Implementing Chapter 369 of the
Acts of 2012
An Act for Humanitarian Medical
Use of Marijuana
Draft Presentation of 105 CMR 725.000
DPH Medical Marijuana Work Group1
April 10, 2013
CHERYL BARTLETT
INTERIM DEPUTY COMMISSIONER
IYAH ROMM
SPECIAL ADVISOR TO THE COMMISSIONER
PRISCILLA FOX
DEPUTY GENERAL COUNSEL
ALISON MEHLMAN
DEPUTY GENERAL COUNSEL
On Behalf of the DPH Medical Marijuana Work Group
1Cheryl
Bartlett, Alice Byrd, Dr. Madeleine Biondolillo, Julian Cyr, Dr. Alfred DeMaria, Andy
Epstein, Priscilla Fox, Donna Levin, William Luzier, Alison Mehlman, Kara Murray, Jenny
Nathans, Lydie Ultimo, Iyah Romm, Dr. Lauren Smith, & Jay Youmans
1
Agenda
•An Act for the Humanitarian Medical Use of Marijuana
•Public Engagement and Outreach
•Key Policy Decisions
•Detailed Review of Regulations – Integrated Q & A
o
o
o
o
o
Definitions
Individual Registrations
MMTC Registration
MMTC Operations
General Provisions
•Next Steps
2
Overwhelming passage – “Yes” in 349 communities
Lawrence
No: 51%
Yes: 49%
Mendon
No: 51%
Yes: 49%
3
An Act for Humanitarian Medical Use of Marijuana
Does
•Require DPH to promulgate regulations allowing
patients with debilitating medical conditions to
obtain and consume medical marijuana without
state legal penalty;
•Require DPH to define key parameters, including
“bona-fide physician patient relationship,”
“debilitating medical condition,” and “60-day
supply;”
•Allow home-cultivation under specific hardship
parameters;
•Include provisions for caregivers to support
patients using medical marijuana;
•Allow MMTCs (up to 35 in year 1) to grow,
process, and dispense marijuana to qualifying
patients;
•Empower DPH as the authority to oversee all
cultivation, dispensing, sales, and consumption of
marijuana; and
•Gives DPH the authority to make key
programmatic and policy decisions.
Does Not
•
•
•
•
•
•
•
Give immunity under federal law or
obstruct federal enforcement of federal
law;
Supersede MGL prohibiting possession,
cultivation, transport, distribution, or sale
of marijuana for non-medical purposes;
Allow the operation of a motor vehicle,
boat or aircraft while under the influence
of marijuana;
Require any health insurer or government
entity to reimburse any person for the
expenses of the medical use of marijuana;
Require any health care professional to
authorize the use of medical marijuana for
a patient;
Require any accommodation of the
medical use of marijuana in any
workplace, school bus or grounds, youth
center or correctional facility; or
Require any accommodation of smoking
marijuana in any public place.
4
Agenda
•An Act for the Humanitarian Medical Use of Marijuana
•Public Engagement and Outreach
•Key Policy Decisions
•Detailed Review of Regulations – Integrated Q & A
o
o
o
o
o
Definitions
Individual Registrations
MMTC Registration
MMTC Operations
General Provisions
•Next Steps
5
Listening Sessions, Meetings and Written Comment
• Listening Sessions:
o 200+ attendees at each and
150+ testimonials in total
• Stakeholder Meetings:
o More than 65 meetings with
patient advocates, industry
experts, law enforcement,
physicians, elected officials,
municipal leaders, and more.
• Written Comments:
Access
Security/Community
Impact
MMTC Allocation,
Compassionate Use, etc
60-Day Supply
Physician Certification
Local Concerns (e.g.
advertising, landlords)
Bona Fide Relationship
Diversion/IT Tracking
Debilitating Condition,
Hardship Cultivation, Youth
Hardship Cultivation
o Hundreds of written
comments from diverse array
of stakeholders.
Key Themes
6
Summary of Public Response After Regulation Release
“The Department of Public Health has done a thoughtful and responsible job with a difficult task in
proposing regulations to implement the medical marijuana law. DPH has also narrowed the boundaries
of medical conditions and allowed for physician judgment in determining what conditions may qualify
for medical marijuana, and has included use of the Prescription Monitoring Program in certifying
patients. Today’s regulations suggested by the Department of Public Health show clear evidence that
careful consideration was given to what is best for patients, communities, and the Commonwealth.”
- Physician Leader
“DPH is clearly committed to implementing a model program of strictly medical use…from the patient’s
perspective, these draft regulations look mostly positive.”
- Patient Advocate
“In terms of safety and security, Massachusetts has set the new gold standard with their requirement
for oversight from seed to sale, which safely eliminates and prevents diversion and crime… DPH clearly
spent time, energy, resources and a tremendous amount of effort into putting together the best
regulations I have seen in the industry to date. They make it work for everybody, whether they are a
patient, dispensary operator, law enforcement officer or regulator. The regulations proposed will
eliminate opportunity for diversion, and therefore should please and allay fears of the public in general,
city and town officials and law enforcement”
- Industry Expert
While voters overwhelmingly approved the framework for Massachusetts' medical marijuana program
through the ballot in November, the Department of Public Health was tasked with writing regulations to
fill in the details and make the program operational. As a longtime advocate for responsible medical
marijuana legislation in the legislature, I am impressed by the due diligence of DPH to get the job done
right and the comprehensive regulations that have been put forth as a result.
- Legislative Leader
7
Agenda
•An Act for the Humanitarian Medical Use of Marijuana
•Public Engagement and Outreach
•Key Policy Decisions
•Detailed Review of Regulations – Integrated Q & A
o
o
o
o
o
Definitions
Individual Registrations
MMTC Registration
MMTC Operations
General Provisions
•Next Steps
8
Key Policy Decisions
• Stakeholders:
o Evaluated each
stakeholder comment
individually
• Examination of
Other States:
o Reviewed regulations
of all other states
with active or indevelopment medical
marijuana programs
o Specific focus on
regional and model
states:
• CO, CT, NM, NJ,
RI, ME, VT,
9
Advertising
Comment(s) Received Prior to
Issuance of Regulations
•
•
DPH should 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-toconsumer advertising.
Regulation
•
•
DPH proposes limiting advertising,
building signage, and public
communication by MMTCs so as to ensure
appropriate public messaging.
Provisions include prohibition of use of
colloquial terms in naming MMTCs, as well
as prohibiting reference to medical
benefits of marijuana without clear
supporting evidence.
10
Continuing Medical Education
Comment
Regulation
•No specific comments were received
regarding CME, however many stakeholders
indicated concerns regarding lack of physician
education.
•Physician must complete a minimum of 2.0
Category 1 continuing professional education
credits (CMEs) on the subject of medical
marijuana and substance abuse before
certifying a debilitating medical condition.
•Programs must 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.
•These CME events may be online to allow
greater access and ease of use by physicians.
•After January 1, 2014, DPH will require that
registering physicians attest to having
completed a CME course prior to issuing
written certifications of a debilitating medical
condition.
o
o
o
Physicians indicated a lack of comfort with
knowledge of medical marijuana – including
appropriate use and/or misuse
Patients indicated concern for lack of access
that may result from insufficient physicians
comfortable certifying patients for medical
marijuana use
Substance abuse prevention advocates
indicated discomfort with lack of physician
education around potential misuse of product
by patients, including risk factors and
treatment
11
Debilitating Medical Condition
Regulation
Comment
•Largely recommended leaving the
determination of need for medical marijuana
to physician discretion.
•Some stakeholders encouraged clarification
of “debilitating” through a regulatory
definition.
•Numerous patients who benefited from
marijuana have undiagnosed or rare
conditions. Further defining debilitating
conditions may limit access.
•Minor modifications to statutory
definition (in bold)
o 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.
•Further defines debilitating to clarify
intent:
o
“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.”
12
Defining a Bona-Fide Physician-Patient Relationship
Comment
•Nearly all stakeholders stated that DPH
not overregulate the physician-patient
relationship.
•Veterans expressed concern that an
overly restrictive definition, such as one
requiring multiple visits prior to
certification, would impose an access
burden.
•BORiM proposed the following
definition:
o
“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.”
Regulation
•“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.”
•BORiM & DPH enforcement authorities
13
Hardship Cultivation
Comment
Regulation
•Many advocated for strict limitation on home
cultivation, including through all mechanisms
available.
•Many commented that home cultivation is
more expensive and often presents many
more quality assurance challenges than
obtaining product from a MMTC.
•Most commented that hardship cultivation
should be an approach of last resort.
•Many suggested that DPH encourage
“compassionate use programs” in MMTCs.
•Many patients and advocates expressed
significant support for home cultivation, and
encouraged DPH to minimize barriers to
hardship cultivation registrations
•Massachusetts will be the first state to
develop hardship cultivation criteria.
•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. Therefore the following criteria
must be met for a hardship cultivation
registration to be obtained:
o Physical incapacity to access
reasonable transportation
o Verified financial hardship
o Lack of treatment center within a
reasonable distance of the
qualifying patient’s residence or
lack of access to delivery
14
Laboratory Testing
Comment
•
•
•
Consensus that some defined level of
quality assurance testing requirements are
required for MMTCs to ensure safe and
quality product.
Some 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 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).
Regulation
•Describes a required quality assurance and
periodic testing plan in the application for
approval as a treatment center, with DPH to
use responses in evaluating applications.
•Further specifies 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.
15
Municipal Oversight
Comment
Regulation
•Highly varied comment.
•Many (especially larger municipalities) seek
extensive oversight of industry, while many
others favor a model in which state has sole
oversight.
•Several municipalities indicated interest in
collecting fees and acting as designee of state
on local level, especially with regard to food
inspections.
•Landlords and municipal leadership
expressed concern for the liabilities and
impacts associated with medical marijuana.
•Inclusive, but non-burdensome framework
for engaging municipal government. Notably,
no other state’s regulations describe a specific
role for local health.
o
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.).
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.
16
Patient Designation of MMTCs
Comment
•
Limited comment was received on patient
designation.
Regulation
•A qualifying patient must designate one
MMTC (unless applying for a hardship
cultivation registration).
•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, cutting down on waste
and diversion, while allowing for critical seedto-sale tracking.
•A qualifying patient may designate a MMTC
once in a 120-day period with notification to
DPH.
•No limit on the number of patients who can
designate a single center.
17
Personal Caregivers
Comment
Regulation
•Highly varied comment regarding models
of MMTC infrastructure and registrations
included discussion of personal caregivers
as a cottage industry – cultivating in co-ops
on behalf of many patients.
•Little testimony focused directly on the
characteristics of personal caregivers.
•At least twenty-one (21) years old who assists
with a qualifying patient’s medical use of
marijuana, and is not the qualifying patient’s
physician.
•Except in the case of a healthcare worker, a
caregiver may only serve one patient.
•A qualifying patient may have up to two
caregivers.
o
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.
18
Youth Access
Comment
•Significant concern about direct and indirect
impacts of this program on youth.
•Pediatric experts commented that those
under 18 years of age should be restricted
from accessing medical marijuana.
o
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 and DPH should pursue the
allowance of youth use in one of two models:
o
o
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.
Regulation
•Restrictive model for access to those under
18 years of age. No state prohibits youth
access.
•Two physicians must certify the patient’s
debilitating medical condition, at least one of
whom must be a board-certified pediatrician.
Parental/guardian consent is required prior to
youth registration and parent must serve as
caregiver. Youth access is restricted to only
those youth with a life-limiting illness.
o 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.
19
60-Day Supply
Comment
•Highly varied recommendations were
received (as little as 3 to 4 oz. to as much as 24
oz.).
•Consistent comment was made that the 60day supply was intended to be definition for
possession.
•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 and that patients’ needs will diverge
further given the varied methods of
consumption
•Some stakeholders recommended broad
physician discretion while others advocated
for a specific, regulated cap.
•DPH should allow 30-days dispensing at any
given time consistent with narcotics.
Regulation
•Allows 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 or dispensed at a given time.
•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 time indicated in
the certification.
•Physician may over-ride 10 ounce limit for
acutely ill patients.
20
Agenda
•An Act for the Humanitarian Medical Use of Marijuana
•Public Engagement and Outreach
•Key Policy Decisions
•Detailed Review of Regulations – Integrated Q & A
o
o
o
o
o
Definitions
Individual Registrations
MMTC Registration
MMTC Operations
General Provisions
•Next Steps
21
Key Definitions – In Review – 725.004
•
Bona Fide Physician-Patient Relationship means a relationship between a certifying 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.
•
Debilitating Medical Condition means cancer, glaucoma, positive status for human immunodeficiency virus
(HIV), acquired immune deficiency syndrome (AIDS), hepatitis C, amyotrophic lateral sclerosis (ALS),
Crohn’s disease, Parkinson’s disease, and multiple sclerosis (MS), when such diseases are debilitating, and
other debilitating conditions as determined in writing by a qualifying patient’s certifying physician.
o
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.
•
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.
•
Massachusetts Resident means a person whose primary residence is located in Massachusetts.
•
Medical Marijuana Treatment Center (MMTC) means a not-for-profit entity registered under 105 CMR
725.000, that acquires, cultivates, possesses (including development of related products such as edible
MIPs, tinctures, aerosols, oils, or ointments), processes, transfers, transports, sells, distributes, dispenses,
or administers marijuana, products containing marijuana, related supplies, or educational materials to
registered qualifying patients or their personal caregivers who have designated such entity as the patient’s
registered MMTC. Unless otherwise specified, MMTC refers to the site(s) of dispensing, cultivation, and
preparation of any marijuana products, including MIPs, if any.
22
Agenda
•An Act for the Humanitarian Medical Use of Marijuana
•Public Engagement and Outreach
•Key Policy Decisions
•Detailed Review of Regulations – Integrated Q & A
o
o
o
o
o
Definitions
Individual Registrations
MMTC Registration
MMTC Operations
General Provisions
•Next Steps
23
Registration of Certifying Physicians – 725.005
• Physician must hold an active full license, with no prescribing
restriction, to practice medicine in Massachusetts and an
MCSR.
• Physician submits simple documentation to the IT system and
is automatically enrolled.
• Registration is indefinite unless:
o Physician’s license is suspended, revoked, or restricted with regard to prescribing, or the
physician has voluntarily agreed not to practice medicine;
o MCSR is suspended or revoked;
o Physician fraudulently issues a written certification of a debilitating medical condition;
o Physician has certified a qualifying patient for a debilitating medical condition on or after
January 1, 2014, without appropriate completion of CME
• Ongoing responsibility to notify DPH of change in information
– lack of notification is grounds for action against registration
to certify patients – MCSR not implicated.
• BORiM and DPH enforcement authorities
24
Issuing a Written Certification – 725.010
• After January 1, 2014, physician must have previously completed 2.0
hours of category 1 CME.
• Physician must comply with pertinent licensure standards.
• Delegation is prohibited and a bona-fide relationship is required.
• PMP must be used prior to certifying a patient to review prescription and
MMJ history.
• Patient without active disease may not be certified.
• Initial certifications may not be issued without an office visit (including
history, physical exam, risks/benefits, etc).
• Certification ranges from 15 days – 1 year. 60 day supply is automatic
unless specified.
o
o
Allowable amount of substance dispensed tied to length of certification
Physician override
• Examination of patients at MMTCs is prohibited as are any financial or
otherwise beneficial relationships between MD and MMTC.
• Self-certification is prohibited and certification of co-workers/family
members must comply with all regulations.
• Certifying youth requires two physicians, at least one of whom is a board
certified pediatrician.
o
o
Required parental/guardian consent and parent must serve as caregiver
Life limiting illness
25
Registration of Qualifying Patients – 725.015
• Patient submits requisite documentation (including photo ID and
designated MMTC) to IT system.
• Includes written acknowledgement of the limitations on his or her
authorization to cultivate, possess, and use marijuana for medical
purposes in the Commonwealth and an attestation that the patient will
not engage in diversion.
• Registration is valid for 5 years – note distinct from certification period.
• Patients using MMJ prior to effective date of regulations must apply to
DPH by January 1, 2014.
• Ongoing notification requirements to DPH.
• Patient may change designated MMTC once in a 120-day period.
26
Registration of Personal Caregivers – 725.020
•
Patient submits requisite documentation (including photo ID) to IT system on
behalf of caregiver – even if caregiver is a HCW, requisite attestations and
acknowledgement of limitations as for registering patients, and indicates
whether caregiver will be cultivating.
•
Caregivers in place prior to effective date of regulations must apply to DPH by
January 1, 2014.
•
Caregiver may serve only one patient – waiver process for co-located
individuals or parents.
o
No such limit for health care workers.
•
Each patient may have two caregivers – but only one may cultivate.
•
Caregiver may not receive payment or other compensation for services
rendered as a personal caregiver – HCWs may not be compensated beyond
normal wages.
•
Registration valid for five years.
•
Ongoing notification requirements.
27
Responsibilities of Personal Caregivers – 725.025
May
•
•
•
•
•
Transport a patient to and from a
MMTC;
Obtain and transport marijuana on
behalf of a patient;
Cultivate marijuana on behalf of a
patient who has obtained a hardship
cultivation registration;
Prepare marijuana for consumption by
a patient; and
Administer marijuana to a patient.
May Not
•
•
•
•
Consume marijuana that has been
dispensed to or cultivated on behalf of a
patient;
Sell or otherwise divert marijuana;
Cultivate marijuana for personal use; or
Provide marijuana to anyone other than
the patient.
28
Registration of Dispensary Agents – 725.030
• All individuals associated with an MMTC, including volunteers, must
be registered as dispensary agents.
• Dispensary agents must be 21yo and not have been convicted of a
felony drug offense.
o A recent CORI must be submitted for each DA applicant
• Registration is tied to an MMTC not the individual and upon
severance of that relationship, the dispensary agent registration is
void – immediate notification is required.
• Annual renewal is required, including annual CORI – may be paid for
by individual or the MMTC.
• Ongoing notification requirement.
29
Hardship Cultivation Registration – 725.035
•
Individual must have:
o
o
o
o
o
Verified financial hardship (<133% FPL, on SSI, or receives MassHealth); or
Physical incapacity to access reasonable transportation, as demonstrated by an inability to use public transportation
or drive oneself, lack of a personal caregiver with a reliable source of transportation, and lack of a MMTC that will
deliver marijuana to the patient’s or personal caregiver’s primary address; or
Lack of a MMTC within a reasonable distance of the patient’s residence and lack of a MMTC that will deliver
marijuana to the patient’s or personal caregiver’s primary address.
Clear demonstration of lack of feasible alternatives.
Written explanation of ability to meet regulatory requirements
•
Individual may only cultivate at one location, or have one caregiver cultivate at
one location.
•
Hardship cultivation registration must be annually renewed, irrespective of
certification or registration status.
•
Cultivation may only be so much as to support personal use.
•
Cultivation and storage must be in a secure, enclosed, locked area accessible
only to the patient or personal caregiver and cannot be visible from the street
or other public areas.
•
Ongoing notification requirements, and requirement to register by January 1,
2014 if previously cultivating.
30
Agenda
•An Act for the Humanitarian Medical Use of Marijuana
•Public Engagement and Outreach
•Key Policy Decisions
•Detailed Review of Regulations – Integrated Q & A
o
o
o
o
o
Definitions
Individual Registrations
MMTC Registration
MMTC Operations
General Provisions
•Next Steps
31
Registration of MMTCs (General) – 725.100
• No more than three MMTCs may be owned or controlled directly or
indirectly by the same entity, or by any executive, or by any other entity
owned or controlled by one or more of such executives.
• Each MMTC:
o
o
o
o
Must incorporate as a non-profit pursuant to MGL c180.
Must make vaporizers available for sale
May cultivate only at one site – either colocated with dispensary or freestanding – not both.
Must have a program to provide reduced cost or free marijuana
• All officers, executives, and board members of a MMTC must be registered
as dispensary agents.
• Prohibition on:
o
o
o
Sales or distribution of product except to registered qualifying patients
Free samples
Internet/mail ordering,
• Ongoing required (appropriate) access to DPH, law enforcement,
emergency responders, etc.
• Comprehensive incident reporting requirements, including 24 hour
notification where necessary.
• Criminal and regulatory compliance history are important factors of
review.
32
Registration of MMTCs (Phase 1 Application) – 725.100
• Upon DPH publication of Notice of Application Opportunity,
entity must submit:
o Documentation of non-profit status as incorporated in MA
o Documentation of $500,000 in escrow
o Documentation that no officer, director, or board member of the entity, and no
prospective employee or volunteer of the MMTC, has been convicted of a felony drug
offense;
o A description of any legal or regulatory enforcement actions in another state against any
related entity regarding cultivation, processing, distribution, or sale of medical
marijuana;
o An attestation signed that the entity is prepared to pay a non-refundable application fee
if selected to advance to Phase 2;
o Application fee;
o A description of the proposed location for the MMTC; and
o Any other information required by the Department.
33
Registration of MMTCs (Phase 2 Application) – 725.100
• Comprehensive application, including but not limited to:
o
o
o
o
o
o
o
o
o
o
Evidence of local support or non-opposition.
Non-refundable fee
Legal details of entity (articles of incorporation, etc) and proposed MMTC location(s), including
guarantee that cultivation of, or sale of, marijuana is permissible on the property
Evidence of sufficient interest in the property (ownership, 5 year lease, etc)
Evidence of compliance with ADA and local codes/ordinances/regulations
Evidence that MMTC can begin operations within 120 days (that is, growth can begin within 120
days of receipt of registration)
Detailed policies, procedures, and legal documents such as list of creditors, insurance policies, etc
An analysis of the projected patient population and projected need in the service area of the
proposed MMTC
Details of dispensary agent training curricula
Evidence of meeting detailed suitability criteria, including experience running a non-profit
organization or other business and history of providing medical marijuana services or other health
care services, including provision of services in other states.
• Review of Applications will be Merit Based:
o
o
o
Developing Explicit Criteria – e.g. demonstrated expertise, municipal support (or lack thereof)
Application review process to ensure transparency & limit challenges
Clear communication & expectation setting regarding process and timeline
34
Agenda
•An Act for the Humanitarian Medical Use of Marijuana
•Public Engagement and Outreach
•Key Policy Decisions
•Detailed Review of Regulations – Integrated Q & A
o
o
o
o
o
Definitions
Individual Registrations
MMTC Registration
MMTC Operations
General Provisions
•Next Steps
35
MMTCs Operational Requirements (General) – 725.105
• Policies, Procedures, and Protocols:
o Must be maintained on site, including but not limited to security, quality, cultivation,
inventory, staffing, emergency response, confidentiality/privacy, and patient education.
• Cultivation:
o Cultivation, production of MIPs, and dispensing may occur only in one location – each MMTC
may have up to two sites.
o Cultivation must adhere to USDA Organic Standards.
• Lab Testing:
o MMTC must test for contaminants and have protocols for responding to issues.
o Testing info must be on product labels.
• Food Products:
o Must be prepared consistent with 105 CMR 500.000: Good Manufacturing Practices for Food,
and with the requirements for food handlers specified in 105 CMR 300.000: Reportable
Diseases, Surveillance, and Isolation and Quarantine Requirements.
• Detailed Sanitary and Storage Requirements
o Describes specific requirements for DAs consistent with health care and food preparation.
o Storage includes requirements for adequate security, lighting, ventilation, temperature,
humidity, space, equipment, and separation of soiled products.
36
MMTCs Packaging & Labeling Requirements – 725.105
• Labels must include the following information:
o
o
o
o
o
o
Patient and MMTC info
Quantity of usable marijuana (and leaf-form equivalent)
Date of packaging
Key identifiers such as batch and lot numbers
Testing information
THC level
• Opaque packaging and storage
• Labels must also include this statement: “This product has not
been analyzed or approved by the FDA. There is limited
information on the side effects of using this product, and
there may be associated health risks. Do not drive or operate
machinery when under the influence of this product. KEEP
THIS PRODUCT AWAY FROM CHILDREN.”
37
MMTCs Inventory, Record Keeping & Waste – 725.105
• Seed-to-sale tracking/inventory is required at all times,
including pre-destruction waste.
• Detailed record-keeping requirements are specified, similar to
health care facilities, including destruction records and postclosure maintenance.
• Liquid waste must be disposed of consistent with DEP
requirements.
• Solid waste must be disposed of through witnessed
incineration.
o MMTCs must accept unused, excess, or waste product from any patient or caregiver and
dispose of it accordingly.
38
MMTC Patient Education and Advertising – 725.105
• Detailed patient education requirements are instituted –
including on use, abuse, waste disposal, storage, etc.
o Appropriate literacy level and language accessibility
• Advertising and marketing are significantly limited, including:
o Medical symbols, images of marijuana, related paraphernalia, and colloquial references
to cannabis and marijuana are prohibited from use in logos
o Limits on external signage, including no advertising, price listing, or graphics
o Prohibition on visible products from exterior of MMTCs
o Prohibition on sales or gifting of novelty items bearing reference to marijuana
o Prohibition on encouraging recreational or youth use in advertising.
39
MMTC Security and Transportation – 725.105
• Extensive security requirements, including:
o
o
o
o
o
o
Established limited access areas
Comprehensive alarm systems (silent/duress/hold-up alarm or automatic voice dialer)
Surveillance cameras
Safes/vaults
Routine inspection (every 30 days) of all security systems
Annual contracted evaluation of security systems by DPH approved vendor
• Extensive transportation requirements, including:
o Weighing, inventorying, and accounting for all product
• Documenting and reporting discrepancies
o Shipping manifests
o Transportation in secure, locked compartment in secured, unmarked vehicle
o Two DAs present at all times (may be contracted vendor with additional security
personnel present)
o Open lines of communication at all times
40
Inspection and Enforcement – 725.300-510
• DPH may inspect a MMTC at any time without prior notice. All areas
of a MMTC, all dispensary agents and activities, and all records are
subject to such inspection. DPH may direct a MMTC to test
marijuana or MIPs for contaminants in addition to routine testing.
o Unannounced Inspections
• Standard DPH protocols for Statements of Deficiency and Plans of
Correction are adopted in these regulations.
• Detailed grounds are established in these regulations for:
o Denial of MMTC initial application
o Denial of MMTC renewal application and MMTC registration revocation
• Including ability for DPH to restrict sales by an MMTC during a disciplinary process
o Denial, void, or revocation of registration cards or hardship cultivation registration
o Summary cease and desist and quarantine order
o Summary suspension order
• Hearing requirements and rights are established consistent with
MGL c30A, including due process for appeals.
41
Municipal Requirements – 725.600
• A MMTC and other registered persons must comply with all
local rules, regulations, ordinances, and bylaws.
• DPH does not mandate any involvement by municipalities or
local boards of health in the regulation of MMTCs, qualifying
patients with hardship cultivation registrations, or any other
aspects of medical marijuana.
• Nothing in these regulations prohibits appropriate, lawful
local oversight and regulation, including fee requirements,
that does not conflict or interfere with these regulations.
42
Agenda
•An Act for the Humanitarian Medical Use of Marijuana
•Public Engagement and Outreach
•Key Policy Decisions
•Detailed Review of Regulations – Integrated Q & A
o
o
o
o
o
Definitions
Individual Registrations
MMTC Registration
MMTC Operations
General Provisions
•Next Steps
43
Confidentiality – 725.200
• Information held by the Department about applicants for
registration as a qualifying patient, personal caregiver, or
dispensary agent, and registered qualifying patients, personal
caregivers, and dispensary agents is exempt from public records
requests and may only be released by the Department to:
o The data subject or the data subject’s authorized representative, pursuant to M.G.L. c. 66A;
o Department staff for the purpose of carrying out their official duties with regard to the
medical marijuana program;
o An individual or entity pursuant to an order from a court of competent jurisdiction;
o Law enforcement personnel for the sole purpose of verifying a cardholder’s registration and
certification; and
o The Board of Registration in Medicine when necessary in connection with referrals to said
Board concerning violations of 105 CMR 725.000.
• Applications, supporting information, and other information
regarding a MMTC are not confidential except relating to patients or
caregivers.
• Information held by a MMTC about registered qualifying patients
and personal caregivers is confidential and shall not be disclosed
without the written consent except to the Department.
44
Waivers – 725.700
• The Commissioner or designee may waive one or more of the
requirements imposed by 105 CMR 725.000 upon finding
that:
o Compliance would cause undue hardship to the registrant;
o Non-compliance does not jeopardize the health or safety of any patient or the public;
o The registrant has instituted compensating features that are acceptable to the
Department; and
o The registrant provides to the Commissioner written documentation supporting its
request for a waiver.
• Given the complexity and magnitude of this regulation, DPH
intends to use this waiver provision – consistent with hospital
licensure regulations – for unforeseen circumstances, which in
repetition, would lead to regulatory changes.
45
Agenda
•An Act for the Humanitarian Medical Use of Marijuana
•Public Engagement and Outreach
•Key Policy Decisions
•Detailed Review of Regulations – Integrated Q & A
o
o
o
o
o
Definitions
Individual Registrations
MMTC Registration
MMTC Operations
General Provisions
•Next Steps
46
Next Steps
• On April 19, 2013 DPH will hold three public hearings in Plymouth,
Boston, and Northampton to receive further comment on the
proposed regulations.
• DPH will accept written comment until 5pm on April 20, 2013.
o Mail postmarked by 5pm will be accepted.
• 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.
• The draft regulations will be released to council prior to the May 8
meeting for review – they will not be released publicly at that time.
47
Ongoing Information System Development
• Core Functions
o Register the treatment centers and all of their employees who will have to
undergo CORI checks;
o Register the thousands of patients and caregivers who will need to supply
substantial personally identification information;
o Connect and mesh with the PMP system (or equivalent function) so that we can
track potential problematic use;
o Allow 24/7 access to police and other public safety officials to verify that an
individual can possess marijuana under this law;
o Allow real time updates of registration information, selection of caregivers,
selection of treatment centers;
o Track data and perform analytics so we can properly oversee this new industry
and allow us to detect any fraud or abuse;
o Have appropriate security and access limitations to protect
sensitive/confidential information.
48
Revenue Neutrality – Programmatic Domains and
Approaches
• Fee Setting – Separate Process Beginning in the Coming
Weeks
o MMTCs
• Multiphasic
o Application and annualized registration
o Individuals
• Patients – at cost of annualized registration workflows
• Caregivers – free
• Physicians – free
• Evaluation
49
Registering MMTCs – Dispensary Review and Selection
• Merit Based:
o Developing Explicit Criteria – e.g. demonstrated expertise, municipal support (or lack thereof)
o Model to Ensure Transparency & Limit Challenges
o Public Communication & Expectation Setting
• Competitive Application Process – Beginning in Summer and
Continuing into the Autumn:
• Phase 1 – Qualifications
• Phase 2 – Full Applications
• Phase 3 – Registration Processes/Inspection/Operations
• Key Themes:
o Model to Ensure Geographic Allocation
o Low-Income Access Programs and Emphasis on Delivery
o Preferential Selection of Massachusetts Residents, Women, Veterans, and Minorities
50
Public Education and Outreach
• Dual and potentially competing messages regarding medical
marijuana use and substance abuse prevention
• Messaging focused on preventing potential increase in youth
use – supported by advertising provisions.
• Planning ongoing for public awareness campaigns before
MMTCs open – also supported by advertising provisions.
51
On Behalf of the DPH Medical Marijuana Work Group
•
•
•
•
•
•
•
•
•
Interim Commissioner Dr. Lauren Smith
Cheryl Bartlett – Commissioner’s Office
Alice Byrd – Commissioner’s Office
Dr. Madeleine Biondolillo – Bureau of
Health Care Safety and Quality
Julian Cyr – Bureau of Environmental
Health
Dr. Al DeMaria – Bureau of Infectious
Diseases
Andy Epstein – Commissioner’s Office
Priscilla Fox – Office of the General
Counsel
Donna Levin - Office of the General
Counsel
•
•
•
•
•
•
•
William Luzier – Interagency Council on
Substance Abuse and Prevention
Alison Mehlman – Office of the General
Counsel
Kara Murray - Bureau of Health Care
Safety and Quality
Jenny Nathans – Bureau of Health Care
Safety and Quality
Lydie Ultimo – Bureau of Substance
Abuse Services
Iyah Romm – Commissioner’s Office
Jay Youmans – Commissioner’s Office
Thank You
52