Scope statements
Controlled Substances Board
Subject
Classify as a schedule III controlled substance under state law any FDA approved prescription drug product containing gamma-hydroxybutyric acid.
Objective of the rule. By final rule of the Drug Enforcement Administration (DEA), adopted effective March 3, 2000, gamma-hydroxybutric acid (GHB) was classified as a schedule I and schedule III controlled substance under the federal Controlled Substances Act (CSA) pursuant to Public Law 106-172. GHB is currently only classified as a schedule I controlled substance under the Wisconsin Controlled Substances Act in ch.
961, Stats. The objective of the rule is to bring state classification of GHB into conformity with federal law.
Policy Analysis
Drugs that are classified as “controlled substances" under federal and state laws are subject to higher civil and criminal penalties for their illicit possession, distribution and use. Health care providers are also subject to greater record keeping requirements respecting their obtaining, prescribing and dispensing of such drugs. This is due to the fact that certain drugs have a greater likelihood of abuse, addiction and adverse consequences to patient health if utilized inappropriately, than do other drugs. The DEA administers the CSA. In doing so, it is empowered to schedule a drug as a controlled substance. Schedule III controlled substances are listed in
21 CFR 1308.13. Section 1308.13 (c) (5) lists GHB as included in that classification for any drug product containing GHB for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act. Public Law 106-172 authorized the DEA to classify GHB as a schedule I and schedule III controlled substance. This forms basis for the DEA action. The board has been requested to initiate rulemaking to create a GHB classification which mirrors federal law to enable citizens of this state to benefit from FDA approved prescription drug products containing GHB.
Statutory authority
Staff time required
It is estimated that 100 hours will be needed to promulgate the rule.
Health and Family Services
Subject
The Department proposes to make relatively minor or technical changes to a variety of its administrative rules via a single rulemaking order. The “Omnibus" order will cover proposed changes to the following Department administrative rule chapters:
TCB 1, relating to the Tobacco Control Board;
HFS 56, relating to foster home care for children;
HFS 83, relating to community-based residential care facilities;
HFS 88, relating to licensed adult family homes;
HFS 90, relating to early intervention services for children from birth to age 3 with developmental needs;
HFS 101, relating to the introduction and definitions to the Medicaid rules;
HFS 103, relating to Medicaid eligibility;
HFS 104, relating to Medicaid recipient rights and duties;
HFS 105, relating to Medicaid provider certification;
HFS 106, relating to Medicaid provider rights and responsibilities;
HFS 107, relating to Medicaid covered services;
HFS 108, relating to the general administration of the Medicaid program;
HFS 111, relating to the licensing of emergency medical technicians-intermediate and approval of EMT-intermediate operational plans;
HFS 120, relating to health care information;
HFS 124, relating to hospitals;
HFS 131, relating to hospices;
HFS 132, relating to nursing homes;
HFS 133, relating to home health agencies;
HFS 134, relating to facilities for the developmentally disabled;
HFS 144, relating to immunization of students;
HFS 145, relating to control of communicable diseases;
HFS 155, relating to injury prevention grants.
Administrative rules have the full force and effect of law. Administrative rulemaking, also known as “rule promulgation," is an agency function that has been delegated to the agency by the legislature. Agency rulemaking is governed by subchapter II of ch.
227, Stats. Given that agency-issued rules impose legal requirements on others or set legal conditions for others so the agency can administer programs authorized by statute, the process of permanent rulemaking by agencies is, by design, methodical and lengthy.
For a variety of reasons, the Department periodically needs to make minor revisions to its administrative rules. Often, the revisions have little or no substantive effect on those regulated by the rules. While such revisions may be made as part of larger, substantive modifications to a particular chapter of rules, the time and expense associated with a rule promulgation effort usually precludes such minor, individual chapter changes. Therefore, the Department plans to issue, as a single proposed rulemaking order, minor changes to a variety of chapters of its administrative rules. If, in the course of identifying the desired changes, the Department identifies more substantive needed changes, it may also aggregate, by program, collective substantive changes to rules in one or more separate rulemaking orders. Under the existing budgetary restrictions, doing so is a viable means of conserving precious agency resources while improving the Department's body of administrative code.
Statutory authority
Staff time required
The Department anticipates that about 50 hours of staff time will be required to draft, review and revise, as necessary, the proposed rulemaking order.
Insurance
Subject
Objective of the rule. To establish the annual fees which participating health care providers must pay to the patients compensation fund as required by statute for the fiscal year starting July 1, 2003.
Policy Analysis
Existing policies are as set forth in the statutes cited in the next section and in the rules themselves; no new or alternate policies are contemplated at this time.
Statutory authority
Staff time required
40 hours estimated state employee time to promulgate these rules; other resources will include the review and recommendation of the board's actuarial committee based on the analysis and recommendations of the fund's actuaries and the director of state courts.
Natural Resources
Subject
Proposed hunting and trapping regulation changes to be included on the 2003 Spring Questionnaire.
Policy Analysis
The department is initiating the annual rule development cycle for the 2003 Spring Fish and Wildlife Hearings. The following rule proposals will come before the Board in January 2003 for approval to hold public hearings. These hearings will be held in conjunction with the Conservation Congress Spring Meetings held on April 7, 2003. The effective dates of these rules will vary depending upon urgency and program timelines. The following rule proposals are:
