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PA Bulletin, Doc. No. 01-1379

RULES AND REGULATIONS

Title 28--HEALTH
AND SAFETY

DEPARTMENT OF HEALTH

[28 PA. CODE CH. 4]

Head Injury Program

[31 Pa.B. 4064]

   The Department of Health (Department) hereby adopts Chapter 4 (relating to head injury program) to read as set forth in Annex A.

Scope and Purpose

   The regulations establish standards by which the Department will administer the Catastrophic Medical and Rehabilitation Fund (Fund). The Emergency Medical Services Act (act) (35 P. S. §§ 6921--6928) establishes the Fund. Section 14(e) of the act (35 P. S. § 6934(e)) states that the Fund ''shall be available to trauma victims to purchase medical, rehabilitation and attendant care services when all alternative financial resources have been exhausted. . . .'' Section 14(e) of the act also permits the Department to adopt regulations to prioritize the distribution of moneys from the Fund by classification of traumatic injury. The final-form rulemaking provides that the Department will use moneys from the Fund to provide designated services to persons who have incurred a traumatic brain injury (TBI).

   The Department has established a Head Injury Program (HIP or Program), administered by its Division of Child and Adult Health Services (Division), to make distributions from the Fund. Parameters for participation in the Program, including eligibility requirements, are established in the final-form rulemaking. The regulations also address Program administration, including assessment procedures, services to be reimbursed by HIP, funding and time limitations on participation and appeal procedures.

Public Comments

   Notice of proposed rulemaking was published at 29 Pa.B. 2671 (May 22, 1999), with an invitation to submit written comments within 30 days.

   Within the 30-day comment period, the Department received several comments. Subsequently, the Department received comments from the Independent Regulatory Review Commission (IRRC); Senator Vincent Hughes, Minority Chair of the Senate Public Health and Welfare Committee; and Representative Linda Bebko-Jones of the 1st Legislative District. A meeting to discuss these comments prior to the preparation of the final-form rulemaking was held on July 13, 1999, among representatives of the Department, IRRC, the House Health and Human Services Committee and the Senate Committee on Public Health and Welfare.

   It should be noted that, although the final-form regulations and the underlying Program have not substantively changed, the final-form version of the regulations virtually rewrites and reorganizes the proposed regulations to improve organization and clarity. The final-form regulations have been restructured first to follow the process of the applicant's placement on the waiting list, applying, being assessed and enrollment in the chronological order that each actually takes place. This enables an individual seeking to understand the Program to get a clearer picture of ''what happens next.'' Although this process is no different than it was when the regulations were originally proposed, it was not presented in serial fashion at that time.

   The final-form regulations also clarify the two separate stages of evaluating eligibility for the Program, with the first stage being consideration of requirements that can be evaluated on paper, including domicile, general financial situation and absence of certain preexisting medical conditions. Meeting these requirements makes an applicant eligible for an in-depth assessment. The outcome of this assessment will determine whether the applicant is eligible to be accepted into the Program and receive rehabilitation services. Again, this is how the Program was conceived at the time the regulations were first proposed; the process is simply made clearer in the final-form version.

   A considerable amount of the information in the final-form version of the regulations was taken from the regulations as they were first proposed. Although detail has been added in a number of areas, those details are largely not ones that have been newly conceived. Rather, it was determined that the addition of the information would assist readers of the final-form regulations to understand how the Program works.

   In addition, a number of changes have been made in response to comments. Because the changes in form, if not in content, are so sweeping, the comments to the proposed regulations are addressed under the current section in which the subject matter addressed by the comment appears. Following is a discussion of the comments received by the Department and the Department's response to them.

Section 4.1--Scope and purpose.

   No comments addressing this section were received. The proposed section was revised to remove the statement that the Department will provide rehabilitation services ''facilitated through case management.'' This phrase was inserted elsewhere because it is a substantive provision that is too specific to be included in a section addressing the scope and purpose of the chapter. Language is inserted to follow the statute more closely by specifying that the Fund may be used to pay for ''medical, rehabilitation and attendant care services'' for persons with TBIs.

Section 4.2--Definitions

   This section contains definitions of terms used in the chapter.

Comment

   The definition of ''day services'' should be revised to include physical abilities as one of the abilities day services are designed to improve.

Response

   The Department accepts the recommendation, and has made the suggested change to the definition of ''day services.''

Comment

   The Division should be specifically mentioned in the proposed definition of ''Division'' as the division that will be responsible to administer HIP.

Response

   The Department accepts the recommendation.

Comment

   It is proposed that the term ''exhausted'' be defined as the point at which alternative financial resources (AFRs) have been applied for and denied or fully utilized. It is unclear what ''exhausted'' means in terms of AFRs. This term may not be necessary if the financial eligibility criteria are specified in more detail.

Response

   The Department agrees with the comment. The term ''exhausted'' is not defined in the final-form regulations. The financial eligibility criteria for participation in HIP are now specified in § 4.6(a)(1)(v) (relating to assessment), which requires applicants to have AFRs not in excess of 300% of Federal Poverty Income Guidelines to participate in the Program. AFRs are defined as all income subject to Federal income tax, funds available to an individual by virtue of experiencing a TBI and funds available to an individual through other State or Federal programs. These are resources that must be used to pay for HIP services until these resources are reduced to the threshold amount. Because the final-form regulations now make clear that an applicant or client cannot have AFRs in excess of 300% of the Federal poverty level, it is not necessary to require that AFRs be ''exhausted.''

Comment

   The term ''legal representative'' is used but not defined in the proposed regulations. This term should be defined to refer to one who is legally empowered to act for a head injury applicant or client. This will clarify who can act in this capacity and will also avoid repeatedly iterating a list of persons who may or may not be so empowered.

Response

   The Department agrees with the comment. The term ''authorized representative'' is now defined in this section to include any individual authorized by law to make a decision for an applicant or client. Defining ''authorized representative'' as one who is legally authorized to act for an applicant or client clarifies that the input of an authorized substitute decision maker is acceptable. Whether or not an authorized representative exists, the applicant or client, of course, is free to share information with, and solicit the assistance of, parents, guardians or anyone else the applicant or client chooses.

Comment

   The definition of ''legal representative'' should include a reference to ''minor.''

Response

   The Department disagrees. The final-form regulations provide that only individuals who are 21 years of age or older may participate in HIP. Therefore, no reference to minors is needed.

Comment

   The definition of ''rehabilitation'' should include ''home facilitation'' in the list of services that are included.

Response

   The Department accepts the recommendation. The defined term that appears in the final-form regulations is ''rehabilitation services,'' as opposed to ''rehabilitation.'' ''Home facilitation'' is included in the list of services contemplated by the term ''rehabilitation services.'' Additionally, part of the remaining substance of the proposed definition was moved to § 4.9 (relating to rehabilitation period).

Comment

   The final sentence of the definition of ''rehabilitation service plan'' should be deleted, as it inappropriately contains substantive provisions and duplicates language found in the substantive portions of the final-form regulations.

Response

   The Department agrees with this comment. The final sentence has been deleted.

Comment

   The definition of ''rehabilitation service plan'' should include ''the client's parent, guardian or representative'' among those who collaborate in the development of the rehabilitation service plan.

Response

   The Department agrees with the recommendation in part. Much of the proposed definition of ''rehabilitation service plan,'' including the part that addressed with whom the provider could collaborate in developing the plan, has been moved to § 4.8 (relating to rehabilitation service plan). The term ''authorized representative'' is now used. It is more comprehensive than ''parent, guardian or representative.'' Section 4.8 does state that the provider may collaborate with the applicant's or client's significant others, such as family or healthcare providers, in the development of a rehabilitation service plan. This permits the provider the flexibility to consult with members of the individual's support system, who may be most aware of the individual's needs, when developing and revising a rehabilitation service plan for an applicant or client.

Comment

   The definition of ''rehabilitation services'' should include therapeutic recreation and prevocational services. These services assist community integration and community reentry skills.

Response

   The Department agrees with the comment, and has incorporated these services in the definition of ''rehabilitation services.''

Section 4.3--Services eligible for payment.

   This section lists the services that may be paid for through HIP.

Comment

   Proposed § 4.7 appears to limit payment for services to ''clients.'' However, the services that will be paid by HIP include assessments. It would seem that assessments are for applicants, who are not necessarily clients. This should be revised to be consistent.

Response

   The Department agrees. Paragraph (1) states that assessments of applicants by providers are among the services for which HIP will pay.

Comment

   Case managers should be reimbursed for travel time.

Response

   The Department disagrees. The fee schedule utilized by HIP establishes the rate at which case managers can be reimbursed for their time. This rate assumes delivery of services to clients, and does not reimburse for travel time. The fee schedule does, however, allow for reimbursement for mileage. Because HIP funds are limited, the Department has determined that case management reimbursement will be limited to actual services delivered.

Comment

   Education and training sessions should be offered to case managers to improve their knowledge, resource bases and facilitate information exchange among them.

Response

   The Department disagrees. It will be the responsibility of the providers with whom the Department contracts to ensure that useful educational opportunities are available to case managers and other staff in their employ.

Section 4.4--Requirements for provider participation.

Comment

   The proposed regulations do not indicate what the ''appropriate National accrediting [bodies] as approved by the Department,'' referred to in proposed § 4.7(4) are, or how a member of the public could find out what they are. The final-form regulations should specify approved National accrediting bodies, or should state how a list of these may be obtained.

Response

   The Department agrees. Subsection (a) states that a list of Department-approved National accrediting bodies will be published from time to time in the Pennsylvania Bulletin. Additionally, a list can be obtained by contacting the Division. At this time, the only National accrediting body approved by the Department is the Commission for Accreditation of Rehabilitation Facilities (CARF). CARF is currently the predominant National accrediting body for rehabilitation providers in the field of brain injury rehabilitation. The Department will certainly consider other qualified bodies for approval as the opportunity arises.

Comment

   Requiring rehabilitation facilities to obtain accreditation makes voluntary accreditation mandatory. A requirement of specific accreditation of HIPs could result in lack of access to HIP and head injury services for patients in some regions of this Commonwealth. Minimum standards for HIPs should be defined in the final-form regulations and not deferred to accreditation.

Response

   The Department rejects the recommendation. The Department believes that the requirement that HIP providers be certified by qualified accrediting bodies assures that uniform National recognized standards of care are available to all enrolled HIP clients, and serves as a continued quality assurance tool and measure.

Section 4.5--Application for enrollment as a HIP client.

   This section addresses the procedures for securing and filing an application for enrollment in HIP.

Comment

   Is there a specific application form? How do applicants obtain a copy?

Response

   Subsection (a) provides a contact address at the Department and also states that individuals may contact the Department by electronic mail or facsimile. Individuals who are interested in enrolling in HIP or arranging enrollment for another should write to the Eligibility Specialist at the address provided, by e-mail at: eterrell@state.pa.us or by fax at (717) 772-0323. If there is not sufficient funding to enable HIP to consider accepting a new client at the time the individual makes contact with the Division, the individual will be placed on a waiting list under subsection (c). Subsection (d) makes clear that the Division will provide application materials, including an application form, when the individual qualifies to receive an application; that is, whenever there is sufficient funding for HIP to be able to consider new applicants and the individual is next on the waiting list.

Comment

   What verifying documentation must accompany the application form?

Response

   The application must be accompanied by a physician's statement (the format for which will be provided by the Department), a completed Commonwealth income tax form, documentation of insurance including copies of any insurance cards and documentation of citizenship and residency. This will be explained to the applicant or the applicant's authorized representative at the appropriate time. The explanation will be in the instructions the Division provides for completing the application form.

Comment

   The final-form regulations should contain a provision that clearly addresses the status of the individuals currently on the waiting list. This provision should also outline the process of notifying those individuals of the Department's changes to HIP policy.

Response

   The Department accepts the recommendation in part. Subsection (c) states that individuals on the waiting list will be asked to submit applications in the order that their requests to be placed on the list were received by the Division. Consequently, those individuals who are on the waiting list as of the date these final-form regulations are adopted will be able to apply for enrollment before individuals who are placed on the list after them. The section also states that individuals who are on the waiting list who have already received case management services through HIP, but never received rehabilitation services through HIP, will be given first priority. This class of individuals, those who receive case management services before receiving rehabilitation services, will cease to exist after the individuals who currently comprise the class are handled by the Program. This section further states that those persons who have never received rehabilitation services through HIP will be given priority over those who have previously received rehabilitation services through HIP.

   The Department will send letters to all current HIP clients upon the adoption of these final-form regulations, explaining the new policies and the benefits to which they will be entitled. The Department will also send letters to all individuals on the waiting list. Additionally, the final-form rulemaking will be published in the Pennsylvania Bulletin and will be posted on the Department's website.

Comment

   The Department should clarify how the waiting list referenced in proposed § 4.5(b) will be prioritized--for example, by date of application, degree of injury or some other criteria.

Response

   As previously stated, individuals on the waiting list will be asked to submit applications in the order that their requests to be placed on the waiting list were received. The exceptions to this are individuals who are receiving or have received case management services prior to formal enrollment in HIP, who will be given first priority as stated in subsection (c), and individuals who previously received HIP services and who are reapplying. Individuals who have never received HIP rehabilitation services will be given priority over former HIP clients, as stated in subsection (e).

Comment

   The Department should clarify whether an applicant must reapply once the applicant is placed on the waiting list, and how reapplicants will be prioritized.

Response

   As explained in subsection (a), individuals do not formally begin the application process until the Division notifies them that it is their turn to apply. They are placed on the waiting list because there are no funds available to add them to the Program when they initially contact the Division. Their addition to the waiting list is accomplished via a signed letter sent to the Division. Individuals on the waiting list are then invited to submit an application for enrollment in HIP as funding becomes available and their turn arrives. If an application were to be filed at the time an individual is placed on the waiting list, it would probably be stale by the time the Division is ready to consider the individual for enrollment in HIP.

Section 4.6--Assessment.

   This section first sets forth the criteria an applicant must meet to be eligible for an assessment, and then explains the assessment process.

Comment

   According to proposed § 4.4(f), the Department will notify an applicant of eligibility within 30 days from the receipt of a complete application. How will the date when an application is ''complete'' be determined and recorded?

Response

   Information dealing with the application process is now included in § 4.5 (relating to application for enrollment as a HIP client). An application will be considered to be complete on the day that the Division has received all of the information necessary to process the application. For example, an applicant is permitted to claim that the applicant's income as it appears on the Federal income tax form or other reporting document is no longer representative, as long as the applicant is able to support that claim. If the applicant fails to include supporting documentation, the Division may have to request it in order to verify that claim. The Division will record the date that it has received all of the required and requested information so that it is able to proceed with evaluating the application. When the application is complete, the Division will determine whether an applicant is eligible for an assessment.

Comment

   Proposed § 4.6 states that the Department will conduct evaluations to determine an applicant's initial eligibility for HIP, as well as a client's eligibility for continuing enrollment. Proposed § 4.4 does not refer to these evaluations. The referenced language in proposed § 4.6(a) should be placed in the section dealing with eligibility.

Response

   The Department agrees with this comment and has revised this section to fully describe the assessment process.

Comment

   The use of the phrase ''the Department will deem'' in proposed § 4.4(a)--(c) is unnecessary and should be deleted.

Response

   The Department agrees with the comment, and has deleted the phrase.

Comment

   The requirement in proposed § 4.4(a)(1) that an applicant must have sustained a TBI ''on or after'' July 3, 1985, in order to be eligible, is confusing. It should simply read ''The applicant suffered a TBI after July 2, 1985.''

Response

   The Department agrees with the comment. Subsection (a)(1)(i) now reads, ''[t]he applicant sustained a TBI after July 2, 1985.''

Comment

   It is unclear why it is necessary, as required by proposed § 4.4(a)(2), for an applicant to demonstrate the intent to maintain a permanent home in this Commonwealth for the indefinite future, and how the Department would enforce this requirement.

Response

   The Department disagrees with the comment, but has revised the final-form regulations to improve clarity. The final-form regulations no longer require the applicant to ''demonstrat[e] the intent to maintain a permanent home in this Commonwealth for the indefinite future.'' Rather, subsection (a)(1)(ii) states that an applicant must have been domiciled in this Commonwealth both at the time of the injury and at the time application is made, to be eligible to participate in HIP.

   ''Domicile'' is a generally accepted legal concept. It is defined as an individual's true, fixed and permanent home to which that individual intends to return. A person can have only one legal domicile at any given time. If a person goes to a place and intends to make it a permanent home for an indefinite period, the person is domiciled there. If an individual takes up temporary residence in this Commonwealth, but intends to return to a fixed address elsewhere, the person is not a domiciliary of this Commonwealth.

   The Department believes that the domicile requirement is reasonable, and may be ascertained rather simply. The Division need only ascertain where the applicant resided when the accident occurred, whether the applicant resides in this Commonwealth at the time of application and the applicant's intentions regarding place of future residence. The requirement is difficult to enforce only in that one cannot keep an applicant from taking up temporary residence in this Commonwealth and misrepresenting the applicant's true intentions. However, the requirement that an individual must have been a domiciliary of this Commonwealth at both the time of the injury and the time of application to HIP goes a long way to ensuring that only true domiciliaries can present themselves. This requirement has been established to ensure that HIP's limited funds are used to assist Commonwealth residents. It would not be appropriate to allow HIP funds to be utilized by domiciliaries of other states when there are eligible Commonwealth domiciliaries whom HIP will be unable to assist due to financial limitations.

Comment

   The Department proposes to restrict enrollment in HIP to individuals who are 21 years of age or older, and has stated that individuals under 21 years of age are eligible to receive services through other programs administered by the Departments of Education (DOE), Labor and Industry (L&I) and Public Welfare (DPW). However, individuals under 21 years of age are not automatically eligible for these programs. The Department should clarify the need to restrict eligibility for HIP to individuals who are 21 years of age or over, as stated in proposed § 4.4(a)(4), and explain how the programs provided by DOE, L&I and DPW are appropriate alternatives for head injured individuals under 21 years of age. Note, for example, that individuals who are under 21 years of age, but have graduated from high school, may not be eligible for services from DOE.

Response

   Due to limitations on the amount of funding available for HIP, the Department seeks to serve underserved individuals through the Program. Because there are a number of programs that make services similar to those afforded by HIP available to individuals under 21 years of age, the Department has elected to make HIP available only for individuals who are at least 21 years of age.

   The Office of Social Programs of DPW has established the Community Services Program for Persons with Physical Disabilities (CSPPPD). The CSPPPD provides services to individuals who have severe, chronic disabilities that have manifested before 22 years of age, including disabilities due to head injuries, and who are residents of or applicants to nursing facilities. Clients of this program have substantial functional limitations. Through CSPPPD, they live in the community and are provided with services such as service coordination, advocacy, peer counseling and support groups, community-integration activities, equipment-related assessment and transportation.

   The Office of Social Programs of DPW also offers the Attendant Care Program and Centers for Independent Living (CILs), both of which are funded through the Federal Rehabilitation Act of 1973 (P. L. 93-112). Although the primary focus of the Federal legislation is on vocational rehabilitation, the Attendant Care Program provides for care services for severely disabled persons without job potential. Services include personal care attendants. The legislation additionally establishes CILs that serve people with all types of disabilities, including those stemming from head injury. These centers offer housing referral, training in independent living skills, training for personal assistants, assistive technology and peer counseling.

   All children under 21 years of age with disabilities, including those due to TBI, are guaranteed a free, appropriate education in the least restrictive environment under the Federal Individuals with Disabilities Education Act (IDEA) (P. L. 101-476). DOE has the responsibility for public education, including education under IDEA. Schools must prepare an Individual Education Plan (IEP) for each child with a disability in cooperation with the parents. The IEP is very important to the brain-injured child who requires a high level of repetition, cueing and practice.

   While it is true that individuals who are under 21 years of age who have graduated from high school are no longer eligible for services from DOE, an alternative source of services to head-injured minors is the Office of Medical Assistance, which provides a broad range of medically necessary services to enrolled children under 21 years of age. DPW now works closely with the Department, DOE and L&I to ensure that the service needs of children with disabilities are met. Further, L&I's Office of Vocational Rehabilitation (OVR) administers joint State- and Federal-funded vocational rehabilitation services to assist persons with mental and physical disabilities to find jobs. The Federal Rehabilitation Act of 1973, which establishes this program, includes provisions for supportive employment so that all persons have the opportunity to work in jobs in the community, regardless of the level of their disability. According to its 1998-2000 State and Strategic Plans, OVR has a number of plans, policies and procedures regarding the transition of students with disabilities to vocational rehabilitation services. Students are to receive transition services. These services, as defined in the 1992 amendments to the Rehabilitation Act and the IDEA, are a coordinated set of outcome-oriented activities designed to promote movement from school to post-school activities, including post-secondary education, vocational training and integrated employment (including supported employment), continuing and adult education, adult services and independent living or community participation. Transition services are based on the student's preferences and interests, and include instruction, community experiences, the development of post-school adult living objectives and, when appropriate, the acquisition of daily living skills and functional vocational evaluation. OVR partners with DOE to coordinate these programs and services to assist students through the transition out of the public education system.

Comment

   The proposed regulations limit participation to individuals over 21 years of age, but do not state an upper age limit. The maximum age of participation in HIP should be limited to individuals under the age of 60--65. Scientific studies of head-injured patients indicate that those over 55--60 years of age do not benefit meaningfully from aggressive inpatient rehabilitation. Limiting participation in this way would save funding for younger individuals who would be far more likely to benefit from HIP services.

Response

   The Department disagrees with the recommendation. A maximum age limit is both unnecessary and unfair to older head trauma sufferers. The individual applicant's potential to benefit from HIP services is gauged through an assessment prior to enrollment in the Program. If the completed assessment indicates that HIP services will not be beneficial, the applicant will not be enrolled as a client in HIP.

Comment

   Proposed § 4.4(a)(3) refers to ''HIP financial eligibility criteria,'' but fails to state what those criteria are. The final-form regulations should define this term and specify these important criteria so potential applicants are on notice as to the requirements that they will have to meet.

Response

   The Department agrees with the recommendation. Although ''financial eligibility criteria'' is not a defined term, the final-form regulations state what financial eligibility criteria applicants must meet. Subsection (a)(1)(v) provides that an applicant's AFRs must be at or below 300% of Federal poverty level. Subsection (a)(1)(v)(A) and (B) state how AFRs will be assessed.

Comment

   Proposed § 4.3(c) states that the Department ''will use the Fund to pay for clients' HIP services which would not otherwise be available to clients with TBI who have exhausted alternative financial resources.'' The last part of this sentence is redundant and unnecessary because, under the eligibility requirements found in proposed § 4.4(a)(3), AFRs must be exhausted for a person to become a client in the first place.

Response

   The Department agrees with this comment. The final-form regulations do not contain the referenced statement. The final-form regulations also do not require AFRs to be ''exhausted.'' Rather, subsection (a)(1)(v) establishes a requirement that applicants have AFRs in the amount of 300% of the Federal poverty level or less.

Comment

   The proposed regulations are not clear as to the extent that a client must use resources before becoming eligible for HIP services. For example, the definition of AFRs that must be ''exhausted'' includes income that must be used for needs other than rehabilitation services, and seems to indicate that an individual must be impoverished before being considered eligible for HIP. The final-form regulations should specify the income and/or assets that the Department will consider in making a determination of financial eligibility.

Response

   The Department agrees with the comment. Because of the confusion engendered by the use of the term ''exhausted,'' the final-form regulations do not include it. Instead, the final-form regulations provide simply that individuals must have AFRs in the amount of 300% or less of Federal poverty level. AFRs include: any income subject to Federal income tax; funds available to the individual by virtue of having experienced the TBI; and funds available to the individual through other State or Federal programs. AFRs do not include other assets.

Comment

   The Department should describe the procedures and standards it will use for the evaluations to determine an applicant's initial eligibility.

Response

   The final-form regulations distinguish between an individual's eligibility for an assessment and enrollment. An applicant is initially determined to be eligible for an assessment, which assessment will be used to determine whether HIP services would be appropriate for that person. An applicant's eligibility for an assessment will be evaluated based on the application form and its accompanying documentation. Subsection (a) contains all of the criteria that must be met for an applicant to be eligible for an assessment. The requirements of subsection (a)(1) are largely self-explanatory. The application form will require the applicant to identify the date the TBI was sustained. Documentary proof of residence and United States citizenship will be required. Although the applicant can answer as to age, documents, including insurance forms, will be required and will serve as a check on the other information provided. Documentary proof of income must be provided and will be evaluated as explained in subsection (a)(1)(v)(A) and (B). The required proof will include, but will not be limited to, a completed Federal income tax form.

   Subsection (a)(2) provides that, to be eligible for an assessment, an applicant cannot have an impairment that is attributable to certain listed conditions. A physician's statement will be requested under subsection (a)(1)(iv). It will be on a form provided by the Department and is to be completed by the applicant's physician. It will ask whether the applicant's impairment is attributable to any of the enumerated conditions. The physician is, therefore, responsible to provide this information. The Division will use that statement in determining whether the applicant is eligible for an assessment.

   Subsection (a)(3) states that an applicant must not manifest any symptom that would prevent the applicant from participating in the assessment or would prevent the provider from completing a full assessment. Again, the Division will request the applicant's physician to provide this information on the physician's statement.

   Finally, subsection (a)(4) requires the applicant to complete an assignment agreement assigning to the Department rights in future proceeds which may accrue to the applicant as a result of the TBI, up to the amount expended for HIP services for that individual. If an applicant refuses to complete it, the applicant will not be deemed eligible for enrollment in HIP.

Comment

   An applicant is ineligible for HIP if the applicant has significant preexisting psychiatric, organic or degenerative brain disorders, under proposed § 4.4(c)(4). Who makes the determination that an applicant's impairment is the result of a preexisting condition?

Response

   Ultimately, the Division makes that determination. The subject matter addressed in proposed § 4.4(c)(4) is addressed in subsection (a)(2) in the final-form regulations. As previously stated, the Division will require applicants to submit a statement that must be completed and signed by their attending physicians. Additionally, the Division may request access to an applicant's medical record. The applicant will be ineligible for HIP due to a preexisting condition if either the physician's statement or the patient record demonstrates that the applicant's impairment is due to one of the conditions listed in subsection (a)(2).

Comment

   What if an individual with a history of emotional illness sustains a TBI?

Response

   Proposed subsection (c)(4), now subsection (a)(2)(iv), specifically makes patients with certain conditions, including significant preexisting psychiatric disorders, ineligible for HIP.

Comment

   An applicant is ineligible for HIP if the impairment is due to a ''cerebral vascular accident'' under proposed § 4.4(c)(5). The Department should define this term, which has previously been defined in Stedman's Medical Dictionary (Williams & Williams, 1982) as ''an obsolete and inappropriate term for 'stroke.' ''

Response

   The Department agrees with this comment, and has replaced the term ''cerebral vascular accident'' with ''stroke'' in subsection (a)(2)(v).

Comment

   How will an individual's eligibility be affected if the individual has a TBI and then sustains a stroke as a result of the TBI?

Response

   Subsection (a)(2)(v) provides that applicants are not eligible for HIP services for any impairment which is the result of a stroke. However, if an individual has sustained a stroke subsequent to the TBI, the affected individual could still apply for HIP services. Eligibility for an assessment would depend upon whether the impairment is attributable to the TBI rather than the stroke. If an assessment is necessary in order to be able to make this determination, the applicant will be assessed. If the applicant's impairment is determined to be due to TBI, eligibility will depend upon the applicant's ability to benefit from HIP services, just as it would for an applicant who had not suffered a stroke subsequent to the TBI.

Comment

   How will an individual's eligibility be affected if the individual is transitioning through an agitated phase of Ranchos Level IV? Is there a duration level?

Response

   Subsections (b)(4) and (d) provide that applicants who demonstrate suicidal or homicidal behavior or potentially harmful aggression are precluded from participating in HIP. Therefore, applicants who are transitioning through an agitated phase of Ranchos Level IV would be ineligible for the Program if they exhibit aggressive or homicidal behavior because of it. Individuals who are transitioning through an agitated phase of Ranchos Level IV have to demonstrate the ability to benefit from HIP services at the time the application is made, just like any other applicant. The duration of the agitated phase is therefore irrelevant except as it affects the applicant at the time application is made. The applicant is free to reapply if the applicant is initially rejected due to transitioning through an agitated phase of Ranchos Level IV.

Comment

   What are the criteria and the process by which an applicant's eligibility for enrollment in HIP is evaluated?

Response

   As discussed previously, an applicant is eligible for an initial assessment if the applicant meets the criteria specified in subsection (a)(1), if the impairment is not caused by the conditions described in subsection (a)(2), if the applicant does not exhibit the symptoms described in subsection (a)(3) and signs the assignment agreement as required by subsection (a)(4). A HIP provider will then perform an assessment to enable the Division to determine whether the applicant is eligible for HIP enrollment. The applicant will choose the provider who will perform the assessment from a list of approved providers that will be supplied by the Division. As providers are approved, they will be added to the list.

   The Division will determine whether the applicant is eligible for enrollment, and the period during which the applicant will be enrolled and receive rehabilitation services, based upon the outcome of the assessment. The assessment process includes face-to-face interviews with both the applicant and the applicant's significant other, close family members or authorized representative, if appropriate. The part of the assessment directly involving the applicant may take place at the facility or at the applicant's home or the facility where the applicant is residing at the time. In addition to the interviews, under subsection (c), the applicant's medical records, including, but not limited to, all treatment records relating to the TBI, are examined.

   The assessment process is intended to identify the applicant's areas of need, upon which rehabilitation will be focused. The assessment will identify: the applicant's physical, emotional and psychological needs; potential for improvement; areas to be addressed through rehabilitation services; facility and community resources needed; and how choices can be provided for the applicant. This identification of the applicant's needs and ability, and how to best serve the applicant, is accomplished by consulting several sources, including medical records, significant others and the applicant. A team of professionals from relevant disciplines who will be designated by the provider conducts the assessment, as required by the contract between the Department and the provider. If it is determined that the applicant can benefit from services offered by the provider, the assessment team will establish ultimate discharge goals, assign the applicant a treatment team of professionals from each identified area of need and draft a rehabilitation service plan for submission to the Department.

   Best practice measures will be used to make the initial determination as to whether the applicant can benefit from services offered by the provider. Providers will be given a standardized intake form, developed by the Department and its consulting neuropsychologist, that measures the applicant's current functional living abilities, including degree of independence, as well as whether the applicant can make progress in various functional abilities, including physical, cognitive and psychosocial functions. If appropriate, the applicant's readiness for vocational training is assessed. The form draws upon a number of generally accepted performance measures, and will be revised as best practice standards change.

Comment

   The statement in proposed § 4.4(b) that an applicant's eligibility will be determined based on a case manager's recommendation and ''other neuropsychological evaluations as deemed appropriate by the Department'' is confusing and unclear. If the Department intends to require each applicant to undergo a neuropsychological evaluation, the requirement should be clearly established.

Response

   At this time, a neuropsychological evaluation no older than 1 year is necessary as part of the assessment. In many cases, the provider will not need to perform an evaluation because one may have already been done at the acute-care facility and will be part of the applicant's medical record. The Department's contract with the provider will require that, if a current neuropsychological evaluation is not available, the provider will perform one or ensure that one is performed. Ordinarily, the Department's consulting neuropsychologist will not perform the evaluation.

Comment

   The Department should provide more information about the role and term of its neuropsychological consultant and the role of the Department's neuropsychological consultant in providing neuropsychological evaluations should be clarified.

Response

   The Department's neuropsychological consultant provides technical assistance and advice to the Program on clinical issues as requested. The Department presently contracts with the consultant for a term of 3 years. As previously explained, the Department's consulting neuropsychologist will not ordinarily perform the neuropsychological evaluation necessary to the assessment.

Comment

   The Department should explain how applicants' medical histories would be utilized in the evaluation process.

Response

   Provider examination of the applicant's medical history is an important part of the assessment. It assists in determining whether the applicant can benefit from HIP services and, if so, what specific rehabilitation services the applicant needs. The Division may also request the applicant's medical records to use in making the determination as to whether an applicant meets the subsection (a)(2) and (3) symptom and condition criteria for enrollment.

Comment

   It is inappropriate to have a determination of achievement of maximum medical improvement made by a case manager and/or neuropsychologist. A physiatrist, neurosurgeon, neurologist or other person with medical experience in brain injury rehabilitation should review applicants to determine their potential to benefit from HIP services. These board-certified professionals are best qualified to recognize subtle changes in a patient's neurologic recovery.

Response

   The Department disagrees with the comment. HIP focuses upon rehabilitation. HIP providers are not medical facilities. Rather, they are facilities that provide post-acute rehabilitation services, which consist of physical and mental therapies that are most often directly provided by nonphysician professionals who may or may not be supervised by a physician. Although the facilities are all under the supervision of physicians who practice in relevant areas and who will be involved in the assessment process as appropriate, those physicians will not necessarily be neurosurgeons, neurologists or physiatrists. While the persons who directly provide HIP rehabilitation services are not likely to be neurosurgeons, neurologists or physiatrists, medical specialists may have worked with the applicant during the applicant's treatment in an acute care facility prior to entering the Program, and their expertise and conclusions as evidenced in the medical record are an important part of the evidence weighed in the assessment process.

Comment

   The determination of ability to benefit and live more independently should be accomplished through the use of generally accepted performance measures such as the Functional Independence Measure. Specific outcome measures can show improvement when more global outcome measures show no change. A more systemized and careful determination of a patient's ability to benefit from rehabilitation services should be mandatory.

Response

   The Department will use best practice measures to determine whether an applicant is able to benefit from HIP services. These may incorporate or include the use of the Functional Independence Measure and other specific outcome measures.

Comment

   Proposed § 4.4 states that an individual would be ineligible for HIP if the Department deems that the individual lacks the potential to benefit and live more independently as a result of HIP services. Individuals who suffer from TBI may not show improvement in a consistent fashion. The final-form regulations should stipulate that the patient should be given 3 months over which to demonstrate progress when the eligibility determination is being made.

Response

   The recommendation is rejected. Substantial funding would be needed to pay for a 3-month assessment period. The Department lacks sufficient funds to provide HIP services to all persons who may benefit from the services. The Fund can be used to serve more persons with TBI if the applicants are ready and able to benefit from rehabilitation services at the time of the assessment. An applicant who is initially found ineligible is free to reapply, and may later qualify to participate in HIP if progress is made after the initial application.

Section 4.7--Enrollment.

   This section discusses client enrollment, including determination of eligibility and maximum term of enrollment.

Comment

   Proposed § 4.4(f) should provide that applicants will be notified when they are ineligible, as well as when they are eligible.

Response

   The Department accepts the recommendation. This matter is addressed in subsection (a). It states that an applicant will be notified of the Division's decision on an application for enrollment (whatever that decision may be) within 16 days of the Division receiving the completed assessment from a provider.

Comment

   Under proposed § 4.4(b), a case manager with only 2 years of experience makes the critical determination as to the applicant's potential to benefit from HIP services. This is inappropriate. The Department should clarify the case manager's role in determining an applicant's potential to benefit from HIP services.

Response

   The Department agrees with the comment. The Department has removed from proposed § 4.4(b) the reference to the case manager's recommendation. Subsection (b) states that the provider shall assess the applicant and determine whether the applicant can benefit from HIP services. Case managers employed by the provider may or may not participate in the assessment of the applicant as part of the assessment/treatment team assigned by the provider. In this capacity, the case manager would provide information and input relevant to the determination of whether an applicant can benefit from services. The team assigned by the provider will make recommendations to the Division. As clarified in subsections (a) and (b), the Division will make the ultimate determination of an applicant's potential to benefit.

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