Scope Statements
Health Services
This statement of scope was approved by the governor on July 26, 2012.
Rule No.
DHS 132, Nursing homes.
Relating to
The establishment of rules to guide the actions of the quality assurance and improvement committee to review proposals and award moneys for innovative projects.
Rule Type
Permanent.
Detailed Description of the Objective of the Proposed Rule
The department intends to cross-reference s.
50.04 (8) (b), Stats., as authority to establish and maintain a quality assurance and improvement committee to review proposals and award moneys for innovative projects, and to promulgate rules to guide the actions of the quality assurance and improvement committee.
Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
Existing s.
DHS 132.16 requires the department to establish a quality assurance and improvement committee to review proposals and award funds for innovative projects approved by the committee as directed under s.
50.04 (8) (b), Stats., as created by
2011 Wisconsin Act 70. Under s.
DHS 132.16, members are appointed by the department's secretary for a term of up to 12 months and include representatives from the department, the board on aging and long term care, disability, aging and long term care advocates, facilities, and other persons with an interest or expertise in quality improvement or delivery of long term care services. Facility members must comprise at least half of the committee membership. The committee is required to:
•
Meet at least annually.
•
Develop criteria for review and approval of projects for the Secretary of Health Service's approval.
•
Review proposals submitted by facilities and approve proposals, defer a determination pending additional information, or deny proposals submitted based upon the criteria approved by the Secretary.
•
Identify projects to be addressed based on areas of need within a facility or corporation, the state or regions.
•
Develop opportunities and strategies for general improvement of licensed facilities.
•
Encourage proposals that develop innovative cost-effective methods for improving the operation and maintenance of facilities and that protects residents' rights, health, safety and welfare and improves residents' quality of life.
•
Disseminate within the department and to facilities and other interested individuals and organizations the information learned from approved projects.
•
Prepare an annual report to the Secretary of Health Services.
In reviewing s.
DHS 132.16, the department has determined that except for not referencing s.
50.04 (8), Stats., as authority for the committee and rules, s.
DHS 132.16 establishes and maintains a quality assurance and improvement committee to review proposals and award moneys for innovative projects and guides the actions of the committee, as directed by s.
50.04 (8), Stats.
Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
The department's authority to promulgate the rules are as follows:
Section
50.02 (2) (a), Stats.: The department, by rule, shall develop, establish and enforce regulations and standards for the care, treatment, health, safety, rights, welfare and comfort of residents in community-based residential facilities and nursing homes and for the construction, general hygiene, maintenance and operation of those facilities which, in the light of advancing knowledge, will promote safe and adequate accommodation, care and treatment of residents in those facilities; and promulgate and enforce rules consistent with this section. Such standards and rules shall provide that intermediate care facilities, which have 16 or fewer beds may, if exempted from meeting certain physical plant, staffing and other requirements of the federal regulations, be exempted from meeting the corresponding provisions of the department's standards and rules. The department shall consult with the department of safety and professional services when developing exemptions relating to physical plant requirements.
Section
50.04 (8), Stats.:
Protection and cost effectiveness programs; quality assurance.
(a) The department may distribute moneys from the appropriation account under s.
20.435 (6) (g) for innovative projects designed to protect the property and the health, safety, and welfare of residents in nursing homes and to improve the efficiency and cost effectiveness of the operation of facilities so as to improve the quality of life, care, and treatment of residents.
(b) The department shall establish and maintain a quality assurance and improvement committee to review proposals and award moneys for innovative projects, as described in par. (a), that are approved by the committee. The department shall promulgate rules to guide the actions of the quality assurance and improvement committee.
Section
227.11 (2), Stats.: Rule-making authority is expressly conferred as follows:
(a) Each agency may promulgate rules interpreting the provisions of any statute enforced or administered by the agency, if the agency considers it necessary to effectuate the purpose of the statute, but a rule is not valid if the rule exceeds the bounds of correct interpretation. All of the following apply to the promulgation of a rule interpreting the provisions of a statute enforced or administered by an agency:
1. A statutory or nonstatutory provision containing a statement or declaration of legislative intent, purpose, findings, or policy does not confer rule-making authority on the agency or augment the agency's rule-making authority beyond the rule-making authority that is explicitly conferred on the agency by the legislature.
2. A statutory provision describing the agency's general powers or duties does not confer rule-making authority on the agency or augment the agency's rule-making authority beyond the rule-making authority that is explicitly conferred on the agency by the legislature.
3. A statutory provision containing a specific standard, requirement, or threshold does not confer on the agency the authority to promulgate, enforce, or administer a rule that contains a standard, requirement, or threshold that is more restrictive than the standard, requirement, or threshold contained in the statutory provision.
Estimate of Amount of Time that State Employees will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
The department will spend approximately 8 staff hours for rulemaking. No other resources are necessary to develop the rule.
List with Description of All Entities that may be Affected by the Proposed Rule
The proposed rule would affect nursing homes and any individual or entity that submits a proposal to the quality assurance and improvement committee for review and request for money.
Summary and Preliminary Comparison with any Existing or Proposed Federal Regulation that is Intended to Address the Activities to be Regulated by the Proposed Rule
Section 1919(h)(2)(A)(ii) of the Social Security Act provides that Civil Money Penalty (CMP) funds collected by a state must be applied to the protection of the health or property of residents of nursing facilities that the state. The Centers for Medicare and Medicaid Services (CMS) collects CMP funds from nursing facilities that have failed to maintain compliance with federal nursing home requirements. CMS then distributes those funds received from Medicaid nursing facilities and from the Medicaid part of dually-participating skilled nursing facilities (SNFs) to the states. CMP funds may be used to support activities that benefit residents, including assistance to support and protect residents of a facility that closes or is decertified; projects that support resident and family councils and other consumer involvement in assuring quality care in facilities; and facility improvement initiatives approved by the Secretary of Health and Human Services. The quality assurance and improvement committee is the mechanism used by the Department of Health to review proposals and award CMP funds approved by the U. S. Department of Health and Human Services.
Anticipated Economic Impact of Implementing the Rule (Note: if the Rule is Likely to have a Significant Economic Impact on Small Businesses)
The department anticipates that the proposed rule will have little or no economic impact locally or statewide.
Contact Person
Pat Benesh, 608-264-9896.
Natural Resources
Environmental Protection—Air Pollution Control, Chs.
NR 400—
This revised statement of scope was approved by the governor on August 30, 2012. The original was approved by the governor on July 25, 2012 and published in
Register No. 680 on August 14, 2012.
Rule No.
AM-21-12
Relating to
Revisions to Chapters
NR 405 and
408 to maintain consistency with federal permit guidelines and to Chapters
NR 400 and
410 consistent with the repeal of Chapter
NR 411 for indirect source permits.
Rule Type
Permanent.
Detailed Description of the Objective of the Proposed Rule
The objective of this rule package is to revise language in chs.
NR 405 and
408 to maintain consistency with federal requirements and definitions. Additionally, sections of chs. NR 400 and 410 need to be repealed due to the repeal of ch. NR 411.
In May 2006, the Wisconsin Department of Natural Resources (WDNR) requested approval by the U.S. Environmental Protection Agency (USEPA) of rules promulgated by Wisconsin to incorporate federal New Source Review Reform requirements as a revision to the State Implementation Plan (SIP). The USEPA approved the SIP revisions, but subsequently requested changes to language in chs.
NR 405 and
408. The changes pertain to the fuel use prohibition that is part of the definition of “major modification".
Chapter
NR 405.02 (25i) defines “Regulated NSR air contaminant" and specifically identifies volatile organic compounds as a precursor for ozone. USEPA has requested inclusion of nitrogen oxides (NO
x) in the definition for clarification purposes. Similarly USEPA requires, through its 2008 New Source Review Rule, explicit identification of NO
x and sulfur dioxide (SO
2) as precursors to particulate matter with a diameter of 2.5 micrometers or less (PM
2.5) within the definition of “Regulated NSR air contaminant". The WDNR proposes to make the necessary rule changes to address these issues.
On April 27, 2011, the Joint Committee for Review of Administrative Rules (JCRAR) adopted a motion under s.
227.26 (2) (d), Wis. Stats., suspending ch.
NR 411. Subsequent passage of legislation introduced by JCRAR in support of the suspension (see
2011 Wisconsin Act 121), resulted in the repeal of ch.
NR 411. The primary purpose of ch.
NR 411 had been to control carbon monoxide emissions from indirect sources through conditions established in construction and operation permits. Therefore the WDNR proposes to repeal rules whose only purpose is in support of ch.
NR 411. Rules proposed for repeal include ss.
NR 400.02 (101) and
(106), and
410.03 (3). Sections
NR 400.02 (101) and
(106) define `modified indirect source' and `new indirect source' respectively. Section
NR 410.03 (3) establishes fees for the application and issuance of permits to construct or modify an indirect source under ch.
NR 411.
Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
In a letter dated June 17, 2009, the USEPA notified the WDNR that the definition of the term “major modification" in s.
NR 405.02 was inadequate because it failed to identify permits issued under federal authority. Wisconsin's Prevention of Significant Deterioration (PSD) program was approved into its SIP on June 28, 1999. Before that, PSD construction permits were issued under federal authority. When ch.
NR 405.02 (21) (b) (5) was written, the references to federal authority were inadvertently left out. Because the federal citations were left out of the rule, USEPA identified that in a very limited situation, the current state definition would allow a source to make a change to use a different fuel or raw material without undergoing major new source permit review for the change, even though the change could be prohibited under a federal permit. The WDNR will amend this definition to ensure that it is consistent with USEPA rule and policy and recognizes all federally issued permits.
The alternative to this rule action is to keep the rules as they are which USEPA has already identified as an inconsistency with federal PSD program. However, in a Federal Register filed June 15, 2012, USEPA disapproved narrow portions of the SIP pertaining to permit requirements in NR 405 and 408 that would be addressed with this rulemaking. In the Federal Register, USEPA stated that they are under obligation to promulgate a Federal Implementation Plan (FIP) addressing the disapproved portions of the SIP within 2 years. The Federal Register states that the FIP will not be promulgated if WDNR rectifies the deficiencies within the 2 year timeframe.
The proposed clarifications of NOx as a precursor to ozone and NOx and SO2 as precursors to PM2.5 are not policy changes, but statements of fact. On June 15, 2012, USEPA disapproved a narrow portion of Wisconsin's SIP for the 1997 ozone National Ambient Air Quality Standard pertaining to air construction permitting. This was done because NOx was not identified as a precursor to ozone as part of PSD permit program requirements. The final disapproval triggered a requirement that USEPA promulgate a FIP addressing the deficiency no later than 2 years from the date of disapproval. In a federal register notice dated August 2, 2012, USEPA proposed to disapprove additional portions of Wisconsin's SIP submission for the 2006 PM2.5 NAAQS because PM2.5 precursors are not specifically identified. Section 110(a)(2)(c) of the Clean Air Act requires that precursors to PM2.5 are identified in the PSD program requirements. Final disapproval to portions of the SIP relating to identifying precursors of PM2.5 will also result in the promulgation of a FIP unless the deficiencies are addressed.
Not repealing sections of chs.
NR 400 and
410 in response to the repeal of ch.
NR 411 by the legislature would potentially create confusion and perpetuate an inconsistency with WDNR rules.
Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
285.11 (17), Wis. Stat., requires WDNR to “Promulgate rules, consistent with the federal clean air act, that modify the meaning of the term `modification' as it relates to specified categories of stationary sources
…". The proposed rule to make the WDNR definition of “major modification" consistent with the federal definition is necessary to be consistent with the statutes and the federal clean air act.
Section
285.11 (1), Wis. Stats., establishes that the WDNR shall “Promulgate rules implementing and consistent with this chapter and s.
299.15.". Section
285.60 (11) (b), Stats., effective March 21, 2012, establishes that the WDNR may not require a permit under this chapter for an indirect source. The proposed repeal of rules whose sole purpose is to support the issuance of permits for indirect sources is therefore necessary to be consistent with the statutes and to establish consistency within the administrative code.
Estimate of Amount of Time that State Employees will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
Approximately 300 hours will be spent by WDNR staff.
List with Description of All Entities that may be Affected by the Proposed Rule
The WDNR believes that the number of major sources affected by the proposed rule changes to chs.
NR 405 and
408 will be small, if any. Under Wisconsin's Title V operation permit program all requirements that apply to a source are included in its operation permit. WDNR clearly recognizes that requirements contained in a federally issued major source construction permit apply to the source and are therefore included in the source's Title V operation permit issued by the WDNR, making the requirement fully enforceable under state and federal law. The WDNR is not aware of a single situation where this type of requirement existed in a federal construction permit and was not included the state Title V operation permit.
The addition of language to clarify that NOx is a precursor to ozone and NOx and SO2 are precursors to PM2.5 will have no impact on any entities.
No entities will be affected by the proposed repeal of rules related to indirect sources. Since ch. NR 411 has already been repealed through legislative action, rules whose only purpose was to support the implementation of ch. NR 411 are already moot. Therefore the proposed repeal of these rules will not have any effect.
Summary and Preliminary Comparison with any Existing or Proposed Federal Regulation that is Intended to Address the Activities to be Regulated by the Proposed Rule
The rule changes proposed to chs.
NR 405 and
408 are requested by USEPA to maintain consistency with federal major modification definitions.
The rule changes proposed to ch.
NR 405 with regard to precursor identification are required by USEPA to maintain consistency with federal definitions and avoid FIP promulgation with regard to portions of Wisconsin's infrastructure SIP.
Anticipated Economic Impact of Implementing the Rule (Note: if the Rule is Likely to have a Significant Economic Impact on Small Businesses)
The economic impact due to the changes proposed to chs.
NR 405 and
408 is expected to be minimal, in part because there are few permits that would be affected by this change. PSD sources are large emitters by definition and do not typically include small business, so the impact to small businesses should be minimal at most.
Chapter NR 411 has been repealed, and the department is now proposing to repeal rules whose only purpose was to support the implementation of ch.
NR 411. Therefore, the proposed repeal of these rules will have no economic impact.
Contact Person
Gail Good, Wisconsin Department of Natural Resources, 101 South Webster Street, PO Box 7921, Madison, WI 53707-7921, 608 267-0803,
gail.good@wisconsin.gov.
Safety and Professional Services —
Pharmacy Examining Board
This statement of scope was approved by the governor on August 23, 2012.
Rule No.
Phar 7.01 (1) (e).
Relating to
Delivery of prescription drugs.
Rule Type
Permanent.
Finding/Nature of Emergency (Emergency Rule Only)
N/A.
Detailed Description of the Objective of the Proposed Rule
The Wisconsin Pharmacy Examining Board seeks to modify s.
Phar 7.01 (1) (e) to allow the delivery of prescription medications to a location of the patient's choice. Under the current rule, a pharmacist, or pharmacist-intern under the direct supervision of a pharmacist, may only deliver prescription drugs directly to the patient at the pharmacy or the prescription drug may be delivered to patient's residence. If a patient wanted the prescription drug to be delivered elsewhere or if the pharmacy wanted to deliver elsewhere, the pharmacy was required to obtain a variance to the delivery pursuant to s.
Phar 7.01 (4). The proposed modification to s.
Phar 7.01 (1) (e) would allow the pharmacy, pharmacist, or pharmacist-intern to deliver the prescription drug to the location of a patient's choice without being required to first obtain a delivery variance from the Board.
Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
The Board has determined that the rule, as it currently exists, does not grant enough flexibility for a patient to have the prescription medication delivered to a location of his or her choice because the rule does not permit pharmacies or pharmacists to deliver to a location of a patient's choice, without first obtaining a delivery variance from the Board. The Board has determined that permitting the delivery to a location of a patient's choice would be a helpful service to patients and to pharmacies/pharmacists without negatively impacting public safety. In addition, if the proposed modifications to the rule are enacted, the pharmacy or pharmacist would not need to wait until the board's next scheduled meeting for a determination on a delivery variance request, if previously submitted to the board.
Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
450.02 (3) (a), Stats., authorizes the board to promulgate rules “[r]elating to the
…distribution and dispensing of prescription drugs." Under s.
450.01 (7), Stats., the definition of dispense “means to deliver a prescribed drug or device to an ultimate user
…"
Section
15.08 (5) (b), Stats., allows each examining board to “promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession."
Estimate of Amount of Time that State Employees will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
20 hours.
List with Description of All Entities that may be Affected by the Proposed Rule
Pharmacies, pharmacists, and patients.
Summary and Preliminary Comparison with any Existing or Proposed Federal Regulation that is Intended to Address the Activities to be Regulated by the Proposed Rule
None.
Anticipated Economic Impact of Implementing the Rule (Note: if the Rule is Likely to have a Significant Economic Impact on Small Businesses)
No economic impact.
Contact Person
Kris Anderson, DSPS (608) 261-2385.
