The Effective Representation Of Parties In State Professional Licensing Board Proceedings

advertisement
The Effective Representation Of Parties In State
Professional Licensing Board Proceedings
By
Raymond P. Pepe
+1.717.231.5988
[email protected]
October 2007
Revised from original version presented
in November 2006 to the Pharmacy
Law XII Seminar of the National
Association of Pharmacy Law and
the National Association of Chain
Drug Stores
Proceedings before state professional licensing boards may involve disciplinary
proceedings; disputes regarding the issuance of licenses, certifications or approvals to
individuals or facilities; and proceedings pertaining to the development of licensing board
policies and regulations. The effective representation of professionals and professional
corporations and partnerships in these proceedings depends in substantial measure upon
the understanding and proper application of principles of state administrative practice
and procedure unique to each of these types of proceedings as applied in the context
of occupational licensing law.
Critical Issues in Disciplinary Proceedings
Identifying and Protecting the Interests of Diverse Parties
Because disciplinary board proceedings may involve multiple parties, including licensed
or registered professionals, facilities and business associations authorized to offer
professional services, facility owners and other persons, it is essential at the outset of any
proceeding to identify how the interests of various parties will potentially be affected and
to explore the benefits and costs of using separate counsel for all parties versus common
counsel for all or some subset of the affected parties. The ethical issues regarding when
the representation of two or more parties is permissible; the types of notifications and
cautions necessary regarding any use of common counsel; and the need for joint-defense
agreements to protect attorney-client privilege are generally well understood. What is less
well recognized is the need to forge constructive working relationships among counsel
for multiple parties and the strategic advantages that may be obtained through the use
of separate counsel even when separate representation does not appear to otherwise
be required or warranted.
One of the greatest risks of using separate counsel for parties whose interests diverge
is that the zeal of counsel for individual parties to protect their specific interests will
generate a suboptimal outcome for all parties to a proceeding. While inevitably in some
circumstances the representation of individual interests is of necessity a zero-sum game,
in far too many other instances the failure of counsel to work together cooperatively to
promote the common interest of all parties forfeits opportunities to resolve controversies
in a more desirable manner. Unfortunately, there is no general formula or specific
approach to follow to avoid these problems. Instead, it is imperative for parties to
proceedings to select mature representatives with sound judgment who can work
together well and effectively pursue opportunities to promote the common interests of all
parties to proceedings, while at the same time being realistic and honest in recognizing
the pragmatic imperatives essential to protecting the interests of their individual clients.
Counsel should also be selected with experience in dealing with licensing board
proceedings in the jurisdiction involved, because the customs and practices of boards
are often unique and not well documented.
Even where the interests of multiple parties to proceedings do not materially diverge, it is
also worthwhile at the outset of any engagement to consider whether the use of separate
counsel will be strategically beneficial. For example, where the outcome of proceedings
turns on the credibility of parties not themselves the target of disciplinary complaints
and who face little realistic risk of sanctions, but whose interests technically diverge
from those of other parties, the perceived independence
and reliability of testimony offered by such parties may
be enhanced by separate representation. In addition,
during the investigatory stages of proceedings and in the
course of the consideration of settlement options, the use of
separate counsel for such parties may open up avenues of
access to information and create alternative channels for
communication that may not be equally available to counsel
for the primary target of disciplinary proceedings.
Identifying Sources for
Third-Party Recovery
Various forms of insurance coverage may be available to
parties to disciplinary proceedings and for other persons
affected by the outcome of such proceedings. Coverage
that may be available includes not only professional liability
insurance, but may also involve errors and omissions policies,
officers and directors coverage, business interruption
insurance and fidelity policies which may provide coverage
for losses incurred due to unlawful conduct or a breach of
fiduciary duty. Far too often, however, parties either fail to
recognize that coverage may be available either to cover
losses incurred or the cost of representation, or conclude
that coverage is not available based upon a cursory review
of policy provisions and discussions with the representatives
of agents or representatives of insurers who may be either
ill-informed or less than candid in discussions of policy
provisions. The failure to promptly evaluate and identify
sources of coverage also often leads to the loss of otherwise
available coverage when notice is not provided in a timely
manner to insurers regarding claims.
To evaluate the availability of insurance coverage, at the
outset of any significant controversies, a careful assessment
should be conducted of current and prior insurance
policies and guidance sought regarding any ambiguous
policy provisions. Where the consequences of adverse
outcomes in disciplinary proceedings are substantial, it
may be worthwhile to have a review of available insurance
coverage reviewed by specialized counsel experienced in
the protection of policyholder interests.
To the extent coverage may be available, care should
be taken to ensure that written instructions are provided
to insurance brokers directing them to provide written
notifications to affected carriers. In this regard, it is important
to recognize that many brokers may not operate as agents
of various insurers and only as sales representatives, and
therefore notice to a broker may not constitute notice to the
insurer. Accordingly, it is important to follow up any initial
discussions with brokers regarding the provision of notice
to carriers to ensure that notice is actually provided and to
ensure that brokers do not make independent judgments in
questionable cases regarding the availability of insurance
benefits.
In addition to evaluating potential sources of insurance
coverage, parties to disciplinary proceedings should also
determine whether proceedings trigger any relevant hold
harmless or indemnity agreements. Depending upon the
facts and circumstances, indemnities may be available for
violations of professional standards that occurred prior to the
purchase of a licensed business or its assets. Likewise, when
help supply services are utilized to provide professional
personnel, technicians or other employees, the agreement
with the help supply agency may provide indemnities for
misconduct of the personnel supplied by the agency.
Developing Strategies Based
Upon a Risk Assessment
While some professional licensing boards have adopted
schedules of fines and sanctions associated with various
types of violations, more typically, no formal guidelines or
standards exist to guide a board in imposing sanctions for
misconduct. Instead, often the only guidance provided
consists of the maximum permissible sanctions authorized
by law. As a result, in many jurisdictions even minor
violations result in the issuance of a rule to show cause why
licenses or permits should not be suspended or revoked for
alleged violations and why the maximum permissible fines
and monetary penalties authorized by law should not be
imposed. In these circumstances, it is critical at the outset
of any engagement to initiate research regarding the types
of sanctions historically levied by the board for the type
of conduct alleged. Even where boards maintain formal
penalty guidelines, such research is warranted to determine
whether and to what extent actual board practices deviate
from published standards. Unfortunately, this research may
need to be performed “on site” since frequently these types
of administrative decisions are not published or reported
electronically. Such research should never be discounted,
however, since it often reveals information remarkably
inconsistent with demands made by prosecuting counsel.
Research regarding the likely range of sanctions that may
be imposed by boards will provide guidance helpful in
October 2007 | determining whether and to what extent to vigorously
contest allegations of professional misconduct or to initiate
settlement discussions with board counsel. In addition,
such research typically provides valuable insight critical
to the successful negotiation of settlement agreements and
may provide a basis to contest the imposition of sanctions
inconsistent with board precedents. Under the law of most
states, it is arbitrary and capricious for boards to deviate
substantially from its precedents and established practices
without good cause.
In addition to reviewing the pattern of sanctions imposed
by licensing boards, it is also important to evaluate the
potential collateral consequences of adverse board actions.
For example, under CMS Medicare Provider Agreements
and State Medicaid Provider Agreements, changes in
information regarding “adverse legal actions” previously
reported must typically be updated within 30 to 90 days of
the changes occurring. Once this information is reported,
CMS or State Medicaid agencies may initiate proceedings
to revoke provider agreements. If this occurs, federal and
state law typically prevent the transfer of a licensed business
or its assets to certain related parties to avoid the impact
of any debarment. Comparable provisions are also often
included in other public and private healthcare participating
provider agreements.
Mortgages, franchise agreements and loan documents may
also require the prompt reporting of disciplinary actions
taken against licensed professionals, entities offering
professional services, and their personnel. Once reported,
lenders may enjoy broad discretion to declare defaults
and accelerate loan payment obligations. Fortunately,
the prompt reporting of disciplinary proceedings and the
full disclosure of the outcome of proceedings often enable
parties to avoid the revocation of provider agreements
or debarment from participation in public healthcare
benefit plans. Conversely, the failure to promptly report
such information and incorrect characterization of the
outcome of proceedings may in themselves provide a basis
for suspension or revocation of provider agreements or
debarment, even for violations which in themselves may be
comparatively minor.
Clearly Defining Administrative
Procedures
State administrative procedures acts and rules of procedure
may vary substantially from jurisdiction to jurisdiction and
many licensing boards may not have clearly established
rules of procedure to govern disciplinary proceedings.
Board rules of procedure may also provide certain options
to parties to disciplinary proceedings, such as allowing
matters to proceed before hearing examiners who will
issue reports and recommendations for review by boards
or alternatively allowing contested proceedings to be
conducted directly before boards. Options may also
exist to seek informal conferences with designated board
members or third parties to seek the informal resolution of
proceedings in a manner similar to mediation. Developing
the most effective approach to the representation of parties
to board proceedings requires understanding the options
available and selecting alternatives best suited to the needs
of any particular case.
At the outset of proceedings, a thorough review should be
conducted regarding applicable rules of procedure and
administrative practices with a focus on identifying service
requirements, deadlines, discovery mechanisms (if any),
requirements for pre-hearing reports and conferences, the
availability of various types of procedural and dispositive
motions, opportunities for briefing and argument, and posthearing remedies, including requests for reconsideration of
adverse determinations. Because board practices are often
highly informal and subject to change, in order to clearly
understand and best take advantage of available procedural
options, there is no substitute for a pre-hearing conference in
which a full discussion of procedural requirements occurs.
In pre-hearing conferences, it is essential to obtain not only
a clear understanding of the applicable rules of procedure,
but also to identify the expectations and particular
requirements of individual hearing officers or boards.
Care should be taken, however, not to make premature
commitments regarding the management of a case that may
limit available procedural options. Instead, the goal should
be to clearly understand the applicable administrative rules
and requirements, while preserving as much flexibility as
possible to change strategies and procedural approaches
to a case as proceedings unfold.
One important goal to pursue in evaluating relevant
administrative procedures is to ensure a fair and level
playing field upon which to mount a defense of disciplinary
charges. While due process requires a separation of
functions between prosecutorial and adjudicative officers,
the disqualification of board members or hearing officers
October 2007 | subject to potential bias prohibits ex parte communications
and limits the use of administrative notice of facts and
information outside the official record; the extent to which
these protections exist in practice may deviate substantially.
Understanding the extent to which such protections are
actually provided in any particular jurisdiction is helpful in
developing strategies for the presentation of a defense, but
may also provide potential grounds for a successful appeal
of any adverse adjudications. Careful attention to due
process requirements and a frank discussion of the mutual
expectations of adverse parties may also make participants
in disciplinary proceedings more attune to the necessity to
conduct fair and impartial hearings.
An additional goal that should be pursued in discussions
regarding rules of administrative procedure is to take
appropriate measures to protect the confidentiality of
information. These measures, where appropriate, should
not only insure that potentially damaging information is
submitted under seal, but also that appropriate orders and
authorizations are obtained for the disclosure of protected
health care information subject to HIPPA protections.
Taking Full Advantage of
Available Discovery
In many types of disciplinary proceedings, nothing
approaching discovery available under the applicable
rules of civil procedure exists. Instead, evidence likely
to be presented at a hearing by prosecuting counsel can
sometimes only be identified by allegations included in
disciplinary complaints or rules to show cause, pre-hearing
reports and through the filing of freedom of information
requests.1 Assertions of privileges to preserve the
confidentiality of investigative reports and the attorney work
product of board counsel may also severely limit access to
information in advance of hearings.
The absence of traditional discovery mechanisms in
professional licensing proceedings may or may not pose
problems depending upon the facts or circumstances of
particular cases. The inability of counsel defending parties
to disciplinary proceedings to obtain access to evidence
likely to be presented in a hearing is typically mirrored
by the inability of prosecuting counsel to similarly obtain
information from parties subject to disciplinary complaints
and from prospective witnesses. How the risks and benefits
associated with the limited access to pre-hearing information
affect a particular case requires a careful exercise of
judgment by counsel.
To the extent access to evidence likely to be presented by
board counsel in advance of a hearing is determined to
be important to the presentation of an effective defense,
several options should be considered to obtain the required
information. Requests should be routinely made to conduct
file reviews of all public information available regarding
parties to proceedings in the possession of licensing boards.
Motions can be filed with hearing officers or boards
requesting the issuance of pre-hearing orders requiring the
disclosure of witnesses, exhibits, expert reports and any and
all exculpatory evidence in the possession of prosecuting
counsel and investigators. In conferences with hearing
officers or boards, requests can be made that pre-hearing
reports disclose the scope, extent and anticipated content
of testimony likely to be presented. While hearing officers
and boards may refuse to grant such requests, even in the
absence of established board practice to the contrary, it
should not be assumed that such requests will not be fruitful.
In addition, denials of requests for information essential to
a fair and impartial hearing may provide a basis for the
pursuit of subsequent appeals.
Exploring Settlement Options
Except in unusual circumstances, it is rare for licensing boards
to pursue disciplinary action against licensed professionals
or facilities without substantial justification for doing so.
While extenuating and mitigating factors may exist, and
disputes may exist regarding the appropriate interpretation
of relevant laws and regulations or the scope and extent
of appropriate sanctions, it is rare to be called upon to
defend parties to disciplinary proceedings who are without
substantial responsibility for activity the licensing boards
characterize as professional misconduct. Accordingly,
in many circumstances, the negotiation of consent orders
terminating proceedings represents a preferable alternative
Some jurisdictions take the position that the only discoverable information consists of documents the disclosure of which can be compelled through
freedom of information requests. Because exceptions from compelled disclosure typically exist for investigatory reports, pursuing this option may appear
fruitless. Nonetheless, surprising amounts of useful information can often be learned from public file reviews, both due to the less than thorough cleansing
of files for privileged information or through the discovery of references to information which then may be subject to disclosure pursuant to motions filed
with hearing examiners and boards.
1
October 2007 | to proceeding with contested hearings, especially when the
costs and potential collateral consequences of participating
in contested proceedings are taken into consideration.
decision regarding the best venue may depend upon the
personal characteristics and experience of hearing officers
and board members.
The principal difficulties sometimes encountered in
negotiating reasonable settlements to disciplinary complaints
involve how to deal with overly aggressive prosecuting
attorneys unwilling to reasonably compromise; requirements
that parties agree to standard terms and conditions in
consent orders that appear unreasonable; or with the
possibility that the manner in which a settlement is structured
may trigger more serious consequences for pharmacies
and pharmacists in the form of the termination of provider
agreements or potential criminal prosecution.
Generally, proceeding before hearing officers typically
represents the best option if (1) complex factual evidence
will be presented subject to conflicting interpretations; (2)
threshold legal questions exist that fall outside the expertise of
board members to effectively resolve; (3) multiple witnesses
and exhibits are likely to be presented; or (4) emotionally
charged and adversarial confrontations with complaining
witnesses are likely to occur. In these circumstances, the
availability of a detailed written record and proposed
report to the licensing board from which parties may take
exceptions provides a better opportunity for effective
advocacy and careful reconsideration of relevant facts
and circumstances. Proceedings before hearing officers,
however, are also likely to be much more protracted and
expensive, a factor that may be very important to affected
parties.
Some options to consider to increase the likelihood of a
favorable consent agreement are to request an informal
conference before an individual member of the board
authorized to conduct such proceedings and make
recommendations for settlement (and who is then typically
recused from participation in any subsequent contested
hearing if settlement negotiations are unsuccessful), to
request mediation before a neutral party familiar with
pharmacy operations, or to recommend the preparation of
investigatory reports to be used exclusively for purposes of
settlement discussions prepared by independent experts.
The latter approach may be particularly useful when
disputes arise regarding contested standards of industry
practice in specialized areas in which board members may
not have significant experience.
In drafting settlement agreements, care should also be
taken to limit the admissibility of any admissions contained
in settlement agreements only to proceedings to enforce the
agreements and to include where possible within the text
of agreements or in supporting documentation authorized
for disclosure any mitigating circumstances pertinent to
violations for later potential use in response to inquiries that
may be generated by public and private benefit plans and
certification agencies.
Determining the Role of Hearing
Examiners
In jurisdictions in which the option to proceed before a
hearing examiner or directly before a licensing board
exists, electing the best option for a particular case may
represent one of the most difficult challenges faced in the
defense of disciplinary proceedings, especially because a
In contrast, proceeding directly before licensing boards
may represent the best option where (1) the primary issue
presented involves the scope and extent of sanctions to be
imposed and witnesses are likely to persuasively present
evidence of mitigating circumstances; (2) an understanding
of the practical problems faced in day-to-day operations will
be helpful in obtaining a favorable resolution; or (3) giving
board members an opportunity to personally evaluate
the demeanor and credibility of witnesses is important.
In deciding to proceed directly before a licensing board,
however, counsel must consider the potential that board
members (who typically are only nominally compensated)
will react unfavorably to the need to participate in a
hearing and the possibility that their clients may not present
sympathetic figures when presented for direct scrutiny.
Making Effective Use of Stipulations
Notwithstanding how thoroughly a case is prepared,
witnesses are always likely to make unanticipated statements
and admissions when presented for direct and crossexamination. While sometimes such unanticipated testimony
can be very beneficial to the outcome of proceedings,
often the opposite occurs. The demeanor of witnesses
(especially defendants who feel they are being unjustly
subject to disciplinary proceedings) may also detract from
the effectiveness of a defense. Accordingly, it is usually
October 2007 | desirable to narrow the scope of contested facts as much as
possible through the effective use of stipulations. Narrowing
the scope of contested issues may also reduce the cost of
proceedings and better focus adjudicators on the resolution
of critical factual questions without getting lost in irrelevant
and extraneous details.
In jurisdictions subject to the legal residuum rule, it is obviously
critical to properly object to hearsay evidence. In other
jurisdictions, however, the principles that underlie the rule
should be articulated as a basis for giving hearsay evidence
less probative value than other evidence and to disregard
such evidence unless independently corroborated.
Unfortunately, it can sometimes prove to be difficult to
persuade state board counsel to agree to any extensive set
of stipulated facts. This may occur because board counsel
face crowded dockets and lack the time and resources to
work on stipulations or due to their fears (which are often
justified) that stipulations (often prepared by more seasoned
adversaries) may prejudice their ability to obtain favorable
rulings and stiff penalties. Some alternatives to increase
the likelihood that useful stipulations will be generated are
recommendations made to hearing examiners or board
representatives in pre-hearing conferences that scheduling
orders be issued mandating the exchange of agreed upon
and contested findings of facts and that parties meet and
confer, beginning at dates substantially in advance of the
scheduled hearing, to discuss stipulations and settlement
options.
Similar issues arise with respect to other rules of evidence.
For example, in some jurisdictions rules limiting the use
of judicial notice are not applicable in administrative
proceedings. This represents a particularly thorny problem
in pharmacy board proceedings where board members
may be tempted to use their independent knowledge and
expertise as a basis upon which to make determinations. To
reduce the possibility of the misuse of administrative notice,
and to discourage boards from relying upon evidence
outside of the record, pre-hearing orders can be used to
establish comparable requirements prior to the taking of
administrative notice by a hearing officer or board. For
example, in the same manner as required for the judicial
notice of facts not within the record of proceedings, prior
notice and an opportunity to rebut any administrative
noticed facts can be required.
Understanding the Relevance of the
Rules of Evidence
Presenting Exculpatory and
Mitigating Evidence
In virtually all jurisdictions, the rules of evidence do not
apply in administrative hearings and hearsay evidence is
admissible. Care should be taken, however, to not lose
sight of the role played by the rules of evidence in ensuring
the reliability of evidence and in using instances of noncompliance with the usual rules of evidence to suggest
that certain types of testimony should be given reduced
probative value or disregarded.
Unlike criminal trials which typically have bifurcated
proceedings to determine guilt and to impose sanctions,
in most circumstances state licensing boards use the
same record for the purpose of determining whether
unprofessional conduct has occurred and to determine the
appropriate sanctions. This clearly poses a challenge to
counsel defending pharmacies and pharmacists because
an effort to directly present character witnesses may create
a presumption, even if unstated, that the unprofessional
conduct has occurred and that parties are pleading for
lenience.
In several jurisdictions, the so-called “legal residuum”
rule provides that although admissible in administrative
proceedings, hearsay evidence if properly objected to is
not competent to support a finding of fact based solely
upon such evidence, and if admitted without objection may
support a finding of fact only if it is corroborated by other
competent evidence in the record. Often the legal residuum
rule is articulated as a requirement for constitutional due
process, especially in proceedings involving property rights
such as those that occur in licensing board proceedings. In
some states, such as California, New Jersey and Florida,
various permutations of the rule are embodied into state
statutory law.
Clearly the best way to avoid this dilemma is to ask a
hearing officer or board to conduct bifurcated proceedings.
If such requests are rejected or are not practical in the
circumstances, it may be necessary to find creative ways
to present character testimony and make the hearing
officer or board aware of mitigating factors without clearly
acknowledging or suggesting that the evidence is being
presented for such a purpose. This can be accomplished
by background testimony regarding the long history of
operations of a facility or the conduct of an individual
October 2007 | without disciplinary complaints or by presenting evidence
regarding the location or services provided by a facility
suggesting that its continued operation is critical to the
continued provision of professional services to certain
communities.
It may also be useful in disciplinary proceedings to describe
actions taken by a facility after complaints have occurred
to avoid future complaints in the same area. If presented
skillfully, such testimony rather than appearing to provide
an admission of guilt may instead illustrate the commitment
of a facility to establishing good business practices and
suggest to a hearing officer or licensing board the type of
order to issue in lieu (in whole or in part of civil penalties),
i.e., a mandate to prepare and submit for review a facility
compliance plan.
Licensing Controversies
Licensing board proceedings concerning the issuance
of licenses, approvals and certifications unrelated to
disciplinary matters, but instead relating to the actual
physical requirements for the operation of a facility, the
granting of reciprocal licensing privileges or other regulatory
matters, pose at least one important set of issues that may
be less relevant in disciplinary proceedings, namely, the
applicability and validity of non-regulatory “statements of
policy” or “guidance documents,” or of board practices
imposed uniformly but not reduced to written directives.
Licensees often protest the application of such requirements
and question their legal validity. State precedent has
emerged in three primary directions with respect to
administrative requirements not imposed by regulations.
Recognizing how to handle controversies regarding such
administrative requirements requires an appreciation of the
relevant state law.
In some jurisdictions, policies that are treated as “binding
norms” which are not properly incorporated into published
administrative rules are treated as void and unlawful and
may not be properly relied upon as a basis for refusing to
issue a license or for imposing conditions upon a license.
In such jurisdictions, the relevant documents or policies
should be identified and documented and appropriate
motions objecting to their use filed. Upon appeal, unless the
reliance upon the documents or policies constituted harmless
error, adjudications relying on such documents or policies
may generally be vacated.
Other jurisdictions recognize the practical need for policies
and guidance documents not incorporated into regulations,
and afford these documents two substantially different
degrees of recognition. In most jurisdictions, if an agency
adopts statements of policies or guidance documents not
intended to have the force and effect of administrative
regulations, such documents may be treated as valid
“statements of policy” or “interpretative rules,” but may
not be binding upon a hearing examiner or board and
are never binding upon a court considering an appeal.
Instead, in many circumstances a hearing examiner or
board enjoys the discretion to apply or not apply such
policies or documents to the extent appropriate. Even where
a hearing officer or board determines its actions are bound
by such documents or policies, however, upon appeal a
court may decide whether or not the application of the
policy is reasonable and appropriate without affording the
document or policy any significant degree of deference. In
such jurisdictions, practitioners must stress the non-binding
nature of the documents or policies and suggest reasons
that the documents or policies do not provide the most
reasonable and appropriate interpretation of statutory
requirements in a particular setting.
One final set of state practices is highly problematic. Some
states treat policies not incorporated into valid administrative
regulations as mere interpretations of validly adopted rules
and hold that an agency’s interpretation of its own rules must
be upheld unless clearly contrary to law, unconstitutional or
arbitrary and capricious. In such jurisdictions, the best
approach is to illustrate that the challenged policies are
not in fact mere interpretations of existing rules, but instead
represent new rules that have been invalidly adopted.
Rulemaking and Policy Setting Proceedings
Rulemaking typically poses significant challenges for
professional licensing boards because in most jurisdictions
boards are not provided the staff and resources necessary
to develop any significant regulatory initiatives and board
members are nominally compensated appointees who
lack the expertise, time and background necessary to
function as their own regulatory staff. These problems may
pose particularly acute challenges for licensing boards in
jurisdictions in which tradition or practice prevents boards or
their staff members from issuing advisory opinions regarding
various issues without the adoption of formal administrative
rules.
October 2007 | At least two alternatives are available for individuals and
organizations promoting the adoption of new regulatory
standards in jurisdictions in which boards lack the capacity
or willingness to initiate rulemaking proceedings. It may
be possible either to take advantage of formal or informal
options for “negotiated rulemaking” or to petition pharmacy
boards to consider and adopt specific proposed rules.
In recent years, many jurisdictions have adopted formal
negotiated rulemaking laws. Unfortunately, many of
these laws have remained largely unutilized because of
fear of their often highly detailed prescriptive procedural
requirements. Upon closer examination, however,
the procedures mandated by these laws are often less
burdensome in practice than seems apparent, especially
when agencies are engaged in adopting technical rules
sometimes typical in pharmacy board practice that do not
involve controversial public policy issues. Accordingly,
for major regulatory initiatives of significant importance,
consideration should be given to utilizing formal negotiated
rulemaking requirements.
An alternative to formal negotiated rulemaking that may be
considered in many jurisdictions is the use of informal advisory
committees to develop proposed rules for consideration by
pharmacy boards. Fortunately, most regulatory negotiation
statutes provide optional, not mandatory, procedures for
boards to work cooperatively with stakeholder groups to
develop proposed rules, and in most jurisdictions, there are
no formal restrictions or limitations upon the development
and use of advisory committees to develop regulatory
proposals for consideration by pharmacy boards.
Finally, the option of formally proposing rules for
consideration by agencies by way of petition should also
be considered. Many states authorize rulemaking petitions
whereby parties may draft detailed rules and present
the rules to boards for consideration by way of petition.
Typically, a board will then study the rules and make a
determination about whether to publish the rules for notice
and comment either as submitted or with modifications
adopted by the board. This option may be attractive
because it allows proposed rules to be quickly promulgated
for notice and comment without the necessity of a licensing
board formally endorsing the recommendations. Instead, all
that is required is for a board to conclude that the topic and
recommendations have sufficient merit to be promulgated
for notice and comment.
K&L Gates comprises multiple affiliated partnerships: a limited liability partnership with the full name Kirkpatrick & Lockhart Preston Gates Ellis LLP qualified in
Delaware and maintaining offices throughout the U.S., in Berlin, and in Beijing (Kirkpatrick & Lockhart Preston Gates Ellis LLP Beijing Representative Office); a
limited liability partnership (also named Kirkpatrick & Lockhart Preston Gates Ellis LLP) incorporated in England and maintaining our London office; a Taiwan
general partnership (Kirkpatrick & Lockhart Preston Gates Ellis) which practices from our Taipei office; and a Hong Kong general partnership (Kirkpatrick &
Lockhart Preston Gates Ellis, Solicitors) which practices from our Hong Kong office. K&L Gates maintains appropriate registrations in the jurisdictions in which its
offices are located. A list of the partners in each entity is available for inspection at any K&L Gates office.
This publication/newsletter is for informational purposes and does not contain or convey legal advice. The information herein should not be used or relied upon in
regard to any particular facts or circumstances without first consulting a lawyer.
Data Protection Act 1998—We may contact you from time to time with information on Kirkpatrick & Lockhart Preston Gates Ellis LLP seminars and with our regular
newsletters, which may be of interest to you. We will not provide your details to any third parties. Please e-mail [email protected] if you would prefer not to
receive this information.
©1996-2007 Kirkpatrick & Lockhart Preston Gates Ellis LLP. All Rights Reserved.
October 2007 | 
Download