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PA Bulletin, Doc. No. 02-1168

RULES AND REGULATIONS

Title 4--ADMINISTRATION

Title 28--HEALTH AND SAFETY

DEPARTMENT OF HEALTH

[4 PA. CODE CH. 259]

[28 PA.COCE CHS. 701 AND 703]

Drug and Alcohol Facilities and Services--Standards for Approval of Prevention and Intervention Activities

[32 Pa.B. 3201]

   The Department of Health (Department) deletes 4 Pa. Code §§ 259.1 and 259.2 and 28 Pa. Code § 701.13 and Chapter 713 and amends 28 Pa. Code § 701.1 to read as set forth in Annex A. The provisions being deleted pertain to standards for approval of drug and alcohol abuse prevention and intervention activities. These activities are generally referred to as prevention activities.

Purpose of the Amendments

   This final-form rulemaking deletes the regulations relating to approval of prevention and intervention activities. A key benefit of this final-form rulemaking is that Department staff and other limited resources will no longer be needed to review prevention and intervention activities and, therefore, may be directed toward oversight of entities providing substance abuse treatment services. This final-form rulemaking will increase the efficiency of the Division of Drug and Alcohol Program Licensure in carrying out its regulatory oversight of the substance abuse treatment delivery system. It will also enhance the redirection of State government efforts from general prevention activities to specific treatment activities to ensure the safe and effective delivery of substance abuse treatment services.

   The Department is deleting these provisions because regulation of the substance abuse service delivery system has changed significantly over the past few years, rendering these regulations obsolete. More changes are predicted in the coming years based on current plans to change the health care delivery system at both the State and Federal levels. Even now, much is being done in the field of substance abuse prevention which does not fit within the regulatory definitions of prevention activities that are being deleted. Hence, those activities are not regulated. Nonetheless, they are appropriate and relevant prevention activities. Moreover, the lack of Department approval of these activities under a regulatory scheme has not compromised their quality or effectiveness. Further, much of what has been defined and regulated is no longer being conducted due to the evolving nature of drug and alcohol abuse prevention services.

   To better address the needs of the substance abuse service delivery system and maximize benefits from existing resources, it is necessary to modify regulatory oversight and cease the approval of prevention activities. This elimination will reduce the overload on survey staff resources and enable the Department to focus its attention on the oversight of activities that actually provide treatment to the substance abusing client.

   The prevention activities that the Department will no longer approve do not provide treatment to clients. The Department's resources will be better used by focusing on activities through which specific substance abuse treatment services are being provided. Prevention activities and services generally provide to the general population and special high risk groups only, information regarding the nature and extent of alcohol and other drug abuse and addictions and their effects on individuals, families and communities.

   The Department has been approving approximately 100 prevention activities. Notwithstanding the elimination of the approved processes effected by the deletion of the regulations, the Department will continue to impact these activities, but at less cost and with greater efficiency.

   Within the Department, the Bureau of Drug and Alcohol Programs (BDAP), which funds and monitors prevention programs through contracts, and provides counties with funding to provide drug and alcohol services for the citizens of this Commonwealth who do not have insurance or resources to pay for treatment. Single County Authorities (SCAs) prepare prevention plans tailored to the needs of their respective geographic areas. The Department approves these plans and formulates a Statewide plan based on the plans prepared by the SCAs.

   Statewide prevention programs provide current information on the effects of drugs and alcohol and assist individuals in developing or improving skills that will enable them to choose a lifestyle free of substance abuse. Educational sessions, workshops and media presentations are used. Also, an information clearinghouse is funded by the Department. Primary emphasis has been given to youth, and a special curriculum is now used in school districts to provide drug and alcohol prevention programs.

   The Student Assistance Program (SAP), which encompasses all 501 Commonwealth school districts, provides school personnel with the knowledge and skills needed to identify students using alcohol or drugs. Students are referred to professional evaluators and, if needed, receive treatment services. Special services are designed to divert certain criminal offenders into rehabilitation programs.

   The funding of prevention activities by the Department is accomplished through contracts with the SCAs. After the plans referred to previously are submitted, reviewed and approved, the Department funds the SCAs according to a previously established funding formula. The SCAs then provide the prevention services or subcontract to other prevention providers. While for the most part, SCA funding is given to approved prevention providers, the drug and alcohol prevention services being performed are generally not activities that fit within the obsolete definitions of prevention activities that are being deleted. Nevertheless, these funded activities are in line with the current best practices in prevention. Clearly, the provision of these services is appropriate. What this underscores is that since the current activities being performed do not fit within the old definitions, the deletion of some of those definitions is necessary. What it also underscores is that licensure of defined prevention activities is no longer feasible or necessary. The rapid evolution of prevention activities would necessitate a constant revision of the regulations. The funding processes are better suited to deal with the pace of change. The Department's role in those processes ensures its continuing involvement and impact on prevention activities.

   The monitoring of the prevention activities is adequately accomplished by the staff of BDAP's Division of Prevention, which provides up-front technical assistance in the planning of prevention activities and continues prevention assistance and monitoring, and its Division of Program Monitoring, which performs post-performance review and audit to determine compliance with the terms of the entire contract with the SCAs, including the terms addressing prevention.

   Almost every Federal and State dollar that is spent on prevention in this Commonwealth passes through the State and counties to prevention providers. The small amount that does not pass through the State is distributed directly by the Federal government to counties or providers through grants. That grant process requires application and review by the Federal government and, in most cases, requires the recipient to have prior prevention experience. Thus, this process contains the necessary checks and balances to ensure that unqualified operators do not receive funds. As for the remainder of the public dollars, the Department, through its agreements with the counties, monitors the services that are being provided, the amounts that are being spent and the results of the services. There is very little chance, if any, that these funds will be provided to individuals or entities that are unscrupulous or unqualified operators.

Current Prevention System

   Because of the dramatic change in procedures, at least as they have been identified by regulation, a detailed discussion of how the prevention system works without the regulations may be helpful.

A.  Prevention Plan Contractual Requirements

   First, prevention funds provided to the county must be used to develop and implement a comprehensive system of resources that includes a broad array of prevention strategies directed at individuals not identified to be in need of treatment. The services are to be provided either directly by the county or through one or more public or nonprofit private entities. Prevention program activities are to be provided in a variety of settings to targeted populations that are severely affected by risk factors associated with substance abuse, determined through community-wide biannual needs/risk assessments.

   Second, the delivery of comprehensive prevention services has been formalized into six major categories of strategies to meet Federal Substance Abuse Prevention and Treatment (SAPT) Block Grant requirements. Services that were previously fragmented as singular activities are now identified by agencies as part of their overall plan for the comprehensive provision of prevention programming to impact their targeted populations. As a management agency for drug and alcohol services, the county must budget for and implement prevention strategies under each category as appropriate to meet the unique needs of its community and fulfill Federal SAPT requirements for this Commonwealth.

   Third, the county must submit written reports to the Department at times the Department requires in accordance with the BDAP Report Schedule. The reports need to contain information identified by the Department relating to the activities and categories already discussed.

B.  Performance Based Prevention Services

   The county is required to plan, deliver and evaluate prevention services using BDAP's Performance Based Prevention System. The services must focus on the reduction of risk factors that contribute to substance abuse and the development or enhancement of protective factors that build resilience among individuals, families and communities to reduce targeted risk factors.

   The county must ensure that all prevention and early intervention services funded by the county are included in the county's plan to deliver performance based prevention services. The county's prevention plan and annual updates as approved by the Department are incorporated into the county agreement and serve as the county's work statement for prevention and early intervention services.

   The county must also ensure that the following criteria are adhered to in the implementation of performance based prevention:

   (1)  Prevention and early intervention services shall be directed towards reducing risk factors identified by the county through a needs/risk assessment of its service area.

   (2)  Needs/risk assessment shall be conducted at least every 2 years using the Department's needs/risk assessment survey instrument and its methodologies for obtaining statistical data.

   (3)  Risk factors deemed by the needs/risk assessments to be most seriously affecting substance abuse within targeted areas shall be identified in the development of long-term (3-5 year) goals, using the Department's performance based prevention process.

   (4)  Baseline data shall be gathered to determine the current level or risk factors existing within the targeted areas and establish a maximum achievable percentage by which each risk factor is to be reduced.

   (5)  Standardized indicators established for each risk factor in the performance based prevention software (PBPS) shall be used to measure the reduction of risk and utilized by the county periodically to assess the reduction of risk factors.

   (6)  A comprehensive structure of measurable objectives, using the six Federal categories of prevention identified in the agreement, shall be developed as a framework for planning and delivering program services that build protective factors for reducing risks associated with substance abuse.

   Following are the six Federal categories and examples of activities that comprise the overall concept of prevention services to reduce the abuse of alcohol, tobacco and other drugs:

   (1)  Information dissemination. This category provides awareness and knowledge on the nature and extent of alcohol, tobacco and drug use, abuse and addiction and the effect on individuals, families and communities. It also provides knowledge and awareness of available prevention programs and services. Information dissemination is characterized by one-way communication from the source to the audience, with limited contact between the two. Examples of acceptable activities include, but are not limited to:

   *  Clearinghouse/information resource centers.

   *  Resource directories.

   *  Media campaigns.

   *  Brochures.

   *  Radio/TV public service announcements.

   *  Speaking engagements.

   *  Health fairs/health promotion.

   *  Information line.

   (2)  Education. This category involves two-way communication which is distinguished from information dissemination by the fact that interaction between the education/facilitator and the participants is the basis of its activities. Activities under this category are to affect critical life and social skills, including decision-making, refusal skills, critical analysis (such as media messages) and systematic judgment abilities. Examples of acceptable activities include, but are not limited to:

   *  Classroom or small group sessions (spanning all age groups).

   *  Parenting and family management classes.

   *  Peer leader/helper programs.

   *  Education programs for youth groups.

   *  Education groups for children of substance abusers.

   (3)  Alternative activities. This category operates under the assumption that healthy activities will deter participants from the use of alcohol, tobacco and other drugs. The assumption is that constructive and healthy activities offset the attraction to, or otherwise meet, the needs usually filled by alcohol, tobacco and other drugs and would, therefore, minimize or obviate resort to the latter. The BDAP will not fund alternative activities unless they are linked to educational or skill-building activities. Examples of acceptable activities include, but are not limited to:

   *  Drug free dances/parties.

   *  Youth/adult leadership activities.

   *  Community service activities.

   (4)  Problem identification and referral. This category targets those persons who have experienced first use of illicit/age-inappropriate use of tobacco, and those individuals who have indulged in the first use of illicit drugs and alcohol, to assess if their behavior can be reversed through education. Examples of acceptable activities include, but are not limited to:

   *  Employee assistance programs (EAP).

   *  SAP.

   *  Driving Under the Influence programs.

   (5)  Community-based process. This category aims directly at building community capacity to enhance the ability of communities to more effectively provide prevention and treatment services for alcohol, tobacco and drug abuse disorders. Activities include organizing, planning, enhancing efficiency and effectiveness of services, interagency collaboration, coalition building and networking. Examples of acceptable activities include, but are not limited to:

   *  Community and volunteer training.

   *  Training key leaders, staff/officials.

   *  Multiagency coordination and collaboration

   *  Systematic planning.

   *  Accessing service and funding.

   *  Community team building.

   (6)  Environmental. This category establishes or changes written and unwritten community standards, codes, ordinances and attitudes thereby influencing incidence and prevalence of the abuse of alcohol, tobacco and other drugs used in the population. This category is divided into two subcategories to permit distinction between activities that center on legal and regulatory initiatives and those that relate to action-oriented initiatives. Examples of acceptable activities include, but are not limited to:

   *  Promoting establishment or review, or both, of alcohol, tobacco and other drug use policies in schools.

   *  Technical assistance to communities to maximize law enforcement procedures governing the availability and distribution of alcohol, tobacco and other drugs.

   *  Modifying advertising practices.

   *  Product pricing strategies.

   The county must ensure that its contracted providers plan, develop, deliver and evaluate science-based program services that coincide with the specific objectives and Federal categories of prevention. Program services must reflect strategies and practices proven to build protective factors within the targeted populations or communities in which they are delivered. The selection of appropriate instruments for evaluating program services must be planned by the county and its contracted providers during the planning of services and shall be applied to evaluate the process, outcomes and impact of prevention services.

   Evaluation methodologies may include tracking and assessment of individuals participating in prevention program services. These methodologies must be administered to determine changes in attitudes or behaviors and awareness, knowledge and skills achieved as a result of the services received by participants. This data must be recorded within the appropriate modules of the PBPS data collection system.

   The county must monitor, analyze and collect data, as determined by the Department, from its providers monthly. The county must require service providers to collect and analyze service data for quality improvements and submit monthly recommendations to the county. Data must be collected and maintained using the Department's PBPS. The county must aggregate data and submit quarterly data to the Department in accordance with the BDAP Report Schedule.

   The county must also evaluate the PBPS data produced by its providers and use it to determine compliance in meeting its annual objectives and to develop methods for improvements in program services. Specific data requested by the Department shall be aggregated through quarterly reports. The Department will monitor the county, evaluate quarterly reports, and provide technical assistance as needed to assist the county in achieving its annual objectives and outcomes toward the reduction of risk factors.

   The county must collaborate with agencies and organizations within its service area to establish, deliver and measure comprehensive strategies for reducing identified risk factors that contribute to substance abuse. Data generated by these collaborative efforts shall be used to study and measure the reduction of risk factors within the service area. The county and its contracted providers must cooperate with the BDAP and its evaluators in conducting sample impact studies in communities they serve to determine changes in risk factors.

C.  Reduction of Youth Access to Tobacco

   The county must address the reduction of tobacco use among youth within its prevention plan to comply with Federal requirements. These activities must be in addition to the county's goals, objectives and provision of services for reducing identified risk factors, when the assessment of risk factors does not indicate tobacco use as severely impacting substance abuse within the county's service area. In addressing the requirements to reduce tobacco use among youth in the county's service area, the county shall at a minimum perform the following functions:

   (1)  The county must conduct or otherwise secure contracted services in its service area to provide merchant education activities for over-the-counter retailers and establishments having vending machines. These activities must include educating retailers and vending machine operators of their responsibilities and obligations under State and Federal laws relating to youth tobacco sales, youth access to tobacco, as well as emphasizing the health effects of tobacco use. Activities may include, but are not limited to, direct contact with merchants, use of media (that is, TV, radio, newspapers, billboards), educating through vehicles such as trade associations, as well as through community and business responsibility initiatives.

   (2)  The county must conduct or otherwise ensure that merchant compliance checks are conducted within its geographic area. It must also participate with health district office personnel in conducting semiannual compliance activities.

   (3)  The county must coordinate with community partners to encourage local efforts to develop strategies to reduce the sales of tobacco products to youth. Partners may include, but are not limited to, the district tobacco prevention consultant, the district chronic disease team of consultants, State Health Improvement Plan, Pennsylvania Tobacco Prevention Network tobacco coalitions, the American Cancer Society, the American Heart Association, the American Lung Association, health care providers and other voluntary organizations. Coordination efforts shall address, but not be limited to, youth access to tobacco product issues, education and cessation initiatives.

   (4)  The county must address the foregoing requirements as an addendum to the County's Prevention Plan when the assessment of risk factors does not indicate tobacco use as severely impacting substance abuse within the county's service area.

D.  Student Assistance Programs

   The Department provides the county with money under the Safe and Drug Free Schools and Communities Act of 1986, Pub.L. No. 100-297, as amended by the Anti-Drug Abuse Act of 1988, Pub.L. No. 100-690, 20 U.S.C.A. § 3171 et seq., as amended by the Safe and Drug Free Schools and Communities (SDFSC) Act of 1994. The county must use the SDFSC funds for consultation services to school district personnel and core team members, and for assessment and group intervention services for those students involved in SAP. The SDFSC funds may not be used for the provision of treatment services.

   The Department also provides the county with State funds and the SAPT Block Grant funds to support SAP. The Department provides the county with State funds annually for consultation, assessment, group intervention or treatment services. The SAPT Block Grant funds provided for SAP under the contract must be used for treatment services only. The amounts provided are for drug treatment services and for alcohol treatment services.

   The county must use these funds to provide or arrange for the provision of programs offering drug abuse education, prevention or counseling to students at compulsory school age, including:

   (1)  Programs to provide drug abuse counseling in a school by trained personnel.

   (2)  Programs that stress the use of peers to combat student abuse of drugs and alcohol.

   (3)  Programs that stress community involvement in combating student abuse of drugs and alcohol.

   (4)  Programs that train Core Team members and teachers to encourage parent involvement in SAP.

   (5)  Other appropriate programs that target students and parent involvement in SAP.

   The programs provided with these funds must be designed to prevent or eliminate student abuse of drugs or alcohol.

   The county must use funds provided to expand, extend or replicate a program that has a proven record of success at either the State or local level in preventing or eliminating student abuse of drugs and alcohol.

   The county must also ensure that the program to be expanded, extended or replicated is appropriate for the students to be served, based on an assessment of their most important needs.

   The county, prior to receiving the funds must provide to the Department, at a time and in a manner and containing or accompanied by other information and assurances the Department may reasonably require, the following:

   (1)  A discussion of why the particular program is appropriate for and responds to the particular needs of the students to be served.

   (2)  A complete description of the success of the program in reducing or eliminating drug or alcohol abuse of compulsory school age students.

   (3)  An assurance that funds shall be used to supplement, not supplant, other Federal, State and local funds expended.

   Quarterly SAP Statistical and Fiscal Report Forms and semiannual SAP Treatment Report Forms must be submitted as prescribed by the Department and in accordance with the BDAP Report Schedule. These reports will be used by the Department to monitor the use of the funds received and activities performed. This monitoring of activities and use of funds will be performed to assure compliance with applicable Federal requirements and to assure that performance goals are being achieved. Monitoring will cover each program function or activity. The county must assure the accuracy of those reports.

Comments

   Proposed rulemaking was published at 31 Pa.B. 2125 (April 21, 2001). A 30-day comment period was provided. The Department received comments from five commentators. The commentators were the Independent Regulatory Review Commission (IRRC), the Council on Alcohol and Drug Abuse (CADA), the Lackawanna County Commission on Drug and Alcohol Abuse, the County of Chester and the Pennsylvania Association of County Drug and Alcohol Administrators, Inc. (PACDAA). The letters from the County of Chester and PACDAA were nearly identical.

   The comments are directed toward the rescission in general and not toward any particular section. Thus, it is not possible to list the comments according to sections. Therefore, the Department will summarize the comments in their entirety and respond, without relating them to a particular section or sections being deleted.

Comment:

   The proposed rulemaking deleted the standards for approval of prevention and intervention activities for drug and alcohol facilities and services. We question the impact on the public health and the reasonableness of deleting these regulations without proffering any proposed rulemaking to take their place. Item #16 of the Regulatory Analysis Form states that a workgroup was convened to develop an alternative to the current regulations. However, the alternative is not discussed in the Preamble to the proposed rulemaking.

   With the deletion of these regulations, how will the Department provide oversight of drug and alcohol prevention services and programs? The Department should also explain what alternative will be in place when the Department submits its final-form rulemaking.

Response:

   There will be no impact on the public health by deleting these regulations even though there are no new regulations to replace them. As already discussed, the deleted regulations have been ineffective and without value to the field of prevention for some time. In fact, through the BDAP's Division of Prevention, the standards of prevention services have been remarkably advanced and improved, despite the current obsolete regulations. The Department currently provides oversight of drug and alcohol services and programs through its contracts with the local SCAs and their subcontracts. This alternative form of monitoring prevention services has been in place for some time. This monitoring and oversight allows for more flexible program services which are in line with current standards of practice, provides for better and more regular monitoring of programs and services, and protects the public health in this area far better than the deleted regulations did.

   The comment regarding the workgroup will be discussed in responding to another comment.

Comment:

   There is no alternate approval process proposed to take the place of the current standards, leaving prevention activities an unregulated activity in this Commonwealth. While the rescission of the current process is necessary, to do so with no alternative process in place presents a window of opportunity for anyone to claim they deliver such services. This will possibly do harm to the field of substance abuse prevention.

Response:

   While it is true that there will be no regulatory approval process upon rescission of the current regulations, no regulatory process is necessary because of the funding process, as has already been explained. The lack of regulation does not hamper quality prevention services. The services will still be monitored.

   As previously explained, monitoring is performed by two different divisions within the BDAP. Contract review, evaluation and notification of the programs is taking place. Whenever certain activities within an SCA are found to be deficient, the divisions provide assistance to allow for correction. If continued problems exist, the contracts allow for the withholding of funds for the period of time until deficiencies are corrected.

   This area is one that lends itself less to regulation by the Division of Drug and Alcohol Program Licensure and more to monitoring by the Division of Prevention.

   The Department disagrees that the lack of regulation presents a ''window of opportunity.'' In fact, almost anyone can claim to deliver prevention services now. Much of what is appropriate and considered current practice in the field of prevention is already outside the scope of the regulations. For example, Drug Abuse Resistance and Education (D.A.R.E.) is a longstanding prevention program which, because of the archaic definitions in the regulation, is completely outside the scope of regulation by the Department. There are many other worthy programs that provide valuable prevention services which are not regulated.

   The Division of Prevention monitors these prevention services and their funding through the SCA contracts and thus ensures that ''fly-by-night'' operations will not suddenly appear and receive funds. All subcontracts are subject to review by the BDAP, either prior to execution or during the term by the BDAP's Divisions of Treatment and Program Monitoring. If programs are not providing the appropriate quality services, and thus causing the SCA to not comply with the contractual terms, the BDAP has the ability to mandate prompt changes. Further, the SCAs are also required to monitor their own subcontractors. The regular and continuous monitoring of prevention providers and the services and activities they are conducting, by both the Department and SCAs, assures that only quality, experienced prevention programs will receive funds.

Comment:

   Until a time as an alternative process is in place which will preserve the integrity and professionalism of the prevention field, the Department should continue its regulation of prevention programs.

Response:

   The alternative process already in place through the BDAP's contracting process does more to preserve the integrity and professionalism of the prevention field than the obsolete regulations did. In fact, prior to this rescission, there were very few prevention services being delivered which were covered by the regulations. The quality and integrity of prevention services is measured and preserved by the outcomes and results as currently monitored by the BDAP. The quality and integrity of the prevention field is not maintained simply because programs are able to comply with some minimal, obsolete standards and thereby secure a certificate of approval to hang on a facility wall. Compliance with the repealed regulations indicated nothing regarding the quality of the prevention services being offered.

Comment:

   While the Department agrees that the existing regulations are not relevant to and do not reflect current drug and alcohol prevention practice in this Commonwealth, we believe these deletions will put at great risk drug and alcohol prevention services and significant public dollars used to fund the services.

   A large amount of State, Federal and local public funding supports drug and alcohol prevention services throughout this Commonwealth. These services touch on most segments of our communities. Therefore it is essential that we ensure a baseline standard is met. By eliminating standards, without any alternative to replace them, it appears that the Department is devaluing prevention and the need for these services.

   There has been a great deal of work done on an alternative by many stakeholders. However, there has yet to be a finished product distributed that has had any, much less adequate, time for comment from affected parties. There should be no elimination of the current prevention regulations until an alternative, which has been commented on by affected parties, has been definitively established.

   Finally, adequate financial resources for implementation must accompany whatever alternative is established. The transfer of this responsibility from licensing to another entity results is a shift in costs that must be addressed. The fiscal impact note for the proposed rulemaking states that there would be ''no measurable fiscal impact on the Commonwealth, local government, the private sector or the general public.'' We strongly disagree with this statement.

   Whatever alternative is established will require oversight. If this occurs by means of the SCA contracts, it will require new staff at the county level. If it occurs by means of an independent certification body, it will require funding to the selected body from the State, a new fee from prevention providers, or both. As many prevention organizations are grass-roots nonprofits, the need to pay this fee may also have the unintended effect of eliminating effective resources. If no alternative is established then large amounts of taxpayer funds are put at risk for ineffective use.

Response:

   This comment is a combination of the comments submitted by two commentators. Because both comments were virtually identical, the Department combined them. Both commentators begin their comments by stating that the current regulations do not reflect, and are not relevant to, the current drug and alcohol prevention practice. Given that statement, there can be no greater reason for eliminating the regulations being deleted. These commentators are recommending that the Department keep in place something they admit serves no useful function in the prevention field. The reasons for this position are unclear.

   The remainder of the comment makes assertions of alleged potential harm due to the deletion of the regulations without an explanation of the harm that would occur. The first assertion is that the lack of regulation will put at risk prevention services and significant public dollars used to fund these services. The comment provides no explanation for this assertion; however, it is the Department's position that this statement is not accurate in any event. Almost every Federal and State dollar that is spent on prevention in this Commonwealth passes through the Commonwealth and counties to prevention providers. The small amount that does not is distributed directly by the Federal government to counties or providers through grants. That grant process requires application to and review by the Federal government and in most cases requires the recipient to have prior prevention experience. Thus, the funding processes contain the necessary checks and balances to ensure that unqualified operators do not receive funds, spend them inappropriately and harm the field. As for the remainder of the public dollars, the Department, through its agreements with the counties, currently monitors the services that are being provided, the amounts that are being spent and the results of the services. There is very little chance, if any, that these funds will be provided to individuals or entities that are unscrupulous or unqualified operators.

   The second point of the comment suggests that regulations are needed to assure that the ''baseline'' standard is met. Apparently, it is the thought that this ''baseline'' can be established by regulation. Again, this assertion is unfounded. Under the current method of funding and delivering prevention services, counties are required to submit plans to the BDAP, which are tailored to the specific needs of the counties. These needs vary from county to county. It is not possible to establish a Statewide ''baseline'' for prevention services when each geographical region differs in its needs and varies in its approach to the delivery of prevention services. To try to hold the entire State to one minimal standard in prevention actually undermines the objective of prevention as it is defined today.

   Rather than enhancing prevention, the deleted regulations undermine the quality and innovation by holding providers to outdated standards. Moreover, the deleted regulations did not regulate every prevention provider. The prevention system that is in place through the agreements between the BDAP and the counties actually enhances prevention by allowing for individualized delivery of services specifically addressing the counties' needs. Prevention has been brought to the forefront of the battle against drug and alcohol addiction by the BDAP funding and monitoring system which may evolve and change as the need arises.

   The next point in the comment relates to the workgroup. The workgroup first met in the Spring of 1998 and met regularly thereafter for 2 years. It has not met since the Spring of 2000. The purpose of the workgroup was to establish minimal criteria for the provision of prevention services. Accomplishing this objective is not dependent on the deleted regulatory scheme. The deleted regulations were not effective or useful and served no practical or functional purpose in advancing the cause of prevention. Therefore, maintaining them would have served no legitimate purpose irrespective of whether an ''alternative'' has been established. Maintaining outdated regulations, which are used to approve only a small number of entities actually providing preventive services, would only continue to divert valuable and limited public resources away from other necessary areas of regulation and reduce the overall effectiveness of those public resources.

   The next part of this comment discusses resources for implementation of ''whatever alternative is established.'' That alternative is already established and resources have already been transferred to accommodate this system. The current process of monitoring prevention is performed by the BDAP and the SCAs through the funding processes. Personnel are already engaged in this work at both the State and local levels. The processes will continue, as they are now, with no further ''shift in costs'' necessary when the regulations are rescinded. The rescission of the regulations will not have any measurable fiscal impact on the Commonwealth, local government, the private sector or the general public. Even if there is a shift in costs as alleged, that shift would be just that. It would be a shift or reallocation, not an increase. Thus, again, there still would be no measurable fiscal impact. Dollars spent by the Department and the SCAs will, however, be used in a way that will yield better results.

   The last point in the comment restates those previously made and already addressed. Whether adjustments to the current funding system will require new staff, which the Department believes will not be the case, and whether independent certification will eliminate grass-roots nonprofit organizations, which the Department believes should not be the case, these issues are not a function of the repeal of ineffective regulations. The deletion does not affect these concerns one way or the other. As discussed previously, the lack of regulation in no way puts large amounts of taxpayer funds at risk of ineffective use. The current oversight system in place adequately protects against any alleged risks.

   All of the commentators are in agreement with the Department that the regulations the Department is deleting need to be deleted. The disagreement is whether there is a need to replace them with new regulations. New regulations are not necessary. Upgrading the regulatory scheme, as opposed to terminating the regulatory scheme, would be inconsistent with the objectives and goals articulated in Executive Order 1996-1.

   The prevention services delivery system currently in place through agreement between the Department and the SCAs is quite extensive. To receive the Federal and State prevention funds, the SCAs are required to comply with the contractual provisions of their agreements with the Department. This is the most effective system for the Department to monitor and influence the delivery of prevention services in this Commonwealth.

Fiscal Impact

   The deletion of the regulations for approval of drug and alcohol abuse prevention and intervention activities will have no measurable adverse fiscal impact on the Commonwealth, local government, the private sector or the general public. The major issues of concern raised by comments were increased personnel costs and risk of public dollars being spent ineffectively. These concerns are not substantiated. With the current prevention system, which operates through agreements between the BDAP and the local authorities, the State and local personnel are already in place. The deletion of the regulations will not cause an increase in personnel requirements. The deletion of the regulations will decrease costs of regulatory compliance by providers, thereby allowing them to reallocate their resources to other areas, such as the provision of additional prevention services.

   Additionally, the Commonwealth will be able to redirect its limited regulatory resources to areas needing greater regulatory oversight and achieve a more efficient use of those resources.

E.  Paperwork Estimate

   A prevention service monitoring system is already in place through the BDAP. Therefore, there will be no additional paperwork requirements for the Commonwealth, local governments or the private sector resulting from the deletions of the regulations. There will be a decrease in paperwork resulting from the discontinuation of the approvals. Applications for approval will be eliminated, as will the paperwork relating to the annual reviews.

F.  Effective Date/Sunset Date

   The deletion of the regulations will be effective upon publication in the Pennsylvania Bulletin as final-form rulemaking. No sunset date is necessary. The Department will monitor the effectiveness of retained regulations and alternative initiatives on an ongoing basis.

G.  Statutory Authority

   The Department was authorized by the General Assembly under Reorganization Plan No. 2 of 1977 (71 P. S. § 751-25), Reorganization Plan No. 4 of 1981 (71 P. S. § 751-31) and the Pennsylvania Drug and Alcohol Abuse Control Act (71 P. S. §§ 1690.101--1690.115) (Act 63), to assume the functions and responsibilities of the Governor's Council on Drug and Alcohol Abuse (Council). The Council's authority to regulate and promulgate rules and regulations was transferred to the Department through those reorganization plans. See Reorganization Plan No. 2 of 1977 (transferring duties under the Public Welfare Code with regard to regulation, supervision and licensing of drug and alcohol facilities to the Council), Reorganization Plan No. 4 of 1981 (transferring the functions of the Council to the Department and establishing the Council as an advisory council) and the 1985 Amendments to Act 63, as amended by act of December 20, 1985 (P. L. 529, No. 119) (amending Act 63 to reference the Pennsylvania Advisory Council on Drug and Alcohol Abuse). This final-form rulemaking was promulgated under these provisions.

H.  Regulatory Review

   Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on April 11, 2001, the Department submitted a copy of the proposed rulemaking to IRRC and to the Chairpersons of the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare for review and comment.

   Under section 5(c) of the Regulatory Review Act, the Department also provided IRRC and the Committees with copies of all comments received. In preparing this final-form rulemaking, the Department has considered all comments from IRRC, the Committees and the public.

   Under section 5.1(d) of the Regulatory Review Act (71 P. S. § 745.5a(d)), on May 1, 2002, this final-form rulemaking was deemed approved by the Committees. IRRC met on May 9, 2002, and approved this final-form rulemaking in accordance with section 5.1 (e) of the Regulatory Review Act. The Office of Attorney General approved this final-form rulemaking on June 14, 2002.

I.  Contact Person

   Questions regarding this final-form rulemaking may be submitted to John C. Hair, Director, Bureau of Community Program Licensure and Certification, 132 Kline Plaza, Suite A, Harrisburg, PA 17104, (717) 783-8665. Persons with a disability may also submit questions regarding the final-form rulemaking by using V/TT (717) 783-6514 for speech and/or hearing impaired persons or the Pennsylvania AT&T Relay Service at (800) 654-5984 [TT]. Persons with a disability who need this document in an alternative format (that is, large print, audio tape or Braille) should contact John Hair so that necessary arrangements may be made.

Findings

   The Department finds that:

   (1)  Public notice of intention to adopt regulations adopted by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202), and the regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.

   (2)  A public comment period was provided as required by law and the comments received were considered.

   (3)  The adoption of this final-form rulemaking in the manner provided by this order is necessary and appropriate.

Order

   The Department, acting under the authorizing statutes, orders that:

   (a)  The regulations of the Department are amended by deleting 4 Pa. Code §§ 259.1 and 259.2 and 28 Pa. Code §§ 701.13 and 713.1--713.5, 713.11--713.18, 713.21--713.29 and 713.41--713.43; and by amending 28 Pa. Code § 701.1 to read as set forth in Annex A.

   (b)  The Secretary of Health shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as required by law.

   (c)  The Secretary of Health shall submit this order, Annex A, a Regulatory Analysis Form and a Repeal Analysis Form to IRRC, the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare for their review and action as required by law.

   (d)  The Secretary of Health shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.

   (e)  This order shall take effect upon publication in the Pennsylvania Bulletin.

ROBERT S. ZIMMERMAN, Jr.,   
Secretary

   (Editor's Note:  For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 32 Pa.B. 2646 (May 25, 2002).)

   Fiscal Note:  Fiscal Note 10-164 remains valid for the final adoption of the subject regulations.

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