Iowa: Occupational therapists must provide direct, on-site and in-sight supervision for a minimum of four (4) hours per month to occupational therapy assistants. They must also identify in the treatment plan what has specifically been delegated to the occupational therapy assistant.
Illinois: Supervision is required of occupational therapy assistants depending upon the varying patterns as determined by the demands of the areas of patient/client service and the competency of the individual assistant. The supervision is structured according to the assistant's qualifications, position, level of preparation, depth of experience and the environment within which he/she functions. However, there are minimal supervisory requirements. For instance, for an occupational therapy assistant who has less than one year of work experience, a minimum of 5% on-site, face-to-face supervision per month by an occupational therapist is required.
Michigan: Michigan does not appear to have any specific rules governing the supervisory requirements for occupational therapy assistants. Their rules appear to be limited to obtaining a credential.
Minnesota: Minnesota requires face-to-face collaboration between an occupational therapist and an occupational therapy assistant every two weeks, at a minimum. Face-to-face collaboration is required more frequently if necessary to execute a patient's care.
Summary of factual data and analytical methodologies:
The board reviewed comments from occupational therapy professionals and held discussions during open session of its meetings regarding the impact of current supervision rules on the provision of care.
Analysis and supporting documents used to determine effect on small business
No significant impact on small businesses is anticipated. There are no additional compliance or paperwork requirements.
Section
227.137, Stats., requires an “agency" to prepare an economic impact report before submitting the proposed rule-making order to the Wisconsin Legislative Council. The Department of Regulation and Licensing is not included as an “agency" in this section.
Initial Regulatory Flexibility Analysis
These proposed rules will have no significant economic impact on a substantial number of small businesses, as defined in s.
227.114 (1), Stats. The Department's Regulatory Review Coordinator may be contacted by email at
larry.martin@drl.state.wi.us, or by calling (608) 266-8608.
Fiscal Estimate
Summary
The department estimates that the proposed rule will have no significant fiscal impact.
Anticipated costs incurred by private sector
The department finds that this rule has no significant fiscal effect on the private sector.
Text of Proposed Rule
SECTION 1. OT 1.02 (3m) is created to read:
(3m) “Direct contact" means an occupational therapist shall communicate with an occupational therapy assistant face-to-face, or by telephone, electronic communication, or group conferences.
SECTION 2. OT 4.04 (4) is renumbered OT 4.04 (4) (a) and is amended to read:
(4) (a) When general supervision is allowed, the supervising occupational therapist shall have direct contact on the premises with the occupational therapy assistant and face-to face contact with the client at least once every 2 weeks. In the interim between direct contacts, the occupational therapist shall maintain contact with the occupational therapy assistant by telephone, written reports and group conferences. The occupational therapist shall record in writing a specific description of the supervisory activities undertaken for each occupational therapy assistant. The written record shall include client name, status and plan for each client discussed a minimum of one time per calendar month or after the tenth session of occupational therapy, whichever is sooner. The direct contact meetings with the occupational therapy assistant may be held simultaneously or separately from the face-to-face client meetings. These meetings do not need to be held at or during a treatment session, but are intended to review the progress and effectiveness of treatment.
SECTION 3. OT 4.04 (4) (b) is created to read:
(b) The occupational therapist shall record in writing a specific description of the supervisory activities undertaken for each occupational therapy assistant. The written record shall include client name, status and plan for each client discussed.
Notice of Hearing
Pharmacy Examining Board
NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Pharmacy Examining Board, the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order adopting emergency rules to repeal sections
Phar 13.02 (11) (b) to
(e),
13.03,
13.04 and
13.06 (3); to renumber section
Phar 13.02 (11) (f); to renumber and amend section
Phar 13.02 (6); to amend sections
Phar 13.02 (8),
(9),
(11) (intro.) and
(a),
13.05 (2),
13.08,
13.09 (intro.) and
(3),
13.10 (3),
13.11 (1) to
(4),
13.12 (1) to
(3),
13.13 (title) and
(1) to
(4),
13.14 (1) (intro.),
(a) to
(c), and
(2),
13.15 (4),
13.16 and
13.17 (1); and to create sections
Phar 13.02 (3m),
(11) (b) to
(d),
(f) to
(m) and
13.055, relating to the regulation of wholesale prescription drug distributors.
Hearing Information
Date: July 23, 2008
Time: 9:45 a.m.
Location: 1400 East Washington Avenue
(Enter at 55 North Dickinson Street)
Room 121A
Madison, Wisconsin
Appearances at Hearing and Submission of Written Comments
Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may be submitted in writing without a personal appearance by mail addressed to the Department of Regulation and Licensing, Office of Legal Counsel, P.O. Box 8935, Madison, Wisconsin 53708 or by email at
pamela.haack@drl.state.wi.us. Written comments must be received by July 25, 2008, to be included in the record of rule-making proceedings.
Agency Contact Person
Pamela Haack, Paralegal, Department of Regulation and Licensing, Office of Legal Counsel, 1400 East Washington Avenue, Room 152, P.O. Box 8935, Madison, Wisconsin 53708; telephone 608-266-0495; email at pamela.haack@ drl.state.wi.us.
Analysis prepared by the Department of Regulation and Licensing.
Statutes interpreted
Statutory authority
Explanation of agency authority
The Wisconsin Pharmacy Examining Board has authority under ch.
450, Stats., as amended by
2007 Wisconsin Act 20, to promulgate rules for the regulation of wholesale prescription drug distributors.
Related statutes or rules
Plain language analysis
This emergency rule implements the statutory changes set forth in the drug distributor portions of
2007 Wisconsin Act 20. Several key areas are addressed by this emergency rule including, newly required enhanced qualifications for distributor licensing, inspection requirements, identification and qualification of a designated representative, bonding requirements and additional recordkeeping requirements including where appropriate, the maintaining of drug distribution pedigrees.
SECTION 1 requires a licensed manufacturer to maintain and update at least once per month a list of the manufacturer's authorized distributors of record.
SECTION 2 defines “department."
SECTION 3 amends the definition of “wholesale distributor."
SECTION 4 amends the definitions of “facility" and “manufacturer."
SECTION 5 amends the definition of “wholesale distribution."
SECTION 6 repeals portions of the definition of “wholesale distribution" which are no longer applicable.
SECTION 7 amends the definition of “wholesale distribution."
SECTION 8 renumbers and SECTION 9 creates additional provisions for the definition of “wholesale distribution."
SECTION 10 repeals two licensure provisions no longer statutorily required.
SECTION 11 amends a licensure requirement to require proof of an inspection.
SECTION 12 creates a licensure requirement to require a surety bond or irrevocable letter of credit to be filed with the department.
SECTION 13 repeals a requirement that is not statutorily required.
SECTIONS 14 to 19 remove the reference to “devices."
SECTION 20 amends a recordkeeping requirement.
SECTION 21 amends a recordkeeping requirement.
SECTION 22 adds “designated representative" to the list of required responsible persons.
SECTION 23 amends compliance with federal, state and local laws to include the requirement of an electronic track and trace drug pedigree under certain conditions.
Comparison with federal regulations
21 CFR § 203 included federal regulations relating to drug distributorships and drug pedigrees. Only portions of the enacted regulations could be applied after a preliminary injunction that stayed certain provisions was ordered on December 5, 2006 in
RXUSA Wholesalers, Inc. v. HHS.
Comparison with rules in adjacent states
Minnesota:
Statutes: Ch.
151 - Each separate facility is required to be licensed (with an annual renewal) and must satisfy a number of conditions relating to storage, security, container labeling, records retention (must be separately maintained and available for inspection within 2 working days of a board request), management and ownership, inspection procedures. An annual report to the board is required. The board may adopt reciprocity rules if the other state has comparable legal standards and that state would also extend reciprocal treatment.
Rules: § 6800 – 1400 - Distributors must track the source of all drugs, along with the name and address of the seller or transferor and the address of the location from where the shipment was sent. Records must be kept for two years, and lists of responsible persons must be maintained with a description of duties and qualifications.
Iowa:
Rules: § 657 - An annual renewal is required. Board inspectors inspect new distribution locations in Iowa. Minimum qualifications are specified in rule. Lists of officers, directors, managers and others in charge must be maintained. Distributors must verify the authority of the person or business to whom the distribution is intended prior to distribution. If distribution is to sales or manufacturers' representatives, distributors must ensure they maintain distribution records. There are facility, security, storage and record-keeping requirements included. Transaction records must include the source of the drug, name and address of seller/transferor, and the address from where it is shipped, in addition to the recipient, the name and address of the purchaser or transferee and the address where drugs are shipped. Records must be maintained for two years. The code contains an ethical conduct provision.
Illinois:
Rules: Chapter
111 - It is unlawful to distribute a drug for less than fair market value not in accordance with law.
Michigan:
Statute: Chapter
333 - May designate an individual to be the pharmacy, manufacturer, or wholesale distributor licensee.
Rules: § 338 - All locations used in connection with distribution must be listed in the application. Includes requirements for storage, handling and records. Inspections may be performed “at reasonable times in reasonable places." A manufacturer or distributor may only distribute to persons licensed by the board or licensed to prescribe. Procedures for examining containers received and sent for identity to prevent contamination and ensure fitness for distribution. Must record the source and address of the seller or transferor and the location from where the drugs were shipped. Records must be maintained for two years. There must be written policies for receipt, security, storage, inventory and distribution of drugs, plus a crisis management policy. Identity information for persons in charge of distribution, storage and handling must be maintained.
Summary of factual data and analytical methodologies
Department staff reviewed the portions of
2007 Wisconsin Act 20 that pertain to drug distributorships and laws and rules from other states prior to preparing the emergency rules.
Analysis and supporting documents used to determine effect on small business
The statute requires an inspection of drug distributors to be completed prior to the June 1, 2008 effective date of the rule. A review of the department's license files revealed there are approximately 100 distributors licensed in Wisconsin that may not have been inspected within the three years prior to being licensed. The board set the bond or letter of credit amount at $5,000 after a review of the statutory language and other states' requirements.
Section
227.137, Stats., requires an “agency" to prepare an economic impact report before submitting the proposed rule-making order to the Wisconsin Legislative Council. The Department of Regulation and Licensing is not included as an “agency" in this section.
