048-1 Wyo. Code R. §§ 1-6 - Application for Waiver of Rules to Conduct an Innovative Study
(a) A person conducting an innovative study
may request a waiver of Department rules if necessary to carry out the
innovative study.
(b) In order to
receive a waiver of rules to conduct an innovative study, a person undertaking
an innovative study shall submit a waiver application to the Department. The
waiver application must be submitted in the manner and form established by the
Department and include a description of:
(i)
The particular rule or rules for which a waiver is requested; and
(ii) The justifications for a waiver,
including why no alternative exists to accomplish the purposes of the study but
for a waiver being granted.
(c) The waiver application shall be submitted
concurrent to an application for healthcare innovation funding as specified in
Section 4 of this Chapter. The
application for healthcare innovation funding may request a zero dollar amount
if the applicant requires only a waiver of rule to conduct the innovative
study, but the application must satisfy the other requirements of Section
4 of this Chapter.
(d) The review committee established under
Section 5 of this Chapter shall
evaluate waiver applications concurrent with the applications for health care
innovation account funding. The committee may request additional information
from the applicant or from outside experts as needed to evaluate the
application.
(e) Based on the
review committee's evaluation, the review committee shall recommend the
Director to either approve or deny a waiver application.
(f) After receipt of the review committee's
recommendations for all evaluated applications submitted during the open call
period, the Director shall either approve or deny each waiver application.
(i) The Director shall base the decision on
the review committee's recommendation and a determination that:
(A) The grant of a waiver does not pose a
threat to the health, safety, or welfare of Wyoming residents; and
(B) No reasonable alternative exists to
accomplish the purposes of the innovative study but for a waiver being
granted.
(ii) If the
Director approves a waiver request, the Department shall provide the applicant
written notice that states:
(A) The rules
being waived; and
(B) The purpose
for the waiver.
(iii)
The Director's approval of a waiver request is contingent upon successful
execution of an agreement for the innovative study approved by the committee.
(A) An approved waiver request is in effect
only while a successfully executed agreement is also in effect;
(B) If an agreement cannot be reached or the
Attorney General does not approve of the agreement, the Director's approval of
the waiver is deemed revoked.
(iv) If the Director denies a waiver request,
the applicant is not entitled to request a contested case proceeding pursuant
to the Wyoming Administrative Procedure Act,
W.S.
16-3-101 to -115.
(g) If an innovative study is conducted under
a waiver granted by the Director, the applicant shall provide notice of the
waiver to all parties involved in the study. The notice must include the
elements listed under Subsection (f)(ii)(A) and (B) of this Section as well as
the time period for which the waiver is active.
(h) The Director may revoke a waiver at any
time.
(i) The Director's decision to revoke a
waiver must be based on a finding that:
(A)
The grant of a waiver poses a threat to the health, safety, or welfare of
Wyoming residents;
(B) A reasonable
alternative to a waiver exists to accomplish the purposes of the innovative
study; or
(C) The applicant or
others responsible for conducting or overseeing the innovative study have
violated the law or Department policies.
(ii) If the Director revokes a waiver, the
Department shall provide written notice, including an effective date. The
applicant is not entitled to request a contested case proceeding pursuant to
the Wyoming Administrative Procedure Act,
W.S.
16-3-101 to -115.
(i) If an innovative study was conducted
under a waiver which has been revoked by the Department, the applicant shall
provide notice of the revocation, including the effective date, to all parties
involved in the study.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.