Scope Statements
Financial Institutions — Wisconsin Consumer Act
Subject
The rule will create s.
DFI-WCA 1.84, relating to unconscionable conduct.
Policy Analysis
The purpose of the rule is to set forth certain conduct in consumer credit transactions and the collection of debts arising from consumer credit transactions that shall be considered unconscionable and prohibited.
Statutory Authority
Entities Affected by the Rule
Entities subject to the Wisconsin Consumer Act that are engaged in consumer credit transactions and the collection of debts arising from consumer credit transactions.
Comparison with Federal Regulations
The department is aware of no such regulation.
Estimate of Time Needed to Develop the Rule
150 hours.
Health and Family Services
Subject
The rule amends s.
HFS 107.10 (3) (e), relating to allowing recipients of Medicaid services to obtain certain medications in a supply sufficient to last 100 days. At present recipients may only obtain up to a 34 day supply of these drugs.
Policy Analysis
The provisions of the proposed rulemaking order are intended to have a cost-saving effect. The Governor's veto message of
2005 Wisconsin Act 25, the biennial budget act, directed the Department to find savings in the area of pharmacy expenditures for Medicaid recipients. The proposed amendment will allow pharmacies to dispense prescription drugs in larger quantities, making it possible to reduce the number of transactions needed to fulfill a particular recipient's needs for prescription drugs. The cost savings result from the fact that drugs provided in a 100-day supply will result in only one dispensing fee being paid, as opposed to 3 dispensing fees if the same drugs were provided in a 34-day supply.
The pharmacy benefit is just one of numerous benefits offered under the Wisconsin Medicaid program, which is administered by the Division of Health Care Access and Accountability in the Department of Health and Family Services. However, prescribed drugs are one of the costliest benefits provided by the Medicaid program.
In September 2005, the Secretary of the Department of Administration indicated that the Governor would appoint members to a Pharmacy Reimbursement Commission to develop recommendations to achieve biennial savings in Medicaid expenditures on pharmacy services. The Governor instructed the Commission to find savings while compensating pharmacies fairly and protecting benefits to Wisconsin's most vulnerable residents. The 100-day supply was identified as a way to save $3.3 million.
Statutory Authority
Entities Affected by the Rule
Pharmacies will be affected by the proposed rule.
Comparison with Federal Regulations
Section
447.331 (b) of Title 42 of the Code of Federal Regulations specifies upper limits for multiple source drugs. This revision will assist the state in complying with the requirements of that provision, by enabling the state to reimburse recipients for purchasing prescription drugs in greater amounts.
Estimate of Time Needed to Develop the Rule
40 hours.
Pharmacy Examining Board
Subject
The rule affects ch.
Phar 13, relating to the regulation of prescription drug distributors.
Objective of the Rule
Policy Analysis
The Board will decide during the rulemaking process what information to require of a manufacturer in maintaining and updating at least one time per month a list of manufacturers' authorized distributors of record; whether inspections conducted by another state, the National Association of Boards of Pharmacy, or the Wisconsin Pharmacy Examining Board satisfy requirements the Board sets as necessary for effective wholesale distributor facility inspections; and how and when to implement an electronic track and trace `pedigree' system. Other changes authorized by law may be considered during the rulemaking process.
Statutory Authority
Entities Affected by the Rule
Drug manufacturers, drug distributors, drug inspectors and the Wisconsin Department of Regulation and Licensing.
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.
Estimate of Time Needed to Develop the Rule
It is estimated that 100 hours of staff time will be needed to promulgate the rule.
