Interim Commissioner Lauren Smith and Members of the Public Health Council

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1 The Commonwealth of Massachusetts Executive Office of Health and Human Services Department of Public Health 250 Washington Street, Boston, MA DEVAL L. PATRICK GOVERNOR TIMOTHY P. MURRAY LIEUTENANT GOVERNOR JOHN W. POLANOWICZ SECRETARY LAUREN A. SMITH, MD, MPH INTERIM COMMISSIONER Tel: Fax: TO: Interim Commissioner Lauren Smith and Members of the Public Health Council FROM: DPH Medical Marijuana Work Group 1 DATE: April 10, 2013 RE: Informational Briefing on Proposed Regulations at 105 CMR : Implementation of An Act for Humanitarian Medical Use of Marijuana (Chapter 369 of the Acts of 2012) INTRODUCTION The purpose of this memorandum is to inform the Council of a proposed new regulation: 105 CMR , Implementation of An Act for Humanitarian Medical Use of Marijuana. The proposed regulation implements requirements enacted in Chapter 369 of the Acts of BACKGROUND On November 6, 2012, Ballot Question 3, An Initiative Petition for a Law for Humanitarian Medical Use of Marijuana passed with a 63.3% vote (and with a majority in 349 of 351 communities), making Massachusetts the 18 th state in the nation in addition to the District of Columbia to approve the use of medical marijuana. This measure, now Chapter 369 of the Acts of 2012 (the Act), became law on January 1, 2013 and allows qualifying patients with certain defined medical conditions or debilitating symptoms to obtain and use marijuana for medicinal use. Additionally, the law requires DPH to issue regulations providing critical implementation and policy framework by May Chapter 369 eliminates state criminal and civil penalties for the medical use of marijuana by qualifying patients. In order to qualify, a patient must have been diagnosed with a debilitating medical condition as defined in the statute 2 and have obtained a written certification from a physician with whom the patient has a bona fide physician-patient relationship. This certification must 1 DPH Medical Marijuana Work Group: Cheryl Bartlett, Alice Byrd, Dr. Madeleine Biondolillo, Julian Cyr, Dr. Alfred DeMaria, Andy Epstein, Priscilla Fox, Donna Levin, Alison Mehlman, Kara Murray, Jenny Nathans, Lydie Ultimo, Iyah Romm, Dr. Lauren Smith, and Jay Youmans. 2 [C]ancer, glaucoma, AIDS or HIV, Hepatitis C, ALS, Crohn s disease, Parkinson s disease, Multiple Sclerosis, and other conditions as determined in writing by a qualifying patient s physician. Draft Regulation Last Modified

2 state the patient s specific debilitating medical condition and symptoms, and that the potential benefits of the medical use of marijuana outweigh any associated health risks for the patient. The law allows a patient to possess up to a 60-day supply of marijuana for his or her personal use, with DPH to define said quantity and the process through regulation. 3 A patient may designate a personal caregiver to assist the patient s use of medical marijuana; however, the designated caregiver must be at least 21 years old and have registered as a caregiver with DPH. The caregiver, under statute, is prohibited from consuming that supply of medical marijuana. A qualifying patient who has verified financial hardship, a physical inability to access reasonable transportation, or the lack of a treatment center within a reasonable distance of the patient s residence may obtain a hardship cultivation registration from DPH. This allows the patient or caregiver to cultivate only enough plants in a enclosed, locked facility (as defined by regulations) to maintain a 60-day supply of marijuana for the patient s personal use (known as home-cultivation or the hardship waiver ). DPH will seek to minimize the need for homecultivation through stringent caregiver provisions, incentivized compassion programs or low- or no-cost means tested programs at dispensaries, as well as allowing home delivery by treatment centers (i.e. courier system). Chapter 369 allows medical marijuana treatment centers (MMTCs) to cultivate, process and provide medical marijuana to patients or their caregivers. A treatment center must be a nonprofit and apply for a DPH registration by complying with several mandates that include paying a fee, identifying a location with up to one additional cultivation location, and submitting operating procedures to DPH that include cultivation and storage of marijuana only in enclosed and locked facilities. 4 A treatment center s personnel, known as dispensary agents, must register with DPH prior to working or volunteering at a center. Dispensary agents must be at least 21 years of age and have no prior felony drug convictions 5. In calendar year 2013, DPH may register up to 35 treatment centers statewide, with a minimum of one but no more than five centers per county. This number can be modified by DPH in later years. DPH may revoke any registration card for a willful violation of the law. Fraudulent use of a registration card or cultivation registration is a crime punishable by up to 6- months in a house of correction. However, if the fraudulent use was for the sale, distribution or trafficking of marijuana for non-medical use for profit, it is a crime punishable by up to five years in state prison or by two and one-half years in a house of correction. The law does not: 1. Give immunity under federal law or obstruct federal enforcement of federal law; 2. Supersede MGL prohibiting possession, cultivation, transport, distribution, or sale of marijuana for non-medical purposes; 3 DPH and key stakeholders interpret this definition of a 60-day supply to specifically refer to possession, and not to address the patient-specific, clinically appropriate quantity, which is left to the physician. This 60-day supply may be overcome with evidence of a particular qualifying patient s appropriate medical use. 4 Per Chapter 369, DPH must set application fees for the centers so as to defray administrative and regulatory costs of the program and make the law revenue neutral. 5 Per Chapter 369, a CORI check of these employees must be done. Draft Regulation Last Modified

3 3. Allow the operation of a motor vehicle, boat or aircraft while under the influence of marijuana; 4. Require any health insurer or government entity to reimburse any person for the expenses of the medical use of marijuana; 5. Require any health care professional to authorize the use of medical marijuana for a patient; 6. Require any accommodation of the medical use of marijuana in any workplace, school bus or grounds, youth center or correctional facility; or 7. Require any accommodation of smoking marijuana in any public place. Beginning on January 1, 2013, and continuing until the approval and issuance of final DPH regulations, written certification by a physician will constitute a registration card for a qualifying patient. Similarly, until issuance of final regulations, a certified mail return receipt showing compliance with section 12(A)(2)(b) of the Act by a qualifying patient, and a photocopy of the patient s application, will constitute a registration card for that patient s personal caregiver. Additionally, until DPH issues final regulations, the written recommendation of a qualifying patient s physician will constitute a limited cultivation registration; however, limited is not defined. Finally, until final regulations are published, the law allows the qualifying patient to cultivate his or her own supply of marijuana and does not tie this to DPH approval of the 60-day supply limitation. As a practical matter, many aspects of these interim provisions will have to remain in effect even after the final regulations are promulgated, due to the time needed to bring the licensed and approved MMTCs into operation. Chapter 369 clearly codifies that criminal penalties for non-medical uses of marijuana remain in place, with the law simply exempting persons in compliance with the Act from penalties under state law. The law does not purport to give immunity for violations of federal law. Efforts have been made to project statewide need and demand. Although experiences in Colorado, among other states, demonstrates that high acuity conditions represent only a modest proportion of overall patient use, there were 37,049 invasive cancers of all types diagnosed among Massachusetts residents in As of December 2011, there are 18,170 individuals living with HIV or AIDS in Massachusetts. There are approximately 5,000 residents in the Commonwealth living with multiple sclerosis (MS), 600 with amyotrophic lateral sclerosis (ALS), and 100,000 with Hepatitis C. In Colorado, two percent of the total population is registered in Massachusetts that rate would yield 132,000 registrants. 7 PUBLIC ENGAGEMENT AND COMMENTS On February 13, 14, and 27, 2013, the Department conducted listening sessions in Worcester, Boston, and Holyoke respectively. These sessions provided DPH the opportunity to engage a wide-array of stakeholders and content leaders prior to issuance of draft regulations, including legislators, patient-advocates, nationally-recognized dispensaries, prevention advocates, leading clinician and physician groups, municipal leadership, and law enforcement, all while actively learning from other states experiences. During these well-attended events (200+ attendees at each session), the public shared a range of ideas on how to shape the developing program. DPH has been actively soliciting input from these interested parties in shaping these regulations in an effort to put in place a system that is right for Massachusetts, ensuring both 6 Massachusetts Community Health Information Profile (MassCHIP) 7 Colorado Family Physicians' Attitudes Toward Medical Marijuana, Journal of the American Board of Family Medicine, Draft Regulation Last Modified

4 appropriate access, as well as safe communities. It remains clear that Massachusetts success is contingent upon a tight regulatory scheme and industry and patients both agree. In addition to more than a total of 150 testimonials at the three listening sessions, with more than 600 attendees in total, DPH received 68 letters from individual stakeholders, as well as written comments from 16 organizations. Additionally, DPH staff has met with more than 20 organizations individually, as well as engaged legislative leadership. Received testimony covered a wide range of topics, and ranged from high-level policy concerns to detailed comments about program development and individual registration. DPH heard recurrent themes regarding access, product quality, ensuring appropriate use among minors, 60-day supply, definition and dynamics of a physician-patient relationship, definitions and parameters of debilitating medical conditions, as well as municipal oversight concerns. The public also expressed concerns regarding security, advertising, home-cultivation and cost. Many suggested a single, centralized, tightly controlled cultivation facility with distribution statewide to maximize security and product quality. Authors of the ballot initiative have been generally opposed to a centralized cultivation model due to significant concerns that federal law enforcement agencies will specifically target a facility of the necessary size to provide broad supply. The testimony received as of March 8, 2013 is summarized in the attached spreadsheet entitled MMJ Public Commentary The testimony and feedback is summarized at a high-level as follows: 60-DAY SUPPLY: Highly varied recommendations were received on defining a 60-day supply (e.g. as little as 3 to 4 oz. to as much as 24 oz.). A clear theme from the drafters of the ballot initiative was that the 60-day supply was intended to be solely for the purposes of identifying an amount for appropriate, legal possession and is expected to vary from patient to patient. Many commented that there is no known history of overdose, therefore a margin of safety is believed to exist. Many commented that severely debilitated patients or those with acute illnesses will consume significantly greater quantities than patients with more intermittent and moderate needs. Additionally, many noted that patients needs will diverge further given the varied methods of consumption, with more product required for an appropriate medical outcome via ingestion versus smoking or vaporization. Some stakeholders recommended broad physician discretion while others advocated for a specific, regulated cap. Comments were also received recommending that DPH only allow 30-days dispensing at any given time in order to be consistent with prescriptions for narcotics. PRODUCT QUALITY AND SAFETY TESTING: Generally, stakeholders provided consensus that some defined level of quality assurance testing requirements are required for MMTCs to ensure safe and quality product. Some stakeholders recommended in-house testing at MMTCs, while others voiced concern that given the nascent marketplace, regulations should not be so specific as to prohibit integration of technological advances over time within the regulatory framework. Nearly all those discussing this subject recommended testing for mold and other contaminants, such as heavy metals, as a requirement, while a subset recommended strain genotyping and potency testing (i.e. THC levels). BONA-FIDE PHYSICIAN-PATIENT RELATIONSHIP: Nearly all stakeholders that commented on this domain recommended that DPH not overregulate the physician-patient relationship. Veterans receiving health care services from federally employed physicians expressed concern that an Draft Regulation Last Modified

5 overly restrictive definition, such as one requiring multiple visits prior to certification, would impose an access burden due to Veterans Affairs (VA) physicians being prohibited from recommending medical marijuana. Accordingly, veterans will be required to seek recommendations from physicians outside the VA system. The Board of Registration in Medicine (BORiM) proposed the following definition: Bona Fide Physician Patient Relationship means a relationship between a physician, acting in the usual course of his or her professional practice, and a patient in which the physician has completed and documented a full assessment of the patient's medical history and current medical condition, including a physical and mental status examination, and has responsibility for the ongoing care and treatment of the patient. 8 SECURITY/DIVERSION PROTECTION/IT TRACKING: A vast majority of stakeholders, including those represented at the public listening sessions, legislators, industry, and law enforcement personnel, have expressed significant concern regarding diversion and community security. Many commented that the regulatory framework should: 1) mandate seed-to-sale tracking of all products, 2) include comprehensive and detailed requirements for security of MMTCs (including transportation of marijuana), 3) require extensive home security for those selfcultivating, 4) include provisions for a comprehensive, interoperable database allowing communication between the MMTCs, physicians, regulators, and law enforcement personnel, 5) allow comprehensive access to law enforcement as needed, and 6) include medical marijuana in the Prescription Monitoring Program (PMP) to facilitate tracking and surveillance of medical marijuana dispensing patterns and use. Some recommended that zoning/planning at the municipal level be used to restrict placement of MMTCs within communities. Law enforcement additionally expressed concern that competition between MMTCs for market share could have the effect of driving down the price of product on the black market. This in turn would have the unintended consequence of saturating communities with lower-cost marijuana. Law enforcement asked that DPH consider these impacts in drafting regulations regarding the cost of product. MMTCS AND PHYSICIAN CERTIFICATION: Many stakeholders weighed in on issues relating to local governance, profit-sharing, and oversight. Across the Commonwealth, comments suggested that DPH should require Massachusetts residency for owners of MMTCs, and that with the expected influx of out-of-state businesses, at a minimum, those with experience doing business locally should be given some level of priority. There has been near unanimous feedback that certifying physicians should have Massachusetts licensure. Where many states have approached allocation of MMTC registrations through a lottery model, there was near unanimity in recommending that DPH select registrants based on specific and explicit merit-based criteria to ensure the capacity of the registrant to comply with the necessary quality, access, security, and safety requirements. HARDSHIP CULTIVATION: Home cultivation under a hardship cultivation registration, and local oversight/authority are clearly the two issues of greatest concern to municipal leadership, real estate and landowner associations, and law enforcement. In regards to hardship cultivation, many, including the drafters of the referendum, advocated for strict limitation on home cultivation, including through all mechanisms available. Many commented that home cultivation is more expensive 9 and often presents many more quality assurance challenges than obtaining 8 Notably the BORiM definition was modified and served as the basis for DPH s proposed definition of bona-fide physician-patient relationship. 9 Some patients testified that a primary reason to grow at home was the economic barrier of purchasing from a MMTC. Numerous MMTCs and advocates noted that this is an erroneous belief and that home cultivation is in fact more expensive than purchasing finished product. Draft Regulation Last Modified

6 product from a MMTC. Most commented including the drafters of the initiative that hardship cultivation should be an approach of last resort. Given concerns about financial inability to procure marijuana, many suggested that DPH encourage compassionate use programs in MMTCs. This program would provide some proportion of a MMTC s product to be sold at low- or no-cost to those patients that meet certain, defined state-recognized means criteria. ADVERTISING/COMMUNICATIONS: Comments were received (including from industry) recommending that DPH limit advertising, building signage, and public communication by MMTCs so as to ensure appropriate public messaging. Recommendations included prohibiting use of colloquial terms in naming MMTCs, as well as a prohibition on direct-to-consumer advertising. DEBILITATING MEDICAL CONDITIONS: Nearly all comments received on debilitating medical conditions recommended leaving the determination of need for medical marijuana to physician discretion. A few stakeholders encouraged clarification of debilitating through a regulatory definition. Almost all agree that rather than further defining or expanding eligibility by codifying other conditions that may be viewed as debilitating, physician discretion should be allowed with emphasis on debilitating symptoms (using the example of an asymptomatic HIV patient). DPH heard from numerous patients who benefited from marijuana who had undiagnosed or rare conditions, but who experienced debilitating symptoms. There was the indication that by further defining debilitating conditions, the unintended consequence might be limiting access for a large portion of the population that may find this treatment to be most appropriate. PROTECTION OF YOUTH: Many stakeholders expressed significant concern about direct and indirect impacts of this program on youth. Many pediatric experts (primary care, youth substance abuse treatment, pain management), including the Massachusetts Chapter of the American Academy of Pediatrics, testified or provided comment that those under 18 years of age should be restricted from accessing medical marijuana, and that significant corresponding education campaigns should be developed to prevent youth use given the mixed messages inherent in sanctioning the use of marijuana in some circumstances but not others and the evidence that youth use has increased in states with medical marijuana programs. The pediatric concerns primarily relate to a lack of evidence of efficacy in minors and evidence of a deleterious effect of marijuana on the developing brains of children and youth. Others commented that age restrictions were not consistent with the intent of the ballot measure; however, that DPH should pursue the allowance of youth use in one of two models: 1) only allowing physician certification of youth with life-limiting illness, but prohibiting use for chronic illnesses including pain and ADHD, or 2) allowing youth use but only with parental consent and certification by two physicians independent from one another. While there has been broad physician, substance abuse prevention, and law enforcement feedback to restrict the use of medical marijuana to those 18 or older, drafters of the ballot initiative have stated that placing age restrictions would be strongly opposed by their advocacy community. LOCAL/PROPERTY OWNER CONCERNS: DPH received comments from landlords and municipal leadership expressing concern for the liabilities and impacts associated with medical marijuana. Concerns ranged from the use of smoke-able forms of marijuana in non-smoking spaces (both rented residences and public spaces), to the federal liabilities of cultivating or using product in federally subsidized housing or programs (i.e. HUD housing, federally funded programs such as veterans homes, hospitals, substance programs, etc.). Landlords also expressed concerns regarding the difficulty of determining if a tenant was authorized to possess or cultivate marijuana and the potential for damage to their property if a tenant established a personal cultivation area. Draft Regulation Last Modified

7 SUMMARY OF KEY POLICY RECOMMENDATIONS In addition to receiving extensive public feedback, DPH conducted a comprehensive state-bystate review of key policy issues. After reviewing the regulatory frameworks of all 18 existing or proposed programs (17 states and the District of Columbia), staff built a cross-walk of key issues with seven comparative states five from areas surrounding Massachusetts (Connecticut, Maine, New Jersey, Rhode Island, and Vermont) and two model western states (Colorado and New Mexico). Continuing Medical Education (CME): DPH recommends that a physician must complete a minimum of 2.0 Category 1 continuing professional education credits (CMEs) on the subject of medical marijuana before certifying a debilitating medical condition and recommending the potential benefits for use of medical marijuana. To ensure access, implementation of this requirement should be delayed for at least six months after promulgation of regulations. DPH will work with BORiM and the Massachusetts Medical Society (MMS) to determine the most appropriate length of delay. Programs should be planned and implemented by an organization accredited by the Accreditation Council for Continuing Medical Education (ACCME), American Osteopathic Association, American Academy of Family Physicians, or a state medical society recognized by the ACCME. DPH envisions that these CME events may be online to allow greater access and ease of use by physicians. The session shall include an explanation of the proper use of marijuana, including contraindications, side effects, and dosage, and shall also include information on substance abuse recognition, diagnosis, and treatment related to marijuana. DPH will require that registering physicians attest to having completed a CME course prior to registration. Debilitating Medical Condition: DPH recommends adopting the statutory language as is for debilitating medical condition with minor modifications (bolded) 10 but further defining debilitating as follows: Debilitating means causing weakness, cachexia/wasting syndrome, intractable pain, or nausea, or impairing strength or ability, and progressing to such an extent that one or more major life activities are substantially limited. 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. Defining a 60-Day Supply: DPH recommends allowing up to 10 ounces of finished product in leaf form (or equivalent) as a 60-day supply for the purposes of defining a maximum amount of medical marijuana that can legally be possessed at a given time. This amount of supply is based on a review and comparison of dispensing across states as well as stakeholder feedback. DPH proposes describing only a cap so that the certifying physician can use his or her best judgment in describing the needs of his/her individual patient. DPH further recommends that a physician s certification for a debilitating condition must indicate the time period for which such certification is valid; however, this physician determination may not exceed one year. The amount of medical marijuana that a patient may be dispensed would be in direct proportion to the period of 10 Debilitating Medical Condition means cancer, glaucoma, positive status for human immunodeficiency virus, acquired immune deficiency syndrome (AIDS), hepatitis C, amyotrophic lateral sclerosis (ALS), Crohn s disease, Parkinson s disease, and multiple sclerosis when such diseases are debilitating, and other debilitating conditions as determined in writing by a qualifying patient s physician. Draft Regulation Last Modified

8 time indicated in the certification; up to 10 ounces for a 60-day supply (e.g. certification for six days would allow dispensation of up to one ounce). Defining a Bona-Fide Physician-Patient Relationship: Based upon the framework provided by BORiM, DPH recommends the following definition: Bona Fide Patient Relationship means a relationship between a physician, acting in the usual course of his or her professional practice, and a patient in which the physician has conducted a clinical visit, completed and documented a full assessment of the patient s medical history and current medical condition, has explained the potential benefits and risks of marijuana use, and has a role in the ongoing care and treatment of the patient. Fees: DPH will develop a fee framework upon finalization of a projected budget. DPH, EHS, ANF, and the Administration have finalized a timeline for fee promulgation, with a preliminary budget and fee framework anticipated to be ready for release shortly. Based upon models identified in other states, all fees will be annualized and will be developed to ensure budget neutrality. MMTC fees will provide the primary source of revenue in order to comply with the Act s provision that the law be revenue neutral. The final fee proposal will be announced for public comment in a parallel process to regulation comment the time for comment on fees is expected to be late spring. Hardship Cultivation: Those states that allow home cultivation permit patients to select this approach without additional administrative process. A patient s ability to cultivate at home is not dependent on financial, physical, or geographic hardship in those states. Massachusetts will be the first state to develop such criteria and this approach is reflective of the broad concerns shared by patients and advocacy organizations, as well as law enforcement and municipal leadership. In order to avoid the diversion and security complications associated with widespread home cultivation, DPH intends to minimize hardship cultivation by optimizing access through a variety of approaches, including: 1) mandating the provision of low-income subsidies at all MMTCs, 2) allowing secure home delivery where necessary, and 3) encouraging personal caregivers to pick up product in lieu of cultivation. DPH therefore recommends the following criteria and definitions: Ø Physical incapacity to access reasonable transportation: An inability to use public transportation or drive oneself, lack of a personal caregiver with a reliable source of transportation, and lack of access to a MMTC that will deliver medical marijuana to the patient s or personal caregiver s primary address. Ø Verified financial hardship: A patient who submits satisfactory evidence of being a recipient of MassHealth, Supplemental Security Income, or the applicant s income does not exceed 133% of the federal poverty line, adjusted for family size. Ø Lack of treatment center within a reasonable distance of the qualifying patient s residence: Lacks access to a treatment center within a reasonable distance from the qualifying patient s residence, and does not have a MMTC that will deliver medical marijuana to the patient s or personal caregiver s primary address. Ø Laboratory Testing: While a clear need has been articulated, because there are as yet no established, widely accepted, and available tests for medical marijuana, DPH recommends requiring a quality assurance and periodic testing plan in the application for Draft Regulation Last Modified

9 approval as a treatment center, and DPH will use responses in evaluating applications. DPH further recommends specifying a requirement that the MMTC must test for contaminants as specified by the Department, including at least pests, mold, mildew, heavy metals and the presence of pesticides, while including provisions such that the Department may require additional testing without regulatory change. Ø Municipal Oversight: Recognizing the highly varied interest in regulating medical marijuana at the local level, DPH has developed an inclusive, but non-burdensome framework for engaging municipal government. Notably, no other state s regulations describe a specific role for local health. DPH thus recommends the following: o o o DPH has responsibility for the medical marijuana program throughout the state, including registration of individuals and MMTCs, inspection of MMTCs, enforcement, etc. It should be noted that involvement, partnership, or in some cases, the possibility of potential leadership of these efforts will be determined through sub-regulatory guidance and on an individual basis. DPH will not mandate any local involvement. Local governments, including boards of health, would be authorized to pass local regulations that do not conflict with state law, such as local zoning regulations, local fees, etc. Patient Designation of Medical Marijuana Treatment Centers: DPH recommends that when applying for or renewing a registration card, a qualifying patient must provide the name, address and telephone number of the medical marijuana treatment center (MMTC) from which the qualifying patient or his or her primary caregiver will purchase medical marijuana, unless the qualifying patient will be applying for a hardship cultivation registration. A qualifying patient shall designate only one MMTC. Limiting a patient to one MMTC would give MMTCs the ability plan for and cultivate an appropriate number of marijuana plants for their patients needs. This will cut down on waste and diversion, while allowing for critical seed-to-sale tracking. A qualifying patient may then change his or her designated MMTC once in a 120-day period with notification to DPH. 11 MMTCs must then limit their inventory of seeds, plants, and useable marijuana to reflect current patient needs as identified by the number of patients registered with the MMTC. There should not be a limit on the number of patients who can designate a single center. Personal Caregivers: Personal caregiver means a person who is at least twenty-one (21) years old who has agreed to assist with a qualifying patient s medical use of marijuana, and is not the qualifying patient s physician. An employee of a hospice provider, nursing, or medical facility providing care to a qualifying patient may serve as a personal caregiver. DPH recommends that except in the case of an employee of a hospice, nursing facility, or medical facility providing care to a qualifying patient, a caregiver may only serve one patient. A qualifying patient may have up to two caregivers. However, only one of the two personal caregivers may cultivate marijuana on behalf of the qualifying patient if said patient has obtained a hardship cultivation registration days, or four months, is the average growth cycle for a marijuana plant. Requiring the patient to stay at one MMTC for a growth cycle would allow MMTCs to plan for and grow the appropriate number of marijuana plants for their patient s needs. This would cut down on wastage and diversion and allow for seed-to-sale tracking. Draft Regulation Last Modified

10 Youth Access: Recognizing the significant concerns of the pediatric community, DPH proposes a more restrictive model for access to those under 18 years of age. Notably, no other state prohibits youth access, despite the fact that the national American Academy of Pediatrics opposes the use of marijuana in children and youth. DPH proposes that for youth seeking medical marijuana, two physicians must certify the patient s debilitating medical condition, at least one of whom must be a board-certified pediatrician. Additionally, parental consent should be required prior to youth registration. Finally, given concerns for long-term impacts of medical marijuana on normal neurological development, DPH proposes that youth access be restricted to only those youth with a life-limiting illness. 12 Advertising/Communications: DPH proposes limiting advertising, building signage, and public communication by MMTCs so as to ensure appropriate public messaging. This includes prohibiting use of colloquial terms in naming MMTCs, as well as prohibiting reference to medical benefits of marijuana without clear supporting evidence. SUMMARY OF OPERATIONAL NEEDS The Department is also in the process of identifying the program s operational needs, including analyzing necessary technology infrastructure. DPH anticipates the development of an online system for functions such as registration, fee collection, and auditing of patient eligibility, as well as integrating medical marijuana into the existing Prescription Monitoring Program (PMP). Developing and executing a rigorous and appropriately transparent procurement process, hiring staff, training inspectors, obtaining bridge funds, and implementing a plan for security and diversion prevention remain critical pre-roll out tasks that are intrinsically linked to the final production and enactment of the state s regulations. Prior to final promulgation of regulations, it is critical that a timeline for developing the infrastructure to support access to medical marijuana is available to stakeholders so that expectations for registration of patients, caregivers, and MMTCs are clearly established. Due to a lack of start-up resources provided by the ballot measure, the medical marijuana program is currently being developed with the existing expertise of an internal DPH team, including the DPH Medical Marijuana Work Group. Longitudinally, the program will be maintained through fees on participants once qualifying patients, personal caregivers, providers, and treatment centers are registered. PROCEDURAL NEXT STEPS SUMMARY The public comment period will run from March 29 through April 20. On April 19, 2013 DPH will hold three public hearings in Plymouth, Boston, and Northampton to receive further comment on the proposed regulations. Following the comment period, Department staff will return to the Council on May 8, 2013 to provide a review of the testimony, to present any changes proposed in response to the testimony, and to request approval for promulgation of the regulation. 12 Life-Limiting Illness means a debilitating medical condition that does not respond to curative treatments, where reasonable estimates of prognosis suggest death may occur within six months. Draft Regulation Last Modified