A new type of subginival, local anesthesia applied by applicator, not by injection, is available is being marketed in Wisconsin. The current rule concerning certification of dental hygienists to administer local anesthesia does not explicitly contemplate local anesthetics administered in this manner, so a definition of “local anesthesia" is being created to clarify educational requirements for dental hygienists who apply local, subginival anesthesia by applicator.
SECTION 1 renumbers DE 7.02.
SECTION 2 creates a definition for “local anesthesia" to except drugs administered topically or by applicator from dental hygienists' educational requirements for the administration of local anesthesia.
Summary of, and comparison with, existing or proposed federal regulation: There is no existing or proposed federal regulation for summary and comparison.
Comparison with rules in adjacent states:
Illinois: No board decision. To consider week of 4/11/05.
Iowa: No board decision.
Michigan: No board decision.
Minnesota: Treated the same as any other subginival medicament.
Summary of factual data and analytical methodologies:
The Dentistry Examining Board discussed how chapter DE 7 applies to Oraqix, a new medicament that is administered via a surface applicator rather than by injection. In considering the rule as currently written, the board decided the rule is not clear as applied to the new medicaments because it was written to require training for administering injection of local anesthetics. The board also decided that because of the recent introduction of the product type, the rule did not contemplate training requirements necessary to administer it. The board decided by consensus that a course requirement for local anesthetics delivered via surface applicators should not be subject to the course requirement for injections.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact report:
This proposed rule will impact all dental hygienists licensed in Wisconsin. There are no small businesses affected by this rule that meet the statutory definition contained in s.
227.114 (1), Stats. The certification of no impact on small business is based on the fact that a substantial number of the 4,886 total active licensed hygienists work as employees of a dentist as defined by the practice limitation in s.
447.06, Stats. The proposed rule does not include any additional reporting or bookkeeping requirements. The proposed rule requires dental hygienists to obtain additional professional skills related to coursework for providing local anesthetics delivered via surface applicators.
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.
Anticipated costs incurred by private sector:
The department finds that this rule has no significant fiscal effect on the private sector.
Fiscal Estimate
The proposed rule will have no impact on the department's funds.
Effect on Small Business
These proposed rules will have no significant economic impact on 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.
Agency Contact
Pamela Haack, Paralegal, Department of Regulation and Licensing, Office of Legal Counsel, 1400 East Washington Avenue, Room 152, P.O. Box 8935, Madison, Wisconsin 53708-8935. Telephone: (608) 266-0495. Email:
pamela.haack@drl.state.wi.us.
Place where comments are to be submitted and deadline for submission: Comments may be submitted to Pamela Haack, Paralegal, Department of Regulation and Licensing, Office of Legal Counsel, 1400 East Washington Avenue, Room 152, P.O. Box 8935, Madison, Wisconsin 53708-8935. Email
pamela.haack@drl.state.wi.us. Comments must be received on or before May 15, 2006, to be included in the record of rule-making proceedings.
TEXT OF RULE
SECTION 1. DE 7.02 is renumbered DE 7.02 (1).
SECTION 2. DE 7.02 (2) is created to read:
DE 7.02 (2) “Local anesthesia" as used in this chapter means a drug administered other than topically or by applicator for the elimination of sensation, especially pain, in one part of the body. “Local anesthesia" includes medication administered by regional injection.
Notice of Hearing
Health and Family Services
NOTICE IS HEREBY GIVEN that pursuant to ss.
227.11 (2) and
255.056 (2) and
(7), Stats., and interpreting ss.
255.05, Stats., the Department of Health and Family Services proposes to amend ch.
HFS 148 (title), ss.
HFS 148.01,
148.02,
148.03 (1) to
(3) and
(13),
148.04 (1),
(2) (a) (intro),
(b) and
(note),
(3) and
(note),
148.05,
148.06 (title),
(1) (intro),
(2) (a) (title) and (intro),
(a) 1.,
(b) (intro) and
(title),
(b) 3. and
(note),
(3) (intro),
(4) and
(5),
148.07 (2),
(3),
(4) (c) and
(4) (c) (note),
148.08 and
148.09, and
148.11 (1) and
(2) (b), and to create s.
HFS 148.03 (3m) and
(14m), relating to the cancer drug repository program authorized under s.
255.056, Stats., and affecting small business.
Hearing Date(s) and Location(s)
Date and Time:
Tuesday, April 4, 2006
9:00 AM - 11:00 AM
Location:
1 West Wilson
Room 950 B
Madison, WI
The hearing site is fully accessible to people with disabilities. If you are hearing impaired, do not speak English or have circumstances that might make communication at a hearing difficult; you require an interpreter or a non-English large print or taped version of the proposed rules, contact the person at the address or telephone number given below at least 10 days before the hearing. With less than 10 days notice, an interpreter may not be available.
Place Where Written Comments May be Submitted
Written comments may be submitted at the public hearing or submitted to the Department using the Wisconsin Administrative Rule Website at:
http://adminrules.wisconsin.gov. Written comments may also be sent to:
Doug Englebert, R.Ph.
DHFS - Bureau of Quality Assurance
Room 950 1 West Wilson St.
Madison, WI 53711
Ph. 608-266-5388; Fax: 608-267-7119
Deadline for Comment Submission
The deadline for submitting comments to the Department is 4:30 p.m. on April 12, 2006.
Analysis Prepared by the Department of Health and Family Services
The Department currently manages the cancer drug repository program under s.
255.056, Stats., and ch.
HFS 148, which allows pharmacies and medical facilities, including hospitals, and clinics or offices used by physicians to accept donated, unused cancer drugs and supplies for dispensation to eligible individuals.
2005 Wisconsin Act 16 expanded the cancer drug repository program effective January 1, 2006 to allow drugs and supplies for the treatment of chronic diseases to be donated and dispensed under the program. This expansion requires the Department to modify ch.
HFS 148, to reflect the changes made to s.
255.056, Stats.
Through this rulemaking order, the Department proposes to modify ch.
HFS 148 to insert the term “chronic disease" where appropriate. The Department also proposes to remove the alternative $15 handling fee prescribed under s.
HFS 148.08 to avoid any conflicts that may occur between this alternative amount and the Medicaid dispensing fee which is used as the basis of the handling fee amount that can be charged to persons eligible to receive drugs and supplies under the program.
Initial Regulatory Flexibility Analysis
The Department currently manages the cancer drug repository program under s.
255.056, Stats., and ch.
HFS 148, which allows pharmacies and medical facilities, including hospitals and clinics or offices used by physicians to elect to accept donated, unused cancer drugs and supplies for dispensation to eligible individuals.
2005 Wisconsin Act 16 expanded the cancer drug repository program effective January 1, 2006 to allow drugs and supplies for the treatment of chronic diseases to be donated and dispensed under the program. This expansion requires the Department to amend ch.
HFS 148, to reflect the changes made to s.
255.056, Stats.
Through this rulemaking order, the Department will modify ch.
HFS 148 to reflect the changes in s.
255.056, Stats. The Department also proposes to remove the alternative $15 handling fee prescribed under s.
HFS 148.08 to avoid any conflicts that may occur between this alternative amount and the Medicaid dispensing fee which is used as the basis of the handling fee amount that can be charged to users of the program.
The proposed expansion of the drug repository program will directly impact current and potential pharmacy or medical facility participants in the drug repository program, including those that meet the definition of small business under s.
227.114 (1), Stats. Sixteen pharmacies and no medical facilities currently participate in the cancer drug repository program. Analysis of the 2002 Economic Census (Wisconsin data) for the pharmacy industry (NAICS Code 44611), suggests that most of the pharmacies, including the current 16 pharmacy participants, are small businesses as defined under s.
227.114 (1), Stats. Medical facilities, as defined under s.
943.145, Stats., are hospitals, and clinics or offices of physicians licensed under ch.
448, Stats. An analysis of the 2002 Economic Census (Wisconsin data) for these facilities (NAICS Codes 6211- offices of physicians; 622 - hospitals; 621491- HMO medical centers; and 621493 - freestanding ambulatory surgical and emergency centers) suggests that the average facility does not meet the definition of small business under s.
227.114 (1), Stats.
Current participating entities (and potential participants) may incur additional costs for inspection, storage, dispensing, distribution, and destruction of expired donated drugs or supplies of the additional drugs and supplies. To cover these costs, entities may charge a handling fee that is up to 300% of the Medicaid dispensing fee (which is currently $4.38) or $13.14 per prescription. This amount is comparable to what non-participating pharmacies receive for prescription dispensing fees. A 2002 study commissioned by the Wisconsin Medicaid program found that in the year 2000, dispensing fees, which included the cost of packaging, labeling, computer systems, salaries, rent, utilities, etc., averaged between $6.95 and $7.35 per prescription with expected annual increases between 6 and 12 percent. Adjusting for cost increases, the Department determined that in 2005, dispensing fees could range from $9.30 to $11.56 per prescription.
If a participating entity chooses not to collect a handling fee, that entity will bear the costs of inspection, storage, dispensing, distribution, and destruction of expired donated drugs or supplies.
The proposed rules do not impose form requirements or requirements for reporting or recordkeeping, or performance, operational or design standards.
The expansion of the drug repository program to include chronic diseases drugs and supplies and amend the handling fee provision prescribed under s.
HFS 148.08, will not have a significant economic impact on current or potential pharmacy or medical facility participants in the drug repository program, including those that meet the definition of small business under s.
227.114 (1), Stats.
Small Business Regulatory Coordinator
Rosie Greer
608-266-1279
Fiscal Estimate
The proposed rules will not affect state or local government costs or have a significant economic impact on pharmacies or medical facilities. The proposed rules will affect only those pharmacies and medical facilities that elect to participate in the drug repository program, including those that meet the definition of small business under s.
227.114 (1), Stats.
Obtaining Copies of Rules and Fiscal Estimate
A copy of the full text of the rules and the fiscal estimate can be obtained at no charge from the Wisconsin Administrative Rules Website at
http://adminrules.wisconsin.gov or by contacting the contact person at the address given below.
Contact Person
Doug Englebert, R.Ph.
DHFS - Bureau of Quality Assurance
Room 950 1 West Wilson St.
Madison, WI 53711
Ph. 608-266-5388; Fax: 608-267-7119
Notice of Hearing
Regulation and Licensing
NOTICE IS HEREBY GIVEN that pursuant to ss.
227.11 (2) and
458.24, Stats., and interpreting ss.
458.24 and
458.26 (3) (b), Stats., and according to the procedure set forth in s.
227.16 (2) (e), Stats., the Department of Regulation and Licensing will adopt the following rules as proposed in this notice, without public hearing unless, within 30 days after publication of this notice, on
March 15, 2006, the Department of Regulation and Licensing is petitioned for a public hearing by 25 natural persons who will be affected by the rule; a municipality which will be affected by the rule; or an association which is representative of a farm, labor, business or professional group which will be affected by the rule.
Analysis prepared by the Department of Regulation and Licensing.
Explanation of agency authority
The Department of Regulation and Licensing is authorized under ss.
227.11 (2) and
458.24, Stats., to promulgate rules establishing the standards for appraisal practice for licensed and certified appraisers.
Related statute or rule: There are no related statutes or rules other than those listed above.
Plain language analysis: In this proposed rule-making order, the Department of Regulation and Licensing proposes to amend ch.
RL 87 Appendix I, which incorporates by reference the 2005 edition of the Uniform Standards of Professional Appraisal Practice (USPAP). Currently, the 2005 edition of USPAP states that the effective date of the publication is from January 1, 2005 to December 31, 2005. The department proposes to amend the rule to state that the effective date of the publication is from January 1, 2005 to June 30, 2006. The department also proposes to incorporate by reference the 2006 edition of USPAP.
SECTION 1. The department proposes to amend Appendix I, which incorporates by reference the 2005 edition of USPAP, to change the expiration date from December 31, 2005 to June 30, 2006. The department also proposes to amend Appendix I to incorporate by reference the 2006 edition of USPAP.
