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VIII. Model Practice Act

and Regulatory Policy

The continually expanding efforts of State legislatures to maintain the health, safety, and welfare of their citizens have given rise to a large number and variety of administrative licensing and regulatory agencies. Recognizing the agencies roles, Federal statutes and regulations on the control of substances of potential abuse reserve to the States and their agencies the authority to determine fitness to practice and hence the right to prescribe, administer, and dispense controlled substances.

The rights are obtained directly for many health professionals, nurses, and pharmacists, and indirectly through the registration of individual and institutional practitioners.*

The specific authority obligating Federal agencies to cooperate with the States and to register practitioners licensed by State regulatory bodies is found in the following sections of the Comprehensive Drug Abuse Prevention and Control Act of 1970:

• Section 303 (f). Practitioners shall be registered to dispense or conduct research with controlled substances in schedule II, III, IV, or V if they are authorized to dispense or conduct research under the law of the State in which they practice.... Pharmacies (as distinguished from pharmacists) when engaged in commercial activities, shall be registered to dispense controlled substances in schedule II, III, IV, or V if they are authorized to dispense under the law of the State in which they regularly conduct business. (Emphasis added.)

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Section 503 (a). The Attorney General shall cooperate with local, State, and Federal agencies concerning traffic in controlled substances and in suppressing the abuse of controlled subst

ances.

This Federal legislation has resulted in a number of cooperative programs with the States to clarify roles, train State enforcement and regulatory personnel, and assign Federal personnel directly to State and local compliance investigative units. These efforts have focused upon how the States might improve the effectiveness of their health care licensing and upon regulating actions that relate to controlled substances abuse.

A major objective of the effort to develop a Model Practice Act is to submit the act and its supporting research to the National Conference of Commissioners on Uniform State Laws. The development, publication, and submission of this document to the States and the National Conference of Commissioners on Uniform State Laws by Federal drug agencies should be viewed as part of a larger congressionally mandated policy to assist the States. To this end, the philosophy of the recommended Model Practice Act provides that:

• The Federal Government continues to utilize State licensing, regulatory, and disciplinary procedures as a primary tool to control practitioners violating the Controlled Substances Act. • Federal efforts to improve the effectiveness and efficiency of the State boards and licensing agencies in resolving the problems with errant registrants to be accomplished through the Model Practice Act for the health professions.

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Hearing procedures often are established in a State's administrative code or equivalent legislation. If not, this part of the Model Practice Act would contain sections relating to hearings, subpena powers, initiation of charges, presentation of charges, rights of counsel, investigations, suspension, revocation of a license and other penalties, rules of evidence, and the standard of evidence upon which a finding can be made.

The last characteristic of the Model Practice Act concerns the judicial procedures for appealing decisions of the board. Differences among State judicial systems will require that the Model Practice Act allows for some variation in such structures. Still, considerable uniformity can be obtained. Of particular importance are the following:

• Status of the Board's decision pending

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(3) Specified Administrative Hearing and Appellate Procedures

Model administrative hearing procedures and procedures for the appellate process.

(4) Maintenance of Specialized Professional Expertise as a Part of the Regulatory Process

The general powers and duties related to the areas of professional expertise granted to the respective boards are maintained. Mechanisms for appointment to the boards as well as the necessary qualifications for membership on the boards. are provided. However, provisions for lay representation on the boards have been developed to allow this alternative approach.

(5) Scope of Practice

Descriptions of the scope of practice for health care professions.**

(6) Specifications Concerned with Board Decisionmaking

Parliamentary rules for the general decisionmaking of the boards.

The provisions for board rulemaking and similar regulations included within the Model Practice Act are discussed in the next section.

2. STRUCTURAL

CHARACTERISTICS

The proposed Model Practice Act specifically provides for the following:*

(1) Centralized Administrative Functions

A centralized licensing authority or department of registration responsible for all administrative, investigatory, and enforcement functions, with a supervisory commission of registration composed of the board presidents as trustees.

(2) Retention of Individual Professional Boards

Individual licensing boards for each of the concerned professions.

'Editor's Note: Only the characteristics of the proposed Model Practice Act are summarized here. The Model Practice Act is contained in a separate Drug Enforcement Administration publication entitled, "A Model Health Professions Practice Act and State Regulatory Policy". This publication may be obtained at a cost of $1.25 from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. (Stock No. 027-00400022-9.)

3. MODEL POLICIES,

PRACTICES, AND
OBJECTIVES FOR
REGULATORY BOARDS

AND INTERACTING
ENTITIES

In order to implement the model Practice Act properly and achieve a properly functioning regulatory system, certain goals should be established, as well as the policies and practices necessary to meet these goals. While the boards are the principals in such activities, other such as the commission, the attorney general's office, and the respective professional associations in each State have roles in the professional health practice regulatory process due to their interaction with the boards.

It is critical that the particular observations and topics treated therein be studied thoroughly by ap

**See glossary for descriptions.

propriate members of each of the groups and agencies. For example, the policy requirement of a given board for licensed practitioners to continue education as a condition of license renewal gives new meaning and importance to the development of health practice standards by the appropriate professional association; this is a reciprocal relationship because the boards certainly will wish to evaluate and utilize those standards. The latter example demonstrates not only the need for all members of the community to be fully aware of their fellow members' roles, but also the importance of continuous communication between all members so that the "system" will be properly "lubricated."

In addressing the rulemaking roles of the boards, two topics must be discussed: basic description of proposed regulatory environment and underlying philosophy, and specific topics critical to the smooth functioning of the environment.

(1) Basic Description of Proposed Regulatory Environment and Underlying Philosophy

The Model Practice Act establishes an organ called the commission to relieve the boards of those common functions not requiring the professional expertise which typifies the background and the qualifications of the members of that board (with the possible exception of the optional lay members for the boards and States having same). Other advantages are increased uniformity of procedure, the economic effects which result from eliminating duplication, and a reduction of board member involvement in litigation.

The basic rule for determining whether a given activity is within the jurisdiction of a board or the commission is:

• When the decision requires the professional expertise of any one of the concerned boards as a licensing entity then the activity warrants a decision of that board.

• If such is not the case, the activity falls within the jurisdiction of the commission.

Therefore, the jurisdiction of the concerned boards is specific and the jurisdiction of the commission is residual. All policies, rules, regulations, and directives developed to implement the Act should reflect the application of this primary rule. If any question arises concerning the application of the latter rule, and a given board feels that the commission has exceeded its jurisdiction as defined by this Act, then that board is empowered to contest the alleged abuse in the appropriate State court.

The basic concept underlying this proposed regulatory environment is that the individual boards will allocate the bulk of their time and effort to issues concerning the regulation, admission to practice, and discipline of health professionals. As such they should convene and deliberate on a regular basis. Their basic role in disciplinary hearings is judge, not prosecutor. It is intended that the commission bear the direction of all investigations, and that the attorney general or his designee be charged with the responsibility for prosecution.

Alternatively, the commission, could rely very heavily upon its executive director and the department of registration for the execution of its duties. Other than its annual meeting, the commission would convene on a less regular basis than the boards and only when there is a need for it to discharge policymaking, planning, budgeting, and promulgating of rules and regulations duties. This approach allows commission members (the board presidents) to function primarily in their board member roles rather than as members of an administrative body (commission).

(2) Specific Topics Critical to the Smooth Functioning of the Environment

Although the topics discussed in this section are not directly related, they all are intended to enhance the effective operation of the health practice regulatory environment.

• Continuing Education for Licensees

Continuing education is to be a primary requirement for relicensure. The boards should rely heavily upon the standards and recommendations of their respective professional associations who should regard this role as seriously as their role in initial licensure of a practitioner. Maintenance of quality in a profession should have a priority comparable with that of the initial licensing of practitioners.

• Dedication and Specialization of Designees of the Attorney General

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Legal staff from the office of the attorney general should be dedicated and specialized. Further it would be appropriate for the respective boards to have funds available for legal counsel for special purposes.

Development of Health Practice Standards by the State Professional Associations

The State professional associations must play an extremely active role in developing health care professional practice standards to achieve the basic objective of the regulatory environment, i.e., quality health practice. To determine qualification for licensure, boards must have the tools to measure credentials and skills; such tools are well-developed health care professional practice standards. This topic is related to the proposed requirement for continuing éducation of practitioners. However, this topic is more general than that. It includes all types of guidance which place the practitioner "on warning" with respect to these practices and/or neglect of practice, and which reasonably may be expected to subject the health care professional to review and possible disciplinary action by the appropriate health care professional board.

4. IMPLEMENTATION

Although the Model Practice Act has been developed for submission to the National Conference of Commissioners on Uniform State Laws, States may wish to undertake more immediate actions. According to circumstances, they may choose to:

• Adopt the basic substance of the Act as it now reads simply by adding, modifying, or deleting the appropriate provision(s)

• Adopt the basic jurisprudential philosophy underlying the Act and develop a new model act premised on this philosophy.

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