CR_14-011 Creates Chapter DE 8, relating to patient dental records.

Statutory authority

Section 961.335 (8) , Wis. Stats.

Explanation of agency authority

The controlled substances board may promulgate rules relating to the granting of special use permits including, but not limited to, requirements for the keeping and disclosure of records, filing of applications, and suspension or revocation of permits.

Related statute or rule

Section 961.335 , Wis. Stats., and ch. CSB 3 , Wis. Admin. Code

Plain language analysis

The proposed rule states the basis for denying or limiting a special use authorization which is based upon consideration of public health and safety. It includes consideration of the following: an act which causes a violation which would result in suspension or revocation under current rules; making false statements on an application; violating federal or state statutes related to have the ability to have controlled substances special use and an act which shows the person would be unable to safely use the SUA due to alcohol or other substance use.

Summary of, and comparison with, existing or proposed federal regulation

Federal regulations requires any person who possesses, manufactures, distributes or dispenses any controlled substances to register with the U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control.

The proposed rule included the criteria used by the federal government in granting/denying a DEA registration because once the special use authorization permit is granted, the person would also need DEA registration.

Comparison with rules in adjacent states

Illinois: In Illinois a registration to manufacture, distribute, or dispense a controlled substance or purchase, store, or administer euthanasia drugs may be denied, refused renewal, suspended or revoked if a person: provided false or fraudulent material information in any application; has been convicted of a felon related to any controlled substance; has had their federal DEA registration suspended or revoked; has been convicted of bribery, perjury or other infamous crime; violated any provision of the controlled substances act; or failed to provide effective controls against the diversion of controlled substances in other than legitimate medical, scientific or industrial channels.

Iowa: In Iowa, a registration to manufacture, distribute, dispense, prescribe, import or export, conduct research or instructional activities or conducts chemical analysis with controlled substances in Iowa may be denied if the board determines that the issuance of the registration would be inconsistent with the public interest. In determining the public interest, the board shall consider the following factors: maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific or industrial channels; compliance with applicable state and local law; any convictions related to any controlled substance; past experience in the manufacture or distribution of controlled substances, and the existence in the applicant's establishment of effective controls against diversion; furnishing false or fraudulent material in any application for registration; suspension or revocation of the federal DEA registration; and any other factors relevant to and consistent with the public health and safety.

Michigan: Michigan has 7 different licenses for controlled substances based upon the purpose of the applicant. The license shall be granted unless the issuance of the license would be inconsistent with the public interest. In determining the public interest, the following shall be considered: maintenance of effective controls against diversion to other than legitimate and professionally recognized therapeutic, scientific, or industrial channels; compliance with applicable state and local law; conviction relating to a controlled substance; past experience in the manufacture or distribution of controlled substances and the existence in the applicant's establishment of effective controls against diversion; furnishing false or fraudulent material in an application for a controlled substance license; suspension or revocation of the federal dea registration; and any other factor relevant to and consistent with the public health and safety.

Minnesota: In Minnesota, a person who engages in research, teaching or educational projects involving the use, study or testing of controlled substances is required to apply for a registration permit. The board may deny, suspend, revoke, or refuse to renew any registration based upon the following: fraud or deception in connection with securing the registration; habitual indulgence in the use of narcotics, stimulants, or depressant drugs or habitual indulgence in intoxicating liquors in a manner which could cause conduct endangering public health; unprofessional conduct or conduct endangering public health; gross immorality; conviction of theft of drugs or the unauthorized use, possession or sale thereof; violation of the provisions of the rules of the board;

Summary of factual data and analytical methodologies

The proposed rule states the basis for denying or limiting a special use authorization which is based upon consideration of public health and safety.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis

This rule was posted for economic impact comments for a period of 14 days and none were received.

Fiscal Estimate and Economic Impact Analysis

The Fiscal Estimate and Economic Impact Analysis is attached.

Initial Regulatory Flexibility Analysis or Summary

This rule does not have an impact on small business.

Agency Contact Person

Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone [phone]; email at [e-mail] .

STATE OF WISCONSIN DEPARTMENT OF ADMINISTRATION DOA-2049 (R03/2012)	Division of Executive Budget and Finance 101 East Wilson Street, 10th Floor P.O. Box 7864 Madison, WI 53707-7864 FAX: [phone]
ADMINISTRATIVE RULES Fiscal Estimate & Economic Impact Analysis

1. Type of Estimate and Analysis
X Original   ⍽ Updated   ⍽ Corrected
2. Administrative Rule Chapter, Title and Number
CSB 3.045
3. Subject
Granting a limited special use authorization and denial of a special use authorization
4. Fund Sources Affected			5. Chapter 20, Stats. Appropriations Affected
⍽ GPR   ⍽ FED   X PRO   ⍽ PRS   ⍽ SEG   ⍽ SEG-S			20.165(1)(g)
6. Fiscal Effect of Implementing the Rule
X No Fiscal Effect ⍽ Indeterminate	⍽ Increase Existing Revenues ⍽ Decrease Existing Revenues		⍽ Increase Costs ⍽ Could Absorb Within Agency's Budget ⍽ Decrease Cost
7. The Rule Will Impact the Following (Check All That Apply)
⍽ State's Economy ⍽ Local Government Units		⍽ Specific Businesses/Sectors ⍽ Public Utility Rate Payers ⍽ Small Businesses (if checked, complete Attachment A)
8. Would Implementation and Compliance Costs Be Greater Than $20 million? ⍽ Yes   X No
9. Policy Problem Addressed by the Rule
The current rules do not provide a basis for which the controlled substances board may exercise its discretion and deny a person a special use authorization or grant a limited special use authorization.
10. Summary of the businesses, business sectors, associations representing business, local governmental units, and individuals that may be affected by the proposed rule that were contacted for comments.
This rule was posted for economic comments for a period of 14 days and no comments were received.
11. Identify the local governmental units that participated in the development of this EIA.
None
12. Summary of Rule's Economic and Fiscal Impact on Specific Businesses, Business Sectors, Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole (Include Implementation and Compliance Costs Expected to be Incurred)
None.
13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
The benefit of implementing the rule is to give the applicant notice of the basis for which a denial or granting of a limited special use authorization may occur.
14. Long Range Implications of Implementing the Rule
The long range benefit is for applicants to have notice of the basis for which a denial or limited special use authorization may occur.
15. Compare With Approaches Being Used by Federal Government
The federal regulations require any person who possesses, manufactures, distributes or dispenses any controlled substances to register with the U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control. A DEA registration may be denied for the following: providing false information on an application, conviction of a law relating to controlled substances, having a state license has been disciplined or has committed acts would render registration inconsistent with the public interest.
16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota )
Illinois, Iowa, Michigan and Minnesota list reasons for a denial of a registration or license related to controlled substances similar to Wisconsin's special use authorization permit.
17. Contact Name				18. Contact Phone Number
Sharon Henes				[phone]

This document can be made available in alternate formats to individuals with disabilities upon request.

Notice of Hearing

Safety and Professional Services —
Dentistry Examining Board

CR 14-011

NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Dentistry Examining Board in ss. 15.08 (5) (b) and 227.11 (2) (a) , Wis. Stats., and interpreting ss. 146.81 and 447.02 , Wis. Stats., the Dentistry Examining Board will hold a public hearing at the time and place indicated below to consider an order to create Chapter DE 8 , relating to patient dental records.

Hearing Information

Date:   Wednesday, March 5, 2014
Time:   8:30 a.m.
Location:   1400 East Washington Avenue
  (enter at 55 North Dickenson Street)
  Room 121A
  Madison, Wisconsin

Appearances at the Hearing

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 also be submitted in writing without a personal appearance by mail addressed to the Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, Wisconsin 53708-8366. Written comments must be received at or before the public hearing to be included in the record of rule-making proceedings.

Place where Comments are to be Submitted and Deadline for Submission

Comments may be submitted to Jean MacCubbin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, WI 53708-8366, or by email to [e-mail] . Comments must be received at or before the public hearing to be held on March 5, 2014, or by email to be included in the record of rule-making proceedings.

Copies of Rule

Copies of this proposed rule are available upon request to Jean MacCubbin, Administrative rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, P.O. Box 8366, Madison, Wisconsin 53708-8366, by email at [e-mail] or on our website at http://dsps.wi.gov/Default.aspx?Page=44e541e8-abdd-49da-8fde-046713617e9e .

Analysis Prepared by the Department of Safety and Professional Services

Statutes interpreted

Sections 146.81 (1) and (4) and 447.02 , Stats.

Statutory authority

Sections 15.08 (5) (b) and 227.11 (2) (a) , Stats.

Explanation of agency authority

Section 15.08 (5) (b) , Stats., requires all examining boards 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."

Section 227.11 (2) (a) , Stats., authorizes all agencies to promulgate rules interpreting the statutes it enforces or administers, when deemed necessary to effectuate the purpose of such statutes.

Related statute or rule

Section 146.81 (1) and (4) , Stats.

Plain language analysis

The proposed rule is to outline the minimum requirements for patient dental records. The rule considers ss. 146.81 (1) and (4) , Stats., whereby dentist is defined as a healthcare provider and consequently required to maintain patient health records as specified in s. 146.81 (4) , Stats. No additional requirements are proposed in this newly created chapter.

SECTION 1. This section creates a new chapter, DE 8 patient dental records and substantially mirrors the patient health records as specified in ch. Med 21 , Wisc. Admin. Code. Specific areas of compliance include: retention, confidentiality, destruction and falsification of records.

SECTION 2. This section identifies when in the rule-making process the rule shall become effective.

Summary of, and comparison with, existing or proposed federal regulation

An Internet-based search of the U.S. Code and Federal Register did not reveal any laws or proposals related to patient dental records, with the exception of the move to electronic records for Medicaid patients in 2016.

Comparison with rules in adjacent states

An Internet-based search of the four adjacent states revealed the following:

Illinois: In Illinois Department of Financial and Professional Regulation oversees dentists; no rules requiring patient dental records were found.

Iowa: In Iowa, chapter 27 of the Iowa code, 650—27.11 (153,272C), relates to record keeping. Patient dental records must be maintained for a minimum of six years after the date of last examination, prescription, or treatment and for a minor for 6 years after the age of majority. . Similar to other states, when electronic records are kept, a duplicate hard copy record or use of an unalterable electronic record must be maintained.

Michigan: In Michigan the Board of Dentistry rule, 1120 (R 338.11101 - 338.11821), requires records to be maintained for 10 years after the last treatment. In addition charting of dental procedures and a listing of medications administered are two additional requirements unlike proposed in this rule.

Minnesota: In Minnesota, the related rule is 3100.9600, record keeping. This rule requires records to be maintained for 7 years after the last treatment. In the case of a minor patient, the records must be maintained for 7 years beyond the age of majority. In addition an emergency contact, information related to any insurance coverage, and providing an electronic backup are three additional requirements unlike proposed in this rule.

Summary of factual data and analytical methodologies

No factual data and analytical methodologies were used to draft these rules.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis

The issue of patient dental records was raised in the context of not having a retention policy and the impact on associated costs related to the amount of storage dentist and firms are currently are maintaining. Section 146.81 (4) , Stats., provides a period for destruction of records 5 years after the date of the last entry, or for such longer period as may be otherwise required by law.

Pursuant to s. IV, 3. a., EO # 50, the rules herein were posted on both the state's and the department's administrative rules websites for 14 days in order to solicit comments regarding the rule's potential economic impact on businesses, business sectors, professional associations, local government units, or potentially interested parties.

It is expected that this proposed rule will result in a decrease expense at least in the cost of hard-copy record storage. No specific data was collected or analyzed to come to this conclusion.

Fiscal Estimate and Economic Impact Analysis

The Fiscal Estimate and Economic Impact Analysis is attached.

Initial Regulatory Flexibility Analysis or Summary

These proposed rules do not have an 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 [e-mail] , or by calling [phone].

Environmental Assessment/Statement [if required]:

N/A

Agency Contact Person

Jean MacCubbin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708-8366; telephone [phone] or telecommunications rely at 711; email at [e-mail] .

STATE OF WISCONSIN DEPARTMENT OF ADMINISTRATION DOA-2049 (R03/2012)	Division of Executive Budget and Finance 101 East Wilson Street, 10th Floor P.O. Box 7864 Madison, WI 53707-7864 FAX: [phone]
ADMINISTRATIVE RULES Fiscal Estimate & Economic Impact Analysis

1. Type of Estimate and Analysis
X Original   ⍽ Updated   ⍽ Corrected
2. Administrative Rule Chapter, Title and Number
Ch. DE 8, Patient Dental Records
3. Subject
Dental Patient Records; record Retention, Record Guidelines
4. Fund Sources Affected			5. Chapter 20, Stats. Appropriations Affected
⍽ GPR   ⍽ FED   X PRO   ⍽ PRS   ⍽ SEG   ⍽ SEG-S			20.165(1)(g)
6. Fiscal Effect of Implementing the Rule
X No Fiscal Effect ⍽ Indeterminate	⍽ Increase Existing Revenues ⍽ Decrease Existing Revenues		⍽ Increase Costs ⍽ Could Absorb Within Agency's Budget ⍽ Decrease Cost
7. The Rule Will Impact the Following (Check All That Apply)
⍽ State's Economy ⍽ Local Government Units		⍽ Specific Businesses/Sectors ⍽ Public Utility Rate Payers ⍽ Small Businesses (if checked, complete Attachment A)
8. Would Implementation and Compliance Costs Be Greater Than $20 million? ⍽ Yes   X No
9. Policy Problem Addressed by the Rule
Currently there are no guidelines or policies on patient dental records retention in chs. DE 1 to 13. Licensees report that hard copy retention of records requires storage and in some cases, off-site storage. Electronic record storage is an option and hard-copy storage could be reduced depending on retention policies. In both cases, a reduction in cost is evitable in the long-term.
10. Summary of the businesses, business sectors, associations representing business, local governmental units, and individuals that may be affected by the proposed rule that were contacted for comments.
Licensed dentists and dental firms.
11. Identify the local governmental units that participated in the development of this EIA.
None known.
12. Summary of Rule's Economic and Fiscal Impact on Specific Businesses, Business Sectors, Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole (Include Implementation and Compliance Costs Expected to be Incurred)
There are no known adverse economic impacts on these specific businesses.
13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
The rule considers s. 146.81 (4), Stats., patient health records, making the rules under the authority of the Dentistry Examining Board in compliance with state Statutes. An option would be to continue without guidelines on patient records.
14. Long Range Implications of Implementing the Rule
The overhead cost of hard copy record storage is expected to be reduced over time.
15. Compare With Approaches Being Used by Federal Government
None found.
16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota )
With the exception of the state of Illinois, the three adjacent states require dental records retained for periods of 5, 7 or 10 years.
17. Contact Name				18. Contact Phone Number
Jean MacCubbin				608.266.0955

This document can be made available in alternate formats to individuals with disabilities upon request.