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Dedicated to protecting and improving the health and environment of the people of Colorado

To:

Members of the State Board of Health

From:

Natalie Riggins, Medical Marijuana Program Manager, Center for Health and Environmental Data (CHED); and Ken Gershman, MD, MPH, Manager, Medical Marijuana Research Grant Program, Disease Control and Environmental Epidemiology Division (DCEED)

Through:

Dana Erpelding, Director, CHEDDE and Rachel Herlihy, MD, MPH, Director, DCEEDRH

Date:

July 15, 2015

Subject:

Rulemaking Hearing Proposed Amendments to 5 CCR 1006-2, Medical Use of Marijuana

The Medical Marijuana Registry (MMR) is proposing modifications to the Medical Use of Marijuana regulations. The proposed modifications include: remove unnecessary notary requirements; add post-traumatic stress disorder (PTSD) as a new debilitating medical condition, and; address issues brought to the department’s attention by the Office of Legislative Legal Services (OLLS) after review of regulation changes approved by the Board of Health in September 2014. Two technical clarifications to correctly identify a paragraph number and correctly reference the State Administrative Procedure Act are included as part of the Regulation 2 proposed changes. Notice of this rulemaking hearing was sent to stakeholders including: Medical Marijuana Registry stakeholder lists (physicians, caregivers, centers, and “general”), Scientific Advisory Council of the Medical Marijuana Research Grant Program, Colorado Medical Society, Colorado Psychiatric Society, Colorado Academy of Family Physicians, and the petitioner. Details of significant stakeholder comments are included under the relevant proposed regulation modifications below. A. MODIFICATIONS TO REGULATION 2: APPLICATION FOR A REGISTRY IDENTIFICATION CARD AND REGULATION 4: CHANGE IN APPLICANT INFORMATION 1. Removing the requirement to have a Notary in Regulation 2 and Regulation 4 Board of Health Regulation 2 and Regulation 4 currently include a notary requirement. This requirement was first initiated as a result of a noted trend of caregivers submitting patient change forms without the patient’s knowledge or consent. The Medical Marijuana Registry patient verification procedures approved by the Board in September 2014 ensure changes to the patient’s record are patient driven. With these adjustments, it is no longer necessary for patients to notarize their application. Removing the notarization requirement reduces the burden on applicants to find and pay for a notary. 2. Minor Technical Cleanup of Regulation 2

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The Medical Marijuana Registry proposed to conduct minor cleanup of Regulation 2 part B.5. and part I.2. These two technical clarifications identify a paragraph number by Arabic numeral rather than Roman numeral and correctly reference the State Administrative Procedure Act. B. MODIFICATIONS TO REGULATION 6: DEBILITATING MEDICAL CONDITIONS AND THE PROCESS FOR ADDING NEW DEBILITATING MEDICAL CONDITIONS 1. Adding PTSD as New Debilitating Medical Condition On January 27, 2015, the department received a petition from a patient to add PTSD to the list of debilitating conditions for which an individual may apply for participation in the Medical Marijuana Registry. The department reviewed the information submitted in support of the petition and conducted a search of the medical literature for peer-reviewed published randomized controlled trials or well-designed observational studies concerning the use of marijuana for PTSD. This information was presented to the Medical Marijuana Scientific Advisory Council (SAC) on April 10, 2015. Based on the following considerations, the SAC recommended that the department request the Board of Health to add PTSD as a new debilitating condition: There is evidence based on one small, well designed, randomized controlled trial that a synthetic cannabinoid (nabilone) similar to THC (primary cannabinoid in marijuana) is effective in treating PTSD nightmares and possibly other PTSD symptoms. There are several supportive lower quality studies also involving either nabilone or THC.  Disrupted sleep (nightmares and insomnia) is a core component of PTSD associated with significant distress, functional impairment and poor health; it is linked to PTSD development and maintenance. Current PTSD treatments are quite limited in their ability to manage PTSDrelated sleep disturbance. Existing treatments for PTSD (pharmacotherapy and psychotherapy) have limitations, do not necessarily result in adequate responses in most of those treated, may not be acceptable to some patients, and may not be available everywhere. In addition, many of the supporting studies of treatment efficacy were conducted among a subset of persons with PTSD who may not be representative of all persons with PTSD. There are only two FDA-approved drugs for treating PTSD; a number of other recommended drugs are used off-label. This highlights how accepted conventional treatments are not all subject to the same rigorous process of review and approval. Although persons with PTSD have access to recreational marijuana in this state, such access is not statewide, and there may be preferred products available only through medical marijuana centers. The network of caregivers also helps address gaps in access to medical marijuana. Some persons with PTSD may be receiving medical marijuana cards by selecting a different debilitating condition (e.g., pain) in their application to the Medical Marijuana Registry (MMR). Adding PTSD provides the MMR an opportunity to obtain more accurate information from applicants, and will improve the department’s understanding of MMR patients’ medical marijuana needs. Although marijuana is not without some adverse effects, this is also true of essentially all FDA-approved drugs, including narcotic pain medications which have substantial abuse potential including the risk of lethal overdosing.

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The department proposes that the addition of PTSD as a new debilitating condition be limited to a period of four years. At that point, any new evidence of benefit and harm would be reassessed based on additional published results from further clinical trials and well-designed observational studies, such as those approved for funding by the Board of Health as part of the Medical Marijuana Research Grant Program. Several concerns have been communicated in writing to either CDPHE or the Board regarding this proposal from two members of the SAC. These concerns, followed by the Department’s comments, include: a) “… there are inherent dangers related to cannabis use and PTSD, with recent literature noting worse outcomes …” CDPHE Comments: Although potentially concerning, the literature referenced is not a peer-reviewed journal publication, but rather an abstract of a talk presented in December 2014 at the annual meeting of the American Academy of Addiction and Psychiatry. The paper has not yet been published and thus the methods and findings have not yet been publicly available for review and critique. The Department sought feedback from an expert VA researcher on PTSD who has seen the paper pre-publication. Aspects that influence the paper’s reliability include: the study being a secondary data analysis of administrative data, the study being non-generalizeable because the study population consisted of veterans entering intensive residential treatment - which is a very small subset of veterans with PTSD, the study being non-generalizeable to all veterans with PTSD because approximately 74% of veterans nationally do not receive their health care in the VA system (source: FY14 data – Dept. of Veterans Affairs) and the study being non-generalizeable to civilians with PTSD. Based upon the paper being in prepublication and our preliminary assessment, the Department does not recommend that the Board of Health rely upon the study at this time. b) “… psychiatrists are highly unlikely to make recommendations for marijuana use in PTSD patients. Consequently, physicians with no psychiatric training will be making these recommendations, practicing outside their scope of expertise …” CDPHE Comments: It is a requirement of the MMR that a physician certify a debilitating medical condition. Physicians other than psychiatrists often manage the more routine mental health conditions and might make recommendations for medical marijuana for PTSD. Primary care physicians receive training and diagnose and treat some psychiatric conditions such as clinical depression on a routine basis. Standard recommended treatment modalities for PTSD include drug therapy and psychotherapy. The only two FDA-approved drugs for PTSD, sertraline and paroxetine, are commonly prescribed for depression and likely very familiar to many primary care physicians. Recently published (December 2013) guidance in the medical journal, American Family Physician (source: www.aafp.org/afp/2013/1215/p827.html) evidences the appropriateness and support for primary care providers diagnosing and initially managing (and referring as necessary) persons with PTSD. c) “ …. It may become a malpractice concern if something goes awry (psychosis, etc). I would ask that you get input from COPIC on this.” CDPHE Comments:

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The Department contacted COPIC, a Colorado provider of medical professional liability insurance, and spoke with staff involved in policy underwriting and policyholder service. COPIC supports the clinical decision of physicians to certify appropriate patients for use of medical marijuana. In order to assure safe clinical practice and reduce the risk of liability, COPIC asks questions on the application for malpractice insurance regarding the number and percentage of patients for whom the physician recommends medical marijuana; and questions about having a physician-patient relationship, completing full medical assessments, providing follow-up care, and maintaining appropriate documentation. COPIC has never been involved with a liability claim related to adverse effects or clinical outcomes from use of medical marijuana. d) “There have already been three deaths in this state related to marijuana users becoming psychotic and engaging in violent behavior. My concern is that veterans with PTSD and co morbid traumatic brain injuries will be particularly vulnerable to the psychoactive properties of cannabis, and at risk for perpetrating violence toward self and others given their greater access to weapons relative to the general population.” CDPHE Comments: The 3 deaths related to marijuana use were tragic. One concerned a Colorado resident and two involved individuals visiting Colorado. The Department recognizes that there are some risks to medical marijuana treatment. The most concerning risks, however, need to be placed in proper perspective, for example, by comparing them to the risks associated with the use of prescription drugs and prescription drug abuse. The Department is aware of only one of the estimated 500,000 Colorado adult residents who used marijuana (“one or more days in the past month”) during 2014 (source: BRFSS, Health Surveys and Analysis Program, CDPHE) engaging in violent behavior resulting in death (of the spouse in this case). Many veterans anecdotally use marijuana without reported incidents of related violence in Colorado. In contrast, during 2014, there were approximately 330 deaths in Colorado due to prescription drug abuse of opioid analgesics (source: Health Statistics Section, CDPHE). 2. Deleting Role of Medical Marijuana Scientific Advisory Council (SAC) in Reviewing Petitions The rules adopted by the Board of Health in September 2014 authorized the SAC to review and make recommendations concerning petitions to add debilitating conditions. The General Assembly has reviewed the rule and determined that the SAC is not authorized to perform this task. SB 15-100 modifies Regulation 6 to remove the SAC from the petition process. The repeal results in a dangling cross-reference and disjointed language that may confuse stakeholders. The revisions clarify the rule following the feedback by the OLLS and decision of the General Assembly. Though the SAC cannot be utilized in its official capacity, the Department recognizes the expertise of the individual members and may continue outreach to those individuals and other MMR stakeholders that can assist the Department in reviewing petitions to add debilitating conditions.

C. MODIFICATIONS TO REGULATION 14: COLORADO MEDICAL RESEARCH GRANT PROGRAM The Board of Health approved the addition of Regulation 14 in September 2014, which specifies the administration of the Medical Marijuana Research Grant Program by the department, as authorized by § 25-1.5-106.5, C.R.S. The rule authorized the department to establish timelines. Upon review by the OLLS, part A.2 was determined to be overbroad. SB 15-100 modifies Regulation 14 to remove part A.2. The rule revision replaces part A.2 with

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language that is more specific but allows for some flexibility to meet the needs of the grant program and prospective applicants. The revision also adds language regarding the duties of the SAC (with the exception of reviewing petitions to add debilitating conditions) that was previously in Regulation 6, but removed in response to the passage of SB 15-100 (see above). The portions of the packet highlighted in yellow reflect changes to the rulemaking packet since it was presented to the Board of Health in May. The changes recognize feedback received from stakeholders, incorporate suggestions from the Office of the Attorney General, remove the notary requirement for minors as recommended by Board member Nadeen Ibrahim at the May Board of Health meeting, and respond to the Board of Health's request for additional information concerning the Scientific Advisory Council's discussion of PTSD and in particular, the concerns voiced by SAC members.

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Meeting Minutes Date: April 10, 2015 Medical Marijuana Scientific Advisory Council

Time: 8:30 am Place: Hilton Garden Inn Cherry Creek 600 S. Colorado Blvd. Denver, CO 80246

Chair: Dr. Larry Wolk, Executive Director & Note Taker: Elyse Contreras Chief Medical Officer, CDPHE In Attendance: Ken Gershman, Larry Wolk, Lalit Bajaj, Kristen Park, Paula Riggs, Doris Gundersen, Teri Robnett, Joseph Frank, Tim Byers, Kennon Heard (via conference line), Richard Cohen (ad hoc member), Natalie Riggs (non-voting member). Not in Attendance: Stacy Livingwell, Alan Shackelford, Ted Maynard. Topics: 8:30 am Welcome Introductions: I. Richard S. Cohen MD, ad hoc member recommended by petitioner. II. Natalie Riggins, CDPHE Medical Marijuana Registry Program Manager, ex-officio and non-voting member. Review minutes from January meeting: I. Paragraph describing department’s proposal of revised funding for application number 63; Replaced the word “plasma” with “blood” to broaden this reference to cannabinoid level testing in humans. II. MOTION MADE to approve minutes, seconded, approved unanimously. 2015 Meetings: I. Bylaws require the council to meet quarterly. II. Informal decision made to hold the next quarterly meetings in June and October. III. An online poll will be sent to SAC members to determine the best dates. Review of PTSD Petition and SAC Discussion Presentation; I. Overview of the “Evidence Base to Assess the PTSD Petition” by Ken Gershman (please refer to the document “SAC slides for 4-10-15” available online on

Presenter Larry Wolk Larry Wolk

Larry Wolk

Ken Gershman Ken Gershman All

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department website). Discussion; I. Need for co-occurring psychotherapy discussed. Recognized that not all veterans have equal access to the psychotherapy. II. Prescribed purposes and availability of Nabilone and Marinol discussed. III. Weighing the benefits of marijuana against the harms discussed. IV. Discussed the need for more inclusive studies, specifically interviews with spouses of persons with PTSD. V. Dr. Cohen stated that his patients have reported that they are benefited by marijuana. He feels that marijuana does work for PTSD. He has seen many PTSD patients and feels PTSD is very prevalent in the population. He believes the different types of marijuana, and the individual cannabinoids need to be researched. VI. Discussed the inability to differentiate medical marijuana users versus retail marijuana users that seek emergency care. VII. Discussed the differences in medical marijuana versus retail marijuana and differences in access. VIII. Discussed the potential problems veterans face with their VA benefits as it relates to using marijuana. IX. Discussed the issue of patients’ willingness to be honest with their physicians regarding marijuana use. X. Discussed weighing the potential patient benefits that marijuana could offer over the perceived risks, and in comparison to the side effects of FDA approved PTSD drugs. XI. Question raised as to whether the council would be doing harm by denying PTSD patients access to medical marijuana. Discussed. XII. Discussed concerns about marijuana not having gone through the rigorous FDA drug approval process that all prescription medications must go through on the federal level. XIII. CDPHE terms for denying the petition reviewed. Discussed in context of other medications and medical practices. XIV. SAC will incorporate the evidence from the published literature, ethics of patient honesty and the psychological wellbeing of patients in this decision. XV. The individual component parts of marijuana (such as CBD) do not apply to this decision. XVI. Ethical issues, transparency and lack of strong science regarding marijuana

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XIX. XX. XXI.

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treatment for PTSD further discussed. Discussion on whether anecdotal evidence should be considered since most of the scientific literature was published during marijuana prohibition and should be considered biased. Dr. Cohen stated many of his patients using marijuana for PTSD return annually because of its efficacy. Approving medical marijuana for PTSD is a good idea in his opinion so this PTSD population may be studied. Pointed out nobody has been harmed with marijuana use, unlike alcohol use. Discussed research studies; the lag time and the two PTSD studies that were recently funded by CDPHE that are being held to the standards of the Board of Health Rules. Discussed the possibilities of a re-classification of marijuana by the Federal Drug Enforcement Agency (DEA). Dr. Wolk’s Summary of the Discussion & Comments: a. The Colorado constitution calls medical marijuana “medicine”, not “alternative medicine”. b. Marijuana is not a magic “pill” but rather should be part of a PTSD treatment plan. c. Many medical marijuana patients are not receiving complete care or treatment that they should (just a one-time per year visit to the doctor to receive a renewed prescription). d. We don't want to mislead patients or providers; this is an imperfect system. e. Physicians are currently recommending and prescribing marijuana under different conditions in order to treat patients with PTSD. It would be more honest for physicians to declare they are prescribing marijuana for PTSD. f. If or when PTSD is added to the list of conditions, it will become difficult to remove should more research become available with evidence that suggests marijuana is not effective for treating PTSD. Other states require documentation of existing conventional treatment for PTSD to qualify for medical marijuana, or documentation of a diagnosis of PTSD. Could consider adding conditional caveats to match what other states have done. Discuss complexities and caveats of approval, including making the approval “time-limited”.

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SAC Recommendation I. Consensus poll taken on whether SAC members recommend CDPHE to approve or deny the petition to add PTSD to the list of medical marijuana conditions. II. Additional consensus poll taken on whether the approval shall be unconditional or conditional, and whether approval shall be time-limited pending results of further research studies. All conditions will be subject to legal compliance. III. SAC members may or may not use CDPHE’s criteria to aide in their decision. Decisions are not binding. IV. Consensus Poll 1; Whether or not to add PTSD to list of Medical Marijuana qualifying conditions? Results: Yea=7, Nay=3. V. Consensus Poll 2; If PTSD is added, should it be conditional (suggestions included; temporary-add, follow examples of other states, incorporate with treatment plans/documentation, re-review of literature to incorporate new research, develop a prescriber-community standard to treat PTSD) or unconditional? Results: 3 conditional, 5 unconditional, 2 abstained. VI. SAC decision is a recommendation to CDPHE only. VII. CDPHE and Dr. Wolk have much to consider; the SAC’s vote, discussions, conflict, and ethical issues. VIII. SAC will be notified when a decision is made. IX. Thanks given to the SAC on behalf of patients and veterans. Adjourned

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STATEMENT OF BASIS AND PURPOSE AND SPECIFIC STATUTORY AUTHORITY for Amendments to 5 CCR 1006-2, Medical Use of Marijuana Basis and Purpose. Board of Health Regulation 2 and Regulation 4 require patients to notarize their application and change of patient information forms. The Medical Marijuana Registry patient verification procedures approved by the Board in September 2014 ensure changes to the patient’s record are patient driven. With these adjustments, it is no longer necessary for patients to notarize their application or change forms. The changes to Regulation 2 and Regulation 4 remove the notarization requirement. In addition, the Medical Marijuana Registry proposes minor cleanup of Regulation 2 part B.5. and part I.2. These two technical clarifications identify a paragraph number by Arabic numeral rather than Roman numeral and correctly reference the State Administrative Procedure Act. On January 27, 2015, the department received a petition from a patient to add posttraumatic stress disorder (PTSD) to the list of debilitating conditions for which an individual may apply for participation in the Medical Marijuana Registry. The department reviewed the information submitted in support of the petition and conducted a search of the medical literature for peer-reviewed published randomized controlled trials or well-designed observational studies concerning the use of marijuana for PTSD. Based upon the current process delineated in Board of Health rules, this information was presented to the Medical Marijuana Scientific Advisory Council (SAC) on April 10, 2015. The SAC recommended that the department request a Board of Health rulemaking hearing to add PTSD as a new debilitating condition. The rules adopted by the Board of Health in September 2014 authorized the SAC to review and make recommendations concerning petitions to add debilitating conditions. The General Assembly has reviewed the rule and determined that the SAC is not authorized to perform this task. SB 15-100 modifies Regulation 6 to remove the SAC from the petition process; this change is effective May 15, 2015. The repeal results in a dangling cross-reference and disjointed language that may confuse stakeholders. The revisions clarify the rule following the feedback by the OLLS and decision of the General Assembly. Though the SAC cannot be utilized in its official capacity, the Department recognizes the expertise of the individual members and may continue outreach to those individuals and other MMR stakeholders that can assist the Department in reviewing petitions to add debilitating conditions. The Board of Health approved the addition of Regulation 14 in September 2014. Regulation 14 specifies the administration of the Medical Marijuana Research Grant Program by the department, as authorized by § 25-1.5-106.5, C.R.S. The rule authorized the department to establish timelines. Upon review by the OLLS, part A.2 was determined to be overbroad. SB 15-100 modifies Regulation 14 to remove part A.2.; this change is effective May 15, 2015. The rule revision replaces part A.2 with language that is more specific but allows for some flexibility to meet the needs of the grant program and prospective applicants. Specific Statutory Authority. These rules are promulgated pursuant to the following statutes: Colorado Constitution, Article XVIII, Section 14 § 25-1.5-106, C.R.S. and § 25-1.5-106.5, C.R.S.

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SUPPLEMENTAL QUESTIONS Is this rulemaking due to a change in state statute? ___X___ Yes in part, the bill number is _SB15-100___; rules are ___ authorized ___ required. __X___ No Is this rulemaking due to a federal statutory or regulatory change? ______ Yes ___X__ No Does this rule incorporate materials by reference? ______ Yes ___X__ No Does this rule create or modify fines or fees? ______ Yes ___X__ No

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REGULATORY ANALYSIS for Amendments to 5 CCR 1006-2, Medical Use of Marijuana 1.

A description of the classes of persons who will be affected by the proposed rule, including classes that will bear the costs of the proposed rule and classes that will benefit from the proposed rule. Removing the notary requirements Medical marijuana patients and caregivers will benefit as they will no longer be required to spend time seeking the services of a notary public and will save the $5 notary fee currently required on the patient application form, patient change of record form, and the caregiver acknowledgement form. These changes provide clarity, and simplify the processes for Medical Marijuana patients and caregivers Minor Technical Cleanup of Regulation 2 These clarifications may assist medical marijuana registry stakeholders when reviewing the rules. Adding PTSD as New Debilitating Medical Condition Individuals with a diagnosis of post-traumatic stress disorder (PTSD) and for whom a physician has recommended the medical use of marijuana would be able to apply for participation in the Medical Marijuana Registry. Deleting Role of Medical Marijuana Scientific Advisory Council (SAC) in Reviewing Petitions None. Though the SAC cannot be used in its official capacity, the Department may still ask stakeholders for feedback when reviewing a petition to add a debilitating condition. Members of the SAC may be asked to participate in the petition review process in their individual capacity. Colorado Medical Research Grant Program – Procedures and Timelines Applicants responding to requests for applications to the Medical Marijuana Research Grant Program will benefit by being provided more specific timeline information.

2.

To the extent practicable, a description of the probable quantitative and qualitative impact of the proposed rule, economic or otherwise, upon affected classes of persons. Removing the notary requirements Medical Marijuana applicants and patients will no longer incur the burden or cost (approximately $5.00) of obtaining a notary. Minor Technical Cleanup of Regulation 2 These clarifications may assist medical marijuana registry stakeholders when reviewing the rules. Adding PTSD as New Debilitating Medical Condition This proposed rule expands the list of eligible conditions for which an individual can apply for participation in the Medical Marijuana Registry. Thus, the number of applicants may increase as a result of this rule, although by how much is difficult to predict. The application process would be identical for an individual with PTSD as for an individual with any of the other qualifying debilitating medical conditions.

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Deleting Role of Medical Marijuana Scientific Advisory Council in Reviewing Petitions None expected as the department may still seek stakeholder feedback to review petitions and provide input to the Department. Colorado Medical Research Grant Program – Procedures and Timelines None as the specific dates and requirements are part of the grant application process. 3.

The probable costs to the agency and to any other agency of the implementation and enforcement of the proposed rule and any anticipated effect on state revenues. Removing the notary requirements There is a nominal one-time cost to update forms, websites and related MMR resources. Minor Technical Cleanup of Regulation 2 None Adding PTSD as New Debilitating Medical Condition The Medical Marijuana Registry may see an increase in applications with the expansion of the number of qualifying debilitating medical conditions. The Medical Marijuana Registry has no way to estimate how many new applications may be received based upon this change, but anticipates that the application fees will be sufficient to cover the costs of the increased numbers of applications. There is a nominal one-time cost to update forms, websites and related MMR resources. Deleting Role of Medical Marijuana Scientific Advisory Council in Reviewing Petitions None Colorado Medical Research Grant Program – Procedures and Timelines None

4.

A comparison of the probable costs and benefits of the proposed rule to the probable costs and benefits of inaction. Removing the notary requirements These changes provide clarity and simplify the application and renewal processes for Medical Marijuana patients and caregivers, and will save applicants and caregivers the $5 notary fee for each form (application, change of patient record and caregiver acknowledgement) submitted. In addition, a notary signature cannot be captured in the new electronic registry system that is currently under development. Once implemented, the new electronic system will save patients, physicians and caregivers time and postage as applications will be submitted electronically, not via the mail. Minor Technical Cleanup of Regulation 2 The proposed rule modification is necessary to provide clarity and consistency of language and format in Regulation 2.

Adding PTSD as New Debilitating Medical Condition Article XVIII, Section 14 of the Colorado Constitution requires the state health agency responsible for administration of the Medical Marijuana Registry to accept petitions from patients and physicians to add debilitating medical conditions to the list of qualifying debilitating medical conditions for the program, and either approve or deny

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such petitions within 180 days of receipt, and to set a rulemaking hearing if the state health agency deems such hearing to be appropriate. Inaction is not an option as the petition process is delineated in the constitution and statute. Deleting Role of Medical Marijuana Scientific Advisory Council in Reviewing Petitions The proposed rule modification is necessary to address the issue raised by OLLS in their review of Regulation 6. Colorado Medical Research Grant Program – Procedures and Timelines The proposed rule modification is necessary to address the issue raised by OLLS in their review of Regulation 14. 5.

A determination of whether there are less costly methods or less intrusive methods for achieving the purpose of the proposed rule. Removing the notary requirements No. These changes are the least costly and intrusive, as the proposed rule modification simplifies the application and renewal processes, removing the current notary cost and burden to patients and caregivers. Minor Technical Cleanup of Regulation 2 No. The proposed rule modification is necessary to provide clarity and consistency of language and format in Regulation 2. Adding PTSD as New Debilitating Medical Condition Article XVIII, Section 14 of the Colorado Constitution requires the state health agency responsible for administration of the Medical Marijuana Registry to accept petitions from patients and physicians to add debilitating medical conditions to the list of qualifying debilitating medical conditions for the program, and either approve or deny such petitions within 180 days of receipt, and to set a rulemaking hearing if the state health agency deems such hearing to be appropriate. § 25-1.5-106, C.R.S. authorizes the department to administer the Medical Marijuana Registry program and promulgate rules of administration in conformance with state law. The proposed rules add PTSD to the current Medical Marijuana Registry program rules that list all other qualifying debilitating medical conditions. Deleting Role of Medical Marijuana Scientific Advisory Council in Reviewing Petitions No. The proposed rule modification is necessary to address the issue raised by OLLS in their review of Regulation 6. Colorado Medical Research Grant Program – Procedures and Timelines No. The proposed rule modification is necessary to address the issue raised by OLLS in their review of Regulation 14.

6.

Alternative Rules or Alternatives to Rulemaking Considered and Why Rejected. Removing the notary requirements No alternatives to rulemaking were considered as the proposed rule change will simplify the application and renewal processes and reduce cost and burden for Medical Marijuana patients and caregivers. Minor Technical Cleanup of Regulation 2 No alternatives to rulemaking were considered as the proposed rule modification is necessary to provide clarity and consistency of language and format in Regulation 2.

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Adding PTSD as New Debilitating Medical Condition As described above, the rule modification proposed amends the current rule, which lists the qualifying debilitating medical conditions, to add PTSD. Without a rulemaking, the department is unable to amend the list. These rules are authorized by § 25-1.5106, C.R.S. Deleting Role of Medical Marijuana Scientific Advisory Council in Reviewing Petitions There are no alternatives to address the issue raised by OLLS in their review of Regulation 6. Colorado Medical Research Grant Program – Procedures and Timelines There are no alternatives to address the issue raised by OLLS in their review of Regulation 14. 7.

To the extent practicable, a quantification of the data used in the analysis; the analysis must take into account both short-term and long-term consequences. Removing the notary requirements The Department contacted notaries to assess the approximate current cost of $5.00. The requirement of a notary does incur a cost of approximately $5.00, that may be burdensome for some Medical Marijuana patients. This new process allows MMR to verify that the patient is aware of all forms submitted in their name, while eliminating the burden of needing a notary. Adding PTSD as New Debilitating Medical Condition There is one small randomized, placebo controlled, cross-over design study of the clinical efficacy of a synthetic analogue (nabilone) of delta-9 tetrahydrocannbinol (THC – the major cannabinoid in marijuana) in male military personnel with PTSD and treatment-resistant nightmares. Administration of this synthetic THC was well tolerated and effective in reducing PTSD-related nightmares, as well as self-reported PTSD global improvement, but not in improving sleep quality and quantity. The citation for this study is: Jetly R et al, Psychoneuroendocrinology 2015; 51:585-588. There are two less rigorously designed, open-label (i.e., no placebo control) clinical studies of efficacy of either oral THC or the synthetic THC analogue, nabilone, that reported supportive results. The oral THC administration was well tolerated and effective in improving global PTSD symptoms, nightmares and sleep quality. The nabilone administration was generally well tolerated and resulted in lessening of severity or total cessation of treatment-resistant nightmares. The citations for these two studies, respectively, are: Roitman P, et al, Clinical Drug Investigation 2014;34:587-591; and: Fraser G, CNS Neuroscience & Therapeutics 2009;15:84-88. Materials that were reviewed by the Department and the Scientific Advisory Council are available as part of the Scientific Advisory Council April 10, 2015 meeting materials.

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STAKEHOLDER COMMENTS for Amendments to 5 CCR 1006-2, Medical Use of Marijuana The following individuals and/or entities were included in the development of these proposed rules: (Please be specific. Identify your stakeholders with enough specificity the Board has context for the extent of the outreach.) The Medical Marijuana Scientific Advisory Council The following individuals and or/entities were notified that this rule-making was proposed for consideration by the Board of Health: The Medical Marijuana Scientific Advisory Council Medical Marijuana Registry Stakeholders Lists Department of Revenue Colorado Medical Society Colorado Psychiatric Society Colorado Academy of Family Physicians Summarize Major Factual and Policy Issues Encountered and the Stakeholder Feedback Received. If there is a lack of consensus regarding the proposed rule, please also identify the Department’s efforts to address stakeholder feedback or why the Department was unable to accommodate the request. Adding PTSD as New Debilitating Medical Condition We have received feedback from two physician members of the Medical Marijuana Scientific Advisory Council (SAC) opposing the majority recommendation of the SAC. These have been addressed in the cover memo to the Board. To date, we have received no further comments. Please identify health equity and environmental justice (HEEJ) impacts. Does this proposal impact Coloradoans equally or equitably? Does this proposal provide an opportunity to advance HEEJ? Are there other factors that influenced these rules? Removing the Notary Requirement This proposal removes the requirement for a Notary on the Medical Marijuana application resulting in a cost savings for all applicants; however, homebound patients and applicants eligible for the indigence fee waiver may benefit more. Minor Technical Cleanup The proposed rule modification is necessary to provide clarity and consistency of language and format in Regulation 2. Adding PTSD as New Debilitating Medical Condition This proposal serves to establish more equitable access to medical marijuana to both veterans and civilians suffering from PTSD, compared with other groups of Coloradoans with debilitating conditions that are already part of the Medical Marijuana Registry. Persons with PTSD who may currently be self-medicating with recreational marijuana may benefit from easier and more affordable access to marijuana through medical marijuana dispensaries.

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DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT Center for Health and Environmental Data MEDICAL USE OF MARIJUANA 5 CCR 1006-2

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2

Regulation 2: Application for a registry identification card

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A.

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B.

In order to be placed in the registry and to receive a registry identification card, an adult applicant must reside in Colorado and complete an application form supplied by the department, and have such application notarized and signed and include the fee payment. The adult applicant must provide the following information with the application:

In order for a minor applicant to be placed in the registry and to receive a registry identification card, the minor applicant must reside in Colorado and a parent residing in Colorado must consent in writing to serve as the minor applicant’s primary care-giver. Such parent must complete an application form supplied by the department, and have such application notarized, signed and include fee payment. The parent of the minor applicant must provide the following information with the application:

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1.

The applicant’s name, address, date of birth, and social security number;

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2.

Written documentation from two of the applicant’s physicians that the applicant has been diagnosed with a debilitating medical condition as defined in regulation six and each physician’s conclusion that the applicant might benefit from the medical use of marijuana;

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3.

The name, address, and telephone number of the two physicians who have concluded the applicant might benefit from the medical use of marijuana;

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4.

Consent from each of the applicant’s parents residing in Colorado that the applicant may engage in the medical use of marijuana;

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5.

Documentation that one of the physicians referred to in (iii) (3) has explained the possible risks and benefits of medical use of marijuana to the applicant and each of the applicant’s parents residing in Colorado; and

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6.

Indicate if a medical marijuana center has been designated to grow for the patient.

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I.

32 33

Appeals. If the department denies an application or, suspends or, revokes a registry identification card, the department shall provide the applicant/patient with notice of the grounds for the denial, suspension, or revocation, and shall inform the patient of the patient’s right to request a hearing. A request for hearing shall be submitted to the department in writing within thirty (30) calendar days from the date of the postmark on the notice. 1.

If a hearing is requested, the patient shall file an answer within thirty (30) calendar days from the date of the postmark on the notice.

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2.

If a request for a hearing is made, the hearing shall be conducted in accordance with the state STATE Administrative Procedure Procedures Act, § 24-4-101, et seq., C.R.S.

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3.

If the patient does not request a hearing in writing within thirty (30) calendar days from the date of the notice, the patient is deemed to have waived the opportunity for a hearing.

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Regulation 4: Change in applicant information

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A.

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50 51

Regulation 6: Debilitating medical conditions and the process for adding new debilitating medical conditions

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A.

Debilitating medical conditions are defined as cancer, glaucoma, and infection with or positive status for human immunodeficiency virus. Patients undergoing treatment for such conditions are defined as having a debilitating medical condition.

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B.

1.

Debilitating medical condition also includes a chronic or debilitating disease or medical condition other than HIV infection, cancer or glaucoma; or treatment for such conditions, which produces for a specific patient one or more of the following, and for which, in the professional opinion of the patient’s physician, such condition or conditions may reasonably be alleviated by the medical use of marijuana: cachexia; severe pain; severe nausea; seizures, including those that are characteristic of epilepsy; or persistent muscle spasms, including those that are characteristic of multiple sclerosis.

2.

FOR APPLICATIONS RECEIVED BETWEEN SEPTEMBER 14, 2015 AND SEPTEMBER 14, 2019, AN ADDITIONAL DEBILITATING MEDICAL CONDITION FOR WHICH AN APPLICANT MAY APPLY FOR THE MEDICAL MARIJUANA PROGRAM REGISTRY INCLUDES POST-TRAUMATIC STRESS DISORDER (PTSD).

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When there has been a change in the name, address, physician or primary care-giver of a patient who has been issued a registry identification card, that patient must notify the department within ten days by submitting a completed and notarized Change of Address or Care-giver form as prescribed by the Department. A patient who has not designated a primary care-giver at the time of application to the department may do so in writing at any time during the effective period of the registry identification card, and the primary care-giver may act in this capacity after such designation. The Department shall not issue a new registry identification card to the patient on the sole basis of a new or change of primary care-giver.

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C.

Patients who have had a diagnosis of a debilitating medical condition in the past but do not have active disease and are not undergoing treatment for such condition are not suffering from a debilitating medical condition for which the medical use of marijuana is authorized.

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D.

The department shall accept physician or patient petitions to add debilitating medical conditions to the list provided in paragraphs A and B of this regulation, and shall follow the following procedures in reviewing such petitions.

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1.

Receipt of petition; review of medical literature. Upon receipt of a petition, the executive director, or his or her designee, shall review the information submitted in support of the petition and shall also conduct a search of the medical literature for peer-reviewed published literature of randomized controlled trials or well-designed observational studies in humans concerning the use of marijuana for the condition that is the subject of the petition using PUBMED, the official search program for the National Library of Medicine and the National Institutes of Health, and the Cochrane Central Register of Controlled Trials.

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2.

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Department denial of petitions. The department shall deny a petition to add a debilitating medical condition within (180) days of receipt of such petition without any hearing of the board in all of the following circumstances:

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a.

If there are no peer-reviewed published studies of randomized controlled studies nor well-designed observational studies showing efficacy in humans for use of medical marijuana for the condition that is the subject of the petition;

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b.

If there are peer-reviewed published studies of randomized controlled trials or well-designed observational studies showing efficacy in humans for the condition that is the subject of the petition, and if there are studies that show harm, other than harm associated with smoking such as obstructive lung disease or lung cancer, and there are alternative, conventional treatments available for the condition; OR

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c.

If the petition seeks the addition of an underlying condition for which the associated symptoms that are already listed as debilitating medical conditions for which the use of medical marijuana is allowed, such as severe pain, are the reason for which medical marijuana is requested, rather than for improvement of the underlying condition; or.

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d

If a majority of the ad hoc medical advisory panel recommends denial of the petition in accord with paragraph (3) of this section D.

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3.

IF THE CONDITIONS OF DENIAL SET FORTH IN PARAGRAPH (2) ARE NOT MET, THE DEPARTMENT SHALL PETITION THE BOARD WITHIN 90 DAYS OF RECEIPT OF A PETITION FOR A RULEMAKING HEARING TO CONSIDER ADDING THE CONDITION TO THE LIST OF DEBILITATING MEDICAL CONDITIONS.

[This editorial comment is informational and will not be included in the adopted rule: Lines 106-131 have been repealed by the General Assembly through the rule review bill, SB 15-100. The repeal is effective May 15, 2015.] 3.

Medical marijuana scientific advisory council. a.

The medical marijuana scientific advisory council shall perform all of the following duties:

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i.

Objectively evaluate research proposals and provide a peer review process that guards against funding research that is biased in favor or against particular outcomes for proposals submitted for the Colorado medical marijuana research grant program;

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ii.

Provide policy guidance in the creation and implementation of the Colorado medical marijuana research grant program and in scientific oversight and review, and;

116 117

iii.

Review petitions to add a debilitating medical condition to the registry and make a denial or approval recommendation to the department.

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b.

The medical marijuana scientific advisory panel council will review petitions to add debilitating medical conditions if the conditions for denial set forth in paragraphs (2)(A),(B) and (C) of this section d are not met. When reviewing petitions to add debilitating medical conditions to the registry, the ad hoc member of the council may be replaced by an ad hoc physician in the field relevant to the petition. Such individual may be recommended by the petitioner.

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c.

The council shall review the petition information presented to the department and any further medical research related to the condition requested, and make

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recommendations to the executive director, or his or her designee, regarding the petition.

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128 129 130 131 4.

132 133

Within (120) days of receipt of a petition to add a debilitating medical condition, the department shall petition the board for a rulemaking hearing to consider adding the condition to the list of debilitating medical conditions if the council recommends approval of the petition to add the condition.

Final agency action. The following actions are final agency actions, subject to judicial review pursuant to C.R.S. § 24-4-106:

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a.

Department denials of petitions to add debilitating medical conditions.

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b.

Board of health denials of rules proposed by the department to add a condition to the list of debilitating medical conditions for the medical marijuana program

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Regulation 14: Colorado medical research grant program

139

A.

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Procedures for grant application to the grant program 1.

IN ORDER TO ENSURE OBJECTIVITY IN EVALUATING RESEARCH PROPOSALS, THE GRANT PROGRAM SHALL ESTABLISH A SCIENTIFIC ADVISORY COUNCIL (COUNCIL). a.

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THE COUNCIL SHALL PERFORM ALL OF THE FOLLOWING DUTIES:

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i.

PROVIDE POLICY GUIDANCE IN THE CREATION AND IMPLEMENTATION OF THE RESEARCH GRANT PROGRAM AND IN SCIENTIFIC OVERSIGHT AND REVIEW.

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ii.

OBJECTIVELY EVALUATE RESEARCH PROPOSALS AND PROVIDE A PEER REVIEW PROCESS THAT GUARDS AGAINST FUNDING RESEARCH THAT IS BIASED IN FAVOR OF OR AGAINST PARTICULAR OUTCOMES.

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iii.

SUBMIT RECOMMENDATIONS TO THE DEPARTMENT AND THE STATE BOARD OF HEALTH FOR RECOMMENDED GRANT RECIPIENTS, GRANT AMOUNTS, AND GRANT DURATION.

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12.

Grant application contents. a.

At a minimum, all applications shall be submitted to the department in accordance with these rules and shall contain the following information:

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i.

A description of key personnel, including clinicians, scientists, or epidemiologists and support personnel, demonstrating they are adequately trained to conduct this research.

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ii.

Procedures for outreach to patients with various medical conditions who may be suitable participants in research on marijuana.

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iii.

Protocols suitable for research on marijuana as medical treatment including procedures for collecting and analyzing data and statistical methods to be used to assess significant outcomes.

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iv.

Demonstration that appropriate protocols for adequate patient consent and follow-up procedures are in place.

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A process for a grant research proposal approved by the grant program to be reviewed and approved by an institutional review board that is able to approve, monitor, and review biomedical and behavioral research involving human subjects.

[This editorial comment is informational and will not be included in the adopted rule: Line 175 has been repealed by the General Assembly through the rule review bill, SB 15-100. The repeal is effective May 15, 2015.] 23.

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Timelines for grant application.

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Grant applications may be solicited on dates determined by the department.

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a.

ABSENT APPROVAL FROM THE BOARD OF HEALTH, THE DEPARTMENT WILL SEEK APPLICATIONS NO MORE THAN THREE TIMES PER YEAR.

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b.

THE DEPARTMENT WILL NOTIFY PROSPECTIVE APPLICANTS OF THE OPPORTUNITY TO APPLY.

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c.

PROSPECTIVE APPLICANTS WILL HAVE A MINIMUM OF THIRTY DAYS TO APPLY.

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d.

APPLICATIONS WILL BE REVIEWED WITHIN 120 DAYS OF SUBMISSION AND REFERRAL OF RECOMMENDED APPLICATIONS TO THE BOARD OF HEALTH WILL BE WITHIN 180 DAYS OF SUBMISSION.

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