Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1.
Condition added by commissioner.
The commissioner may periodically revise the list of qualified
medical conditions eligible for treatment with medical cannabis.
A. Revisions to the list must reflect:
(1) advances in medical science;
(2) evidence-based medicine and other
peer-reviewed research demonstrating treatment efficacy; or
(3) other therapeutic factors that will
improve patient care.
B.
In determining whether a condition qualifies, the commissioner must consider
the adequacy of available evidence that medical cannabis will provide relief
and the report of the Medical Cannabis Review Panel established in subpart
3.
Subp. 2.
Requests for adding a condition.
Any person may request the commissioner to add a qualifying
medical condition not listed in Minnesota Statutes, section
152.22, subdivision
14, to the list by applying on a form provided by the commissioner. Requests
under this subpart will be accepted beginning June 1, 2016.
A. The commissioner shall only accept
requests during June and July of each year and will dismiss requests received
outside of this period.
B. The
commissioner must post notice on the department's medical cannabis Web site by
May 1 each year, announcing the open period for accepting requests and
describing the procedure for submitting requests.
C. Each request must be limited to one
proposed qualifying medical condition. The commissioner must dismiss a request
if it contains multiple proposals.
D. The commissioner must dismiss a request to
add a medical condition that has been previously considered and rejected by the
commissioner, unless the request contains new scientific evidence or research
or describes substantially different symptoms.
E. If the commissioner dismisses a timely
request, the commissioner must notify the person making the request of the
reason that the request was dismissed.
F. The commissioner must forward the request
to the review panel for review unless the request is dismissed.
G. The commissioner must provide the review
panel with a review of evidence-based medicine and other peer-reviewed research
demonstrating treatment efficacy for the requested condition.
Subp. 3.
The Medical
Cannabis Review Panel.
A. The
commissioner must appoint a Medical Cannabis Review Panel composed of seven
members, including at least one medical cannabis patient advocate and two
health care practitioners, one with expertise in pediatric medicine.
B. The Medical Cannabis Review Panel must
review requests submitted under subpart 2 and report to the commissioner on the
public health impacts, including therapeutic factors and known potential risks,
of the proposed additional medical conditions .
C. Members serve a three-year term or until a
successor is appointed and qualified. If a vacancy occurs, the commissioner
must appoint a replacement to complete the original term created by the
vacancy.
D. Members may serve
multiple terms.
E. Members must not
hold a direct or indirect economic interest in a registered medical cannabis
manufacturer or serve on the board of directors or as an employee of a
registered medical cannabis manufacturer.
F. Members must disclose all potential
conflicts of interest having a direct bearing on any subject before the review
panel.
Subp. 4.
Review panel meetings.
A. The
Medical Cannabis Review Panel must meet at least one time per year to:
(1) review requests that the commissioner has
received for the approval of proposed qualifying medical conditions;
(2) review the status of those medical
conditions for which the commissioner has deferred approval or rejection;
and
(3) review new medical and
scientific evidence about current qualifying medical conditions.
B. The commissioner must post a
notice on the department's medical cannabis Web site at least 30 calendar days
before a review panel meeting. Notice must include the date, time, and location
of the meeting, a brief description of the requests received, and information
on how public comment will be received, including a deadline, if any.
C. The
Medical Cannabis Review Panel must submit a written report to the commissioner
by November 1 after conducting the public meeting. The written report must
include potential public health benefits and risks of adding or rejecting the
proposed qualifying medical condition.
Subp. 5.
Commissioner review.
A. Upon receiving the Medical Cannabis Review
Panel's report, the commissioner must render a decision by December 1 and must:
(1) approve the request and forward the
medical condition as required by item C; or
(2) reject the medical condition.
B. The commissioner must
communicate the commissioner's decision to the requesting party along with the
reasons for the decision and publish the decision on the department's medical
cannabis Web site by December 1.
C.
The commissioner must forward a newly approved qualifying medical condition to
the chairs and ranking minority members of the legislative policy committees
having jurisdiction over health and public safety by January 15 as required by
Minnesota Statutes, section
152.27,
subdivision 2. If the legislature does not provide otherwise by law, the
commissioner must publish the newly approved qualifying medic m,al condition in
the State Register and on the department's medical cannabis Web site before its
August 1 effective date.
Subp.
6.
Requests for adding a delivery method.
Any person may request that the commissioner add a delivery
method not listed in Minnesota Statutes, section
152.22, subdivision
6, to the list by applying on a form provided by the commissioner. Requests
under this subpart will be accepted beginning June 1, 2016.
A. The commissioner shall only accept
requests during June and July of each year and will dismiss requests received
outside of this period.
B. The
commissioner must post notice on the department's medical cannabis Web site by
May 1 each year, announcing the open period for accepting requests and
describing the procedure for submitting requests.
C. The commissioner must post the request to
add a delivery method, along with information about how to submit public
comment on the department's medical cannabis Web site. The commissioner must
allow at least 30 days for public comment.
D. Each request must be limited to one
proposed delivery method. The commissioner must dismiss a request if it
contains multiple proposals.
E. The
commissioner must dismiss a request to add a delivery method that has been
previously considered and rejected by the commissioner, unless the request
contains new scientific evidence or research or describes substantially
different therapeutic benefits.
F.
If the commissioner dismisses a timely request, the commissioner must notify
the person making the request of the reason that the request was
dismissed.
G. The commissioner must
consider the request and any written comments from the public. The commissioner
must render a decision by December 1, and must:
(1) approve the request and forward the
delivery method to be added as required by item I; or
(2) reject the delivery method.
H. The commissioner must
communicate the commissioner's decision to the requesting party along with the
reasons for the decision.
I. The
commissioner must forward an approved delivery method to be added to the chairs
and ranking minority members of the legislative policy committees having
jurisdiction over health and public safety by January 15 as required by
Minnesota Statutes, section
152.27,
subdivision 2, and if the legislature does not provide otherwise by law,
publish the addition in the State Register and on the department's medical
cannabis Web site.