (redesignated as ''Payor of last resort'').
One commentator stated that the wording of the subsection implies that after private insurance is billed, early intervention funds will be used only in the interim until the insurance payments begin. Two commentators suggested that funding sources be listed in the order in which they can be accessed, since the intent of the subsection was unclear. Two other commentators stated that counties should not be held accountable for not using funds that are not accessible because the family did not consent, with one suggesting the addition of the clause ''so long as the use of those funds is without cost to the families, and the families have consented.''
Response
The Department revised the heading of the section and the language in subsection (a) to clarify that the intent of this section is to codify the Federal requirement (at 42 U.S.C.A. § 1440(a) and 34 CFR 303.527(a) (relating to payor of last resort)) that the early intervention system be the payor of last resort and that other available public and private funding sources must be used to pay for services before early intervention funds are expended. If parental consent is needed to access a funding source but the family does not consent to the use of that funding source, then the funding source is not available and need not be used before early intervention funds may be used.
The Department is unwilling to impose requirements on the use of other funding sources that are not imposed by Federal law and therefore did not add the recommended language. To underscore that this subsection sets forth the same requirements imposed by Federal law and should be interpreted consistent with Federal law as it currently exists and as it may be modified in the future, the Department added the introductory clause ''unless otherwise permitted or mandated by Federal law.''
The Department revised the second sentence of this subsection and redesignated it as subsection (c) to clarify the intent of the sentence that services may not be denied or delayed because another funding source, including Medicaid, is unavailable.
Section 4226.13(b).
One commentator stated that parents should not be compelled to use private insurance to pay for services. Another commentator suggested adding the language ''after being informed of their rights to refuse consent'' to emphasize the voluntary use of private insurance. The same commentator suggested adding the phrase ''but are not limited to'' to introduce the examples of financial losses and recommended additional examples of losses. Other commentators recommended adding language that clarifies that parents cannot be required to apply for Medicaid to receive early intervention services. One commentator suggested that the Department clarify how families will not suffer financial losses if they volunteer to use private insurance. One commentator suggested that language be added to explain that services may not be delayed while securing funding or adjusted to reflect available funding sources. Three commentators raised the same issue in commenting on § 4226.14 (relating to documentation of other funding sources) or on the financial management sections generally.
Response
As previously noted, Federal law requires that all other available public and private funding sources be exhausted before early intervention funds are expended. Thus, available private and public funding sources, including commercial health insurance, must be used to meet the costs of early intervention services as long as the parent consents and the use does not result in a cost to the family.
Because the comments reflected general confusion about the purpose and intent of this subsection, the Department revised the language of the introductory paragraph to convey the meaning of the subsection more clearly and concisely. The Department added the clause ''unless otherwise permitted or mandated by Federal law'' to emphasize the intent that this subsection be interpreted consistent with Federal law as it currently exists and as it may be modified in the future. To clarify that parental consent must be obtained to use private health insurance, the Department used the phrase ''with the consent of the family.'' If the family refuses consent, then private insurance is not available and may not be accessed. As recommended, the Department added the phrase ''but are not limited to'' to introduce the types of costs, to clarify that the itemized list is not exhaustive but merely illustrative and therefore did not amend the list of examples.
The Department finds that access and use of Medical Assistance (MA) funds in this Commonwealth results in no cost to or potential negative impact on children or families. Therefore, although parents are not required to apply for MA for infants and toddlers to receive early intervention services, they should be informed of and encouraged to use all financial resources available to them. The Department is concerned that county MH/MR programs or service providers or agencies not be dissuaded from informing families of all available funding options, including MA, for fear of a finding of noncompliance. Therefore, the Department did not add the recommended language regarding application for Medicaid. As previously noted, the Department revised the second sentence of subsection (a) and redesignated it as subsection (c), which clarifies that services may not be denied or delayed because another funding source, including Medicaid, is unavailable. This clarification addresses the concern raised by these commentators.
Section 4226.14. Documentation of other funding sources.
Several commentators submitted comments to this section, many of which echoed the comments to § 4226.13 (relating to nonsubstitution of funds (redesignated as payor of last resort)). For example, a few commentators emphasized that other funding sources may not be used unless the parent consents and the use results in no cost to the family and that services should not be delayed because other funding sources are unavailable. They suggested adding language in this section to specify these conditions. One commentator suggested removing ''private funding'' as a mandatory funding source.
Some commentators questioned the meaning of ''all other private and public funding sources'' and who is responsible for exhausting the funding. Two commentators expressed concern that this section was intended to require parents to exhaust their personal resources and objected to having to do so. Two commentators recommended that parents should be provided with written details of advantages, disadvantages of and restrictions on or the implications of using the various funding sources. One commentator suggested that the Department prescribe a process to make families aware of various funding sources.
One commentator suggested that the Department specify a time limitation for retaining the permanent file in subsection (a). The same commentator noted that the language in subsection (b) implied that the Department formally approves the county procedures but did not specify the criteria for approval. The commentator recommended that the approval criteria be specified or, if there is no formal approval process, that the phrase ''approved by the Department'' be deleted.
Response
The Department addressed the comments identified in the first paragraph of the comment summary in its responses to § 4226.13 and will not repeat those responses here. Nonetheless, these comments as well as the others reflect considerable confusion over the purpose and intent of this section. This section is not intended to establish a substantive requirement in addition to those set forth in § 4226.13 but is intended only to require that the county MH/MR programs and service coordination providers maintain documentation of compliance with § 4226.13. The Department has reorganized and amended the language of this section to clarify that intent.
The Department added subsection (a) to replace proposed subsection (b) to specify more clearly that the county MH/MR programs must develop procedures to comply with § 4226.13. The Department expects that these procedures would include the means by which parents are informed of potential funding sources and of the conditions that might apply to each. The Department will review compliance with this subsection in the course of its monitoring review of the county MH/MR programs. Therefore, it omitted any reference to Department approval of the procedures from the subsection.
The Department revised redesignated subsection (b), requiring that the service coordinator maintain documentation that attempts have been made to exhaust other available funding sources, as required in § 4226.13, to clarify that the documentation requirement must be read in conjunction with the substantive requirement set forth in § 4226.13.
As recommended, the Department specified that the documentation must be maintained in accordance with the time periods in § 4226.36(d) and (e) (relating to child records). The Department also changed ''child'' to ''infant or toddler with a disability'' to conform the section to the changes made to the definitions of those terms.
Section 4226.15. Interim payments.
One commentator suggested including a specific timeframe rather than the phrase ''in a timely fashion'' in subsection (a) to improve clarity.
Response
The Department deleted the phrase ''in a timely fashion'' as redundant of ''delay'' and therefore unnecessary. ''Delay'' could vary depending on the needs of the child and the family as reflected on the IFSP. Timelines for service delivery are specified in § 4226.75(b).
After internal review, the Department made additional changes to this section to revise the language to be consistent within the section and with other sections by referring to ''funding source'' rather than other terms and by using the terms ''infant or toddler with a disability'' and ''county MH/MR program.'' The Department also changed ''shall'' to ''may'' in subsection (a) to clarify that a county MH/MR program is not required to use State early intervention funds to make interim payments but that States funds are available for that purpose. In subsection (b), the Department changed ''appropriate'' to ''responsible'' to avoid ambiguity and changed ''incurred'' to ''made'' to correct improper usage.
Section 4226.21. Delegation of responsibilities (redesignated as ''Nondelegation of responsibilities'').
The Department reorganized and made other technical changes to this section to clarify that the county MH/MR program remains responsible for compliance with this chapter if it contracts with another agency. The Department also amended the heading to convey the intent of the section more accurately. Finally, the Department deleted the first sentence of redesignated subsection (a) as redundant and therefore unnecessary.
Section 4226.22(a). Eligibility for early intervention services.
One commentator questioned the basis for establishing 25% developmental delay and 1.5 standard deviations as the criteria for eligibility. Two commentators expressed concern that children who are delayed in only one area of development will not be eligible to receive early intervention services and stated that the eligibility criteria suggest that a child would be eligible for early intervention services only if the child's disability or delay resulted in the need for special education or related services. One commentator recommended that adaptive development be defined. One commentator expressly noted support for the 25% delay criterion.
Response
The eligibility criteria are based on research findings and best practices in early intervention as well as criteria that other State programs have established. The Department finds that the criteria are appropriate for identifying those children whose developmental needs may be met with early intervention services. The criteria do not require that children be delayed in more than one developmental area; nor do they require a determination that a child need special education or related services to be eligible for early intervention services.
The meaning of the term ''adaptive development,'' as well as that of the other areas of development, is known within the professional community. Therefore, it is unnecessary to include a definition of an area of development, including adaptive development.
The Department made some technical changes to this subsection to correct syntax errors and to enhance organizational consistency within the subsection and with other sections in the final-form rulemaking.
Section 4226.22(b).
Four commentators stated that the language on informed clinical opinion was more restrictive than that in 34 CFR 303.300 (relating to State eligibility criteria and procedures) and recommended that the subsection be revised to mirror Federal law. One commentator suggested that examples of circumstances when no standardized measures are available or appropriate, and so would require ''informed clinical opinion,'' would improve clarity. Another commentator expressed support for retaining the use of informed clinical opinion.
Response
The Department did not intend to limit use of informed clinical opinion to cases in which other diagnostic tools are unavailable or inappropriate. As specified in § 4226.62(b)(2) (redesignated as § 4226.61(b)(2)), informed clinical opinion must be a component of every evaluation that determines eligibility for early intervention services. The Department revised the language of the subsection to clarify that informed clinical opinion must guide and may be used in lieu of the use of standardized measures and other diagnostic tools.
After careful consideration of the suggestion to include examples of circumstances that would require informed clinical opinion because other diagnostic tools are unavailable or inappropriate, the Department finds that it would be nearly impossible to list all circumstances. Rather than imply a restriction on the use of informed clinical opinion by citing examples of circumstances in the final-form rulemaking, the Department believes that the determination should be left to the judgment of the professionals who are working with the child. Therefore, it did not revise the subsection as suggested.
Section 4226.23. Waiver eligibility (redesignated as ''Eligibility for Medicaid waiver services'').
A number of commentators submitted comments to this section. One commentator recommended technical additions or changes to subsection (a), including: spelling out the acronyms ICF/MR and ICF/ORC in the introductory paragraph; clarifying the term ''applicant and recipient''; and deleting the term ''indefinitely'' from paragraph (3)(iii). Another commentator suggested adding the phrase ''with the parent's consent'' to the introductory paragraph. A third commentator proposed inserting the words ''and'' and ''or'' following the paragraphs and subparagraphs to reflect the eligibility criteria more accurately and adding the word ''qualified'' before ''professional'' in paragraphs (2) and (3).
Commentators also asked how the waiver eligibility criteria were established and requested clarification of the basis for ''more than two standard deviations below the mean'' in paragraph (1)(i), ''slightly'' in paragraph (1)(ii), and ''substantial functional limitation'' in paragraph (3)(ii); questioned whether the concepts of independent living, economic self-sufficiency and self-direction appropriately apply to infants and toddlers and how they might be evaluated in the infant and toddler population; and suggested that the regulation clarify that only eligible services will be funded.
One commentator recommended that subsection (a)(1) be revised to include a ''qualified professional,'' to reflect the approved waiver eligibility criteria. Another commentator proposed that this section be deleted and that § 4226.14 be renamed and revised to require that parents be informed of all funding options. One commentator stated that the form that parents must complete for the waiver program should be revised to promote clearer understanding of the parents' role in the program.
One commentator questioned use of the term ''infant, toddler and family'' in subsection (b) rather than ''applicant or recipient,'' as in subsection (a), and recommended that either consistent terms be used in both subsections or the difference in meaning be explained.
Response
The Department concurs with and made the suggested technical changes identified in the first paragraph of the comment summary. Rather than adding a consent provision to this section, the Department included parental consent for enrollment in the Medicaid waiver program in § 4226.95 (redesignated as § 4226.92 (relating to parental consent)).
The Department agrees that the eligibility criteria as set forth in the proposed rulemaking did not accurately reflect the criteria that the Centers for Medicare and Medicaid Services (CMS) (formerly the Health Care Financing Administration) approved for the waiver program because the conjunctions between the paragraphs and subparagraphs were omitted. To address this issue and remain in conformance with proper regulatory format as prescribed in the Style Manual, the Department reorganized subsection (a) into two subsections and added clauses to introduce each of the subparagraphs in redesignated subsection (b). In reorganizing the section in this manner, the Department did not in any way alter the substance of the eligibility criteria from the proposed rulemaking. As a result of the reorganization, subsection (b) in the proposed rulemaking has been redesignated as subsection (c).
In subsection (a)(2) and (3) (redesignated as subsection (b)(1)(ii) and (2), respectively), the Department clarified that the certifying professional is a ''qualified professional'' as defined in 42 CFR 483.430(a) (relating to condition of participation: facility staffing). This specification, which was inadvertently omitted from the proposed rulemaking, is necessary to conform to the Federally approved eligibility criteria. The Department did not make a similar change to subsection (a)(1) (redesignated as subsection (b)(1)(i)), as recommended, because the approved waiver requires that a psychologist, certified school psychologist or physician make the certification required in that subparagraph.
In response to the requested clarifications of and suggested changes to the eligibility criteria, the Department is unable to revise the criteria outlined in this subsection. The criteria were developed in negotiations with the CMS for approval of the waiver and were a condition of that approval. The source of the criteria is the ICF/MR or ICF/ORC level of care criteria in this Commonwealth, set forth in §§ 6210.62 and 6210.63 (relating to level of care criteria; and diagnosis of mental retardation); the criteria are the same as for all other waiver programs administered by the Office of Mental Retardation, modified somewhat to apply to the infant and toddler population. The few modifications to the criteria were also approved by CMS. The Department recognizes that the areas of independent living, economic self-sufficiency and self-direction do not apply to infants and toddlers, so that an infant or toddler must have substantial functional limitation in three of the four remaining areas of major life activities to be eligible for the waiver program.
A provision specifying that only eligible services may be funded through the waiver program has been added to § 4226.12. The Department did not delete this section or combine it with § 4226.14 because the purpose of this section is to set forth the eligibility criteria for the waiver program, not prescribe that parents should be informed of the program. The Department revised the section heading to clarify that purpose.
No section of the regulations requires that a particular form be used for waiver enrollment. Therefore, the Department did not address the comment about the form in the final-form rulemaking. In response to the comment, the Department will review the existing form to determine if revision is needed.
The Department made some technical changes to correct grammar and punctuation errors and to conform the section to other changes made in the final-form rulemaking.
Section 4226.24. Comprehensive child find system.
The Department received a number of comments to this section. A few commentators noted that the use of the term ''ensure'' throughout the section obligates the county MH/MR program to undertake activities and produce outcomes that cannot always be controlled; that the clause ''and which children are not receiving services'' in subsection (a)(2) is not included in 34 CFR 303.321(b)(2) (relating to comprehensive child find system) and that it is unclear how the county can determine which children should be but are not receiving services; that it would be helpful to specify strategies to structure and improve child find activities in the final-form rulemaking; and that the responsibilities for child find should be performed with the assistance of the State. One commentator asked whether child find is a service coordination function and, if not, who is responsible for child find activities. The same commentator asked whether a specific child find process is recommended. Another commentator suggested that the coordination required in subsection (b) implies that the county MH/MR program is expected to use the identified programs and agencies as county volunteers.
As noted in the response to comments to § 4226.5, two commentators recommended that ''referral'' be defined. They also suggested that the Department specify criteria for establishing when a referral is ''received'' in subsection (f) (redesignated as subsection (g)). One commentator suggested that ''as soon as possible'' in subsection (f)(1) (redesignated as subsection (g)(1)) is vague and recommended including a maximum time frame for assigning a service coordinator after receipt of a referral. Several commentators stated that the 45-day timeline in subsection (f)(2) (redesignated as subsection (g)(2)) is inconsistent with 34 CFR 303.321(e) and suggested that the paragraph be reworded to be consistent with 34 CFR 303.321(e). Some commentators proposed that the requirement for a public awareness program in 34 CFR 303.320 (relating to public awareness program) be included in the final-form rulemaking. Two commentators suggested the State pass legislation that would include the identification of all deaf and hard-of-hearing infants and toddlers in the child find system.
Response
The county MH/MR programs are responsible for developing local child find systems that comply with the requirements of this chapter. Therefore, the term ''ensure'' is appropriate and the Department did not modify the language as suggested. In assessing county compliance, the Department will take the voluntary nature of parental participation in the program into account.
The Department changed ''children'' in subsection (a)(2) to ''at-risk children and infants and toddlers with disabilities'' to conform the language to the revised definitions of those terms. This revision clarifies that the obligation in this paragraph applies to children who have been determined eligible for tracking or early intervention services. The paragraph accurately reflects the Department's intent that county MH/MR programs are responsible for monitoring whether at-risk children are or are not being tracked and whether infants and toddlers with disabilities are or are not receiving needed services. Therefore, the Department retained the second clause of this paragraph, with a minor editorial change.
The child find system is a county-wide initiative, not one directed to a particular child. Therefore, child find is the responsibility of the county MH/MR program, in conjunction with the local interagency coordinating council, not a service coordination function. The Department provides assistance in child find activities by distributing Statewide materials relating to the child find system and providing data to counties to enable them to identify potentially eligible children. Use of the data to identify children is ultimately the responsibility of the county MH/MR programs. Strategies, ideas to improve and specific processes for child find activities are not appropriately included in rulemaking but are addressed on a Statewide basis by Early Intervention Technical Assistance (EITA), the Statewide training and technical assistance system for early intervention, which is another example of the assistance the Department offers to county MH/MR programs in their child find activities.
The Department of course does not expect that the agencies and programs listed in subsection (b) will become the volunteers of the county MH/MR program. Nor does the Department anticipate that the county MH/MR program will meet resistance in its coordination efforts, since each of the identified programs has its own mandate to refer children to appropriate programs, including the county MH/MR program. Nonetheless, recognizing that the county MH/MR program cannot ensure that other programs will cooperate in coordinating efforts, the Department revised the language in this subsection from ''shall ensure that the child find system is coordinated'' to ''shall coordinate the child find system,'' thereby focusing on the actions of the county MH/MR program rather than on the other agencies. The Department will take the degree of cooperation of the other agencies into account in assessing county compliance.
The Department added a definition of ''referral'' in § 4226.5. The definition clarifies that referrals may be made orally or in writing. Although each county MH/MR program must adhere to the definition by accepting both oral and written referrals, the mechanism for receiving referrals varies by county. The Department determined that specifying criteria for what constitutes ''receipt of a referral'' would unnecessarily remove the flexibility the counties need to design their referral systems to meet local needs.
Neither Federal law nor the act requires that a service coordinator be assigned within a specified time period. See 34 CFR 303.321(e)(1). The Department believes that the existing language affords counties flexibility to assign service coordinators consistent with the needs of the referred child.
The Department revised the language on the 45-day timeline in subsection (f)(2) (redesignated as subsection (g)(2)) because it agrees that the language in the proposed rulemaking inadvertently suggested that the IFSP need not be completed within 45 days. As revised, the paragraph clarifies that within the 45-day time period, the county MH/MR program must either complete the MDE and the IFSP for an infant or toddler with a disability or complete the MDE and a tracking plan for an at-risk child.
The Department, not the county MH/MR program, is responsible for implementing a public awareness program. Since the final-form rulemaking applies to the county MH/MR programs and to service providers and agencies, the requirements for a public awareness program are not included in the final-form rulemaking.
The Department does not have the authority to pass legislation. That authority is vested exclusively in the General Assembly. Even without additional legislation, however, children who are deaf or hard of hearing are eligible for early intervention services and are included in the child find system.
The Department added the clause ''unless otherwise permitted or mandated by Federal law'' to subsection (e)(2) to ensure that the time frame for making a referral reflects Federal law as it currently exists in 34 CFR 303.321(d)(2)(ii) and as it may be modified in the future. The Department redesignated subsection (e)(3) as subsection (f) and made corresponding language changes to correct an error in organization. The Department also made other technical changes to correct grammar, punctuation and citation errors.
Sections 4226.25--4226.29 (deleted on final-form).
Many commentators submitted extensive comments on the screening procedures outlined in the proposed rulemaking. Several commentators requested clarification of various provisions, whereas others recommended that the sections be deleted. Commentators questioned the purpose of the initial screening process; expressed concern that children and families could be determined ineligible for early intervention services without an evaluation; noted that the screening process varies across this Commonwealth; and suggested that parents should be informed in writing of their right to request an evaluation if the child is not referred for an evaluation as a result of the initial screening. One commentator requested clarification of the tracking system and suggested that the term be defined.
Response
After careful consideration, the Department has deleted these five sections in their entirety. The screening process is not a Federal or State law requirement. Screening is also not necessary to assure that eligible children are identified as early as possible, since § 4226.24(f)(2) (redesignated as § 4226.24(g)(2)) (relating to comprehensive child find system) mandates that the evaluation be completed and either the child be referred for tracking or the IFSP meeting be conducted within 45 days of referral. Instead, the screening process was established as a mechanism to identify children who clearly would not meet the eligibility criteria for early intervention services, prior to an extensive evaluation process. The Department did not intend to deprive any referred family of the opportunity to have a child evaluated.
The Department's experience with the screening process confirms the observations of some commentators that screening is conducted inconsistently from county to county. That experience also suggests that continuing the screening process is an inefficient and wasteful use of resources, since in many cases it merely inserts an additional step before the child is evaluated. At the same time, the Department acknowledges the concerns expressed by commentators that children and families might be determined ineligible as a result of the screening process. Although parents may challenge the outcome of the initial screening, any such challenge is likely to delay the evaluation.
After taking all of these considerations into account, the Department finds that, on balance, the risk of a child and family being inappropriately diverted from tracking or early intervention services outweighs the incremental benefits associated with maintaining the initial screening. Therefore, the Department has deleted these sections.
The Department added a definition of ''tracking'' in § 4226.5 and expanded § 4226.31 (redesignated as § 4226.26) (relating to tracking system) to specify the components of a tracking system.
Section 4226.30 (redesignated as § 4226.25). At-risk children.
One commentator suggested adding language that would permit a child identified as at-risk to be deemed eligible for tracking with parental consent, if the parent declines the initial MDE. One commentator recommended adding another category of at-risk children, those who have a family history of a genetically related condition such as deafness or hearing loss, to assure early detection of hearing loss in infants and toddlers with hearing parents. One commentator noted that citation to the Department of Health regulations that denote dangerous blood lead levels would improve clarity. One commentator suggested that a child identified as an at-risk child as a result of the initial screening process should also be eligible for tracking.
Response
The Department concurs with the recommendation to permit a child to be deemed eligible for tracking and added subsection (b). The Department finds that it is unnecessary to add children with a genetically related condition such as deafness or hearing loss to the categories of at-risk children. Pediatricians and family care practitioners routinely conduct comprehensive evaluations of a child's health, including hearing, and provide follow-up treatment and referrals. For this category of children, tracking is unlikely to provide any benefit beyond that provided by routine evaluation, treatment and referral services.
According to the Department of Health, it has not promulgated regulations establishing dangerous levels of lead poisoning because the lead prevention program is not a mandatory program. Instead, the Department of Health uses the lead levels published by the Centers for Disease Control and Prevention (CDC). The CDC issues publications on a periodic basis as the need arises, rather than according to an established schedule. Revised publications might or might not supersede the existing publication. The most recent CDC publication is Screening Young Children for Lead Poisoning: Guidance for State and Local Public Health Officials (November 1997), which was updated by Managing Elevated Blood Lead Levels Among Young Children: Recommendations from the Advisory Committee on Childhood Lead Poisoning Prevention (March 2002). Because the Department of Health has issued no regulations and the CDC guidelines are revised periodically, the Department retained the statutory language from the act rather than adding a citation as recommended. The CDC publications are, however, available on the CDC website at www.cdc.gov. The Department also did not amend the section to include the screening process because the initial screening provisions have been deleted from the final-form rulemaking.
As explained in the definitions section, the Department added the population categories of at-risk children to the definition of ''at-risk child.'' Consistent with that revision to the definition, the Department amended and simplified this section by specifying that a child determined to be an at-risk child is eligible for tracking and by deleting the population categories. The Department also added a cross reference to § 4226.26.
Section 4226.31 (redesignated as § 4226.26). Tracking system.
One commentator suggested that ''tracking system'' be defined. The same commentator observed that the section includes no process for initiating a tracking system or procedures to ensure uniformity and recommended that the section specify processes and procedures for implementing a tracking system.
Response
As previously noted, the Department added a definition of ''tracking'' to § 4226.5. In addition, the Department revised this section (redesignated as § 4226.26) and deleted § 4226.32 (relating to contacting families) to combine all elements of the tracking system in one section. The revised section specifies the components of the system, including the frequency and method of contact. The revised section also establishes the use of a standardized tool during the contact, as a means of promoting uniformity throughout this Commonwealth. Finally, the revised section requires the county MH/MR program to maintain written documentation of all contacts.
Section 4226.32(a). Contacting families (deleted on final-form).
One commentator questioned how the 4 month frequency of contacts was determined and whether the county MH/MR program is required to make more frequent contact if recommended by the MDE team. The same commentator suggested that the section specify the substance of the contact. Three commentators recommended against prescribing the frequency of contacts because the frequency should be individualized according to family need. Three other commentators suggested adding a requirement for written documentation of all contacts. One commentator stated that e-mail should be added as a contact option or considered to be a written contact. Another commentator observed that the prescribed frequency is greater than current local practice and asked whether additional personnel will be provided.
Response
As noted in the response to comments to § 4226.31 (redesignated as § 4226.26), the Department deleted this section, incorporating the frequency and method of the contact from this section and prescribing the substance of the contact, as well as a requirement that contacts be documented in writing, in redesignated § 4226.26. Given the tender age of these children, delays must be identified as early as possible to maximize opportunities to enhance development and minimize future delays. For this reason, the Department finds that it is necessary to establish the minimum frequency of contact in regulation. The Department revised the frequency from 4 months to 3 months, recognizing that tracking in most counties is conducted by service coordinators, and 3-month contact has been a Department service coordination requirement since 1994. To ease administration and implementation of the tracking system, as well as avoid unnecessary disruption to families caused by repetitive and overlapping contacts, the Department revised the frequency of the tracking contract to coincide with the service coordination contract. Contacts with the child and family may be more frequent if recommended by the MDE team, with the concurrence of the family or less frequent if requested by the family.
Because, as noted, 3-month contact has been a Department service coordination requirement since 1994, the Department would expect that current practice reflects that requirement and therefore does not anticipate a need for additional personnel. The Department agrees that e-mail is an appropriate written contact if the county MH/MR program confirms that the family has e-mail capability and agrees to that method of contact.
Section 4226.33 (redesignated as § 4226.27). Monitoring responsibilities.
One commentator questioned how and why a county MH/MR program would monitor services provided in another state, as required by subsection (a). The same commentator noted that the phrase ''complete monitoring of each early intervention service provider at least every 12 months'' in subsection (c) is confusing and recommended that the language be revised to reflect that the monitoring is a reporting requirement.
Response
The need to monitor services in another state arises most often when a county MH/MR program contracts with a service provider or agency in a contiguous state to deliver early intervention services to an infant or toddler and family who live in close proximity to the contiguous state. In any case in which the county MH/MR program has contracted with an out-of-State provider, however, the county MH/MR program is responsible for monitoring services provided by that provider.
After additional internal review, the Department revised subsection (a) to clarify that a county MH/MR program is responsible for monitoring those services that it provides directly as well as the services provided through contract with another service provider or agency. The Department also revised subsection (c) to conform to the revisions to subsection (a); to clarify that the monitoring is expected to be conducted on an ongoing basis but at least annually; and to require that documentation of the monitoring be maintained for at least 4 years. The Department also made technical changes to subsection (b) to conform to the revisions to subsection (a).
Section 4226.34. Community evaluations (redesignated as § 4226.28. Self-assessment reviews).
One commentator questioned how the 3-year cycle was established and noted that the statement ''once in every 3 years'' is awkward and should be reworded. Another commentator requested clarification on whether the evaluation required in this section is in addition to or instead of the standardized self-assessment process currently being used. The same commentator asked whether the term ''legal entity advisory board'' is the county MH/MR advisory board.
Response
The Department established the 3-year cycle for conducting the reviews because the families whose infants and toddlers receive tracking or early intervention services change over the course of 3 years because of the age limit of the program and family satisfaction with the program is a critical component of the self-assessment. The Department changed the sentence structure as recommended.
The Department changed the heading and wording of this section to clarify that the reviews required by this section are those currently being conducted. The term ''legal entity advisory board'' was changed to ''county MH/MR advisory board.''
After additional internal review, the Department added the phrase ''including assessment of family satisfaction,'' which was inadvertently omitted from the proposed rulemaking, to clarify that this is an element of the self-assessment. The Department also revised the section to remove the requirement that county MH/MR programs have to develop the assessment system, since the Department has developed the tool to be used and procedures to be followed, which are already in place and being used by counties. As revised, the section requires county MH/MR programs to use the tool and procedures that the Department has developed rather than develop their own.
Section 4226.35. Training (deleted on final-form).
One commentator recommended deleting the terms ''professional'' and ''paraprofessional'' and the phrase ''as approved'' as unnecessary. The same commentator suggested that the section be revised to recognize other certification, licensing and registration authorities. Two commentators recommended that the specific number of annual training hours be included in this section. Other commentators asked what job category this section pertains to, what certification is available to paraprofessionals and whether the Department will develop a formal training format.
Response
The Department deleted this section because it was duplicative of the definition of ''qualified'' in § 4226.5. Section 4226.37(a) (redesignated as § 4226.30(a)) (relating to annual training) specifies the required number of annual hours of training.
Section 4226.36 (redesignated as § 4226.29). Preservice training.
Commentators uniformly commended the Department for adopting both preservice and annual training requirements. One commentator observed that the training requirements seemed to be an attempt to compensate for inadequate qualification requirements elsewhere in the rulemaking. Several commentators submitted suggestions and others expressed some concerns.
Two commentators suggested that the format and time frame for completing preservice training be specified in this section. Other commentators recommended replacing ''to encourage family preferences'' in paragraph (4) with ''will encourage family involvement at all levels'' as more appropriate and deleting ''(for all staff)'' in paragraph (9) as redundant. Some commentators suggested additional training topics, including community resources; family-centered planning and service delivery; typical and atypical development; the nature of disabilities and their impact on families; cultural and social diversity; effective listening; and identifying family strengths and need. One commentator recommended competency-based training as a component or instead of preservice training, including the topics listed in this section in addition to others such as natural environments and IFSP developments and outcomes. One commentator questioned where training in childhood development and health is available to service coordinators.
Several commentators stated that it is inappropriate to require training in cardiopulmonary resuscitation (CPR), fire safety, emergency evacuation and first aid because most children receive services in community-based settings with their families present. Some commentators suggested that this requirement should apply only to direct care staff, and not, for example, to service coordinators, who provide facility-based services. Others noted concerns about issues such as staff liability, ''do not resuscitate'' orders and fire or evacuation plans in family homes. A few commentators recommended that topics such as family training in use of smoke detectors and evacuation plans might be more appropriate. Other commentators supported this training requirement, with one suggesting only that a reasonable time frame, such as 90 to 120 days, be allowed to complete the training.
A number of commentators who supported preservice training expressed concern that it will result in an additional cost by limiting the availability of staff to provide billable direct service hours. Several of the commentators requested that the Department consider a number of payment proposals, including funding for staff development. Two commentators noted that the preservice training requirement might deter interested persons from a job in the field. One commentator recommended that the final-form rulemaking specify who will pay for training.
Response
The Department concurs with the recommendation to specify a timeframe for completing preservice training, and added a requirement that the training be completed before personnel work alone with infants and toddlers or their families. Personnel may work with infants and toddlers or their families if supervised, before completing the required preservice training. The Department did not specify a training format or a number of training hours because it expects that both will vary based on the experience of the individuals receiving training. An individual who has experience in early intervention services may receive preservice training through reading materials and videotapes, whereas an individual with less or no experience is likely to need more hands-on training for a longer period of time. Therefore, the Department determined that the specific format for and length of the training should be left to the judgment of the employer.
The Department changed the language in paragraph (4) to ''encourage family involvement and consider family preferences'' and deleted the parenthetical phrase ''(for all staff)'' in paragraph (9). The Department did not amend the list of topics for training because those are the topics that the Department believes personnel must be familiar with to be effective. Other topics, although not required, are not prohibited. Training and training materials in child development and health are available from a number of organizations, including EITA and the ECELS program of the American Academy of Pediatrics. The Department believes training in CPR, fire safety, emergency evacuation and first aid is good practice for personnel working in public programs regardless of site and therefore retained those topics. It revised paragraph (9) to allow up to 120 days from the date of hire to complete this training.
The county MH/MR programs are responsible for funding preservice training. They receive an annual training allocation from the Department. In addition, the Department allows the counties to take costs associated with staff training into account when developing rates with early intervention service providers or agencies. The Department has also established an extensive training and technical assistance network through EITA, which provides training at no cost to counties and providers.
The Department revised subsection (a) by striking reference to specific provider types and replacing it with the general term ''early intervention personnel.'' The Department also made some technical changes to subsection (a) to correct improper word usage in the introductory paragraph and paragraph (6), to eliminate redundancy in paragraph (9) and to conform the subsection to other changes made in the final-form rulemaking. The Department added subsection (b) to clarify that all preservice training must be documented, not merely that required by paragraph (9), and to specify a record retention period. The Department deleted the parallel provision regarding documentation from paragraph (9).
Section 4226.37 (redesignated as § 4226.30). Annual training.
As with preservice training, many commentators supported an annual training requirement, although a few viewed annual training as an attempt to compensate for lack of education and experience. Several commentators nonetheless expressed reservations about the requirement, for varying reasons. Some commentators believed that 24 hours of training is excessive and that the requirement was generally vague. Other commentators expressed concern that the requirement will have a negative financial impact, questioning their ability to fund training and to recover income lost because staff are unavailable to deliver billable units.
Commentators also requested that the Department clarify whether the 24 required hours are clock hours, credit hours, continuing education credits or in-service hours; whether the training applies to child care providers; and whether the Department approves training providers or programs and, if so, recommended that the process for approval be included in the final-form rulemaking.
One commentator suggested that subsection (a) be revised to replace ''the service coordinator, early interventionist and other early intervention personnel'' with the broader ''all personnel who work directly with the child.'' Two commentators recommended that the phrase ''at least'' be deleted from subsection (a) to avoid the potential for arbitrary variation. One commentator stated that the training topics are too limited and suggested adding the phrase ''may include but are not limited to.''
Commentators offered a number of other suggestions, including requiring therapists to receive training; allowing existing licenses and certifications to be credited as training; reducing the number of training hours; adjusting current rates to account for the cost of training; collecting data on actual costs; and allowing program funding for staff development activities. Some commentators recommended that fire safety, first aid and CPR should be included in annual training, but others objected to including training for the same reasons set forth in the response to comments to § 4226.36 (redesignated as § 4226.29) (relating to preservice training).
One commentator asked the Department to reconsider applying the requirement to part-time staff and independent contractors, claiming it could alter the status of the agency-contractor relationship. Another commentator observed that requiring 24 hours of training before working with families can cause services to be delayed. One commentator asked the Department to clarify the ''annual certification'' in subsection (b). Another commentator stated that the recertification is unnecessary because early intervention personnel are never alone with the child and therefore do not have responsibility for emergency situations.
One commentator recommended that the section should specify who pays for training. The same commentator suggested that this section should specify a timeline for maintaining training records.
Response
The Department finds that it is essential for all early intervention personnel, including therapists, part-time personnel and independent contractors, to be knowledgeable about best practices within the early intervention field. A variety of disciplines are involved in the early intervention program in which licensed or certified practitioners receive training in their area of expertise. Training does not displace the vital need for training specific to the early intervention field, community resources and services for children with disabilities. The required number of hours is 24 clock hours, which the Department believes reflects a reasonable and realistic expectation for personnel in the field.
The Department substituted ''early intervention personnel'' for reference to specific professionals in subsection (a). Because the meaning of the term ''hours'' as used in this section is consistent with the dictionary definition of the term, the Department did not revise this section to specify the type of hours required. The Department also did not revise this section to expand the list of training topics, which are the topics the Department believes are important for early intervention personnel. Conversely, it did not delete the phrase ''at least'' because personnel are not prohibited from receiving more training than the prescribed 24 hours.
Training in fire safety, first aid and CPR are included in ''universal health procedures,'' which is one of the listed training topics. For the reasons stated in the response to comments to redesignated § 4226.29, the Department did not delete this training topic. The annual certification required by subsection (b) is issued for training in universal health procedures such as CPR. Because the Department retained this as a topic in subsection (a), the annual certification continues to be required.
Unlike preservice training, the 24 hours of annual training need not be completed before personnel begin to work with children and families. The Department amended subsection (a) to clarify that the 24 hours of annual training is in addition to the preservice training requirements in redesignated § 4226.29. The annual training requirement does not apply to child care providers, although they would not be prohibited from attending training related to early intervention services.
The Department does not approve training providers or programs and therefore did not include a process for approval in this section. The Department revised subsection (b) to specify a record retention period for annual training records, which parallels that in redesignated § 4229.29.
As noted in response to comments to redesignated § 4226.29, the Department has an extensive training and technical assistance network through EITA that provides trainings at no cost to counties and providers. Training is available throughout the year on a Statewide and regional basis and through teleconferencing. Also available are local trainings that can be designed to meet the needs of a particular county. As also previously explained, the county MH/MR programs receive a training allocation each year from the Department that they can utilize to meet the needs in their local area, in addition to being permitted to account for costs associated with training in the service rates they establish for providers.
The Department made technical changes in subsection (b) to make the wording more succinct.
Section 4226.38. Criminal history records check (redesignated as § 4226.31. Child Protective Services Law).
Some commentators pointed out that the requirement for a child abuse clearance was omitted from this section and recommended that the section be revised to require that all staff who have direct contact with children obtain the clearances. One commentator questioned why Commonwealth residents are not required to submit a Federal Bureau of Investigation (FBI) criminal history check. Another commentator asked if current personnel are grandfathered under the Child Protective Services Law (CPSL) (23 Pa.C.S. Chapter 63), as amended by Act 33 (23 Pa.C.S. § 6344) (Act 33). Two commentators complained that the reporting requirements of the Older Adult Protective Services Law (35 P. S. §§ 10225.101--10225.5102) (OAPSL) overlap with those of the CPSL, leading to confusion and delay. They suggested that the Department and the Department of Aging work together to eliminate overlapping rules and procedures.
Response
The requirement for a child abuse clearance was inadvertently omitted from the proposed rulemaking. Rather than restate the substance of Act 33 in this section, the Department revised this section to require that personnel comply with the CPSL and the Department's accompanying regulations in Chapter 3490 (relating to protective services), which mandate both criminal history records checks and child abuse clearances.
Commonwealth residents are not required to obtain an FBI criminal history clearance under State law. The General Assembly created the difference in procedures for criminal history records checks between residents and nonresidents of this Commonwealth (23 Pa.C.S. § 6344(b)(1) and (3)). Because Act 33 has been in effect since 1986, the Department doubts that any current personnel have not obtained the mandated clearances. Act 33 has contained a grandfathering provision since enactment (23 Pa.C.S. § 6344(k)), whereby personnel employed on the effective date of the law were not required to obtain the mandated clearances. If those same personnel change jobs, however, both criminal history and child abuse clearances are necessary. Current personnel who have obtained the necessary clearances do not need to resubmit for the clearances when the final-form rulemaking becomes effective.
The comments addressed to the OAPSL are more appropriately addressed in a different forum. Act 33 unequivocally prescribes that early intervention services are child care services for which personnel must obtain the prescribed clearances. See 23 Pa.C.S. §§ 6303 and 6344(a). The Department of Aging addressed similar comments in the final-form rulemaking amending 6 Pa. Code Chapter 15 (relating to protective services for older adults) published at 32 Pa.B. 2412 (May 18, 2002). Neither Department has the authority to alter the mandates imposed by the General Assembly.
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