4731-11-04.1 Controlled substances: utilization for chronic weight management.

 

 

 

Rule Summary and Fiscal Analysis (Part A)

 

State Medical Board

Agency Name

 

Sallie Debolt

Division                                                                  Contact

 

30 East Broad Street 3rd floor Columbus OH 43215-6127

614-644-7021

Agency Mailing Address (Plus Zip)                                       Phone                     Fax

[e-mail]

Email

4731-11-04.1

Rule Number

NEW

TYPE of rule filing

Rule Title/Tag Line              Controlled     substances:     Utilization     for     chronic      weight

management.

RULE SUMMARY

1.  Is the rule being filed for five year review (FYR)? No

2.  Are you proposing this rule as a result of recent legislation? No

3.  Statute prescribing the procedure in accordance with the agency is required to adopt the rule: 119.03

4.  Statute(s) authorizing agency to adopt the rule: 4731.05

5.  Statute(s) the rule, as filed, amplifies or implements: 4731.22

6.  State the reason(s) for proposing (i.e., why are you filing,) this rule:

Rule 4731-11-04.1 was developed to regulate the use of new FDA approved controlled substance medications for chronic weight management (long term anorexiants). Ohio has seen exploding numbers of prescriptions for controlled substances that can feed illegal diversion and abuse of those medications. The Medical Board's goal in proposing the new rule is to balance the needs of those Ohioans who need controlled substance medications for legitimate medical purposes against the need to limit controlled substance medication access to reduce

diversion and abuse. The proposed rule is intended to strike the proper balance in that approach.

Moreover, separating the regulations for long term anorexiants from the regulations for short term anorexiants (Rule 4731-11-04) will provide clearer guidance to Medical Board licensees regarding controlled substance weight loss medication utilization.

7.  If the rule is an AMENDMENT, then summarize the changes and the content of the proposed rule; If the rule type is RESCISSION, NEW or NO CHANGE, then summarize the content of the rule:

Proposed new rule 4731-11-04.1 regulates the utilization of controlled substance long term anorexiants for the treatment of obesity on a chronic weight management basis. The U.S. FDA has approved a number of schedule III and IV controlled substance stimulants for "chronic weight management." The FDA labeling does not reflect a time limit on the period over which the drugs may be utilized. New rule 4731-11-04.1 requires that a physician or a physician assistant utilizing long term anorexiants follow the FDA approved labeling instructions. The rule also requires

that the patient has made a good faith effort to lose weight using non-medication means, requires periodic evaluations of the patient, sets out grounds for discontinuation of the long term anorexiants, permits physician assistants to see the patient after the patient is established on the drug, and requires that a physician check OARRS prior to utilizing the drug for chronic weight management purposes.

8.  If the rule incorporates a text or other material by reference and the agency claims the incorporation by reference is exempt from compliance with sections

121.71 to 121.74 of the Revised Code because the text or other material is generally available to persons who reasonably can be expected to be affected by the rule, provide an explanation of how the text or other material is generally available to those persons:

The rule references provisions of the Ohio Revised Code and Ohio Administrative Code that are readily available via an internet search and from the Medical Board's website.

9.  If the rule incorporates a text or other material by reference, and it was infeasible for the agency to file the text or other material electronically, provide an explanation of why filing the text or other material electronically was infeasible:

Not applicable.

10.  If the rule is being rescinded and incorporates a text or other material by reference, and it was infeasible for the agency to file the text or other material, provide an explanation of why filing the text or other material was infeasible:

Not Applicable.

11.  If revising or refiling this rule, identify changes made from the previously filed version of this rule; if none, please state so. If applicable, indicate each specific paragraph of the rule that has been modified:

Pursuant to a comment received at the public hearing, the rule was revised at paragraphs (A)(1)(d) and (A)(3)(b) by changing the phrase "behavior modification" to "intensive behavioral therapy."

12.  Five Year Review (FYR) Date:

(If the rule is not exempt and you answered NO to question No. 1, provide the scheduled review date. If you answered YES to No. 1, the review date for this rule is the filing date.)

NOTE: If the rule is not exempt at the time of final filing, two dates are required: the current review date plus a date not to exceed 5 years from the effective date for Amended rules or a date not to exceed 5 years from the review date for No Change rules.

FISCAL ANALYSIS

13.  Estimate the total amount by which this proposed rule would increase / decrease either revenues / expenditures for the agency during the current biennium (in dollars): Explain the net impact of the proposed changes to the budget of your agency/department.

This will have no impact on revenues or expenditures. 0.00

Not applicable.

14.  Identify the appropriation (by line item etc.) that authorizes each expenditure necessitated by the proposed rule:

Not applicable.

15.  Provide a summary of the estimated cost of compliance with the rule to all directly affected persons. When appropriate, please include the source for your information/estimated costs, e.g. industry, CFR, internal/agency:

There is no cost of compliance for physicians and physician assistants who appropriately monitor their patients who are on controlled substances.

16.  Does this rule have a fiscal effect on school districts, counties, townships, or municipal corporations? No

17.  Does this rule deal with environmental protection or contain a component dealing with environmental protection as defined in R. C. 121.39? No

S.B. 2 (129th General Assembly) Questions

18.  Has this rule been filed with the Common Sense Initiative Office pursuant to

R.C. 121.82? Yes

19.  Specific to this rule, answer the following:

A.) Does this rule require a license, permit, or any other prior authorization to engage in or operate a line of business? No

B.) Does this rule impose a criminal penalty, a civil penalty, or another sanction, or create a cause of action, for failure to comply with its terms? Yes

Violation of the rule may result in administrative licensure discipline for the physician or physician assistant. Discipline might include reprimand, suspension of the license, adminstrative fines under Section 4731.225 of the Revised Code, required course work, and/or revocation of the license. The cost of course work is borne by the licensee.

C.) Does this rule require specific expenditures or the report of information as a condition of compliance? No